Contents
1. Name#
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (November Update) Instrument 2026.
(2)This instrument may also be cited as PB 126 of 2026.
2. Commencement#
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement Information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 November 2026 | 1 November 2026 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3. Authority#
This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
4. Schedules#
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
[1] Schedule 1, Part 1, after entry for Abiraterone in the form Tablet containing abiraterone acetate 250 mg [Brand: ABIRATERONE VIATRIS]
insert:
| Abiraterone | Tablet containing abiraterone acetate 250 mg | Oral | ABURA | VM | MP NP | C17873 | 120 | 2 | 120 |
[2] Schedule 1, Part 1, after entry for Abiraterone in the form Tablet containing abiraterone acetate 500 mg [Brand: ABIRATERONE VIATRIS]
insert:
| Abiraterone | Tablet containing abiraterone acetate 500 mg | Oral | ABURA | VM | MP NP | C17873 | 60 | 2 | 60 |
[3] Schedule 1, Part 1, after entry for Acarbose in the form Tablet 50 mg [Brand: GLYBOSAY; Maximum Quantity: 180; Number of Repeats: 5]
insert:
| Acarbose | Tablet 50 mg (S19A) | Oral | Acarbose 50 mg tablets (Morningside Healthcare, UK) | LM | MP NP | 90 | 5 | 90 | |||||
| Acarbose | Tablet 50 mg (S19A) | Oral | Acarbose 50 mg tablets (Morningside Healthcare, UK) | LM | MP NP | P14238 | 180 | 5 | 90 |
[4] Schedule 1, Part 1, after entry for Acarbose in the form Tablet 100 mg [Brand: GLYBOSAY; Maximum Quantity: 180; Number of Repeats: 5]
insert:
| Acarbose | Tablet 100 mg (S19A) | Oral | Acarbose 100 mg tablets (Morningside Healthcare, UK) | LM | MP NP | 90 | 5 | 90 | |||||
| Acarbose | Tablet 100 mg (S19A) | Oral | Acarbose 100 mg tablets (Morningside Healthcare, UK) | LM | MP NP | P14238 | 180 | 5 | 90 |
[5] Schedule 1, Part 1, after entry for Aclidinium with formoterol [Maximum Quantity: 2; Number of Repeats: 5]
insert:
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C15473 C18989 | P15473 P18989 | 2 | 0 | 1 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C12120 C17707 C17713 C17717 C17719 C17733 C17734 | See Note 3 | See Note 3 | See Note 3 | 1 | C(100) | ||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C16982 C17031 C17032 C17077 C17715 C17731 C18966 C18967 C18968 | P16982 P17031 P17032 P17077 P17715 P17731 P18966 P18967 P18968 | 2 | 3 | 1 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C17005 C17042 C17043 C17044 C17045 C17046 | P17005 P17042 P17043 P17044 P17045 P17046 | 2 | 4 | 1 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C15445 C15446 C16991 C16993 C16999 C17002 C17003 C17030 C17065 C17730 C17736 C18991 | P15445 P15446 P16991 P16993 P16999 P17002 P17003 P17030 P17065 P17730 P17736 P18991 | 2 | 5 | 1 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Amgevita | AN | MP | C15474 C15489 | P15474 P15489 | 2 | 6 | 1 |
[6] Schedule 1, Part 1, after entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 6]
insert:
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C15473 C18989 | P15473 P18989 | 2 | 0 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C12120 C17707 C17713 C17717 C17719 C17733 C17734 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C16982 C17031 C17032 C17077 C18767 C18813 C18814 C18815 C18966 C18967 C18968 C19106 C19115 C19149 | P16982 P17031 P17032 P17077 P18767 P18813 P18814 P18815 P18966 P18967 P18968 P19106 P19115 P19149 | 2 | 2 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C9064 C12174 C13650 C13694 C14496 C14568 C14590 C14655 C14662 C14670 C14672 C14673 C16414 C17715 C17731 C18534 C18549 C18550 C18557 C18562 C18584 C18593 C18604 | P9064 P12174 P13650 P13694 P14496 P14568 P14590 P14655 P14662 P14670 P14672 P14673 P16414 P17715 P17731 P18534 P18549 P18550 P18557 P18562 P18584 P18593 P18604 | 2 | 3 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C17005 C17042 C17043 C17044 C17045 C17046 C18535 C18540 C18543 C18544 C18545 C18587 C18590 | P17005 P17042 P17043 P17044 P17045 P17046 P18535 P18540 P18543 P18544 P18545 P18587 P18590 | 2 | 4 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C11523 C11604 C11606 C11635 C11865 C11867 C11906 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C16725 C16991 C16993 C16999 C17002 C17003 C17030 C17065 C17730 C17736 C18537 C18538 C18542 C18547 C18552 C18594 C18631 C18669 C18721 C18771 C18991 C19157 C19158 C19174 | P11523 P11604 P11606 P11635 P11865 P11867 P11906 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P16725 P16991 P16993 P16999 P17002 P17003 P17030 P17065 P17730 P17736 P18537 P18538 P18542 P18547 P18552 P18594 P18631 P18669 P18721 P18771 P18991 P19157 P19158 P19174 | 2 | 5 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C15474 C15489 | P15474 P15489 | 2 | 6 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C15788 | P15788 | 4 | 2 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C11529 C17620 C17663 | P11529 P17620 P17663 | 4 | 5 | 2 | |||
| Adalimumab | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Amgevita | AN | MP | C16982 C17031 C17032 C17077 C17587 C17617 C17679 C18767 C18813 C18814 C18815 C18966 C18967 C18968 C19106 C19115 C19149 | P16982 P17031 P17032 P17077 P17587 P17617 P17679 P18767 P18813 P18814 P18815 P18966 P18967 P18968 P19106 P19115 P19149 | 6 | 0 | 2 |
[7] Schedule 1, Part 1, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]
insert:
| Adalimumab | Injection 80 mg in 0.8 mL pre-filled pen | Injection | Amgevita | AN | MP | C18535 C18540 C18543 C18544 C18545 C18587 | P18535 P18540 P18543 P18544 P18545 P18587 | 1 | 0 | 1 | |||
| Adalimumab | Injection 80 mg in 0.8 mL pre-filled pen | Injection | Amgevita | AN | MP | C15788 | P15788 | 2 | 2 | 1 | |||
| Adalimumab | Injection 80 mg in 0.8 mL pre-filled pen | Injection | Amgevita | AN | MP | C11529 C17620 C17663 | P11529 P17620 P17663 | 2 | 5 | 1 | |||
| Adalimumab | Injection 80 mg in 0.8 mL pre-filled pen | Injection | Amgevita | AN | MP | C17031 C17032 C17077 C17587 C17617 C17679 C18813 C18814 C18815 C18966 C18967 C18968 C19106 C19115 | P17031 P17032 P17077 P17587 P17617 P17679 P18813 P18814 P18815 P18966 P18967 P18968 P19106 P19115 | 3 | 0 | 1 |
[8] Schedule 1, Part 1, after entry for Albendazole in the form Tablet 400 mg
insert:
| Albendazole | Tablet 400 mg (s19A) | Oral | Albendazole (Micro Labs, Germany) | DZ | MP | C5607 | 60 | 2 | 60 |
[9] Schedule 1, Part 1, entries for Aripiprazole in the form Tablet 30 mg
omit:
| Aripiprazole | Tablet 30 mg | Oral | ARIPIPRAZOLE-WGR | WG | MP NP | C4246 | 30 | 5 | 30 |
[10] Schedule 1, Part 1, entries for Benzathine benzylpenicillin
substitute:
| Benzathine benzylpenicillin | Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe | Injection | Bicillin L-A | PF | MP MW NP PDP | 10 | 0 | 10 | |||||
| Benzathine benzylpenicillin | Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe | Injection | Bicillin L-A | PF | MP MW NP PDP | 10 | 0 | 10 | |||||
| Benzathine benzylpenicillin | Powder for injection 1,200,000 units (s19A) | Injection | Benzylpenicillin benzathine (Brancaster Pharma, UK) | QY | MP MW NP PDP | 10 | 0 | 1 | |||||
| Benzathine benzylpenicillin | Powder for injection 1,200,000 units with diluent 4 mL (S19A) | Injection | Lentocilin S 1200 (Portugal) | NG | MP MW NP PDP | 10 | 0 | 1 | |||||
| Benzathine benzylpenicillin | Powder for injection 1,200,000 units with diluent 4 mL (Spain) (s19A) | Injection | Benzetacil (Spain) | KQ | MP MW NP PDP | 10 | 0 | 1 |
[11] Schedule 1, Part 1, entry for Brentuximab vedotin
(a) omit from the column headed “Circumstances”: C17757
(b) insert in numerical order in the column headed “Circumstances”: C19460
(c) insert in the column headed “Variations”: V19460
[12] Schedule 1, Part 1, entries for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
substitute:
| Budesonide with formoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | Symbicort Turbuhaler 100/6 | AP | MP NP | C4380 | P4380 | 1 | 5 | 1 | |||
| Budesonide with formoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | Symbicort Turbuhaler 100/6 | AP | MP | C10538 | P10538 | 1 | 5 | 1 | |||
| Budesonide with formoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | Symbicort Turbuhaler 100/6 | AP | MP NP | C15755 | P15755 | 2 | 5 | 1 | |||
| Budesonide with formoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | Symbicort Turbuhaler 100/6 | AP | MP | C15577 | P15577 | 2 | 5 | 1 |
[13] Schedule 1, Part 1, entries for Carbomer
omit from the column headed “Authorised Prescriber” (all instances): MP NP AO substitute (all instances): AO MP NP
[14] Schedule 1, Part 1, entries for Carmellose
omit from the column headed “Authorised Prescriber” (all instances): MP NP AO substitute (all instances): AO MP NP
[15] Schedule 1, Part 1, entry for Ciclosporin in the form Solution concentrate for I.V. infusion 50 mg in 1 mL
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C6628 C9831 substitute: C19424 C19503
[16] Schedule 1, Part 1, entries for Clozapine
substitute:
| Clozapine | Oral liquid 50 mg per mL, 100 mL | Oral | Clopine Suspension | DU | MP NP | C19470 | 1 | 0 | 1 | D(100) | |||
| Clozapine | Oral liquid 50 mg per mL, 100 mL | Oral | Clopine Suspension | DU | MP | C5015 C9490 | 1 | 0 | 1 | D(100) | |||
| Clozapine | Oral liquid 50 mg per mL, 100 mL | Oral | Versacloz | DU | MP NP | C19507 | 1 | 0 | 1 | D(100) | |||
| Clozapine | Oral liquid 50 mg per mL, 100 mL | Oral | Versacloz | DU | MP | C5015 C9490 | 1 | 0 | 1 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clopine 25 | DU | MP NP | C19469 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clopine 25 | DU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clozaril 25 | GO | MP NP | C19469 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clozaril 25 | GO | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clozitor | JU | MP NP | C19469 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 25 mg | Oral | Clozitor | JU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 50 mg | Oral | Clopine 50 | DU | MP NP | C19290 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 50 mg | Oral | Clopine 50 | DU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 50 mg | Oral | Clozitor | JU | MP NP | C19290 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 50 mg | Oral | Clozitor | JU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clopine 100 | DU | MP NP | C19467 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clopine 100 | DU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clozaril 100 | GO | MP NP | C19467 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clozaril 100 | GO | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clozitor | JU | MP NP | C19467 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 100 mg | Oral | Clozitor | JU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 200 mg | Oral | Clopine 200 | DU | MP NP | C19429 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 200 mg | Oral | Clopine 200 | DU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 200 mg | Oral | Clozitor | JU | MP NP | C19429 | 200 | 0 | 100 | D(100) | |||
| Clozapine | Tablet 200 mg | Oral | Clozitor | JU | MP | C5015 C9490 | 200 | 0 | 100 | D(100) |
[17] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 1 g (NorthStar, USA) (s19A)
insert:
| Cyclophosphamide | Powder for injection 1 g (Seacross Pharmaceuticals, UK) (s19A) | Injection | Cyclophosphamide (Seacross Pharmaceuticals, UK) | RQ | MP | See Note 3 | See Note 3 | 1 | PB(100) |
[18] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 2 g (Sagent, USA) (s19A)
insert:
| Cyclophosphamide | Powder for injection 2 g (Seacross Pharmaceuticals, UK) (s19A) | Injection | Cyclophosphamide (Seacross Pharmaceuticals, UK) | RQ | MP | See Note 3 | See Note 3 | 1 | PB(100) |
[19] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 20 mg [Brand: Dasatinib Viatris; Authorised Prescriber: MP]
insert:
| Dasatinib | Tablet 20 mg | Oral | MSN Dasatinib | VM | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | MSN Dasatinib | VM | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | MSN Dasatinib | VM | MP | C19223 | P19223 | 60 | 5 | 60 |
[20] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 50 mg [Brand: Dasatinib Viatris; Authorised Prescriber: MP]
insert:
| Dasatinib | Tablet 50 mg | Oral | MSN Dasatinib | VM | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | MSN Dasatinib | VM | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | MSN Dasatinib | VM | MP | C19223 | P19223 | 60 | 5 | 60 |
[21] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 70 mg [Brand: Dasatinib Viatris; Authorised Prescriber: MP]
insert:
| Dasatinib | Tablet 70 mg | Oral | MSN Dasatinib | VM | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | MSN Dasatinib | VM | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | MSN Dasatinib | VM | MP | C19223 | P19223 | 60 | 5 | 60 |
[22] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 100 mg [Brand: Dasatinib Viatris; Authorised Prescriber: MP]
insert:
| Dasatinib | Tablet 100 mg | Oral | MSN Dasatinib | VM | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | MSN Dasatinib | VM | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | MSN Dasatinib | VM | MP | C19223 | P19223 | 30 | 5 | 30 |
[23] Schedule 1, Part 1, entries for Deferasirox
substitute:
| Deferasirox | Tablet 90 mg | Oral | DEFERAMED | DZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | DEFERAMED | DZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Deferasirox ARX | XT | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Deferasirox ARX | XT | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Eferas | AF | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Eferas | AF | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Jadenu | NM | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Jadenu | NM | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 90 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | DEFERAMED | DZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | DEFERAMED | DZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Deferasirox ARX | XT | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Deferasirox ARX | XT | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Eferas | AF | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Eferas | AF | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Jadenu | NM | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Jadenu | NM | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 180 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | DEFERAMED | DZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | DEFERAMED | DZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox ARX | XT | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox ARX | XT | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox FCT MSN | VM | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox FCT MSN | VM | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Deferasirox Sandoz | SZ | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | DEFERASIROX-TEVA | TB | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Eferas | AF | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Eferas | AF | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Jadenu | NM | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Jadenu | NM | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 180 | 2 | 30 | D(100) | ||
| Deferasirox | Tablet 360 mg | Oral | Pharmacor Deferasirox FC | CR | MP NP | C19312 C19318 | P19312 P19318 | 180 | 5 | 30 | D(100) | ||
| Deferasirox | Tablet, dispersible, 125 mg | Oral | Deferasirox Juno | JU | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 168 | 2 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 125 mg | Oral | Deferasirox Juno | JU | MP NP | C19312 C19318 | P19312 P19318 | 168 | 5 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 250 mg | Oral | Deferasirox Juno | JU | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 168 | 2 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 250 mg | Oral | Deferasirox Juno | JU | MP NP | C19312 C19318 | P19312 P19318 | 168 | 5 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 500 mg | Oral | Deferasirox Juno | JU | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 168 | 2 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 500 mg | Oral | Deferasirox Juno | JU | MP NP | C19312 C19318 | P19312 P19318 | 168 | 5 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 500 mg | Oral | Pharmacor Deferasirox | CR | MP NP | C19286 C19311 C19375 C19384 C19386 C19439 C19506 | P19286 P19311 P19375 P19384 P19386 P19439 P19506 | 168 | 2 | 28 | D(100) | ||
| Deferasirox | Tablet, dispersible, 500 mg | Oral | Pharmacor Deferasirox | CR | MP NP | C19312 C19318 | P19312 P19318 | 168 | 5 | 28 | D(100) |
[24] Schedule 1, Part 1, entries for Deferiprone in each of the forms Oral solution 100 mg per mL, 250 mL; and Tablet 500 mg
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C6403 C6448 C9228 C9286 substitute: C19310 C19436 C19437 C19492
[25] Schedule 1, Part 1, entry for Deferiprone in the form Tablet 1000 mg
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C6403 C6448 C9590 C9623 substitute: C19310 C19436 C19437 C19492
[26] Schedule 1, Part 1, entries for Desferrioxamine
(a) omit from the column headed “Authorised Prescriber” (all instances): MP substitute (all instances): MP NP
(b) omit from the column headed “Circumstances” (all instances): C6394 C9696 substitute (all instances): C19476 C19477
[27] Schedule 1, Part 1, entry for Dornase alfa
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C5634 C5635 C5740 C9591 C9592 C9624 substitute: C19378 C19432 C19546 C19554 C19559 C19563
[28] Schedule 1, Part 1, entry for Elafibranor [Authorised Prescriber: MP NP]
omit from the column headed “Circumstances”: C17567
[29] Schedule 1, Part 1, entries for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor
substitute:
| Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor | Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg | Oral | Trikafta | VR | MP NP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor | Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg | Oral | Trikafta | VR | MP NP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor | Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg | Oral | Trikafta | VR | MP NP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor | Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg | Oral | Trikafta | VR | MP NP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
[30] Schedule 1, Part 1, after entry for Eplerenone in the form Tablet 25 mg [Brand: APO-Eplerenone; Maximum Quantity: 60; Number of Repeats: 5]
insert:
| Eplerenone | Tablet 25 mg | Oral | Eplerenone Viatris | AL | MP NP | C18461 | P18461 | 30 | 5 | 30 | |||
| Eplerenone | Tablet 25 mg | Oral | Eplerenone Viatris | AL | MP NP | C18337 | P18337 | 60 | 5 | 30 |
[31] Schedule 1, Part 1, after entry for Evolocumab [Maximum Quantity: 3; Number of Repeats: 5]
insert:
| Evolocumab | Injection 140 mg in 1 mL single use pre-filled pen | Injection | Repatha | AN | MP NP | C19514 C19523 | P19514 P19523 | 4 | 5 | 1 | |||
| Evolocumab | Injection 140 mg in 1 mL single use pre-filled pen | Injection | Repatha | AN | MP NP | C19418 | P19418 | 6 | 5 | 1 |
[32] Schedule 1, Part 1, after entry for Ezetimibe [Brand: Ezetimibe Sandoz; Maximum Quantity: 60; Number of Repeats: 5]
insert:
| Ezetimibe | Tablet 10 mg | Oral | Ezetimibe Viatris | MQ | MP NP | 30 | 5 | 30 | |||||
| Ezetimibe | Tablet 10 mg | Oral | Ezetimibe Viatris | MQ | MP NP | P14238 | 60 | 5 | 30 |
[33] Schedule 1, Part 1, entries for Filgrastim
substitute:
| Filgrastim | Injection 120 micrograms in 0.2 mL single-use pre-filled syringe | Injection | Nivestim | PF | MP NP | C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447 | 20 | 11 | 10 | D(100) | |||
| Filgrastim | Injection 300 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Nivestim | PF | MP NP | C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447 | 20 | 11 | 10 | D(100) | |||
| Filgrastim | Injection 300 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Zarzio | SZ | MP NP | C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447 | 20 | 11 | 5 | D(100) | |||
| Filgrastim | Injection 480 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Nivestim | PF | MP NP | C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447 | 20 | 11 | 10 | D(100) | |||
| Filgrastim | Injection 480 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Zarzio | SZ | MP NP | C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447 | 20 | 11 | 5 | D(100) |
[34] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 75 I.U. in 0.125 mL pre-filled pen [Maximum Quantity: 15; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[35] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 150 I.U. in 0.25 mL pre-filled pen [Maximum Quantity: 15; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[36] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 225 I.U. in 0.375 mL pre-filled pen [Maximum Quantity: 15; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[37] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 300 I.U. in 0.5 mL multi-dose cartridge [Brand: Gonal-f Pen; Maximum Quantity: 2; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[38] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 300 I.U. in 0.5 mL multi-dose cartridge [Brand: Ovaleap; Maximum Quantity: 2; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[39] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 450 I.U. in 0.75 mL multi-dose cartridge [Brand: Gonal-f Pen; Maximum Quantity: 2; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[40] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 450 I.U. in 0.75 mL multi-dose cartridge [Brand: Ovaleap; Maximum Quantity: 2; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[41] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 900 I.U. in 1.5 mL multi-dose cartridge [Brand: Gonal-f Pen; Maximum Quantity: 5; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[42] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 900 I.U. in 1.5 mL multi-dose cartridge [Brand: Ovaleap; Maximum Quantity: 5; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[43] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge [Maximum Quantity: 2; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[44] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge [Maximum Quantity: 4; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[45] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge [Maximum Quantity: 5; Number of Repeats: 0]
insert in the column headed “Section 100/ Prescriber Bag only”: C(100)
[46] Schedule 1, Part 1, entries for Glatiramer
omit:
| Glatiramer | Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen | Injection | Copaxone | TB | MP NP | C16297 C16321 | 12 | 5 | 12 |
[47] Schedule 1, Part 1, entry for IncobotulinumtoxinA [Maximum Quantity: 4; Number of Repeats: 0]
(a) insert in numerical order in the column headed “Circumstances”: C19313
(b) insert in numerical order in the column headed “Purposes”: P19313
[48] Schedule 1, Part 1, entry for Iptacopan
omit from the column headed “Circumstances”: C17603
[49] Schedule 1, Part 1, entry for Ivacaftor in the form Sachet containing granules 25 mg
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[50] Schedule 1, Part 1, entry for Ivacaftor in the form Sachet containing granules 50 mg
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[51] Schedule 1, Part 1, entry for Ivacaftor in the form Sachet containing granules 75 mg
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[52] Schedule 1, Part 1, entry for Ivacaftor in the form Tablet 150 mg
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[53] Schedule 1, Part 1, entries for Lanreotide
substitute:
| Lanreotide | Injection 60 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP NP | C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 60 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP | C7025 C9261 C16024 C16055 C16057 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 60 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP NP | C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 60 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP | C7025 C9261 C16024 C16055 C16057 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 90 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP NP | C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 90 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP | C7025 C9261 C16024 C16055 C16057 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 90 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP NP | C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 90 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP | C7025 C9261 C16024 C16055 C16057 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 120 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP NP | C19534 C19542 C19547 C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 120 mg (as acetate) in single dose pre-filled syringe | Injection | Mytolac | GH | MP | C7025 C9261 C16024 C16055 C16057 C17638 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 120 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP NP | C19534 C19542 C19547 C19548 C19552 C19560 | 2 | 5 | 1 | D(100) | |||
| Lanreotide | Injection 120 mg (as acetate) in single dose pre-filled syringe | Injection | Somatuline Autogel | IS | MP | C7025 C9261 C16024 C16055 C16057 C17638 | 2 | 5 | 1 | D(100) |
[54] Schedule 1, Part 1, entries for Lumacaftor with ivacaftor
omit from the column headed “Authorised Prescriber” (all instances): MP substitute (all instances): MP NP
[55] Schedule 1, Part 1, entry for Mannitol
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C7362 C7367 C9527 C9593 substitute: C19292 C19379 C19380 C19472
[56] Schedule 1, Part 1, entries for Meloxicam in the form Capsule 15 mg
omit:
| Meloxicam | Capsule 15 mg | Oral | Mobic | BY | MP NP | C4907 C4962 | 30 | 3 | 30 |
[57] Schedule 1, Part 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g [Brand: Diaformin Alphapharm XR; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Metformin | Tablet (extended release) containing metformin hydrochloride 1 g | Oral | Diaformin Viatris XR | VY | MP MW NP | C16261 | P16261 | 60 | 5 | 60 | |||
| Metformin | Tablet (extended release) containing metformin hydrochloride 1 g | Oral | Diaformin Viatris XR | VY | MP NP | C14238 | P14238 | 120 | 5 | 60 |
[58] Schedule 1, Part 1, entry for Midostaurin [Pack Quantity: 112]
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[59] Schedule 1, Part 1, entries for Nitrofurantoin
substitute:
| Nitrofurantoin | Capsule 50 mg | Oral | ARX-Nitrofurantoin | XT | MP MW NP | 30 | 1 | 30 | |||||
| Nitrofurantoin | Capsule 50 mg | Oral | Fudantin | NB | MP MW NP | 30 | 1 | 30 | |||||
| Nitrofurantoin | Capsule 50 mg | Oral | Nitrofurantoin BNM | BZ | MP MW NP | 30 | 1 | 30 | |||||
| Nitrofurantoin | Capsule 100 mg | Oral | ARX-Nitrofurantoin | XT | MP MW NP | 30 | 1 | 30 | |||||
| Nitrofurantoin | Capsule 100 mg | Oral | Fudantin | NB | MP MW NP | 30 | 1 | 30 | |||||
| Nitrofurantoin | Capsule 100 mg | Oral | Nitrofurantoin BNM | BZ | MP MW NP | 30 | 1 | 30 |
[60] Schedule 1, Part 1, entries for Octreotide
substitute:
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.05 | NV | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.05 | NV | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.1 | NV | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 100 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.1 | NV | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide GH | HQ | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Octreotide (SUN) | RA | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.5 | NV | MP NP | C19321 C19322 C19442 C19479 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection 500 micrograms (as acetate) in 1 mL | Injection | Sandostatin 0.5 | NV | MP | C8165 C9233 | 90 | 11 | 5 | D(100) | |||
| Octreotide | Injection (modified release) 10 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP NP | C19533 C19539 C19540 C19543 C19544 C19549 | 2 | 5 | 1 | D(100) | |||
| Octreotide | Injection (modified release) 10 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP | C8161 C8197 C9262 | 2 | 5 | 1 | D(100) | |||
| Octreotide | Injection (modified release) 20 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP NP | C19533 C19539 C19540 C19543 C19544 C19549 | 2 | 5 | 1 | D(100) | |||
| Octreotide | Injection (modified release) 20 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP | C8161 C8197 C9262 | 2 | 5 | 1 | D(100) | |||
| Octreotide | Injection (modified release) 30 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP NP | C19533 C19538 C19539 C19540 C19543 C19544 C19549 C19562 C19565 | 2 | 5 | 1 | D(100) | |||
| Octreotide | Injection (modified release) 30 mg (as acetate), vial and diluent syringe | Injection | Sandostatin LAR | NV | MP | C8161 C8197 C9262 | 2 | 5 | 1 | D(100) |
[61] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 5 mg (orally disintegrating)
omit:
| Olanzapine | Tablet 5 mg (orally disintegrating) | Oral | OLANZAPINE ODT-WGR | WG | MP NP | C4246 C5869 | 28 | 5 | 28 |
[62] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 15 mg (orally disintegrating)
omit:
| Olanzapine | Tablet 15 mg (orally disintegrating) | Oral | OLANZAPINE ODT-WGR | WG | MP NP | C4246 C5869 | 28 | 5 | 28 |
[63] Schedule 1, Part 1, entries for Onasemnogene abeparvovec
substitute:
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 13 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 13 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Onasemnogene abeparvovec | Pack containing 14 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
[64] Schedule 1, Part 1, after entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Brand: Ondansetron Tablets Viatris; Maximum Quantity: 10; Number of Repeats: 1]
insert:
| Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Oral | Ondansetron VTRS | AF | MP NP | C4118 | P4118 | 4 | 0 | V4118 | 4 | ||
| Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Oral | Ondansetron VTRS | AF | MP | C5778 | P5778 | 4 | 0 | V5778 | 4 | C(100) |
[65] Schedule 1, Part 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Brand: Ondansetron VTRS; Maximum Quantity: 10; Number of Repeats: 1]
insert in the column headed “Purposes”: P15193
[66] Schedule 1, Part 1, entries for Pegfilgrastim
(a) omit from the column headed “Authorised Prescriber” (all instances): MP substitute (all instances): MP NP
(b) omit from the column headed “Circumstances” (all instances): C7822 C7843 C9235 C9303 substitute (all instances): C19332 C19403 C19449 C19508
[67] Schedule 1, Part 1, entries for Prazosin
omit:
| Prazosin | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) | DZ | MP NP | 100 | 5 | 100 | |||||
| Prazosin | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) | DZ | MP NP | P14238 | 200 | 5 | 100 |
[68] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 2.5 mg [Brand: Rivaroxaban Lupin; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Rivaroxaban | Tablet 2.5 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C10992 | P10992 | 60 | 5 | 60 | |||
| Rivaroxaban | Tablet 2.5 mg | Oral | Rivaroxaban Sandoz | SZ | MP | C11013 | P11013 | 60 | 5 | 60 | |||
| Rivaroxaban | Tablet 2.5 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C14298 | P14298 | 120 | 5 | 60 |
[69] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 10 mg [Brand: ARX-Rivaroxaban 10; Maximum Quantity: 60; Number of Repeats: 5]
insert:
| Rivaroxaban | Tablet 10 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C4402 | P4402 | 30 | 0 | 30 | |||
| Rivaroxaban | Tablet 10 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C4132 | P4132 | 30 | 5 | 30 | |||
| Rivaroxaban | Tablet 10 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C14300 | P14300 | 60 | 5 | 30 |
[70] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 15 mg [Brand: ARX-Rivaroxaban 15; Maximum Quantity: 56; Number of Repeats: 5]
insert:
| Rivaroxaban | Tablet 15 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C4269 | P4269 | 28 | 5 | 28 | |||
| Rivaroxaban | Tablet 15 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C4098 C5098 | P4098 P5098 | 42 | 0 | 42 | |||
| Rivaroxaban | Tablet 15 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C14301 | P14301 | 56 | 5 | 28 |
[71] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 20 mg [Brand: ARX-Rivaroxaban 20; Maximum Quantity: 56; Number of Repeats: 5]
insert:
| Rivaroxaban | Tablet 20 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C4099 C4132 C4268 C4269 | P4099 P4132 P4268 P4269 | 28 | 5 | 28 | |||
| Rivaroxaban | Tablet 20 mg | Oral | Blooms The Chemist Rivaroxaban | BG | MP NP | C14264 C14300 C14301 C14318 | P14264 P14300 P14301 P14318 | 56 | 5 | 28 |
[72] Schedule 1, Part 1, after entry for Sacubitril with valsartan in the form Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg [Brand: Entresto; Maximum Quantity: 112; Number of Repeats: 5]
insert:
| Sacubitril with valsartan | Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18150 | P18150 | 56 | 5 | 56 | |||
| Sacubitril with valsartan | Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18338 | P18338 | 112 | 5 | 56 |
[73] Schedule 1, Part 1, after entry for Sacubitril with valsartan in the form Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg [Brand: Entresto; Maximum Quantity: 112; Number of Repeats: 5]
insert:
| Sacubitril with valsartan | Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18150 | P18150 | 56 | 5 | 56 | |||
| Sacubitril with valsartan | Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18338 | P18338 | 112 | 5 | 56 |
[74] Schedule 1, Part 1, after entry for Sacubitril with valsartan in the form Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg [Brand: Entresto; Maximum Quantity: 112; Number of Repeats: 5]
insert:
| Sacubitril with valsartan | Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18150 | P18150 | 56 | 5 | 56 | |||
| Sacubitril with valsartan | Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg | Oral | MSN-SACUBITRIL/VALSARTAN | VM | MP NP | C18338 | P18338 | 112 | 5 | 56 |
[75] Schedule 1, Part 1, after entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20
insert:
| Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 (S19A) | Inhalation | PMS-SALBUTAMOL (Canada) | RQ | MP NP | C6815 C6825 | 3 | 5 | 1 |
[76] Schedule 1, Part 1, after entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Authorised Prescriber: MP]
insert:
| Sevelamer | Tablet containing sevelamer hydrochloride 800 mg | Oral | Sevelamer Waymade | IX | MP NP | C5491 | P5491 | 180 | 5 | 180 | |||
| Sevelamer | Tablet containing sevelamer hydrochloride 800 mg | Oral | Sevelamer Waymade | IX | MP NP | C14872 | P14872 | 360 | 5 | 180 | |||
| Sevelamer | Tablet containing sevelamer hydrochloride 800 mg | Oral | Sevelamer Waymade | IX | MP | C5530 C9762 | P5530 P9762 | 360 | 5 | 180 | C(100) |
[77] Schedule 1, Part 1, after entry for Sitagliptin in the form Tablet 100 mg [Brand: Xelevia; Maximum Quantity: 56; Number of Repeats: 5]
insert:
| Sitagliptin with metformin | Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | ARX-Sitagliptin/Metformin XR 50/1000 | XT | MP NP | C15276 | P15276 | 56 | 5 | 56 | |||
| Sitagliptin with metformin | Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | ARX-Sitagliptin/Metformin XR 50/1000 | XT | MP NP | C15288 | P15288 | 112 | 5 | 56 |
[78] Schedule 1, Part 1, after entry for Sitagliptin with metformin in the form Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride [Brand: Sitagliptin/Metformin XR Mylan; Maximum Quantity: 112; Number of Repeats: 5]
insert:
| Sitagliptin with metformin | Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | ARX-Sitagliptin/Metformin XR 100/1000 | XT | MP NP | C15276 | P15276 | 28 | 5 | 28 | |||
| Sitagliptin with metformin | Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride | Oral | ARX-Sitagliptin/Metformin XR 100/1000 | XT | MP NP | C15288 | P15288 | 56 | 5 | 28 |
[79] Schedule 1, Part 1, after entry for Tepotinib
insert:
| Teprotumumab | Powder for I.V. infusion 500 mg | Injection | Tepezza | AN | MP | C19494 | P19494 | 3 | 0 | V19494 | 1 | D(100) | |
| Teprotumumab | Powder for I.V. infusion 500 mg | Injection | Tepezza | AN | MP | C19461 C19524 | P19461 P19524 | 6 | 6 | V19461 V19524 | 1 | D(100) |
[80] Schedule 1, Part 1, entry for Tezacaftor with ivacaftor and ivacaftor
omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
[81] Schedule 1, Part 1, entry for Tislelizumab
omit from the column headed “Circumstances”: C16375 substitute: C19495
[82] Schedule 1, Part 1, after entry for Tranexamic acid [Brand: APO-Tranexamic Acid]
insert:
| Tranexamic acid | Tablet 500 mg | Oral | ARX-TRANEXAMIC ACID | XT | MP NP | 100 | 2 | 100 |
[83] Schedule 1, Part 1, entries for Valganciclovir
substitute:
| Valganciclovir | Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL | Oral | Valcyte | PB | MP NP | C4980 C19374 C19463 C19505 C19515 | 11 | 5 | 1 | D(100) | |||
| Valganciclovir | Tablet 450 mg (as hydrochloride) | Oral | Valganciclovir Sandoz | SZ | MP NP | C4980 C19374 C19463 C19505 C19515 | 120 | 5 | 60 | D(100) | |||
| Valganciclovir | Tablet 450 mg (as hydrochloride) | Oral | Valganciclovir Viatris | AL | MP NP | C4980 C19374 C19463 C19505 C19515 | 120 | 5 | 60 | D(100) |
[84] Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL [Brand: DEZTRON; Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C14729 C14735 substitute: C19289 C19428
(c) omit from the column headed “Purposes”: P14729 P14735 substitute: P19289 P19428
[85] Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL [Brand: Zoledronate-DRLA 4; Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C14729 C14735 substitute: C19289 C19428
(c) omit from the column headed “Purposes”: P14729 P14735 substitute: P19289 P19428
[86] Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL [Brand: Zoledronic Acid Accord; Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”: C14729 C14735 substitute: C19289 C19428
(c) omit from the column headed “Purposes”: P14729 P14735 substitute: P19289 P19428
[87] Schedule 1, Part 2, omit entry for Miconazole
[88] Schedule 3, after entry for Responsible Person Code VR
insert:
| VY | Alphapharm Pty Ltd | 93 002 359 739 |
[89] Schedule 4, Part 1, omit entry for Circumstances Code “C4575”
[90] Schedule 4, Part 1, omit entry for Circumstances Code “C4998”
[91] Schedule 4, Part 1, omit entry for Circumstances Code “C5634”
[92] Schedule 4, Part 1, omit entry for Circumstances Code “C5635”
[93] Schedule 4, Part 1, omit entry for Circumstances Code “C5740”
[94] Schedule 4, Part 1, omit entry for Circumstances Code “C5901”
[95] Schedule 4, Part 1, omit entry for Circumstances Code “C5906”
[96] Schedule 4, Part 1, omit entry for Circumstances Code “C6369”
[97] Schedule 4, Part 1, omit entry for Circumstances Code “C6390”
[98] Schedule 4, Part 1, omit entry for Circumstances Code “C6394”
[99] Schedule 4, Part 1, omit entry for Circumstances Code “C6403”
[100] Schedule 4, Part 1, omit entry for Circumstances Code “C6448”
[101] Schedule 4, Part 1, omit entry for Circumstances Code “C6621”
[102] Schedule 4, Part 1, omit entry for Circumstances Code “C6628”
[103] Schedule 4, Part 1, omit entry for Circumstances Code “C6631”
[104] Schedule 4, Part 1, omit entry for Circumstances Code “C6638”
[105] Schedule 4, Part 1, omit entry for Circumstances Code “C6640”
[106] Schedule 4, Part 1, omit entry for Circumstances Code “C6643”
[107] Schedule 4, Part 1, omit entry for Circumstances Code “C6653”
[108] Schedule 4, Part 1, omit entry for Circumstances Code “C6654”
[109] Schedule 4, Part 1, omit entry for Circumstances Code “C6655”
[110] Schedule 4, Part 1, omit entry for Circumstances Code “C6660”
[111] Schedule 4, Part 1, omit entry for Circumstances Code “C6679”
[112] Schedule 4, Part 1, omit entry for Circumstances Code “C6680”
[113] Schedule 4, Part 1, omit entry for Circumstances Code “C7362”
[114] Schedule 4, Part 1, omit entry for Circumstances Code “C7367”
[115] Schedule 4, Part 1, omit entry for Circumstances Code “C7374”
[116] Schedule 4, Part 1, omit entry for Circumstances Code “C7375”
[117] Schedule 4, Part 1, omit entry for Circumstances Code “C7385”
[118] Schedule 4, Part 1, entry for Circumstances Code “C7822”
(a) omit from the column headed “Listed Drug”: Filgrastim
(b) omit from the column headed “Listed Drug”: Pegfilgrastim
[119] Schedule 4, Part 1, entry for Circumstances Code “C7843”
(a) omit from the column headed “Listed Drug”: Filgrastim
(b) omit from the column headed “Listed Drug”: Pegfilgrastim
[120] Schedule 4, Part 1, omit entry for Circumstances Code “C8198”
[121] Schedule 4, Part 1, omit entry for Circumstances Code “C8208”
[122] Schedule 4, Part 1, omit entry for Circumstances Code “C8326”
[123] Schedule 4, Part 1, omit entry for Circumstances Code “C8328”
[124] Schedule 4, Part 1, omit entry for Circumstances Code “C8329”
[125] Schedule 4, Part 1, omit entry for Circumstances Code “C8667”
[126] Schedule 4, Part 1, omit entry for Circumstances Code “C8668”
[127] Schedule 4, Part 1, omit entry for Circumstances Code “C8669”
[128] Schedule 4, Part 1, omit entry for Circumstances Code “C8670”
[129] Schedule 4, Part 1, omit entry for Circumstances Code “C8671”
[130] Schedule 4, Part 1, omit entry for Circumstances Code “C8672”
[131] Schedule 4, Part 1, omit entry for Circumstances Code “C8673”
[132] Schedule 4, Part 1, omit entry for Circumstances Code “C8674”
[133] Schedule 4, Part 1, omit entry for Circumstances Code “C8696”
[134] Schedule 4, Part 1, omit entry for Circumstances Code “C9222”
[135] Schedule 4, Part 1, omit entry for Circumstances Code “C9228”
[136] Schedule 4, Part 1, omit entry for Circumstances Code “C9232”
[137] Schedule 4, Part 1, omit entry for Circumstances Code “C9235”
[138] Schedule 4, Part 1, omit entry for Circumstances Code “C9258”
[139] Schedule 4, Part 1, omit entry for Circumstances Code “C9260”
[140] Schedule 4, Part 1, omit entry for Circumstances Code “C9286”
[141] Schedule 4, Part 1, omit entry for Circumstances Code “C9288”
[142] Schedule 4, Part 1, omit entry for Circumstances Code “C9289”
[143] Schedule 4, Part 1, omit entry for Circumstances Code “C9302”
[144] Schedule 4, Part 1, omit entry for Circumstances Code “C9303”
[145] Schedule 4, Part 1, omit entry for Circumstances Code “C9313”
[146] Schedule 4, Part 1, omit entry for Circumstances Code “C9527”
[147] Schedule 4, Part 1, omit entry for Circumstances Code “C9590”
[148] Schedule 4, Part 1, omit entry for Circumstances Code “C9591”
[149] Schedule 4, Part 1, omit entry for Circumstances Code “C9592”
[150] Schedule 4, Part 1, omit entry for Circumstances Code “C9593”
[151] Schedule 4, Part 1, omit entry for Circumstances Code “C9623”
[152] Schedule 4, Part 1, omit entry for Circumstances Code “C9624”
[153] Schedule 4, Part 1, omit entry for Circumstances Code “C9694”
[154] Schedule 4, Part 1, omit entry for Circumstances Code “C9695”
[155] Schedule 4, Part 1, omit entry for Circumstances Code “C9696”
[156] Schedule 4, Part 1, omit entry for Circumstances Code “C9742”
[157] Schedule 4, Part 1, omit entry for Circumstances Code “C9764”
[158] Schedule 4, Part 1, omit entry for Circumstances Code “C9831”
[159] Schedule 4, Part 1, omit entry for Circumstances Code “C13122”
[160] Schedule 4, Part 1, omit entry for Circumstances Code “C13168”
[161] Schedule 4, Part 1, omit entry for Circumstances Code “C14729”
[162] Schedule 4, Part 1, omit entry for Circumstances Code “C14735”
[163] Schedule 4, Part 1, entry for Circumstances Code “C15782”
omit from the column headed “Listed Drug”: Valganciclovir
[164] Schedule 4, Part 1, entry for Circumstances Code “C15784”
omit from the column headed “Listed Drug”: Valganciclovir
[165] Schedule 4, Part 1, entry for Circumstances Code “C15800”
omit from the column headed “Listed Drug”: Valganciclovir
[166] Schedule 4, Part 1, entry for Circumstances Code “C15814”
omit from the column headed “Listed Drug”: Valganciclovir
[167] Schedule 4, Part 1, entry for Circumstances Code “C15918”
substitute:
| C15918 | P15918 | CN15918 | AfliberceptRanibizumab | Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to age-related macular degeneration (AMD), ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription, ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[168] Schedule 4, Part 1, omit entry for Circumstances Code “C15955”
[169] Schedule 4, Part 1, entry for Circumstances Code “C16309”
substitute:
| C16309 | P16309 | CN16309 | Faricimab | Central retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription, ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[170] Schedule 4, Part 1, entry for Circumstances Code “C16319”
substitute:
| C16319 | P16319 | CN16319 | Faricimab | Branch retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography.orThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription, ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[171] Schedule 4, Part 1, omit entry for Circumstances Code “C16375”
[172] Schedule 4, Part 1, entry for Circumstances Code “C16482”
substitute:
| C16482 | P16482 | CN16482 | Faricimab | Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to age-related macular degeneration (AMD), ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription, ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[173] Schedule 4, Part 1, entry for Circumstances Code “C17278”
substitute:
| C17278 | P17278 | CN17278 | Rotigotine | Parkinson diseaseThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[174] Schedule 4, Part 1, entry for Circumstances Code “C17323”
substitute:
| C17323 | P17323 | CN17323 | Rotigotine | Parkinson diseaseThe treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[175] Schedule 4, Part 1, omit entry for Circumstances Code “C17567”
[176] Schedule 4, Part 1, omit entry for Circumstances Code “C17603”
[177] Schedule 4, Part 1, omit entry for Circumstances Code “C17634”
[178] Schedule 4, Part 1, omit entry for Circumstances Code “C17635”
[179] Schedule 4, Part 1, omit entry for Circumstances Code “C17637”
[180] Schedule 4, Part 1, entry for Circumstances Code “C17661”
substitute:
| C17661 | P17661 | CN17661 | Daratumumab | Untreated multiple myelomaTransitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025, ANDPatient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; OR(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; OR(c) the serum level of free kappa and lambda light chains; OR(d) bone marrow aspirate or trephine; OR(e) if present, the size and location of lytic bone lesions (not including compression fractures); OR(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; OR(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); OR(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; OR(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; OR(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; OR(e) an increase in the size or number of lytic bone lesions (not including compression fractures); OR(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); OR(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
[181] Schedule 4, Part 1, omit entry for Circumstances Code “C17696”
[182] Schedule 4, Part 1, omit entry for Circumstances Code “C17757”
[183] Schedule 4, Part 1, entry for Circumstances Code “C17789”
substitute:
| C17789 | P17789 | CN17789 | Sunitinib | Metastatic or unresectable malignant gastrointestinal stromal tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must not be resectable. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have a WHO performance status of 2 or less. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17789 |
[184] Schedule 4, Part 1, entry for Circumstances Code “C17791”
substitute:
| C17791 | P17791 | CN17791 | Cabozantinib | Locally advanced or metastatic differentiated thyroid cancerContinuing treatmentThe condition must be refractory to radioactive iodine. ORPatient must be deemed ineligible for treatment with radioactive iodine, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17791 |
[185] Schedule 4, Part 1, entry for Circumstances Code “C17794”
substitute:
| C17794 | P17794 | CN17794 | Cabozantinib | Stage IV renal cell carcinoma (RCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST), ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17794 |
[186] Schedule 4, Part 1, entry for Circumstances Code “C17796”
substitute:
| C17796 | P17796 | CN17796 | Olaparib | Castration resistant metastatic carcinoma of the prostateContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[187] Schedule 4, Part 1, entry for Circumstances Code “C17800”
substitute:
| C17800 | P17800 | CN17800 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tabletsThe treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation), ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[188] Schedule 4, Part 1, entry for Circumstances Code “C17805”
substitute:
| C17805 | P17805 | CN17805 | Crizotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[189] Schedule 4, Part 1, entry for Circumstances Code “C17807”
substitute:
| C17807 | P17807 | CN17807 | Cobimetinib | Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug, ANDPatient must be receiving PBS-subsidised vemurafenib concomitantly for this condition, ANDPatient must have stable or responding disease.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17807 |
[190] Schedule 4, Part 1, entry for Circumstances Code “C17809”
substitute:
| C17809 | P17809 | CN17809 | Degarelix | Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostateMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[191] Schedule 4, Part 1, entry for Circumstances Code “C17811”
substitute:
| C17811 | P17811 | CN17811 | Goserelin | Carcinoma of the prostateThe condition must be locally advanced (stage C); ORThe condition must be metastatic (stage D).Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[192] Schedule 4, Part 1, entry for Circumstances Code “C17812”
substitute:
| C17812 | P17812 | CN17812 | LeuprorelinTriptorelin | Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostateMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[193] Schedule 4, Part 1, entry for Circumstances Code “C17814”
substitute:
| C17814 | P17814 | CN17814 | Goserelin and bicalutamideLeuprorelin and bicalutamide | Carcinoma of the prostateThe condition must be metastatic (stage D), ANDPatient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[194] Schedule 4, Part 1, entry for Circumstances Code “C17817”
substitute:
| C17817 | P17817 | CN17817 | Dasatinib | Acute lymphoblastic leukaemiaMaintenance of first complete remissionPatient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition, ANDThe condition must be expressing the Philadelphia chromosome; ORThe condition must have the transcript BCR-ABL, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; ORPatient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Conditions for PBS-subsidy beyond 24 months of treatment:On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that:1) The condition is expressing the Philadelphia chromosome,2) Measurable residual disease (MRD) is present,3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,4) MRD has been confirmed within the preceding 6 months of this authority application,5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable. | Compliance with Authority Required procedures |
[195] Schedule 4, Part 1, entry for Circumstances Code “C17826”
substitute:
| C17826 | P17826 | CN17826 | Imatinib | Acute lymphoblastic leukaemiaMaintenance of first complete remissionPatient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition, ANDThe condition must be expressing the Philadelphia chromosome; ORThe condition must have the transcript BCR-ABL, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine, ANDPatient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; ORPatient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.Conditions for PBS-subsidy beyond 24 months of treatment:On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring that:1) The condition is expressing the Philadelphia chromosome,2) Measurable residual disease (MRD) is present,3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,4) MRD has been confirmed within the preceding months of this authority application,5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable. | Compliance with Authority Required procedures - Streamlined Authority Code 17826 |
[196] Schedule 4, Part 1, entry for Circumstances Code “C17834”
substitute:
| C17834 | P17834 | CN17834 | Ponatinib | Acute lymphoblastic leukaemiaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have progressive disease.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[197] Schedule 4, Part 1, entry for Circumstances Code “C17838”
substitute:
| C17838 | P17838 | CN17838 | Ibrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses), ANDThe treatment must cease upon disease progression.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15). | Compliance with Authority Required procedures |
[198] Schedule 4, Part 1, entry for Circumstances Code “C17847”
substitute:
| C17847 | P17847 | CN17847 | AbemaciclibRibociclib | Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition, ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant, ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[199] Schedule 4, Part 1, entry for Circumstances Code “C17848”
substitute:
| C17848 | P17848 | CN17848 | CapecitabineCyclophosphamideHydroxycarbamideMercaptopurineTemozolomide | For prescribing by certain health practitionersMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[200] Schedule 4, Part 1, entry for Circumstances Code “C17853”
substitute:
| C17853 | P17853 | CN17853 | Ribociclib | Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition, ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant, ANDPatient must require dosage reduction requiring a pack of 21 tablets, ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[201] Schedule 4, Part 1, entry for Circumstances Code “C17854”
substitute:
| C17854 | P17854 | CN17854 | Temozolomide | Glioblastoma multiformePatient must be undergoing concomitant radiotherapy, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[202] Schedule 4, Part 1, entry for Circumstances Code “C17855”
substitute:
| C17855 | P17855 | CN17855 | Vinorelbine | Locally advanced or metastatic non-small cell lung cancerMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[203] Schedule 4, Part 1, entry for Circumstances Code “C17856”
substitute:
| C17856 | P17856 | CN17856 | Sunitinib | Stage IV clear cell variant renal cell carcinoma (RCC)Continuing treatment beyond 3 monthsPatient must have received an initial authority prescription for this drug for this condition, ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST), ANDThe treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib. | Compliance with Authority Required procedures - Streamlined Authority Code 17856 |
[204] Schedule 4, Part 1, entry for Circumstances Code “C17860”
substitute:
| C17860 | P17860 | CN17860 | Lenvatinib | Stage IV clear cell variant renal cell carcinoma (RCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; ORPatient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient's medical record. | Compliance with Authority Required procedures - Streamlined Authority Code 17860 |
[205] Schedule 4, Part 1, entry for Circumstances Code “C17862”
substitute:
| C17862 | P17862 | CN17862 | Sunitinib | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)Continuing treatmentPatient must have received an initial authority prescription for this drug for this condition, ANDPatient must not have disease progression, ANDThe treatment must be as monotherapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 17862 |
[206] Schedule 4, Part 1, entry for Circumstances Code “C17865”
substitute:
| C17865 | P17865 | CN17865 | Lenvatinib | Locally advanced or metastatic differentiated thyroid cancerContinuing treatmentThe condition must be refractory to radioactive iodine, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17865 |
[207] Schedule 4, Part 1, entry for Circumstances Code “C17867”
substitute:
| C17867 | P17867 | CN17867 | Talazoparib | Castration resistant metastatic carcinoma of the prostateThe condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation, ANDPatient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition, ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation, ANDPatient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a: (i) temporary cessation, (ii) permanent discontinuation, ANDThe treatment must not be a PBS-subsidised benefit beyond disease progression.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[208] Schedule 4, Part 1, entry for Circumstances Code “C17870”
substitute:
| C17870 | P17870 | CN17870 | BrigatinibCeritinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be as monotherapy, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[209] Schedule 4, Part 1, entry for Circumstances Code “C17873”
substitute:
| C17873 | P17873 | CN17873 | Abiraterone | Castration resistant metastatic carcinoma of the prostateThe treatment must be used in combination with a corticosteroid, ANDThe treatment must not be used in combination with chemotherapy, ANDPatient must have a WHO performance status of 2 or less, ANDThe treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[210] Schedule 4, Part 1, entry for Circumstances Code “C17875”
substitute:
| C17875 | P17875 | CN17875 | ApalutamideDarolutamideEnzalutamide | Castration resistant non-metastatic carcinoma of the prostateThe condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition, ANDThe condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug, ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Patient must be undergoing concurrent treatment with androgen deprivation therapy, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Prescribing instructions:Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading. | Compliance with Authority Required procedures |
[211] Schedule 4, Part 1, entry for Circumstances Code “C17877”
substitute:
| C17877 | P17877 | CN17877 | Abiraterone and methylprednisoloneApalutamideDarolutamide | Metastatic castration sensitive carcinoma of the prostateThe treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.Patient must be undergoing concurrent androgen deprivation therapy, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[212] Schedule 4, Part 1, entry for Circumstances Code “C17880”
substitute:
| C17880 | P17880 | CN17880 | GoserelinMedroxyprogesterone | Breast cancerThe condition must be hormone receptor positive.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[213] Schedule 4, Part 1, entry for Circumstances Code “C17881”
substitute:
| C17881 | P17881 | CN17881 | Medroxyprogesterone | Endometrial cancerMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[214] Schedule 4, Part 1, entry for Circumstances Code “C17884”
substitute:
| C17884 | P17884 | CN17884 | Imatinib | Dermatofibrosarcoma protuberansContinuing treatmentThe condition must be unresectable; ORThe condition must be locally recurrent; ORThe condition must be metastatic, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have demonstrated a response to the PBS-subsidised treatment, ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed a maximum dose of 800 mg per day.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 17884 |
[215] Schedule 4, Part 1, entry for Circumstances Code “C17885”
substitute:
| C17885 | P17885 | CN17885 | Imatinib | Chronic eosinophilic leukaemia or Hypereosinophilic syndromeContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved and maintained a complete haematological response, ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 17885 |
[216] Schedule 4, Part 1, entry for Circumstances Code “C17886”
substitute:
| C17886 | P17886 | CN17886 | Imatinib | Malignant gastrointestinal stromal tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be given at a dose not exceeding 600 mg per day.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinibPatients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) | Compliance with Authority Required procedures - Streamlined Authority Code 17886 |
[217] Schedule 4, Part 1, entry for Circumstances Code “C17887”
substitute:
| C17887 | P17887 | CN17887 | Imatinib | Aggressive systemic mastocytosis with eosinophiliaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene, ANDPatient must have achieved and maintained a complete haematological response, ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 17887 |
[218] Schedule 4, Part 1, entry for Circumstances Code “C17890”
substitute:
| C17890 | P17890 | CN17890 | Imatinib | Gastrointestinal stromal tumourContinuing treatmentThe treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST), ANDPatient must be at high risk of recurrence following complete surgical resection of primary GIST, ANDThe treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy), ANDPatient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17890 |
[219] Schedule 4, Part 1, entry for Circumstances Code “C17893”
substitute:
| C17893 | P17893 | CN17893 | Idelalisib | Refractory follicular B-cell non-Hodgkin's lymphomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17893 |
[220] Schedule 4, Part 1, entry for Circumstances Code “C17898”
substitute:
| C17898 | P17898 | CN17898 | AcalabrutinibIbrutinibZanubrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Treatment of relapsed/refractory diseaseThe condition must have relapsed or be refractory to at least one prior therapy, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression, ANDPatient must be undergoing treatment through this treatment phase listing for the first time (initial treatment); ORPatient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[221] Schedule 4, Part 1, entry for Circumstances Code “C17900”
substitute:
| C17900 | P17900 | CN17900 | Ibrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses), ANDThe treatment must cease upon disease progression; ORThe treatment must cease upon completion of 15 cycles of treatment with this drug for this condition, whichever comes first.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15). | Compliance with Authority Required procedures |
[222] Schedule 4, Part 1, entry for Circumstances Code “C17906”
substitute:
| C17906 | P17906 | CN17906 | Palbociclib | Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition, ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant, ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[223] Schedule 4, Part 1, entry for Circumstances Code “C17910”
substitute:
| C17910 | P17910 | CN17910 | Olaparib | High grade epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation), ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. | Compliance with Authority Required procedures - Streamlined Authority Code 17910 |
[224] Schedule 4, Part 1, entry for Circumstances Code “C17911”
substitute:
| C17911 | P17911 | CN17911 | Olaparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[225] Schedule 4, Part 1, entry for Circumstances Code “C17912”
substitute:
| C17912 | P17912 | CN17912 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tabletsThe treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation), ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[226] Schedule 4, Part 1, entry for Circumstances Code “C17913”
substitute:
| C17913 | P17913 | CN17913 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tabletsPatient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[227] Schedule 4, Part 1, entry for Circumstances Code “C17915”
substitute:
| C17915 | P17915 | CN17915 | DabrafenibTrametinib | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection, ANDPatient must not have experienced disease recurrence, ANDPatient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[228] Schedule 4, Part 1, entry for Circumstances Code “C17917”
substitute:
| C17917 | P17917 | CN17917 | Binimetinib | Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug, ANDPatient must be receiving PBS-subsidised encorafenib concomitantly for this condition, ANDPatient must have stable or responding disease.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17917 |
[229] Schedule 4, Part 1, entry for Circumstances Code “C17918”
substitute:
| C17918 | P17918 | CN17918 | Fulvestrant | Locally advanced or metastatic breast cancerThe condition must be hormone receptor positive, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be inoperable.Patient must not be premenopausal.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 17918 |
[230] Schedule 4, Part 1, entry for Circumstances Code “C17919”
substitute:
| C17919 | P17919 | CN17919 | Exemestane | Metastatic (Stage IV) breast cancerThe condition must be hormone receptor positive, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDPatient must be receiving PBS-subsidised everolimus concomitantly for this condition.Patient must not be pre-menopausal.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[231] Schedule 4, Part 1, entry for Circumstances Code “C17923”
substitute:
| C17923 | P17923 | CN17923 | Medroxyprogesterone | Endometrial cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[232] Schedule 4, Part 1, entry for Circumstances Code “C17927”
substitute:
| C17927 | P17927 | CN17927 | Zanubrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indicationThe condition must be untreated with drug treatment at the time of the first dose of this drug; ORPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; ORPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[233] Schedule 4, Part 1, entry for Circumstances Code “C17931”
substitute:
| C17931 | P17931 | CN17931 | AcalabrutinibIbrutinibZanubrutinib | Mantle cell lymphomaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[234] Schedule 4, Part 1, entry for Circumstances Code “C17939”
substitute:
| C17939 | P17939 | CN17939 | Abiraterone and methylprednisoloneAbiraterone and prednisolone | Castration resistant metastatic carcinoma of the prostateThe treatment must not be used in combination with chemotherapy, ANDPatient must have a WHO performance status of 2 or less, ANDThe treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[235] Schedule 4, Part 1, entry for Circumstances Code “C17945”
substitute:
| C17945 | P17945 | CN17945 | Olaparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation)The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation), ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[236] Schedule 4, Part 1, entry for Circumstances Code “C17946”
substitute:
| C17946 | P17946 | CN17946 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tabletsPatient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[237] Schedule 4, Part 1, entry for Circumstances Code “C17949”
substitute:
| C17949 | P17949 | CN17949 | DabrafenibEncorafenibVemurafenib | Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug, ANDPatient must have stable or responding disease.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17949 |
[238] Schedule 4, Part 1, entry for Circumstances Code “C17951”
substitute:
| C17951 | P17951 | CN17951 | Trametinib | Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug, ANDPatient must be receiving PBS-subsidised dabrafenib concomitantly for this condition, ANDPatient must have stable or responding disease.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 17951 |
[239] Schedule 4, Part 1, entry for Circumstances Code “C17953”
substitute:
| C17953 | P17953 | CN17953 | Enzalutamide | Castration resistant metastatic carcinoma of the prostateThe treatment must not be used in combination with chemotherapy, ANDPatient must have a WHO performance status of 2 or less, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; ORPatient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[240] Schedule 4, Part 1, entry for Circumstances Code “C17956”
substitute:
| C17956 | P17956 | CN17956 | Goserelin | Anticipated premature ovarian failurePatient must be receiving treatment with an alkylating agent for a malignancy or an autoimmune disorder that has a high risk of causing premature ovarian failure, ANDPatient must not receive more than 6 months' of treatment for this condition in a lifetime.Patient must be pre-menopausal.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[241] Schedule 4, Part 1, entry for Circumstances Code “C17958”
substitute:
| C17958 | P17958 | CN17958 | Medroxyprogesterone | Breast cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDThe condition must be hormone receptor positive.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[242] Schedule 4, Part 1, entry for Circumstances Code “C17960”
substitute:
| C17960 | P17960 | CN17960 | Imatinib | Myelodysplastic or myeloproliferative disorderContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must be PDGFRB fusion gene-positive, ANDPatient must have achieved and maintained a complete haematological response, ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 17960 |
[243] Schedule 4, Part 1, entry for Circumstances Code “C17977”
substitute:
| C17977 | P17977 | CN17977 | Ribociclib | Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition, ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant, ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy, ANDPatient must require dosage reduction requiring a pack of 42 tablets.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[244] Schedule 4, Part 1, entry for Circumstances Code “C17981”
substitute:
| C17981 | P17981 | CN17981 | Olaparib | Early breast cancerContinuing treatmentPatient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition, ANDPatient must not have developed disease recurrence while receiving treatment with this drug for this condition, ANDThe treatment must not be a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply), ANDThe treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[245] Schedule 4, Part 1, entry for Circumstances Code “C17984”
substitute:
| C17984 | P17984 | CN17984 | Dasatinib | Acute lymphoblastic leukaemiaContinuing treatmentThe condition must be expressing the Philadelphia chromosome; ORThe condition must have the transcript BCR-ABL, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib, ANDThe condition must not have progressed.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[246] Schedule 4, Part 1, entry for Circumstances Code “C17991”
substitute:
| C17991 | P17991 | CN17991 | Acalabrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indication - as monotherapyThe condition must be untreated with drug treatment at the time of the first dose of this drug; ORPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; ORPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[247] Schedule 4, Part 1, entry for Circumstances Code “C18002”
substitute:
| C18002 | P18002 | CN18002 | Olaparib | Metastatic breast cancerContinuing treatmentPatient must have received previous PBS-subsidised treatment with this drug in the metastatic setting, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[248] Schedule 4, Part 1, entry for Circumstances Code “C18007”
substitute:
| C18007 | P18007 | CN18007 | Zanubrutinib | Waldenstrom macroglobulinaemiaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[249] Schedule 4, Part 1, entry for Circumstances Code “C18014”
substitute:
| C18014 | P18014 | CN18014 | Gilteritinib | Relapsed or refractory Acute Myeloid LeukaemiaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition, ANDThe treatment must not be for maintenance therapy post-transplant.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.Progressive disease is defined as the presence of any of the following:(a) Leukaemic cells in the CSF; OR(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; OR(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; OR(d) Extramedullary leukaemia. | Compliance with Authority Required procedures |
[250] Schedule 4, Part 1, entry for Circumstances Code “C18015”
substitute:
| C18015 | P18015 | CN18015 | Vinorelbine | Advanced breast cancerPatient must have failed standard prior therapy, which includes an anthracycline.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[251] Schedule 4, Part 1, entry for Circumstances Code “C18017”
substitute:
| C18017 | P18017 | CN18017 | Lenvatinib | Advanced, metastatic or recurrent endometrial carcinomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; ORPatient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 18017 |
[252] Schedule 4, Part 1, entry for Circumstances Code “C18018”
substitute:
| C18018 | P18018 | CN18018 | Lenvatinib | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 18018 |
[253] Schedule 4, Part 1, entry for Circumstances Code “C18022”
substitute:
| C18022 | P18022 | CN18022 | Lorlatinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[254] Schedule 4, Part 1, entry for Circumstances Code “C18025”
substitute:
| C18025 | P18025 | CN18025 | Goserelin | EndometriosisThe condition must be visually proven, ANDThe treatment must be for the short-term (up to 6 months).Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[255] Schedule 4, Part 1, entry for Circumstances Code “C18029”
substitute:
| C18029 | P18029 | CN18029 | Idelalisib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia; ORPatient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia, ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[256] Schedule 4, Part 1, entry for Circumstances Code “C18030”
substitute:
| C18030 | P18030 | CN18030 | Ponatinib | Acute lymphoblastic leukaemiaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[257] Schedule 4, Part 1, entry for Circumstances Code “C18037”
substitute:
| C18037 | P18037 | CN18037 | Exemestane | Metastatic (Stage IV) breast cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDThe condition must be hormone receptor positive, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDPatient must be receiving PBS-subsidised everolimus concomitantly for this condition.Patient must not be pre-menopausal.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. |
[258] Schedule 4, Part 1, entry for Circumstances Code “C18144”
substitute:
| C18144 | P18144 | CN18144 | AfliberceptRanibizumab | Branch retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[259] Schedule 4, Part 1, entry for Circumstances Code “C18145”
substitute:
| C18145 | P18145 | CN18145 | AfliberceptRanibizumab | Central retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[260] Schedule 4, Part 1, entry for Circumstances Code “C18146”
substitute:
| C18146 | P18146 | CN18146 | AfliberceptRanibizumab | Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to pathologic myopia (PM), ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[261] Schedule 4, Part 1, entry for Circumstances Code “C18147”
substitute:
| C18147 | P18147 | CN18147 | Ranibizumab | Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must not be due to pathologic myopia, ANDThe condition must not be due to age-related macular degeneration, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[262] Schedule 4, Part 1, entry for Circumstances Code “C18241”
substitute:
| C18241 | P18241 | CN18241 | FedratinibMomelotinibRuxolitinib | Intermediate-1 risk myelofibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 18241 |
[263] Schedule 4, Part 1, entry for Circumstances Code “C18324”
substitute:
| C18324 | P18324 | CN18324 | FedratinibMomelotinibRuxolitinib | High risk and intermediate-2 risk myelofibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 18324 |
[264] Schedule 4, Part 1, entry for Circumstances Code “C18336”
substitute:
| C18336 | P18336 | CN18336 | Dexamethasone | Central retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; ORPatient must have failed prior treatment with VEGF inhibitors, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[265] Schedule 4, Part 1, entry for Circumstances Code “C18428”
substitute:
| C18428 | P18428 | CN18428 | Dexamethasone | Branch retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO), ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment, ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography, ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; ORPatient must have failed prior treatment with VEGF inhibitors, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[266] Schedule 4, Part 1, entry for Circumstances Code “C18490”
substitute:
| C18490 | P18490 | CN18490 | Brolucizumab | Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to age-related macular degeneration (AMD), ANDPatient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:details of the proposed prescription; ANDa completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[267] Schedule 4, Part 1, entry for Circumstances Code “C18686”
substitute:
| C18686 | P18686 | CN18686 | Acalabrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indication - in combination with obinutuzumabThe condition must be untreated with drug treatment at the time of the first dose of this drug; ORPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy, ANDThe treatment must not be in combination with venetoclax.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; ORPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[268] Schedule 4, Part 1, entry for Circumstances Code “C18706”
substitute:
| C18706 | P18706 | CN18706 | Acalabrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Continuing treatment (treatment cycles 3 to 14 inclusive) of first-line therapy - in combination with venetoclaxPatient must have previously received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDThe treatment must not exceed 14 cycles in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first, ANDThe treatment must be in combination with venetoclax, ANDThe treatment must not be in combination with obinutuzumab.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[269] Schedule 4, Part 1, entry for Circumstances Code “C18726”
substitute:
| C18726 | P18726 | CN18726 | Alectinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this indication (i.e. for stage IIIB/IV NSCLC), ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[270] Schedule 4, Part 1, entry for Circumstances Code “C18888”
substitute:
| C18888 | P18888 | CN18888 | Osimertinib | Non-small cell lung cancer (NSCLC)Patient must be each of: (i) initiating treatment with this drug; (ii) have not previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be continuing treatment with this drug for this condition, with an absence of further disease progression while being treated with this drug, ANDPatient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition, ANDPatient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.PBS-subsidised treatment with this drug is restricted to once per lifetime at any disease stage for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).Prescribers must refer to this drug's approved Therapeutic Goods Administration (TGA) Product Information (PI) for the relevant dosing regimens and treatment duration for the specific stage of NSCLC.For patients receiving treatment with this drug as adjuvant therapy, treatment must cease upon disease progression, or after the completion of three years from the first administered dose, whichever comes first. | Compliance with Authority Required procedures |
[271] Schedule 4, Part 1, entry for Circumstances Code “C18901”
substitute:
| C18901 | P18901 | CN18901 | Alectinib | Resected non-small cell lung cancer (NSCLC)Adjuvant therapyPatient must be both: (i) initiating treatment, (ii) untreated with an Anaplastic Lymphoma Kinase-Tyrosine Kinase Inhibitor (ALK-TKI) for non-small cell lung cancer; ORPatient must be continuing existing PBS-subsidised treatment with this drug; ORPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with ALK-TKI at the time this drug was initiated, ANDThe condition must be/have been at least one of: (i) node positive, (ii) at least 4 cm in size, ANDThe treatment must be for the purpose of adjuvant therapy following surgical resection, ANDThe treatment must be commenced within 26 weeks of surgery, ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing, ANDPatient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 24 months of combined non-PBS and PBS-subsidised treatment for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[272] Schedule 4, Part 1, entry for Circumstances Code “C19060”
substitute:
| C19060 | P19060 | CN19060 | Enfortumab vedotin | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerGrandfather arrangement - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2026, ANDPatient must have/have had a WHO performance status score of no greater than 2 prior to initiation of non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab; ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 19060 |
[273] Schedule 4, Part 1, entry for Circumstances Code “C19061”
substitute:
| C19061 | P19061 | CN19061 | Enzalutamide | Hormone sensitive carcinoma of the prostateThe treatment must be for metastatic disease initiated within 6 months of treatment initiation with androgen deprivation therapy unless contraindicated to androgen deprivation therapy; ORThe treatment must be for non-metastatic disease where a baseline PSA doubling time (PSADT) of 9 months or less was observed, and the patient has undergone: (i) radical prostatectomy, (ii) radiation therapy, (iii) neither of the above as both therapies were contraindicated, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (i.e. subsidy cannot occur across different treatment settings); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation, ANDPatient must be undergoing concurrent androgen deprivation therapy unless contraindicated.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.The following applies to patients who are being treated for non-metastatic disease:(a) patients should cease treatment after 36 weeks if PSA is less than 0.2 ng/mL unless continued treatment is clinically indicated and the patient remains free of metastases;(b) patients who ceased treatment after meeting the suspension criteria (PSA less than 0.2 ng/mL after 36 weeks) should resume treatment if PSA levels increase to greater than or equal to 2.0 ng/mL for patients who had undergone radical prostatectomy, or greater than or equal to 5.0 ng/mL for those without prior prostatectomy, provided there is no evidence of metastatic disease. | Compliance with Authority Required procedures |
[274] Schedule 4, Part 1, entry for Circumstances Code “C19104”
substitute:
| C19104 | P19104 | CN19104 | Ruxolitinib | Polycythemia veraSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have achieved and maintained a response to treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures |
[275] Schedule 4, Part 1, entry for Circumstances Code “C19218”
substitute:
| C19218 | P19218 | CN19218 | Asciminib | Chronic Myeloid Leukaemia (CML)Continuing Treatment for patients with T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; OR(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy | Compliance with Written Authority Required procedures |
[276] Schedule 4, Part 1, entry for Circumstances Code “C19225”
substitute:
| C19225 | P19225 | CN19225 | DasatinibImatinibNilotinib | Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be responding to treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19225 |
[277] Schedule 4, Part 1, entry for Circumstances Code “C19226”
substitute:
| C19226 | P19226 | CN19226 | Ponatinib | Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; ORPatient must have demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[278] Schedule 4, Part 1, entry for Circumstances Code “C19234”
substitute:
| C19234 | P19234 | CN19234 | Asciminib | Chronic Myeloid Leukaemia (CML)Continuing treatment for patients without T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a response at 12-monthly intervals of either: (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19234 |
[279] Schedule 4, Part 1, entry for Circumstances Code “C19280”
substitute:
| C19280 | P19280 | CN19280 | Ribociclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine, ANDPatient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[280] Schedule 4, Part 1, entry for Circumstances Code “C19282”
substitute:
| C19282 | P19282 | CN19282 | Abemaciclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib.Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[281] Schedule 4, Part 1, entry for Circumstances Code “C19283”
substitute:
| C19283 | P19283 | CN19283 | Ribociclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab, ANDPatient must require dosage reduction requiring a pack of 21 tablets.Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, and (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[282] Schedule 4, Part 1, after entry for Circumstances Code “C19283”
insert:
| C19286 | P19286 | CN19286 | Deferasirox | Chronic iron overloadInitial treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a serum ferritin level of greater than 1000 microgram/L, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have a median life expectancy exceeding five years.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures |
| C19289 | P19289 | CN19289 | Zoledronic acid | Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months, ANDMust be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19289 |
| C19290 | P19290 | CN19290 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19290 |
| C19292 | P19292 | CN19292 | Mannitol | Cystic fibrosisThe treatment must be as monotherapy, ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19292 |
| C19310 | P19310 | CN19310 | Deferiprone | Iron overloadPatient must have thalassaemia major, ANDPatient must be unable to take desferrioxamine therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19310 |
| C19311 | P19311 | CN19311 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19311 |
| C19312 | P19312 | CN19312 | Deferasirox | Chronic iron overloadInitial treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures |
| C19313 | P19313 | CN19313 | IncobotulinumtoxinA | Moderate to severe spasticity of the lower limb following an acute eventThe condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more, ANDThe treatment must only be used as second line therapy when standard management has failed; ORThe treatment must only be used as an adjunct to physical therapy, ANDThe treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A), ANDPatient must not have established severe contracture in the limb to be treated, ANDThe treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter.Must be treated by a neurologist; ORMust be treated by an orthopaedic surgeon; ORMust be treated by a rehabilitation specialist; ORMust be treated by a plastic surgeon; ORMust be treated by a geriatrician.Patient must be at least 18 years of age.Standard management includes physiotherapy and/or oral spasticity agents. | Compliance with Authority Required procedures - Streamlined Authority Code 19313 |
| C19318 | P19318 | CN19318 | Deferasirox | Chronic iron overloadInitial treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures |
| C19321 | P19321 | CN19321 | Octreotide | Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19321 |
| C19322 | P19322 | CN19322 | Octreotide | Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19322 |
| C19325 | P19325 | CN19325 | Filgrastim | Mobilisation of peripheral blood progenitor cellsThe treatment must be in a normal volunteer for use in allogeneic transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19325 |
| C19326 | P19326 | CN19326 | Filgrastim | Severe congenital neutropeniaPatient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, ANDPatient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19326 |
| C19327 | P19327 | CN19327 | Filgrastim | Chronic cyclical neutropeniaPatient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19327 |
| C19330 | P19330 | CN19330 | Filgrastim | Chronic cyclical neutropeniaPatient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19330 |
| C19332 | P19332 | CN19332 | FilgrastimPegfilgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19332 |
| C19333 | P19333 | CN19333 | Filgrastim | Mobilisation of peripheral blood progenitor cellsThe treatment must be in a normal volunteer for use in allogeneic transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19333 |
| C19334 | P19334 | CN19334 | Filgrastim | Assisting autologous peripheral blood progenitor cell transplantationThe treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19334 |
| C19339 | P19339 | CN19339 | Filgrastim | Mobilisation of peripheral blood progenitor cellsThe treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19339 |
| C19340 | P19340 | CN19340 | Filgrastim | Assisting autologous peripheral blood progenitor cell transplantationThe treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19340 |
| C19374 | P19374 | CN19374 | Valganciclovir | Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19374 |
| C19375 | P19375 | CN19375 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19375 |
| C19378 | P19378 | CN19378 | Dornase alfa | Cystic fibrosisContinuing treatmentPatient must have initiated treatment with dornase alfa at an age of less than 5 years, ANDPatient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.Patient must be 5 years of age or older.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19378 |
| C19379 | P19379 | CN19379 | Mannitol | Cystic fibrosisThe treatment must be in combination with dornase alfa, ANDPatient must be inadequately responsive to dornase alfa, ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19379 |
| C19380 | P19380 | CN19380 | Mannitol | Cystic fibrosisThe treatment must be in combination with dornase alfa, ANDPatient must be inadequately responsive to dornase alfa, ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19380 |
| C19384 | P19384 | CN19384 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19384 |
| C19386 | P19386 | CN19386 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19386 |
| C19392 | P19392 | CN19392 | Filgrastim | Mobilisation of peripheral blood progenitor cellsThe treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19392 |
| C19395 | P19395 | CN19395 | Filgrastim | Severe congenital neutropeniaPatient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, ANDPatient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19395 |
| C19397 | P19397 | CN19397 | Filgrastim | Severe chronic neutropeniaPatient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; ORPatient must have neutrophil dysfunction, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19397 |
| C19398 | P19398 | CN19398 | Filgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19398 |
| C19399 | P19399 | CN19399 | Filgrastim | Assisting bone marrow transplantationPatient must be receiving marrow-ablative chemotherapy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19399 |
| C19400 | P19400 | CN19400 | Filgrastim | Severe chronic neutropeniaPatient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; ORPatient must have neutrophil dysfunction, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19400 |
| C19403 | P19403 | CN19403 | FilgrastimPegfilgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19403 |
| C19418 | P19418 | CN19418 | Evolocumab | Familial homozygous hypercholesterolaemiaContinuing treatmentThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in conjunction with dietary therapy and exercise.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19418 |
| C19424 | P19424 | CN19424 | Ciclosporin | Management of transplant rejectionThe treatment must be used by organ or tissue transplant recipients.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19424 |
| C19428 | P19428 | CN19428 | Zoledronic acid | Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months, ANDMust be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19428 |
| C19429 | P19429 | CN19429 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19429 |
| C19432 | P19432 | CN19432 | Dornase alfa | Cystic fibrosisContinuing treatmentPatient must have initiated treatment with dornase alfa at an age of less than 5 years, ANDPatient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.Patient must be 5 years of age or older.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19432 |
| C19436 | P19436 | CN19436 | Deferiprone | Iron overloadPatient must have thalassaemia major, ANDPatient must be one in whom desferrioxamine therapy has proven ineffective.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19436 |
| C19437 | P19437 | CN19437 | Deferiprone | Iron overloadPatient must have thalassaemia major, ANDPatient must be unable to take desferrioxamine therapy.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19437 |
| C19439 | P19439 | CN19439 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19439 |
| C19442 | P19442 | CN19442 | Octreotide | Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19442 |
| C19443 | P19443 | CN19443 | Filgrastim | Assisting bone marrow transplantationPatient must be receiving marrow-ablative chemotherapy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19443 |
| C19447 | P19447 | CN19447 | Filgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19447 |
| C19449 | P19449 | CN19449 | Pegfilgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19449 |
| C19460 | P19460 | CN19460 | Brentuximab vedotin | Advanced Stage CD30 positive Hodgkin lymphomaThe treatment must be for first line therapy for this condition, ANDThe treatment must be for curative intent, ANDThe treatment must be in combination with a multi-drug chemotherapy regimen, ANDThe treatment must not be more than 6 treatment cycles under this restriction in a lifetime. | Compliance with Authority Required procedures |
| C19461 | P19461 | CN19461 | Teprotumumab | Active moderate to severe thyroid eye diseaseContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a specialist medical practitioner experienced in the management of thyroid eye disease; or in consultation with a specialist medical practitioner experienced in the management of thyroid eye disease.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated. | Compliance with Authority Required procedures - Streamlined Authority Code 19461 |
| C19463 | P19463 | CN19463 | Valganciclovir | Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19463 |
| C19467 | P19467 | CN19467 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19467 |
| C19469 | P19469 | CN19469 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19469 |
| C19470 | P19470 | CN19470 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19470 |
| C19472 | P19472 | CN19472 | Mannitol | Cystic fibrosisThe treatment must be as monotherapy, ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19472 |
| C19476 | P19476 | CN19476 | Desferrioxamine | Disorders of erythropoiesisThe condition must be associated with treatment-related chronic iron overload.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19476 |
| C19477 | P19477 | CN19477 | Desferrioxamine | Disorders of erythropoiesisThe condition must be associated with treatment-related chronic iron overload.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19477 |
| C19479 | P19479 | CN19479 | Octreotide | Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19479 |
| C19492 | P19492 | CN19492 | Deferiprone | Iron overloadPatient must have thalassaemia major, ANDPatient must be one in whom desferrioxamine therapy has proven ineffective.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19492 |
| C19494 | P19494 | CN19494 | Teprotumumab | Active moderate to severe thyroid eye diseaseInitial treatmentPatient must not have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be both: (i) undergoing re-treatment with this drug for this condition; and (ii) have demonstrated response to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must have a clinical activity score (CAS) of at least three for the most severely affected eye, ANDPatient must have two or more of the following: (i) Proptosis at least 3 mm above normal for race and gender; (ii) Lid retraction of at least 2 mm; (iii) Moderate to severe soft-tissue involvement; (iv) Inconstant or constant diplopia.Patient must be at least 18 years of age.Must be treated by a specialist medical practitioner experienced in the treatment of thyroid eye disease.The following must be provided at the time of application and documented in the patient's medical records for the first prescription only:(1) Baseline clinical activity score (CAS), AND(2) Confirmation of the presence of thyroid eye disease.This includes evidence of two or more of the following:(i) Proptosis at least 3 mm above normal for race and gender;(ii) Lid retraction of at least 2 mm;(iii) Moderate to severe soft-tissue involvement;(iv) Inconstant or constant diplopia.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated. | Compliance with Authority Required procedures |
| C19495 | P19495 | CN19495 | Tislelizumab | Advanced or metastatic gastro-oesophageal cancerPatient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer, ANDPatient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, ANDPatient must not have developed disease progression while receiving treatment for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 19495 |
| C19503 | P19503 | CN19503 | Ciclosporin | Management of transplant rejectionThe treatment must be used by organ or tissue transplant recipients.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19503 |
| C19505 | P19505 | CN19505 | Valganciclovir | Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19505 |
| C19506 | P19506 | CN19506 | Deferasirox | Chronic iron overloadContinuing treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 19506 |
| C19507 | P19507 | CN19507 | Clozapine | SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 19507 |
| C19508 | P19508 | CN19508 | Pegfilgrastim | Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19508 |
| C19514 | P19514 | CN19514 | Evolocumab | Familial heterozygous hypercholesterolaemiaContinuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiranThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran, ANDThe treatment must be in conjunction with dietary therapy and exercise, ANDPatient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 19514 |
| C19515 | P19515 | CN19515 | Valganciclovir | Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19515 |
| C19523 | P19523 | CN19523 | Evolocumab | Non-familial hypercholesterolaemiaContinuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiranThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran, ANDThe treatment must be in conjunction with dietary therapy and exercise, ANDPatient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 19523 |
| C19524 | P19524 | CN19524 | Teprotumumab | Active moderate to severe thyroid eye diseaseContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a specialist medical practitioner experienced in the management of thyroid eye disease; or in consultation with a specialist medical practitioner experienced in the management of thyroid eye disease.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated. | Compliance with Authority Required procedures - Streamlined Authority Code 19524 |
| C19533 | P19533 | CN19533 | Octreotide | Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19533 |
| C19534 | P19534 | CN19534 | Lanreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19534 |
| C19538 | P19538 | CN19538 | Octreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19538 |
| C19539 | P19539 | CN19539 | Octreotide | Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19539 |
| C19540 | P19540 | CN19540 | Octreotide | Functional carcinoid tumourPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19540 |
| C19542 | P19542 | CN19542 | Lanreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19542 |
| C19543 | P19543 | CN19543 | Octreotide | Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19543 |
| C19544 | P19544 | CN19544 | Octreotide | Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19544 |
| C19546 | P19546 | CN19546 | Dornase alfa | Cystic fibrosisPatient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; ORPatient must have significant bronchiectasis on chest high resolution computed tomography scan; ORPatient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; ORPatient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy, ANDPatient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must be less than 5 years of age.Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals. | Compliance with Authority Required procedures - Streamlined Authority Code 19546 |
| C19547 | P19547 | CN19547 | Lanreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19547 |
| C19548 | P19548 | CN19548 | Lanreotide | Functional carcinoid tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19548 |
| C19549 | P19549 | CN19549 | Octreotide | Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19549 |
| C19552 | P19552 | CN19552 | Lanreotide | Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19552 |
| C19554 | P19554 | CN19554 | Dornase alfa | Cystic fibrosisPatient must be 5 years of age or older.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19554 |
| C19559 | P19559 | CN19559 | Dornase alfa | Cystic fibrosisPatient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; ORPatient must have significant bronchiectasis on chest high resolution computed tomography scan; ORPatient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; ORPatient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy, ANDPatient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must be less than 5 years of age.Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals. | Compliance with Authority Required procedures - Streamlined Authority Code 19559 |
| C19560 | P19560 | CN19560 | Lanreotide | Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 19560 |
| C19562 | P19562 | CN19562 | Octreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19562 |
| C19563 | P19563 | CN19563 | Dornase alfa | Cystic fibrosisPatient must be 5 years of age or older.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline, AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 19563 |
| C19565 | P19565 | CN19565 | Octreotide | Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must be unresectable locally advanced disease or metastatic disease, ANDThe condition must be World Health Organisation (WHO) grade 1 or 2, ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. | Compliance with Authority Required procedures - Streamlined Authority Code 19565 |
[283] Schedule 4, Part 2, after entry for Variation Code “V19207”
insert:
| V19460 | Brentuximab vedotin | At the time of the authority application, medical practitioners must request the appropriate maximum amount and number of repeats to complete up to 6 cycles of treatment based on the following: Up to a maximum of 180 mg and 5 repeats may be requested where dosing is administered as part of the BrECADD regimen (i.e. in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone); or Up to a maximum of 120 mg and 11 repeats may be requested where dosing is administered as part of the A+AVD regimen (i.e. in combination with doxorubicin, vinblastine and dacarbazine) |
| V19461 | Teprotumumab | Increased quantities may only be authorised where a patient's weight is greater than 150 kg. |
| V19494 | Teprotumumab | Increased quantities may only be authorised where a patient's weight is greater than 150 kg. |
| V19524 | Teprotumumab | Increased quantities may only be authorised where a patient's weight is greater than 150 kg. |
[284] Schedule 5, entry for Abiraterone [GRP-29232]
insert in the column headed “Brand” after entry for the brand “ABIRATERONE VIATRIS”: ABURA
[285] Schedule 5, entry for Abiraterone [GRP-29234]
insert in the column headed “Brand” after entry for the brand “ABIRATERONE VIATRIS”: ABURA
[286] Schedule 5, after entry for Acarbose in the form Tablet 100 mg
insert:
| Acarbose | GRP-20667 | Tablet 100 mg (S19A) | Oral | Acarbose 100 mg tablets (Morningside Healthcare, UK) |
[287] Schedule 5, after entry for Acarbose in the form Tablet 50 mg
insert:
| Acarbose | GRP-20669 | Tablet 50 mg (S19A) | Oral | Acarbose 50 mg tablets (Morningside Healthcare, UK) |
[288] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen
insert as the first entry in the column headed “Brand”: Amgevita
[289] Schedule 5, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe
insert as the first entry in the column headed “Brand”: Amgevita
[290] Schedule 5, entry for Adalimumab [GRP-29113]
insert as the first entry in the column headed “Brand”: Amgevita
[291] Schedule 5, after entry for Aflibercept in the form Solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL) pre-filled syringe
insert:
| Albendazole | GRP-31320 | Tablet 400 mg | Oral | Eskazole |
| Albendazole | GRP-31320 | Tablet 400 mg (s19A) | Oral | Albendazole (Micro Labs, Germany) |
[292] Schedule 5, entry for Aripiprazole [GRP-20659]
omit from the column headed “Brand”: ARIPIPRAZOLE-WGR
[293] Schedule 5, after entry for Ceftriaxone
insert:
| Cefuroxime | GRP-21541 | Tablet 250 mg (as axetil) | Oral | ARX-CefuroximePharmacor Cefuroxime |
[294] Schedule 5, entry for Dasatinib [GRP-25711]
insert in the column headed “Brand” after entry for the brand “Dasatinib Viatris”: MSN Dasatinib
[295] Schedule 5, entry for Dasatinib [GRP-25721]
insert in the column headed “Brand” after entry for the brand “Dasatinib Viatris”: MSN Dasatinib
[296] Schedule 5, entry for Dasatinib [GRP-25723]
insert in the column headed “Brand” after entry for the brand “Dasatinib Viatris”: MSN Dasatinib
[297] Schedule 5, entry for Dasatinib [GRP-25725]
insert in the column headed “Brand” after entry for the brand “Dasatinib Viatris”: MSN Dasatinib
[298] Schedule 5, entry for Deferasirox [GRP-25308]
insert in the column headed “Brand” after entry for the brand “Deferasirox ARX”: Deferasirox FCT MSN
[299] Schedule 5, entry for Eplerenone [GRP-20663]
insert in the column headed “Brand” after entry for the brand “APO-Eplerenone”: Eplerenone Viatris
[300] Schedule 5, entry for Ezetimibe
insert in the column headed “Brand” after entry for the brand “Ezetimibe Sandoz”: Ezetimibe Viatris
[301] Schedule 5, entries for Glatiramer
omit:
| Glatiramer | GRP-25987 | Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen | Injection | Copaxone |
[302] Schedule 5, entry for Meloxicam in the form Capsule 15 mg
omit from the column headed “Brand”: Mobic
[303] Schedule 5, entry for Metformin [GRP-15054]
insert in the column headed “Brand” after entry for the brand “Diaformin Alphapharm XR”: Diaformin Viatris XR
[304] Schedule 5, entry for Nitrofurantoin [GRP-23944]
insert in the column headed “Brand” after entry for the brand “ARX-Nitrofurantoin”: Fudantin
[305] Schedule 5, entry for Nitrofurantoin [GRP-23946]
insert in the column headed “Brand” after entry for the brand “ARX-Nitrofurantoin”: Fudantin
[306] Schedule 5, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating)
omit from the column headed “Brand”: OLANZAPINE ODT-WGR
[307] Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)
omit from the column headed “Brand”: OLANZAPINE ODT-WGR
[308] Schedule 5, entry for Ondansetron GRP-989
insert in the column headed “Brand” after entry for the brand “Ondansetron Tablets Viatris”: Ondansetron VTRS
[309] Schedule 5, entries for Prazosin
omit:
| Prazosin | GRP-908 | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) |
[310] Schedule 5, entry for Rivaroxaban in the form Tablet 10 mg [GRP-29128]
insert in the column headed “Brand” after entry for the brand “ARX-Rivaroxaban 10”: Blooms The Chemist Rivaroxaban
[311] Schedule 5, entry for Rivaroxaban in the form Tablet 15 mg [GRP-29130]
insert in the column headed “Brand” after entry for the brand “ARX-Rivaroxaban 15”: Blooms The Chemist Rivaroxaban
[312] Schedule 5, entry for Rivaroxaban in the form Tablet 20 mg
insert in the column headed “Brand” after entry for the brand “ARX-Rivaroxaban 20”: Blooms The Chemist Rivaroxaban
[313] Schedule 5, entry for Rivaroxaban in the form Tablet 15 mg [GRP-29134]
insert in the column headed “Brand” after entry for the brand “ARX-Rivaroxaban 15”: Blooms The Chemist Rivaroxaban
[314] Schedule 5, entry for Rivaroxaban [GRP-29137]
insert in the column headed “Brand” after entry for the brand “Rivaroxaban Lupin”: Rivaroxaban Sandoz
[315] Schedule 5, entries for Sacubitril with valsartan [GRP-29537; GRP-29539; GRP-29541]
insert in the column headed “Brand” after entry for the brand “Entresto” (all instances): MSN-SACUBITRIL/VALSARTAN
[316] Schedule 5, after entry for Safinamide [GRP-30156]
insert:
| Salbutamol | GRP-921 | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 | Inhalation | Ventolin Nebules |
| Salbutamol | GRP-921 | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 (S19A) | Inhalation | PMS-SALBUTAMOL (Canada) |
[317] Schedule 5, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg
insert in the column headed “Brand” after entry for the brand “Renagel”: Sevelamer Waymade
[318] Schedule 5, entry for Sitagliptin with metformin [GRP-27961]
insert as the first entry in the column headed “Brand”: ARX-Sitagliptin/Metformin XR 100/1000
[319] Schedule 5, entry for Sitagliptin with metformin [GRP-27963]
insert as the first entry in the column headed “Brand”: ARX-Sitagliptin/Metformin XR 50/1000
[320] Schedule 5, entry for Tranexamic acid
insert in the column headed “Brand” after entry for the brand “APO-Tranexamic Acid”: ARX-TRANEXAMIC ACID
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.