Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024)
[1] Schedule 1, Part 1, after entry for Abemaciclib in the form Tablet 150 mg
insert:
Abiraterone | Tablet containing abiraterone acetate 250 mg | Oral | Abiraterone-Teva | TB | MP | C13945 | | 120 | 2 | | 120 | | |
[2] Schedule 1, Part 1, after entry for Abiraterone in the form Tablet containing abiraterone acetate 250 mg [Brand: Zytiga]
insert:
Abiraterone | Tablet containing abiraterone acetate 500 mg | Oral | Abiraterone-Teva | TB | MP | C13945 | | 60 | 2 | | 60 | | |
[3] Schedule 1, Part 1, entry for Ambrisentan in the form Tablet 5 mg [Brand: Cipla Ambrisentan]
omit from the column headed “Responsible Person”: LR substitute: ZU
[4] Schedule 1, Part 1, entry for Ambrisentan in the form Tablet 10 mg [Brand: Cipla Ambrisentan]
omit from the column headed “Responsible Person”: LR substitute: ZU
[5] Schedule 1, Part 1, after entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Brand: Trovas; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Atovaquone | Oral suspension 750 mg per 5 mL, 210 mL | Oral | ATOVACUE | JM | MP NP | C5609 | | 1 | 0 | | 1 | | |
[6] Schedule 1, Part 1, after entry for Beclometasone with formoterol and glycopyrronium in the form Pressurised inhalation containing beclometasone dipropionate 200 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses
insert:
Belzutifan | Tablet 40 mg | Oral | Welireg | MK | MP | C16180 C16208 C16215 | | 90 | 5 | | 90 | | |
[7] Schedule 1, Part 1, entries for Bortezomib in the form Powder for injection 3.5 mg
omit:
Bortezomib | Powder for injection 3.5 mg | Injection | BORTEZOMIB-TEVA | TB | MP | C11099 C13745 | | See Note 3 | See Note 3 | | 1 | | D(100) |
[8] Schedule 1, Part 1, after entry for Cabazitaxel in the form Solution concentrate for I.V. infusion 60 mg in 6 mL [Brand: Cabazitaxel Ever Pharma]
insert:
Cabergoline | Tablet 500 micrograms | Oral | Dostamine | NB | MP | C5136 C5137 C5357 C5398 | P5136 P5137 P5357 P5398 | 8 | 5 | | 8 | | |
Cabergoline | Tablet 500 micrograms | Oral | Dostamine | NB | MP | C14918 C14959 C14983 C15005 | P14918 P14959 P14983 P15005 | 16 | 5 | | 8 | | |
[9] Schedule 1, Part 1, entries for Carbamazepine in the forms: Tablet 200 mg (controlled release); and Tablet 400 mg (controlled release)
substitute:
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | PDP | | | 200 | 0 | | 100 | | |
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | PDP | | | 200 | 0 | | 200 | | |
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | MP NP | | | 200 | 2 | | 100 | | |
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | MP NP | | | 200 | 2 | | 200 | | |
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | MP NP | | P14238 | 400 | 2 | | 100 | | |
Carbamazepine | Tablet 200 mg (controlled release) | Oral | Tegretol CR 200 | NV | MP NP | | P14238 | 400 | 2 | | 200 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | PDP | | | 200 | 0 | | 100 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | PDP | | | 200 | 0 | | 200 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | MP NP | | | 200 | 2 | | 100 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | MP NP | | | 200 | 2 | | 200 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | MP NP | | P14238 | 400 | 2 | | 100 | | |
Carbamazepine | Tablet 400 mg (controlled release) | Oral | Tegretol CR 400 | NV | MP NP | | P14238 | 400 | 2 | | 200 | | |
[10] Schedule 1, Part 1, omit entries for Carmellose in the form Eye drops containing carmellose sodium 5 mg per mL, 15 mL
[11] Schedule 1, Part 1, omit entries for Carmellose in the form Eye drops containing carmellose sodium 10 mg per mL, 15 mL
[12] Schedule 1, Part 1, omit entries for Carmellose with glycerin
[13] Schedule 1, Part 1, omit entries for Cefepime
[14] Schedule 1, Part 1, after entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 2]
insert:
Clonazepam | Tablet 2 mg (S19A) | Oral | Clonazepam USP (Advagen Pharma, USA) | LM | MP NP | C11746 | P11746 | 100 | 3 | | 100 | | |
Clonazepam | Tablet 2 mg (S19A) | Oral | Clonazepam USP (Advagen Pharma, USA) | LM | MP NP | C6296 | P6296 | 200 | 2 | | 100 | | |
[15] Schedule 1, Part 1, omit entries for Colestyramine in the form Sachet containing 4 g oral powder (s19A)
[16] Schedule 1, Part 1, entries for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
Cyproterone | Tablet containing cyproterone acetate 100 mg | Oral | Pharmacor Cyproterone 100 | CR | MP | | | 50 | 5 | | 50 | | |
Cyproterone | Tablet containing cyproterone acetate 100 mg | Oral | Pharmacor Cyproterone 100 | CR | MP | | P14238 | 100 | 5 | | 50 | | |
[17] Schedule 1, Part 1, entry for Dapagliflozin [Maximum Quantity: 28; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16220
(b) insert in numerical order in the column headed “Purposes”: P16220
[18] Schedule 1, Part 1, entry for Dapagliflozin [Maximum Quantity: 56; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16164
(b) insert in numerical order in the column headed “Purposes”: P16164
[19] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16158
(b) insert in numerical order in the column headed “Purposes”: P16158
[20] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride [Maximum Quantity: 112; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16162
(b) insert in numerical order in the column headed “Purposes”: P16162
[21] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride [Maximum Quantity: 28; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16158
(b) insert in numerical order in the column headed “Purposes”: P16158
[22] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16162
(b) insert in numerical order in the column headed “Purposes”: P16162
[23] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride [Maximum Quantity: 28; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16158
(b) insert in numerical order in the column headed “Purposes”: P16158
[24] Schedule 1, Part 1, entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C16162
(b) insert in numerical order in the column headed “Purposes”: P16162
[25] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 20 mg [Brand: Dasatinib Dr.Reddy's; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Dasatinib | Tablet 20 mg | Oral | Dasatinib Sandoz | SZ | MP | C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | | 60 | | |
Dasatinib | Tablet 20 mg | Oral | Dasatinib Sandoz | SZ | MP | C12522 C12524 C12530 C12561 C12565 C12570 | P12522 P12524 P12530 P12561 P12565 P12570 | 60 | 5 | | 60 | | |
[26] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 50 mg [Brand: Dasatinib Dr.Reddy's; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Dasatinib | Tablet 50 mg | Oral | Dasatinib Sandoz | SZ | MP | C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | | 60 | | |
Dasatinib | Tablet 50 mg | Oral | Dasatinib Sandoz | SZ | MP | C12522 C12524 C12530 C12561 C12565 C12570 | P12522 P12524 P12530 P12561 P12565 P12570 | 60 | 5 | | 60 | | |
[27] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 70 mg [Brand: Dasatinib Dr.Reddy's; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Dasatinib | Tablet 70 mg | Oral | Dasatinib Sandoz | SZ | MP | C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | | 60 | | |
Dasatinib | Tablet 70 mg | Oral | Dasatinib Sandoz | SZ | MP | C12522 C12524 C12530 C12561 C12565 C12570 | P12522 P12524 P12530 P12561 P12565 P12570 | 60 | 5 | | 60 | | |
[28] Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 100 mg [Brand: Dasatinib Dr.Reddy's; Maximum Quantity: 30; Number of Repeats: 5]
insert:
Dasatinib | Tablet 100 mg | Oral | Dasatinib Sandoz | SZ | MP | C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | | 30 | | |
Dasatinib | Tablet 100 mg | Oral | Dasatinib Sandoz | SZ | MP | C12522 C12524 C12530 C12561 C12565 C12570 | P12522 P12524 P12530 P12561 P12565 P12570 | 30 | 5 | | 30 | | |
[29] Schedule 1, Part 1, entry for Daunorubicin with cytarabine
(a) omit from the column headed “Circumstances”: See Note 3 substitute: C16187 C16197
(b) omit from the column headed “Purposes”: See Note 3
[30] Schedule 1, Part 1, entries for Decitabine with cedazuridine
omit from the column headed “Responsible Person” (all instances): OS substitute (all instances): TJ
[31] Schedule 1, Part 1, after entry for Dicloxacillin in the form Capsule 500 mg (as sodium) [Brand: Distaph 500; Maximum Quantity: 48; Number of Repeats: 1]
insert:
Dienogest | Tablet 2 mg | Oral | Visanne | BN | MP NP | C16222 | | 28 | 5 | | 28 | | |
[32] Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
omit from the column headed “Circumstances”: C1250a7 substitute: C12507
[33] Schedule 1, Part 1, after entry for Dutasteride with tamsulosin in the form Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms [Brand: Duodart 500ug/400ug; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Dutasteride with tamsulosin | Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms | Oral | Dutasteride/Tamsulosin Lupin 500/400 | GQ | MP NP | C6189 | P6189 | 30 | 5 | | 30 | | |
Dutasteride with tamsulosin | Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms | Oral | Dutasteride/Tamsulosin Lupin 500/400 | GQ | MP NP | C15004 | P15004 | 60 | 5 | | 30 | | |
[34] Schedule 1, Part 1, entries for Elotuzumab
substitute:
Elotuzumab | Powder for injection 300 mg | Injection | Empliciti | BQ | MP | C12847 | | See Note 3 | See Note 3 | | 1 | | D(100) |
Elotuzumab | Powder for injection 400 mg | Injection | Empliciti | BQ | MP | C12847 | | See Note 3 | See Note 3 | | 1 | | D(100) |
[35] Schedule 1, Part 1, omit entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL
[36] Schedule 1, Part 1, omit entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL
[37] Schedule 1, Part 1, omit entry for Evolocumab in the form Injection 420 mg in 3.5 mL single use pre-filled cartridge
[38] Schedule 1, Part 1, after entry for Ezetimibe in the form Tablet 10 mg [Brand: Zient 10mg; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Ezetimibe | Tablet 10 mg (S19A) | Oral | Ezetimibe USP (Camber, USA) | RQ | MP NP | | | 30 | 5 | | 90 | | |
Ezetimibe | Tablet 10 mg (S19A) | Oral | Ezetimibe USP (Camber, USA) | RQ | MP NP | | P14238 | 60 | 5 | | 90 | | |
[39] Schedule 1, Part 1, after entry for Gabapentin in the form Capsule 400 mg [Brand: Nupentin 400]
insert:
Gabapentin | Tablet 600 mg | Oral | APX-GABAPENTIN | TX | MP NP | C4928 | | 100 | 5 | | 100 | | |
[40] Schedule 1, Part 1, after entry for Ibuprofen in the form Tablet 400 mg [Brand: Brufen; Maximum Quantity: 90; Number of Repeats: 3]
insert:
Ibuprofen | Tablet 400 mg | Oral | WGR-IBUPROFEN 400 | WG | MP NP MW PDP | | | 30 | 0 | | 30 | | |
Ibuprofen | Tablet 400 mg | Oral | WGR-IBUPROFEN 400 | WG | PDP | | P6256 P6282 | 90 | 0 | | 30 | | |
Ibuprofen | Tablet 400 mg | Oral | WGR-IBUPROFEN 400 | WG | MP NP | | P6149 P6214 P6283 | 90 | 3 | | 30 | | |
[41] Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imanib; Maximum Quantity: 60; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C9319
(b) insert in numerical order in the column headed “Circumstances”: C13132
(c) insert in numerical order in the column headed “Purposes”: P9319
(d) insert in numerical order in the column headed “Purposes”: P13132
[42] Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imanib; Maximum Quantity: 60; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C9238
(b) insert in numerical order in the column headed “Circumstances”: C9278
(c) insert in numerical order in the column headed “Purposes”: P9238
(d) insert in numerical order in the column headed “Purposes”: P9278
[43] Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib Sandoz; Maximum Quantity: 60; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C9319
(b) insert in numerical order in the column headed “Circumstances”: C13132
(c) insert in numerical order in the column headed “Purposes”: P9319
(d) insert in numerical order in the column headed “Purposes”: P13132
[44] Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib Sandoz; Maximum Quantity: 60; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C9238
(b) insert in numerical order in the column headed “Circumstances”: C9278
(c) insert in numerical order in the column headed “Purposes”: P9238
(d) insert in numerical order in the column headed “Purposes”: P9278
[45] Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imanib; Maximum Quantity: 30; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C9319
(b) insert in numerical order in the column headed “Circumstances”: C13132
(c) insert in numerical order in the column headed “Purposes”: P9319
(d) insert in numerical order in the column headed “Purposes”: P13132
[46] Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imanib; Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C9238
(b) insert in numerical order in the column headed “Circumstances”: C9278
(c) insert in numerical order in the column headed “Purposes”: P9238
(d) insert in numerical order in the column headed “Purposes”: P9278
[47] Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib Sandoz; Maximum Quantity: 30; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C9319
(b) insert in numerical order in the column headed “Circumstances”: C13132
(c) insert in numerical order in the column headed “Purposes”: P9319
(d) insert in numerical order in the column headed “Purposes”: P13132
[48] Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib Sandoz; Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C9238
(b) insert in numerical order in the column headed “Circumstances”: C9278
(c) insert in numerical order in the column headed “Purposes”: P9238
(d) insert in numerical order in the column headed “Purposes”: P9278
[49] Schedule 1, Part 1, entries for Ketoprofen
omit:
Ketoprofen | Capsule 200 mg (sustained release) | Oral | Oruvail SR | AV | PDP | C6214 | | 28 | 0 | | 28 | | |
Ketoprofen | Capsule 200 mg (sustained release) | Oral | Oruvail SR | AV | MP NP | C6214 | | 28 | 3 | | 28 | | |
[50] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 5 mg
omit:
Lenalidomide | Capsule 5 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 14 | | D(100) |
Lenalidomide | Capsule 5 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 21 | | D(100) |
Lenalidomide | Capsule 5 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 28 | | D(100) |
[51] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 10 mg
omit:
Lenalidomide | Capsule 10 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 14 | | D(100) |
Lenalidomide | Capsule 10 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 21 | | D(100) |
Lenalidomide | Capsule 10 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 28 | | D(100) |
[52] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 15 mg
omit:
Lenalidomide | Capsule 15 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 14 | | D(100) |
Lenalidomide | Capsule 15 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 21 | | D(100) |
Lenalidomide | Capsule 15 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 28 | | D(100) |
[53] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 25 mg
omit:
Lenalidomide | Capsule 25 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 14 | | D(100) |
Lenalidomide | Capsule 25 mg | Oral | Cipla Lenalidomide | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 21 | | D(100) |
[54] Schedule 1, Part 1, entries for Lisdexamfetamine
omit from the column headed “Circumstances” (all instances): C10792 substitute (all instances): C16154
[55] Schedule 1, Part 1, omit entry for Medroxyprogesterone in the form Injection containing medroxyprogesterone acetate 150 mg in 1 mL
[56] Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg [Brand: Diaformin; Maximum Quantity: 200; Number of Repeats: 5]
insert:
Metformin | Tablet containing metformin hydrochloride 500 mg | Oral | Diaformin Viatris | MQ | MP NP | | | 100 | 5 | | 100 | | |
Metformin | Tablet containing metformin hydrochloride 500 mg | Oral | Diaformin Viatris | MQ | MP NP | | P14238 | 200 | 5 | | 100 | | |
[57] Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 1 g [Brand: Metformin Sandoz; Maximum Quantity: 180; Number of Repeats: 5]
insert:
Metformin | Tablet containing metformin hydrochloride 1 g | Oral | METFORMIN-WGR | WG | MP NP | | | 90 | 5 | | 90 | | |
Metformin | Tablet containing metformin hydrochloride 1 g | Oral | METFORMIN-WGR | WG | MP NP | | P14238 | 180 | 5 | | 90 | | |
[58] Schedule 1, Part 1, after entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL [Brand: Biodone Forte]
insert:
Methadone | Tablet containing methadone hydrochloride 10 mg | Oral | METHADONE-AFT | AE | MP NP | C15994 C15996 C16000 | P15994 P15996 P16000 | 20 | 0 | V15994 V15996 V16000 | 20 | | |
Methadone | Tablet containing methadone hydrochloride 10 mg | Oral | METHADONE-AFT | AE | MP NP | C11696 | P11696 | 120 | 0 | V11696 | 20 | | |
[59] Schedule 1, Part 1, entries for Methylphenidate in each of the forms: Capsule containing methylphenidate hydrochloride 10 mg (modified release); Capsule containing methylphenidate hydrochloride 20 mg (modified release); Capsule containing methylphenidate hydrochloride 30 mg (modified release); Capsule containing methylphenidate hydrochloride 40 mg (modified release); and Capsule containing methylphenidate hydrochloride 60 mg (modified release)
omit from the column headed “Circumstances” (all instances): C13922 substitute (all instances): C16152
[60] Schedule 1, Part 1, entries for Methylphenidate in each of the forms: Tablet containing methylphenidate hydrochloride 18 mg (extended release); Tablet containing methylphenidate hydrochloride 27 mg (extended release); Tablet containing methylphenidate hydrochloride 36 mg (extended release); and Tablet containing methylphenidate hydrochloride 54 mg (extended release)
omit from the column headed “Circumstances” (all instances): C10717 substitute (all instances): C16189
[61] Schedule 1, Part 1, entry for Molnupiravir
omit from the column headed “Circumstances”: C15050 C15055 C15056 C15062 substitute: C16190 C16191 C16200 C16201
[62] Schedule 1, Part 1, entries for Nevirapine in the form Tablet 200 mg
omit:
Nevirapine | Tablet 200 mg | Oral | Nevirapine Alphapharm | AF | MP NP | C4454 C4512 | | 120 | 5 | | 60 | | D(100) |
[63] Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir
omit from the column headed “Circumstances”: C13748 C13759 C13821 C15049 substitute: C16155 C16156 C16192 C16223
[64] Schedule 1, Part 1, entries for Nivolumab with relatlimab
substitute:
Nivolumab with relatlimab | Solution concentrate for I.V. infusion containing 240 mg nivolumab and 80 mg relatlimab in 20 mL | Injection | Opdualag | BQ | MP | C16151 C16188 | | See Note 3 | See Note 3 | | 1 | | D(100) |
[65] Schedule 1, Part 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) [Brand: Sevikar 20/5; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Olmesartan with amlodipine | Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) | Oral | APO-OLMESARTAN/AMLODIPINE 40/10 | TY | MP NP | C4373 | P4373 | 30 | 5 | | 30 | | |
Olmesartan with amlodipine | Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) | Oral | APO-OLMESARTAN/AMLODIPINE 40/10 | TY | MP NP | C14839 | P14839 | 60 | 5 | | 30 | | |
[66] Schedule 1, Part 1, entries for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
omit:
Paraffin | Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | Refresh Night Time | VE | MP NP AO | | | 1 | 5 | | 1 | | |
Paraffin | Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | Refresh Night Time | VE | MP NP AO | | P14238 | 2 | 5 | | 1 | | |
[67] Schedule 1, Part 1, after entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride) [Brand: APOTEX-Pioglitazone; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Pioglitazone | Tablet 45 mg (as hydrochloride) | Oral | ARX-PIOGLITAZONE | XT | MP NP | C15321 | P15321 | 28 | 5 | | 28 | | |
Pioglitazone | Tablet 45 mg (as hydrochloride) | Oral | ARX-PIOGLITAZONE | XT | MP NP | C15290 | P15290 | 56 | 5 | | 28 | | |
[68] Schedule 1, Part 1, omit entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg (S19A)
[69] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 2.5 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 120; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 2.5 mg | Oral | RIVOXA | CR | MP NP | C10992 | P10992 | 60 | 5 | | 60 | | |
Rivaroxaban | Tablet 2.5 mg | Oral | RIVOXA | CR | MP | C11013 | P11013 | 60 | 5 | | 60 | | |
Rivaroxaban | Tablet 2.5 mg | Oral | RIVOXA | CR | MP NP | C14298 | P14298 | 120 | 5 | | 60 | | |
[70] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 10 mg [Brand: iXarola; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 10 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C4402 | P4402 | 30 | 0 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C4132 | P4132 | 30 | 5 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C14300 | P14300 | 60 | 5 | | 30 | | |
[71] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 10 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 10 mg | Oral | Rivoxa | CR | MP NP | C4402 | P4402 | 30 | 0 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | Rivoxa | CR | MP NP | C4132 | P4132 | 30 | 5 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | Rivoxa | CR | MP NP | C14300 | P14300 | 60 | 5 | | 30 | | |
[72] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 15 mg [Brand: iXarola; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 15 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C4269 | P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 15 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C4098 C5098 | P4098 P5098 | 42 | 0 | | 42 | | |
Rivaroxaban | Tablet 15 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C14301 | P14301 | 56 | 5 | | 28 | | |
[73] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 15 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 15 mg | Oral | Rivoxa | CR | MP NP | C4269 | P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 15 mg | Oral | Rivoxa | CR | MP NP | C4098 C5098 | P4098 P5098 | 42 | 0 | | 42 | | |
Rivaroxaban | Tablet 15 mg | Oral | Rivoxa | CR | MP NP | C14301 | P14301 | 56 | 5 | | 28 | | |
[74] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 20 mg [Brand: iXarola; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 20 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C4099 C4132 C4268 C4269 | P4099 P4132 P4268 P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 20 mg | Oral | Rivaroxaban Sandoz | SZ | MP NP | C14264 C14300 C14301 C14318 | P14264 P14300 P14301 P14318 | 56 | 5 | | 28 | | |
[75] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 20 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 20 mg | Oral | Rivoxa | CR | MP NP | C4099 C4132 C4268 C4269 | P4099 P4132 P4268 P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 20 mg | Oral | Rivoxa | CR | MP NP | C14264 C14300 C14301 C14318 | P14264 P14300 P14301 P14318 | 56 | 5 | | 28 | | |
[76] Schedule 1, Part 1, after entry for Rivastigmine in the form Transdermal patch 27 mg [Authorised Prescriber MP; Maximum Quantity: 30; Number of Repeats: 5]
insert:
Rizatriptan | Tablet (orally disintegrating) 10 mg (as benzoate) | Oral | APO-RIZATRIPTAN ODT | TW | MP NP | C5708 | | 4 | 5 | | 2 | | |
[77] Schedule 1, Part 1, entry for Testosterone in the form Transdermal cream 50 mg per mL, 50 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C11838 C11891 C11947 C11962 C11963 substitute: C16166 C16194 C16204 C16211 C16212
(b) omit from the column headed “Purposes”: P11838 P11891 P11947 P11962 P11963 substitute: P16166 P16194 P16204 P16211 P16212
[78] Schedule 1, Part 1, entry for Testosterone in the form Transdermal cream 50 mg per mL, 50 mL [Maximum Quantity: 2; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C15622 C15623 C15654 C15739 C15756 substitute: C16186 C16195 C16206 C16207 C16214
(b) omit from the column headed “Purposes”: P15622 P15623 P15654 P15739 P15756 substitute: P16186 P16195 P16206 P16207 P16214
[79] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C14696
(b) omit from the column headed “Purposes”: P14696
[80] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 30 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C14696
(b) omit from the column headed “Purposes”: P14696
[81] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 45 mg [Maximum Quantity: 28; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C14696
(b) omit from the column headed “Purposes”: P14696
[82] Schedule 1, Part 1, entries for Vancomycin
omit:
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | MP | C5717 | P5717 | 2 | 0 | | 1 | | |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | PDP | C5801 | P5801 | 2 | 0 | | 1 | | |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | MP | C5716 C5769 | P5716 P5769 | 5 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | MP | C5717 | P5717 | 1 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | PDP | C5801 | P5801 | 1 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | MP | C5716 C5769 | P5716 P5769 | 3 | 0 | | 1 | | |
[83] Schedule 1, Part 1, after entry for Vancomycin in the form Capsule 250 mg (250,000 I.U.) (as hydrochloride) [Brand: Vancomycin BNM 250mg]
insert:
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | MP | C5717 | P5717 | 2 | 0 | | 1 | | |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | PDP | C5801 | P5801 | 2 | 0 | | 1 | | |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | MP | C5716 C5769 | P5716 P5769 | 5 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | MP | C5717 | P5717 | 1 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | PDP | C5801 | P5801 | 1 | 0 | | 1 | | |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | Vancomycin Viatris | AL | MP | C5716 C5769 | P5716 P5769 | 3 | 0 | | 1 | | |
[84] Schedule 1, Part 1, entries for Varenicline
substitute:
Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | Champix | PF | MP NP | C6871 | | 1 | 0 | | 1 | | |
Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | PHARMACOR VARENICLINE | CR | MP NP | C6871 | | 1 | 0 | | 1 | | |
Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | VARENAPIX | TX | MP NP | C6871 | | 1 | 0 | | 1 | | |
Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | Varenicline Sandoz | SZ | MP NP | C6871 | | 1 | 0 | | 1 | | |
Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | Varenicline Viatris | AF | MP NP | C6871 | | 1 | 0 | | 1 | | |
Varenicline | Tablet 1 mg | Oral | Champix | PF | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | Champix | PF | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | PHARMACOR VARENICLINE | CR | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | PHARMACOR VARENICLINE | CR | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | VARENAPIX | TX | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | VARENAPIX | TX | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | Varenicline Sandoz | SZ | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | Varenicline Sandoz | SZ | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | Varenicline Viatris | AF | MP NP | C6885 | P6885 | 56 | 2 | | 56 | | |
Varenicline | Tablet 1 mg | Oral | Varenicline Viatris | AF | MP NP | C7483 | P7483 | 112 | 0 | | 56 | | |
[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]
substitute:
Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL | Injection | Zoledronate-DRLA 4 | RZ | MP | C14729 C14735 | P14729 P14735 | 1 | 0 | | 1 | | PB(100) |
Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL | Injection | Zoledronate-DRLA 4 | RZ | MP | C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 | P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328 | 1 | 11 | | 1 | | PB(100) |
[86] Schedule 1, Part 2, after entry for Budesonide with formoterol
insert:
Carmellose | Eye drops containing carmellose sodium 5 mg per mL, 15 mL | Application to the eye | Refresh Tears Plus | VE | 1 | | |
Carmellose | Eye drops containing carmellose sodium 10 mg per mL, 15 mL | Application to the eye | Refresh Liquigel | VE | 1 | | |
Carmellose with glycerin | Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL | Application to the eye | Optive | VE | 1 | | |
Evolocumab | Injection 420 mg in 3.5 mL single use pre-filled cartridge | Injection | Repatha | AN | 1 | | |
[87] Schedule 3, after entry for Responsible Person JC
insert:
JM | Glenmark Pharmaceuticals (Australia) Pty Ltd | 23 116 922 500 |
[88] Schedule 3, after entry for Responsible Person TG
insert:
TJ | Taiho Pharma Oceania Pty Ltd | 97 675 212 530 |
[89] Schedule 3, after entry for Responsible Person ZS
insert:
ZU | Seekwell Pty Ltd | 91 624 401 618 |
[90] Schedule 4, Part 1, omit entry for Circumstances Code “C10717”
[91] Schedule 4, Part 1, omit entry for Circumstances Code “C10792”
[92] Schedule 4, Part 1, omit entry for Circumstances Code “C11838”
[93] Schedule 4, Part 1, omit entry for Circumstances Code “C11891”
[94] Schedule 4, Part 1, omit entry for Circumstances Code “C11947”
[95] Schedule 4, Part 1, omit entry for Circumstances Code “C11962”
[96] Schedule 4, Part 1, omit entry for Circumstances Code “C11963”
[97] Schedule 4, Part 1, omit entry for Circumstances Code “C12891”
[98] Schedule 4, Part 1, omit entry for Circumstances Code “C13748”
[99] Schedule 4, Part 1, omit entry for Circumstances Code “C13759”
[100] Schedule 4, Part 1, omit entry for Circumstances Code “C13821”
[101] Schedule 4, Part 1, omit entry for Circumstances Code “C13922”
[102] Schedule 4, Part 1, omit entry for Circumstances Code “C14696”
[103] Schedule 4, Part 1, omit entry for Circumstances Code “C14812”
[104] Schedule 4, Part 1, omit entry for Circumstances Code “C14815”
[105] Schedule 4, Part 1, omit entry for Circumstances Code “C14819”
[106] Schedule 4, Part 1, omit entry for Circumstances Code “C14829”
[107] Schedule 4, Part 1, omit entry for Circumstances Code “C15049”
[108] Schedule 4, Part 1, omit entry for Circumstances Code “C15050”
[109] Schedule 4, Part 1, omit entry for Circumstances Code “C15055”
[110] Schedule 4, Part 1, omit entry for Circumstances Code “C15056”
[111] Schedule 4, Part 1, omit entry for Circumstances Code “C15062”
[112] Schedule 4, Part 1, entry for Circumstances Code “C15303”
omit entry for Circumstances Code “C15303” and substitute:
C15303 | P15303 | CN15303 | Tafamidis | Transthyretin amyloid cardiomyopathy Second and subsequent PBS-subsidised prescriptions for this drug Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND The treatment must be ceased where the patient's heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device. Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment. Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no). If 'no', continued PBS subsidy is available. If 'yes', continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent. Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available. | Compliance with Authority Required procedures |
[113] Schedule 4, Part 1, entry for Circumstances Code “C15456”
omit entry for Circumstances Code “C15456” and substitute:
C15456 | P15456 | CN15456 | Midazolam | Generalized convulsive status epilepticus Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
[114] Schedule 4, Part 1, entry for Circumstances Code “C15457”
omit entry for Circumstances Code “C15457” and substitute:
C15457 | P15457 | CN15457 | Midazolam | Generalized convulsive status epilepticus Initial treatment Patient must have been assessed to be at significant risk of status epilepticus; AND Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years. Patient must be at least one year of age. The treatment must initiated by a specialist physician experienced in the treatment of epilepsy. | Compliance with Authority Required procedures |
[115] Schedule 4, Part 1, entry for Circumstances Code “C15560”
(a) omit from the column headed “Listed Drug”: Carmellose
(b) omit from the column headed “Listed Drug”: Carmellose with glycerin
[116] Schedule 4, Part 1, omit entry for Circumstances Code “C15622”
[117] Schedule 4, Part 1, omit entry for Circumstances Code “C15623”
[118] Schedule 4, Part 1, entry for Circumstances Code “C15640”
(a) omit from the column headed “Listed Drug”: Carmellose
(b) omit from the column headed “Listed Drug”: Carmellose with glycerin
[119] Schedule 4, Part 1, omit entry for Circumstances Code “C15654”
[120] Schedule 4, Part 1, omit entry for Circumstances Code “C15739”
[121] Schedule 4, Part 1, omit entry for Circumstances Code “C15756”
[122] Schedule 4, Part 1, entry for Circumstances Code “C15818”
omit entry for Circumstances Code “C15818” and substitute:
C15818 | P15818 | CN15818 | Trastuzumab emtansine | Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. The pathology report 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). | Compliance with Written Authority Required procedures |
[123] Schedule 4, Part 1, entry for Circumstances Code “C15819”
omit entry for Circumstances Code “C15819” and substitute:
C15819 | P15819 | CN15819 | Trastuzumab emtansine | Early HER2 positive breast cancer Continuing adjuvant treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. | Compliance with Authority Required procedures |
[124] Schedule 4, Part 1, entry for Circumstances Code “C15820”
omit entry for Circumstances Code “C15820” and substitute:
C15820 | P15820 | CN15820 | Trastuzumab | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15820 |
[125] Schedule 4, Part 1, entry for Circumstances Code “C15826”
omit entry for Circumstances Code “C15826” and substitute:
C15826 | P15826 | CN15826 | Trastuzumab deruxtecan | Metastatic (Stage IV) HER2 positive breast cancer Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable). 2) Details of prior HER2 directed drug regimens prescribed for the patient. 3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable). | Compliance with Authority Required procedures |
[126] Schedule 4, Part 1, entry for Circumstances Code “C15827”
omit entry for Circumstances Code “C15827” and substitute:
C15827 | P15827 | CN15827 | Trastuzumab emtansine | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication. | Compliance with Authority Required procedures |
[127] Schedule 4, Part 1, entry for Circumstances Code “C15828”
omit entry for Circumstances Code “C15828” and substitute:
C15828 | P15828 | CN15828 | Trastuzumab emtansine | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. The following information must be provided by the prescriber at the time of application: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH). (b) dates of treatment with trastuzumab and pertuzumab; (c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or (d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. All reports must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Authority Required procedures |
[128] Schedule 4, Part 1, entry for Circumstances Code “C15831”
omit entry for Circumstances Code “C15831” and substitute:
C15831 | P15831 | CN15831 | Trastuzumab | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15831 |
[129] Schedule 4, Part 1, entry for Circumstances Code “C15832”
omit entry for Circumstances Code “C15832” and substitute:
C15832 | P15832 | CN15832 | Trastuzumab deruxtecan | Unresectable and/or metastatic HER2-low breast cancer Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND Patient must have received prior chemotherapy in the metastatic setting; OR Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH). Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2-low status 2) Details of prior drug regimens prescribed for the patient 3) Cardiac function test results | Compliance with Authority Required procedures |
[130] Schedule 4, Part 1, omit entry for Circumstances Code “C16067”
[131] Schedule 4, Part 1, after entry for Circumstances Code “C16148”
insert:
C16151 | P16151 | CN16151 | Nivolumab with relatlimab | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams. | Compliance with Authority Required procedures - Streamlined Authority Code 16151 |
C16152 | P16152 | CN16152 | Methylphenidate | Attention deficit hyperactivity disorder Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND Patient must require continuous coverage over 8 hours; AND The treatment must not exceed a maximum daily dose of 80 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; OR Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; OR Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; OR Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age. A retrospective diagnosis of ADHD for the purposes of administering this restriction is: (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above. | Compliance with Authority Required procedures |
C16154 | P16154 | CN16154 | Lisdexamfetamine | Attention deficit hyperactivity disorder Patient must require continuous coverage over 12 hours; AND The treatment must not exceed a maximum daily dose of 70 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; OR Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; OR Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; OR Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age. A retrospective diagnosis of ADHD for the purposes of administering this restriction is: (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above. | Compliance with Authority Required procedures |
C16155 | P16155 | CN16155 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; OR The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic. Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16155 |
C16156 | P16156 | CN16156 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be both: (i) at least 50 years of age, (ii) at high risk. For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m 2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16156 |
C16158 | P16158 | CN16158 | Dapagliflozin with metformin | Diabetes mellitus type 2 Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16158 |
C16162 | P16162 | CN16162 | Dapagliflozin with metformin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16162 |
C16164 | P16164 | CN16164 | Dapagliflozin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in combination with metformin; unless contraindicated/intolerant; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16164 |
C16166 | P16166 | CN16166 | Testosterone | Androgen deficiency Patient must have an established pituitary or testicular disorder. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16180 | P16180 | CN16180 | Belzutifan | Von Hippel-Lindau (VHL) disease Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same tumour type; AND Patient must not have developed VHL-associated metastatic disease; AND Patient must have demonstrated clinical improvement or stabilisation of the condition while being treated with this drug, the details of which must be kept with the patient's record; AND The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours. Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, clinical improvement or stabilisation of the patient's condition includes but is not limited to: (i) avoidance of surgery; (ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC); (iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s). | Compliance with Authority Required procedures |
C16186 | P16186 | CN16186 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have an established pituitary or testicular disorder. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16187 | P16187 | CN16187 | Daunorubicin with cytarabine | Acute Myeloid Leukaemia Induction therapy Patient must not have received prior chemotherapy as induction therapy for this condition; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The treatment must not exceed two cycles of induction therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient's file. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams. | Compliance with Authority Required procedures |
C16188 | P16188 | CN16188 | Nivolumab with relatlimab | Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be uveal melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must weigh 40 kg or more; AND Patient must be at least 12 years of age. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams. | Compliance with Authority Required procedures - Streamlined Authority Code 16188 |
C16189 | P16189 | CN16189 | Methylphenidate | Attention deficit hyperactivity disorder Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND Patient must require continuous coverage over 12 hours; AND The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive. | Compliance with Authority Required procedures |
C16190 | P16190 | CN16190 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; OR The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic. Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16190 |
C16191 | P16191 | CN16191 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND The treatment must be initiated within 5 days of symptom onset. Patient must be at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with: 1. Any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16191 |
C16192 | P16192 | CN16192 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions: 1. The patient is in residential aged care 2. The patient has disability with multiple comorbidities and/or frailty 3. Neurological conditions, including stroke and dementia and demyelinating conditions 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease 5. Heart failure, coronary artery disease, cardiomyopathies 6. Obesity (BMI greater than 30 kg/m 2) 7. Diabetes type I or II, requiring medication for glycaemic control 8. Renal impairment (eGFR less than 60mL/min) 9. Cirrhosis 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above 11. Past COVID-19 infection episode resulting in hospitalisation. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16192 |
C16194 | P16194 | CN16194 | Testosterone | Constitutional delay of growth or puberty Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16195 | P16195 | CN16195 | Testosterone | Constitutional delay of growth or puberty The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16197 | P16197 | CN16197 | Daunorubicin with cytarabine | Acute Myeloid Leukaemia Consolidation therapy The treatment must be for consolidation treatment following induction treatment with this product; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The treatment must not exceed two cycles of consolidation therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams. | Compliance with Authority Required procedures |
C16200 | P16200 | CN16200 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions: 1. The patient is in residential aged care 2. The patient has disability with multiple comorbidities and/or frailty 3. Neurological conditions, including stroke and dementia and demyelinating conditions 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease 5. Heart failure, coronary artery disease, cardiomyopathies 6. Obesity (BMI greater than 30 kg/m 2) 7. Diabetes type I or II, requiring medication for glycaemic control 8. Renal impairment (eGFR less than 60mL/min) 9. Cirrhosis 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above 11. Past COVID-19 infection episode resulting in hospitalisation. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16200 |
C16201 | P16201 | CN16201 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be both: (i) at least 50 years of age, (ii) at high risk. For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m 2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16201 |
C16204 | P16204 | CN16204 | Testosterone | Micropenis Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16206 | P16206 | CN16206 | Testosterone | Micropenis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16207 | P16207 | CN16207 | Testosterone | Pubertal induction The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16208 | P16208 | CN16208 | Belzutifan | Von Hippel-Lindau (VHL) disease Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2024; AND The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND The condition must have been at least one of the following prior to non-PBS-subsidised treatment with this drug: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND Patient must not have had tumour(s) that require immediate surgery as assessed by the treating clinician prior to non-PBS-subsidised treatment with this drug; AND Patient must have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; OR The condition must have been VHL-associated brain stem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1 at treatment initiation with this drug; AND Patient must not have developed VHL-associated metastatic disease; AND Patient must have demonstrated clinical improvement or stabilisation of the condition, the details of which must be kept with the patient's record. This should be assessed only after a total of 6 months of therapy. Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to: (i) retinal, spinal, or cerebellar haemangioblastoma; (ii) adrenal or extra-adrenal phaeochromocytoma; (iii) renal cell carcinoma; (iv) multiple renal and pancreatic cysts; (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours. For the purpose of administering this restriction, clinical improvement or stabilisation of the patient's condition includes but is not limited to: (i) avoidance of surgery; (ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC); (iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s). A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
C16211 | P16211 | CN16211 | Testosterone | Androgen deficiency Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs. Patient must be aged 40 years or older. Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. Androgen deficiency is defined as: (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16212 | P16212 | CN16212 | Testosterone | Pubertal induction Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16214 | P16214 | CN16214 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs. Patient must be aged 40 years or older. Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. Androgen deficiency is defined as: (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16215 | P16215 | CN16215 | Belzutifan | Von Hippel-Lindau (VHL) disease Initiating or recommencing treatment The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND The condition must be at least one of: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND Patient must not have tumour(s) that require immediate surgery as assessed by the treating clinician; AND Patient must be untreated with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes; AND Patient must have WHO performance status no higher than 1; OR The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1; AND The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours. Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to: (i) retinal, spinal, or cerebellar haemangioblastoma; (ii) adrenal or extra-adrenal phaeochromocytoma; (iii) renal cell carcinoma; (iv) multiple renal and pancreatic cysts; (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours. | Compliance with Authority Required procedures |
C16220 | P16220 | CN16220 | Dapagliflozin | Diabetes mellitus type 2 The treatment must be in combination with metformin; unless contraindicated/intolerant; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16220 |
C16222 | P16222 | CN16222 | Dienogest | Endometriosis | Compliance with Authority Required procedures - Streamlined Authority Code 16222 |
C16223 | P16223 | CN16223 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND The treatment must be initiated within 5 days of symptom onset. Patient must be at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with: 1. Any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16223 |
[132] Schedule 4, Part 2, omit entry for Variation Code “V14812”
[133] Schedule 4, Part 2, omit entry for Variation Code “V14815”
[134] Schedule 4, Part 2, omit entry for Variation Code “V14819”
[135] Schedule 4, Part 2, omit entry for Variation Code “V14829”
[136] Schedule 5, after entry for Abacavir with lamivudine
insert:
Abiraterone | GRP-29273 | Tablet containing abiraterone acetate 250 mg | Oral | Abiraterone-Teva
Zytiga |
Abiraterone | GRP-29283 | Tablet containing abiraterone acetate 500 mg | Oral | Abiraterone-Teva
Zytiga |
[137] Schedule 5, after entry for Atorvastatin [GRP-20251]
insert:
Atovaquone | GRP-29277 | Oral suspension 750 mg per 5 mL, 210 mL | Oral | ATOVACUE
Wellvone |
[138] Schedule 5, after entry for Buprenorphine [GRP-24293]
insert:
Cabergoline | GRP-19705 | Tablet 500 micrograms | Oral | Dostamine
Dostinex |
[139] Schedule 5, after entry for Clonazepam
insert:
Clonazepam | GRP-29271 | Tablet 2 mg | Oral | Paxam 2 |
Clonazepam | GRP-29271 | Tablet 2 mg (S19A) | Oral | Clonazepam USP (Advagen Pharma, USA) |
[140] Schedule 5, entries for Dasatinib
substitute:
Dasatinib | GRP-25848 | Tablet 70 mg | Oral | Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib Sandoz
Dasatinib SUN
DASATINIB-TEVA
Dasatinib Viatris
Sprycel |
Dasatinib | GRP-25849 | Tablet 20 mg | Oral | Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib Sandoz
Dasatinib SUN
DASATINIB-TEVA
Dasatinib Viatris
Sprycel |
Dasatinib | GRP-25853 | Tablet 50 mg | Oral | Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib Sandoz
Dasatinib SUN
DASATINIB-TEVA
Dasatinib Viatris
Sprycel |
Dasatinib | GRP-25880 | Tablet 100 mg | Oral | Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib Sandoz
Dasatinib SUN
DASATINIB-TEVA
Dasatinib Viatris
Sprycel |
[141] Schedule 5, entry for Dutasteride with tamsulosin
insert in the column headed “Brand” after entry for the Brand “Duodart 500ug/400ug”: Dutasteride/Tamsulosin Lupin 500/400
[142] Schedule 5, omit entries for Epoprostenol
[143] Schedule 5, entry for Ezetimibe
substitute:
Ezetimibe | GRP-29270 | Tablet 10 mg | Oral | APO-Ezetimibe
BTC Ezetimibe
EZEMICHOL
EZETIMIBE-WGR
Ezetimibe GH
Ezetimibe Sandoz
Ezetrol
Pharmacor Ezetimibe 10
Zient 10mg |
Ezetimibe | GRP-29270 | Tablet 10 mg (S19A) | Oral | Ezetimibe USP (Camber, USA) |
[144] Schedule 5, entries for Gabapentin
substitute:
Gabapentin | GRP-20038 | Capsule 100 mg | Oral | APX-Gabapentin
Gabacor
GAPENTIN
Neurontin
Nupentin 100 |
Gabapentin | GRP-20075 | Tablet 600 mg | Oral | APX-GABAPENTIN
Gabapentin APOTEX
GAPENTIN
Neurontin
Pharmacor Gabapentin 600 |
Gabapentin | GRP-20089 | Tablet 800 mg | Oral | GAPENTIN
Gabapentin APOTEX
Neurontin
Pharmacor Gabapentin 800 |
Gabapentin | GRP-20136 | Capsule 300 mg | Oral | APX-Gabapentin
Gabacor
Gabapentin Sandoz
GABAPENTIN-WGR
GAPENTIN
Neurontin
Nupentin 300 |
Gabapentin | GRP-20293 | Capsule 400 mg | Oral | APX-Gabapentin
Gabacor
Gabapentin Sandoz
GABAPENTIN-WGR
GAPENTIN
Neurontin
Nupentin 400 |
[145] Schedule 5, entry for Ibuprofen
insert in the column headed “Brand” after entry for the Brand “Brufen”: WGR-IBUPROFEN 400
[146] Schedule 5, omit entry for Ketoprofen
[147] Schedule 5, omit entries for Medroxyprogesterone [GRP-28650]
[148] Schedule 5, entry for Metformin [GRP-19880]
substitute:
Metformin | GRP-19880 | Tablet containing metformin hydrochloride 500 mg | Oral | APX-Metformin
Blooms The Chemist Metformin 500 mg
Diabex
Diaformin
Diaformin Viatris
FORMET 500
Glucobete 500
Metformin GH
Metformin Sandoz
METFORMIN-WGR |
[149] Schedule 5, entry for Metformin [GRP-19944]
insert in the column headed “Brand” after entry for the Brand “Metformin Sandoz”: METFORMIN-WGR
[150] Schedule 5, after entry for Methadone [GRP-27523]
insert:
Methadone | GRP-29269 | Tablet containing methadone hydrochloride 10 mg | Oral | METHADONE-AFT
Physeptone |
[151] Schedule 5, omit entry for Nevirapine
[152] Schedule 5, entry for Olmesartan with amlodipine [GRP-21157]
insert as the first entry in the column headed “Brand”: APO-OLMESARTAN/AMLODIPINE 40/10
[153] Schedule 5, entry for Pioglitazone [GRP-19790]
substitute:
Pioglitazone | GRP-19790 | Tablet 45 mg (as hydrochloride) | Oral | Actos
APOTEX-Pioglitazone
ARX-PIOGLITAZONE
Vexazone |
[154] Schedule 5, entries for Prochlorperazine
omit:
Prochlorperazine | GRP-28600 | Tablet containing prochlorperazine maleate 5 mg (S19A) | Oral | Stemetil (Ireland) |
[155] Schedule 5, entry for Rivaroxaban [GRP-29154]
insert in the column headed “Brand” after entry for the Brand “Rivaroxaban-Teva”: RIVOXA
[156] Schedule 5, entry for Rivaroxaban [GRP-29169]
(a) insert in the column headed “Brand” after entry for the Brand “iXarola”: Rivaroxaban Sandoz
(b) insert in the column headed “Brand” after entry for the Brand “Rivaroxaban-Teva”: RIVOXA
[157] Schedule 5, entry for Rivaroxaban [GRP-29173]
(a) insert in the column headed “Brand” after entry for the Brand “iXarola”: Rivaroxaban Sandoz
(b) insert in the column headed “Brand” after entry for the Brand “Rivaroxaban-Teva”: RIVOXA
[158] Schedule 5, entry for Rivaroxaban [GRP-29164]
(a) insert in the column headed “Brand” after entry for the Brand “iXarola”: Rivaroxaban Sandoz
(b) insert in the column headed “Brand” after entry for the Brand “Rivaroxaban-Teva”: RIVOXA
[159] Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)
insert as the first entry in the column headed “Brand”: APO-RIZATRIPTAN ODT
[160] Schedule 5, entries for Varenicline
substitute:
Varenicline | GRP-26245 | Tablet 1 mg | Oral | Champix
PHARMACOR VARENICLINE
VARENAPIX
Varenicline Sandoz
Varenicline Viatris |
Varenicline | GRP-27996 | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | Champix
PHARMACOR VARENICLINE
VARENAPIX
Varenicline Sandoz
Varenicline Viatris |
