Schedule 1 Amendments
[1] Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL
(a) omit:
| | | a | Amoxycillin Sandoz | SZ | PDP | | | 1 | 0 | 1 | | |
(b) omit:
| | | a | Amoxycillin Sandoz | SZ | MP NP | | | 1 | 1 | 1 | | |
[2] Schedule 1, entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “Cilamox” (all instances): QA substitute: AL
[3] Schedule 1, entry for Atezolizumab
(a) omit from the column headed “Circumstances”: C6999 C7539 C7572
(b) omit from the column headed “Circumstances”: C9348 C9514
(c) insert in numerical order in the column headed “Circumstances”: C10125 C10143 C10182 C10190 C10203 C10204 C10206
[4] Schedule 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
omit from the column headed “Responsible Person” for the brand “Bimtop”: AS substitute: AF
[5] Schedule 1, entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
(a) omit from the column headed “Circumstances”: C4689
(b) insert in numerical order in the column headed “Circumstances”: C10121
[6] Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
(a) omit from the column headed “Circumstances” (all instances): C4689
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10121
[7] Schedule 1, entry for Capecitabine in the form Tablet 500 mg
omit from the column headed “Responsible Person” for the brand “Xelabine”: AS substitute: AL
[8] Schedule 1, entry for Cefazolin in the form Powder for injection 1 g (as sodium)
(a) omit from the column headed “Schedule Equivalent” for the brand “Cefazolin-AFT”: a
(b) omit:
| | | a | Cefazolin Sandoz | SZ | MP NP | C5861 C5882 C5883 C5891 | | 10 | 0 | 10 | | |
[9] Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit:
| | | a | Ceftriaxone Sandoz | SZ | MP NP | C5830 C5862 C5868 | | 5 | 0 | 1 | | |
[10] Schedule 1, entry for Cladribine in the form Injection 10 mg in 5 mL
omit from the column headed “Responsible Person”: AS substitute: AF
[11] Schedule 1, entry for Cladribine in the form Tablet 10 mg
omit from the column headed “Circumstances” (all instances): C8269 C8310 C8311 substitute: C10123 C10170 C10171
[12] Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
| | | a | Clarihexal | HX | MP NP | | | 14 | 1 | 14 | | |
[13] Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646 C9842
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148 C10157
(c) omit from the column headed “Purposes”: P9643 P9645 P9646 P9842 substitute: P10130 P10131 P10148 P10157
[14] Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646 C9842
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148 C10157
[15] Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646 C9842
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148 C10157
(c) omit from the column headed “Purposes”: P9643 P9645 P9646 P9842 substitute: P10130 P10131 P10148 P10157
[16] Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646 C9842
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148 C10157
[17] Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C7565
(b) omit from the column headed “Circumstances”: C7579
(c) insert in numerical order in the column headed “Circumstances”: C10180 C10189
[18] Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C7565
(b) omit from the column headed “Circumstances”: C7579
(c) insert in numerical order in the column headed “Circumstances”: C10180 C10189
(d) omit from the column headed “Purposes”: P7565 P7579
(e) insert in numerical order in the column headed “Purposes”: P10180 P10189
[19] Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 120 mg
omit from the column headed “Circumstances”: C6920 C7732 substitute: C10139 C10140
[20] Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 240 mg
omit from the column headed “Circumstances”: C6913 substitute: C10139
[21] Schedule 1, entry for Dolutegravir with abacavir and lamivudine
(a) omit from the column headed “Circumstances”: C9934
(b) insert in numerical order in the column headed “Circumstances”: C10116
[22] Schedule 1, entry for Donepezil
substitute:
Donepezil | Tablet containing donepezil hydrochloride 5 mg | Oral | a | APO-Donepezil | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Arazil | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aricept | PF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aridon 5 | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aridon APN 5 | RF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil GH | HQ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil Sandoz | SZ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil-DRLA | RZ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | APO-Donepezil | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Arazil | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aricept | PF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aridon 5 | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aridon APN 5 | RF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil GH | HQ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil Sandoz | SZ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil-DRLA | RZ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| Tablet containing donepezil hydrochloride 10 mg | Oral | a | APO-Donepezil | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Arazil | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aricept | PF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aridon 10 | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Aridon APN 10 | RF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil GH | HQ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil Sandoz | SZ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Donepezil-DRLA | RZ | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Pharmacor Donepezil 10 | CR | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | APO-Donepezil | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Arazil | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aricept | PF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aridon 10 | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Aridon APN 10 | RF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil GH | HQ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil Sandoz | SZ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Donepezil-DRLA | RZ | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Pharmacor Donepezil 10 | CR | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
[23] Schedule 1, entry for Dorzolamide
omit from the column headed “Responsible Person” for the brand “Trusamide”: AS substitute: AF
[24] Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Responsible Person” for the brand “Cosdor”: AS substitute: AF
[25] Schedule 1, after entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert:
Durvalumab | Solution concentrate for I.V. infusion 120 mg in 2.4 mL | Injection | | Imfinzi | AP | MP | C10126 C10145 C10174 | | See Note 3 | See Note 3 | 1 | | D(100) |
| Solution concentrate for I.V. infusion 500 mg in 10 mL | Injection | | Imfinzi | AP | MP | C10126 C10145 C10174 | | See Note 3 | See Note 3 | 1 | | D(100) |
[26] Schedule 1, entry for Fingolimod in the form Capsule 250 micrograms (as hydrochloride)
omit from the column headed “Circumstances”: C9794 C9810 substitute: C10093 C10198
[27] Schedule 1, entry for Fingolimod in the form Capsule 500 micrograms (as hydrochloride)
omit from the column headed “Circumstances”: C6868 C7732 substitute: C10162 C10172
[28] Schedule 1, entry for Flucloxacillin in the form Powder for injection 1 g (as sodium monohydrate)
(a) omit:
| | | a | Hospira Pty Limited | PF | PDP | | | 5 | 0 | 10 | | |
(b) omit:
| | | a | Hospira Pty Limited | PF | MP NP | | | 5 | 1 | 10 | | |
[29] Schedule 1, entry for Fluorouracil in the form Injection 2500 mg in 50 mL
omit:
| | | | Fluorouracil Ebewe | SZ | MP | C6266 C6297 | | See Note 3 | See Note 3 | 1 | | D(100) |
[30] Schedule 1, entry for Fluticasone furoate with umeclidinium and vilanterol
omit from the column headed “Circumstances”: C7651 substitute: C10167
[31] Schedule 1, entry for Fluticasone furoate with vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses
(a) omit from the column headed “Circumstances”: C4689
(b) insert in numerical order in the column headed “Circumstances”: C10121
[32] Schedule 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)
(a) omit from the column headed “Circumstances” (all instances): C4689
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10121
[33] Schedule 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
(a) omit from the column headed “Circumstances”: C4689
(b) insert in numerical order in the column headed “Circumstances”: C10121
[34] Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
omit:
| | | a | Voxam | SZ | MP NP | C4755 C6277 | | 30 | 5 | 30 | | |
[35] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
(a) omit:
| | | a | Calcium Folinate Ebewe | SZ | MP | | | 10 | 1 | 1 | | |
(b) omit from the column headed “Schedule Equivalent” for the brand “Leucovorin Calcium (Pfizer Australia Pty Ltd)”: a
[36] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
(a) omit:
| | | a | Calcium Folinate Ebewe | SZ | MP | | | 4 | 1 | 1 | | |
(b) omit from the column headed “Schedule Equivalent” for the brand “Leucovorin Calcium (Hospira Pty Limited)”: a
[37] Schedule 1, entry for Galantamine
substitute:
Galantamine | Capsule (prolonged release) 8 mg (as hydrobromide) | Oral | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| Capsule (prolonged release) 16 mg (as hydrobromide) | Oral | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| Capsule (prolonged release) 24 mg (as hydrobromide) | Oral | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
| | | a | APO-Galantamine MR | TX | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Galantyl | AF | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Gamine XR | RW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
| | | a | Reminyl | JC | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
[38] Schedule 1, after entry for Glycine with carbohydrate
insert:
Glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine | Sachets containing oral powder 35 g, 30 (TYR Sphere20) | Oral | | TYR Sphere20 | VF | MP NP | C5533 | | 4 | 5 | 1 | | |
[39] Schedule 1, entry for Hypromellose in the form Eye drops 5 mg per mL, 15 mL
omit from the column headed “Responsible Person”: AS substitute: AF
[40] Schedule 1, entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL
omit:
| | | | Idarubicin Ebewe | SZ | MP | C6247 | | See Note 3 | See Note 3 | 1 | | PB(100) |
[41] Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL
(a) omit from the column headed “Circumstances”: C8178 C8180 C8206
(b) omit from the column headed “Circumstances”: C9840
(c) insert in numerical order in the column headed “Circumstances”: C10122
[42] Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL
(a) omit from the column headed “Circumstances”: C8178 C8180 C8206 C9840
(b) insert in numerical order in the column headed “Circumstances”: C10122
[43] Schedule 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30
omit from the column headed “Responsible Person” for the brand “Aeron 250”: AS substitute: AL
[44] Schedule 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30
omit from the column headed “Responsible Person” for the brand “Aeron 500”: AS substitute: AL
[45] Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
omit:
| | | | Hospira Pty Limited | PF | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[46] Schedule 1, after entry for Isotretinoin in the form Capsule 20 mg
insert:
| Capsule 30 mg | Oral | | Oratane | OU | MP | C5224 | | 60 | 3 | 60 | | |
[47] Schedule 1, entry for Latanoprost
omit from the column headed “Responsible Person” for the brand “Xalaprost”: AS substitute: AF
[48] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Responsible Person” for the brand “Xalamol 50/5”: AS substitute: AF
[49] Schedule 1, entry for Levodopa with carbidopa in the form Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL
substitute:
| Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL | Intra-intestinal | | Duodopa | VE | MP NP | C10136 C10197 | P10197 | 28 | 5 | 7 | | |
| | | | | MP | C10138 C10160 C10161 C10169 | P10138 P10161 | 28 | 5 | 7 | | C(100) |
| | | | | | MP NP | C10136 C10197 | P10136 | 56 | 5 | 7 | | |
| | | | | | MP | C10138 C10160 C10161 C10169 | P10160 P10169 | 56 | 5 | 7 | | C(100) |
[50] Schedule 1, entry for Levonorgestrel
insert as first entry:
| Intrauterine drug delivery system 19.5 mg | Intrauterine | | Kyleena | SY | MP NP | C5214 | | 1 | 0 | 1 | | |
[51] Schedule 1, entry for Memantine
substitute:
Memantine | Tablet containing memantine hydrochloride 10 mg | Oral | a | APO-Memantine | TX | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 56 | 1 | 56 | | |
| | | a | Ebixa | LU | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 56 | 1 | 56 | | |
| | | a | Memantine generichealth | GQ | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 56 | 1 | 56 | | |
| | | a | Memanxa | RW | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 56 | 1 | 56 | | |
| | | a | APO-Memantine | TX | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 56 | 5 | 56 | | |
| | | | | | NP | C10104 | | 56 | 5 | 56 | | |
| | | a | Ebixa | LU | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 56 | 5 | 56 | | |
| | | | | | NP | C10104 | | 56 | 5 | 56 | | |
| | | a | Memantine generichealth | GQ | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 56 | 5 | 56 | | |
| | | | | | NP | C10104 | | 56 | 5 | 56 | | |
| | | a | Memanxa | RW | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 56 | 5 | 56 | | |
| | | | | | NP | C10104 | | 56 | 5 | 56 | | |
| Tablet containing memantine hydrochloride 20 mg | Oral | a | APO-Memantine | TX | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 28 | 1 | 28 | | |
| | | a | Ebixa | LU | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 28 | 1 | 28 | | |
| | | a | Memantine generichealth | GQ | MP | C10098 C10103 C10104 C10183 C10184 | P10103 P10183 | 28 | 1 | 28 | | |
| | | a | APO-Memantine | TX | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 28 | 5 | 28 | | |
| | | | | | NP | C10104 | | 28 | 5 | 28 | | |
| | | a | Ebixa | LU | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 28 | 5 | 28 | | |
| | | | | | NP | C10104 | | 28 | 5 | 28 | | |
| | | a | Memantine generichealth | GQ | MP | C10098 C10103 C10104 C10183 C10184 | P10098 P10104 P10184 | 28 | 5 | 28 | | |
| | | | | | NP | C10104 | | 28 | 5 | 28 | | |
[52] Schedule 1, entry for Moxonidine in each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Moxotens | RF | MP NP | C4944 | | 30 | 5 | 30 | | |
[53] Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60
omit from the column headed “Responsible Person” for the brand “Ikotab”: AS substitute: AF
[54] Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
(a) omit from the column headed “Circumstances”: C8146 C8182 C8220
(b) omit from the column headed “Circumstances”: C9217
(c) omit from the column headed “Circumstances”: C9311
(d) omit from the column headed “Circumstances”: C9320
(e) omit from the column headed “Circumstances”: C9331 C9832 C9844
(f) insert in numerical order in the column headed “Circumstances”: C10117 C10118 C10119 C10120 C10155 C10156 C10165 C10195
[55] Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit:
| | | a | Hospira Pty Limited | PF | MP | C6369 C6390 C8165 C9232 C9233 C9289 | | 90 | 11 | 5 | | D(100) |
[56] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
omit:
| | | | Oxaliplatin SZ | HX | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[57] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
omit:
| | | | Paclitaxel Ebewe | SZ | MP | | | See Note 3 | See Note 3 | 5 | | D(100) |
[58] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
omit:
| | | | Paclitaxel Ebewe | SZ | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[59] Schedule 1, entry for Pegfilgrastim
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Ziextenzo | SZ | MP | C7822 C7843 C9235 C9303 | | 1 | 11 | 1 | | D(100) |
[60] Schedule 1, entry for Pembrolizumab
(a) omit from the column headed “Circumstances”: C9869
(b) omit from the column headed “Circumstances”: C9895
(c) omit from the column headed “Circumstances”: C9926
(d) omit from the column headed “Circumstances”: C9974
(e) insert in numerical order in the column headed “Circumstances”: C10088 C10142 C10159 C10181
[61] Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); Powder for I.V. infusion 500 mg (as disodium); and Powder for I.V. infusion 1 g (as disodium)
omit:
| | | | DBL Pemetrexed | PF | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[62] Schedule 1, entry for Prednisolone with phenylephrine
substitute:
Prednisolone with phenylephrine | Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL | Application to the eye | | Prednefrin Forte | AG | MP | C6080 C6101 C10095 | P10095 | 1 | 0 | 1 | | |
| | | | | AO | C6087 | | 1 | 0 | 1 | | |
| | | | | | MP | C6080 C6101 C10095 | P6080 P6101 | 1 | 2 | 1 | | |
| | | | | | NP | C6080 C6101 | | 1 | 2 | 1 | | |
[63] Schedule 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Quetia XR | OW | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[64] Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release) 200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Quetia XR | OW | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[65] Schedule 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Quetia XR | OW | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[66] Schedule 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Quetia XR | OW | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[67] Schedule 1, entry for Ramipril in each of the forms: Capsule 10 mg; Tablet 1.25 mg; Tablet 2.5 mg; and Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[68] Schedule 1, entry for Rivastigmine
substitute:
Rivastigmine | Capsule 1.5 mg (as hydrogen tartrate) | Oral | | Exelon | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 56 | 1 | 56 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 56 | 5 | 56 | | |
| | | | | | NP | C10108 | | 56 | 5 | 56 | | |
| Capsule 3 mg (as hydrogen tartrate) | Oral | | Exelon | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 56 | 1 | 56 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 56 | 5 | 56 | | |
| | | | | | NP | C10108 | | 56 | 5 | 56 | | |
| Capsule 4.5 mg (as hydrogen tartrate) | Oral | | Exelon | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 56 | 1 | 56 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 56 | 5 | 56 | | |
| | | | | | NP | C10108 | | 56 | 5 | 56 | | |
| Capsule 6 mg (as hydrogen tartrate) | Oral | | Exelon | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 56 | 1 | 56 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 56 | 5 | 56 | | |
| | | | | | NP | C10108 | | 56 | 5 | 56 | | |
| Transdermal patch 9 mg | Transdermal | | Exelon Patch 5 | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 30 | 1 | 30 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 30 | 5 | 30 | | |
| | | | | | NP | C10108 | | 30 | 5 | 30 | | |
| Transdermal patch 18 mg | Transdermal | | Exelon Patch 10 | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 30 | 1 | 30 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 30 | 5 | 30 | | |
| | | | | | NP | C10108 | | 30 | 5 | 30 | | |
| Transdermal patch 27 mg | Transdermal | | Exelon Patch 15 | NV | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 30 | 1 | 30 | | |
| | | | | | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 30 | 5 | 30 | | |
| | | | | | NP | C10108 | | 30 | 5 | 30 | | |
[69] Schedule 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)
(a) omit from the column headed “Circumstances”: C10011 C10027
(b) omit from the column headed “Circumstances”: C10074
(c) insert in numerical order in the column headed “Circumstances”: C10113 C10132 C10133
[70] Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)
(a) omit from the column headed “Circumstances”: C10011 C10027
(b) omit from the column headed “Circumstances”: C10074
(c) insert in numerical order in the column headed “Circumstances”: C10113 C10132 C10133
[71] Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen
(a) omit from the column headed “Circumstances”: C10011 C10027
(b) omit from the column headed “Circumstances”: C10074
(c) insert in numerical order in the column headed “Circumstances”: C10113 C10132 C10133
[72] Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)
(a) omit from the column headed “Circumstances”: C10011 C10027
(b) omit from the column headed “Circumstances”: C10074
(c) insert in numerical order in the column headed “Circumstances”: C10113 C10132 C10133
[73] Schedule 1, entry for Sucralfate
omit from the column headed “Responsible Person”: AS substitute: AF
[74] Schedule 1, after entry for Tacrolimus in the form Capsule 2 mg
insert:
| Capsule 3 mg (once daily prolonged release) | Oral | | ADVAGRAF XL | LQ | MP | | | 50 | 2 | 50 | | |
| | | | | MP | | P5569 P9697 | 100
CN5569 CN9697 | 3
CN5569 CN9697 | 50 | | C(100) |
[75] Schedule 1, entry for Temozolomide in the form Capsule 5 mg
omit from the column headed “Responsible Person” for the brand “Temizole 5” (all instances): AS substitute: AL
[76] Schedule 1, entry for Temozolomide in the form Capsule 20 mg
omit from the column headed “Responsible Person” for the brand “Temizole 20” (all instances): AS substitute: AL
[77] Schedule 1, entry for Temozolomide in the form Capsule 100 mg
omit from the column headed “Responsible Person” for the brand “Temizole 100” (all instances): AS substitute: AL
[78] Schedule 1, entry for Temozolomide in the form Capsule 140 mg
omit from the column headed “Responsible Person” for the brand “Temizole 140” (all instances): AS substitute: AL
[79] Schedule 1, entry for Temozolomide in the form Capsule 250 mg
omit from the column headed “Responsible Person” for the brand “Temizole 250”: AS substitute: AL
[80] Schedule 1, omit entry for Tenofovir with emtricitabine and rilpivirine
[81] Schedule 1, omit entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
[82] Schedule 1, entry for Teriflunomide
(a) omit from the column headed “Circumstances” (all instances): C6854 C7741 substitute: C10150 C10199
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Teriflunomide Dr.Reddy's | RZ | MP | C10150 C10199 | | 28 | 5 | 28 | | |
[83] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148
(c) omit from the column headed “Purposes”: P9643 P9645 P9646
(d) insert in numerical order in the column headed “Purposes”: P10130 P10131 P10148
[84] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148
[85] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148
(c) omit from the column headed “Purposes”: P9643 P9645 P9646
(d) insert in numerical order in the column headed “Purposes”: P10130 P10131 P10148
[86] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9643 C9645 C9646
(b) insert in numerical order in the column headed “Circumstances”: C10130 C10131 C10148
[87] Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity: 224; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C9842
(b) insert in numerical order in the column headed “Circumstances”: C10157
(c) omit from the column headed “Purposes”: P9842 substitute: P10157
[88] Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity: 224; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9842
(b) insert in numerical order in the column headed “Circumstances”: C10157
[89] Schedule 3
omit:
QA | Aspen Pharma Pty Ltd | 88 004 118 594 |
[90] Schedule 4, Part 1, entry for Atezolizumab
(a) omit:
| C6999 | | | Locally advanced or metastatic non-small cell lung cancer
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 treatment for this condition; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 6999 |
| C7539 | | | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 7539 |
| C7572 | | | Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS subsidised treatment with this drug for this condition was initiated.
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 - Streamlined Authority Code 7572 |
(b) omit:
| C9348 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9348 |
| C9514 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 9514 |
(c) insert in numerical order after existing text:
| C10125 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer. | Compliance with Authority Required procedures - Streamlined Authority Code 10125 |
| C10143 | | | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10143 |
| C10182 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 10182 |
| C10190 | | | Locally advanced or metastatic non-small cell lung cancer
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 systemic anti-cancer therapy for this condition; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10190 |
| C10203 | | | Extensive-stage small cell lung cancer
Continuing treatment
The treatment must be as monotherapy; AND
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. | Compliance with Authority Required procedures - Streamlined Authority Code 10203 |
| C10204 | | | Extensive-stage small cell lung cancer
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2020; AND
The condition must have been untreated prior to initiating non-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
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
The treatment must be in combination with etoposide and a platinum-based antineoplastic if the patient is yet to complete their first 4 cycles of treatment; OR
The treatment must be as monotherapy if being administered as maintenance therapy.
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 - Streamlined Authority Code 10204 |
| C10206 | | | Extensive-stage small cell lung cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with etoposide and a platinum-based antineoplastic drug. | Compliance with Authority Required procedures - Streamlined Authority Code 10206 |
[91] Schedule 4, Part 1, entry for Budesonide with formoterol
(a) omit:
| C4689 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 4689 |
(b) insert in numerical order after existing text:
| C10121 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months. | Compliance with Authority Required procedures - Streamlined Authority Code 10121 |
[92] Schedule 4, Part 1, entry for Cladribine
(a) omit:
| C8269 | | | Relapsing remitting multiple sclerosis
Initial treatment
The condition must be diagnosed by a neurologist; AND
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures |
| C8310 | | | Relapsing remitting multiple sclerosis
Continuing treatment
Must be treated by a neurologist.
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures |
| C8311 | | | Relapsing remitting multiple sclerosis
Grandfather treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have received treatment with this drug for this condition prior to 1 January 2019; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have had at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C10123 | | | Relapsing remitting multiple sclerosis
Grandfather treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have received treatment with this drug for this condition prior to 1 January 2019; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have had at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures - Streamlined Authority Code 10123 |
| C10170 | | | Relapsing remitting multiple sclerosis
Initial treatment
The condition must be diagnosed by a neurologist; AND
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures - Streamlined Authority Code 10170 |
| C10171 | | | Relapsing remitting multiple sclerosis
Continuing treatment
Must be treated by a neurologist.
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures - Streamlined Authority Code 10171 |
[93] Schedule 4, Part 1, entry for Dabrafenib
(a) omit:
| C9643 | P9643 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
| C9645 | P9645 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfathered treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS subsidised treatment within 12 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
| C9646 | P9646 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
| C9842 | P9842 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated with adjuvant BRAF inhibitor with MEK inhibitor for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less. | Compliance with Authority Required procedures - Streamlined Authority Code 9842 |
(b) insert in numerical order after existing text:
| C10130 | P10130 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10131 | P10131 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10148 | P10148 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10157 | P10157 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less. | Compliance with Authority Required procedures - Streamlined Authority Code 10157 |
[94] Schedule 4, Part 1, entry for Dexamethasone
(a) omit:
| C7565 | P7565 | | Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye. | Compliance with Authority Required procedures |
(b) omit:
| C7579 | P7579 | | Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must be unsuitable for treatment with VEGF inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. | Compliance with Written Authority Required procedures |
(c) insert in numerical order after existing text:
| C10180 | P10180 | | Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must be unsuitable for treatment with VEGF inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. | Compliance with Written Authority Required procedures |
| C10189 | P10189 | | Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye; AND
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
[95] Schedule 4, Part 1, entry for Dimethyl fumarate
substitute:
Dimethyl fumarate | C10139 | | | Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10139 |
| C10140 | | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10140 |
[96] Schedule 4, Part 1, entry for Dolutegravir with abacavir and lamivudine
(a) omit:
| C9934 | | | HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9934 |
(b) insert in numerical order after existing text:
| C10116 | | | HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection. | Compliance with Authority Required procedures - Streamlined Authority Code 10116 |
[97] Schedule 4, Part 1, entry for Donepezil
substitute:
Donepezil | C10099 | P10099 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10100 | P10100 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10107 | P10107 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
| C10108 | P10108 | | Mild to moderately severe Alzheimer disease
Continuing
Patient must have received six months of sole PBS-subsidised initial therapy with this drug and has received a written authority approval; AND
Patient must demonstrate a clinically meaningful response to the initial treatment; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 10108 |
| C10110 | P10110 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
[98] Schedule 4, Part 1, after entry for Duloxetine
insert:
Durvalumab | C10126 | | | Unresectable Stage III non-small cell lung cancer
Initial treatment
Patient must have received platinum based chemoradiation therapy; AND
The condition must not have progressed following platinum based chemoradiation therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10126 |
| C10145 | | | Unresectable Stage III non-small cell lung cancer
Continuing 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 be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The treatment must not exceed 12 months in total for this condition under the initial, grandfathering or this continuing restriction combined; AND
The treatment must be once in a lifetime with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10145 |
| C10174 | | | Unresectable Stage III non-small cell lung cancer
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2020; AND
Patient must have received platinum based chemoradiation therapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have progressed following platinum based chemoradiation therapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-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 be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
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 - Streamlined Authority Code 10174 |
[99] Schedule 4, Part 1, entry for Fingolimod
substitute:
Fingolimod | C10093 | | | Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Patient must weigh 40 kg or less. | Compliance with Authority Required procedures - Streamlined Authority Code 10093 |
| C10162 | | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10162 |
| C10172 | | | Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10172 |
| C10198 | | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Patient must weigh 40 kg or less.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10198 |
[100] Schedule 4, Part 1, entry for Fluticasone furoate with umeclidinium and vilanterol
substitute:
Fluticasone furoate with umeclidinium and vilanterol | C10167 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; OR
Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10167 |
[101] Schedule 4, Part 1, entry for Fluticasone furoate with vilanterol
(a) omit:
| C4689 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 4689 |
(b) insert in numerical order after existing text:
| C10121 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months. | Compliance with Authority Required procedures - Streamlined Authority Code 10121 |
[102] Schedule 4, Part 1, entry for Fluticasone propionate with salmeterol
(a) omit:
| C4689 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 4689 |
(b) insert in numerical order after existing text:
| C10121 | | | Chronic obstructive pulmonary disease (COPD)
Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months. | Compliance with Authority Required procedures - Streamlined Authority Code 10121 |
[103] Schedule 4, Part 1, entry for Galantamine
substitute:
Galantamine | C10099 | P10099 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10100 | P10100 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10107 | P10107 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
| C10108 | P10108 | | Mild to moderately severe Alzheimer disease
Continuing
Patient must have received six months of sole PBS-subsidised initial therapy with this drug and has received a written authority approval; AND
Patient must demonstrate a clinically meaningful response to the initial treatment; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 10108 |
| C10110 | P10110 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
[104] Schedule 4, Part 1, after entry for Glycine with carbohydrate
insert:
Glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine | C5533 | | | Tyrosinaemia | |
[105] Schedule 4, Part 1, entry for Ipilimumab
(a) omit:
| C8178 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment - Grandfather patients
The condition must be negative for a BRAF V600 mutation; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
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.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8178 |
| C8180 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment - Grandfather patients
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
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.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8180 |
| C8206 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8206 |
(b) omit:
| C9840 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
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 have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 9840 |
(c) insert in numerical order after existing text:
| C10122 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction 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 ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 10122 |
[106] Schedule 4, Part 1, entry for Levodopa with carbidopa
(a) omit:
| C5473 | | | Advanced Parkinson disease
Maintenance therapy
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
Patient must have been commenced on treatment in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 5473 |
| C6863 | | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 6863 |
| C9405 | | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 9405 |
(b) insert in numerical order after existing text:
| C10136 | P10136 | | Advanced Parkinson disease
Maintenance therapy
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
Patient must have been commenced on treatment in a hospital-based movement disorder clinic; AND
Patient must be undergoing continuous treatment with a dose greater than 2000 mg of levodopa per day without an overnight break. | Compliance with Authority Required procedures - Streamlined Authority Code 10136 |
| C10138 | P10138 | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 10138 |
| C10160 | P10160 | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic; AND
Patient must be undergoing continuous treatment with a dose greater than 2000 mg of levodopa per day without an overnight break. | Compliance with Authority Required procedures - Streamlined Authority Code 10160 |
| C10161 | P10161 | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 10161 |
| C10169 | P10169 | | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic; AND
Patient must be undergoing continuous treatment with a dose greater than 2000 mg of levodopa per day without an overnight break. | Compliance with Authority Required procedures - Streamlined Authority Code 10169 |
| C10197 | P10197 | | Advanced Parkinson disease
Maintenance therapy
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
Patient must have been commenced on treatment in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 10197 |
[107] Schedule 4, Part 1, entry for Memantine
substitute:
Memantine | C10098 | P10098 | | Moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10103 | P10103 | | Moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
| C10104 | P10104 | | Moderately severe Alzheimer disease
Continuing
Patient must have received six months of sole PBS-subsidised initial therapy with this drug and has received a written authority approval; AND
Patient must demonstrate a clinically meaningful response to the initial treatment; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 10104 |
| C10183 | P10183 | | Moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
| C10184 | P10184 | | Moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
[108] Schedule 4, Part 1, entry for Nivolumab
(a) omit:
| C8146 | P8146 | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment - Grandfather patients
The condition must be negative for a BRAF V600 mutation; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition; OR
The treatment must be as monotherapy as maintenance for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
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.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8146 |
| C8182 | P8182 | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8182 |
| C8220 | P8220 | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment - Grandfather patients
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition; OR
The treatment must be as monotherapy as maintenance for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
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.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 8220 |
(b) omit:
| C9217 | | | Locally advanced or metastatic non-small cell lung cancer
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 treatment for this condition; AND
Patient must have stable or responding disease.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9217 |
(c) omit:
| C9311 | | | Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
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.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9311 |
(d) omit:
| C9320 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9320 |
(e) omit:
| C9331 | | | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9331 |
| C9832 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
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
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9832 |
| C9844 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
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 have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 9844 |
(f) insert in numerical order after existing text:
| C10117 | | | Locally advanced or metastatic non-small cell lung cancer
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 systemic anti-cancer therapy for this condition; AND
Patient must have stable or responding disease.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 10117 |
| C10118 | | | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma
Grandfather treatment
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 March 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
A Grandfathered 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 |
| C10119 | | | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures |
| C10120 | | | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures |
| C10155 | | | 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
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 10155 |
| C10156 | | | Unresectable Stage III or Stage IV malignant melanoma
Grandfathered patients treated with nivolumab as first-line therapy in unresectable Stage III or Stage IV malignant melanoma prior to 1 March 2020
Patient must have received non-PBS-subsidised supply of this drug as first-line therapy for unresectable Stage III or Stage IV malignant melanoma prior to 1 March 2020; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
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.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 10156 |
| C10165 | | | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 10165 |
| C10195 | | | Unresectable Stage III or Stage IV malignant melanoma
Induction 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 ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. | Compliance with Authority Required procedures - Streamlined Authority Code 10195 |
[109] Schedule 4, Part 1, entry for Obinutuzumab
omit entry for circumstances code “C7936” and substitute:
| C7936 | | | Stage II bulky or Stage III/IV follicular lymphoma
Grandfather treatment - previously untreated setting
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been untreated prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be in combination with chemotherapy for induction treatment; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to induction treatment with this drug for this condition for maintenance treatment; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. | Compliance with Authority Required procedures |
[110] Schedule 4, Part 1, entry for Pembrolizumab
(a) omit:
| C9869 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9869 |
(b) omit:
| C9895 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
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
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9895 |
(c) omit:
| C9926 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9926 |
(d) omit:
| C9974 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9974 |
(e) insert in numerical order after existing text:
| C10088 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2 - 3 weekly treatment regimen
The condition must be negative for a BRAF V600 mutation; AND
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
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10088 |
| C10142 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10142 |
| C10159 | | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1 - 3 weekly treatment regimen
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have been treated with an adjuvant programmed cell death-1 (PD-1) inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma; OR
Patient must have experienced disease recurrence after at least 6 months from completion of an adjuvant PD-1 inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma, followed by disease progression after treatment with a BRAF inhibitor (with or without MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; AND
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
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10159 |
| C10181 | | | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10181 |
[111] Schedule 4, Part 1, entry for Prednisolone with phenylephrine
(a) insert in the column headed “Purposes Code” for the circumstances code “C6080”: P6080
(b) insert in the column headed “Purposes Code” for the circumstances code “C6101”: P6101
(c) insert in numerical order after existing text:
| C10095 | P10095 | | Severe eye inflammation
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.
Patient must identify as Aboriginal or Torres Strait Islander. | |
[112] Schedule 4, Part 1, entry for Rivastigmine
substitute:
Rivastigmine | C10099 | P10099 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10100 | P10100 | | Mild to moderately severe Alzheimer disease
Initial 2
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Application through this treatment restriction must be made in writing.
Where a course of PBS-subsidised treatment with this drug with this strength was approved under the Initial 1 restriction, no more than 1 month's therapy and sufficient repeats to complete 6 months' initial treatment with this strength of this drug will be authorised under this restriction.
Where no prior approval has been issued before this application, up to a maximum of 1 month's therapy plus 5 repeats will be authorised. | Compliance with Authority Required procedures |
| C10107 | P10107 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
| C10108 | P10108 | | Mild to moderately severe Alzheimer disease
Continuing
Patient must have received six months of sole PBS-subsidised initial therapy with this drug and has received a written authority approval; AND
Patient must demonstrate a clinically meaningful response to the initial treatment; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 10108 |
| C10110 | P10110 | | Mild to moderately severe Alzheimer disease
Initial 1
Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
Up to a maximum of 2 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. This application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment with this drug with this strength. | Compliance with Authority Required procedures |
[113] Schedule 4, Part 1, entry for Somatropin
(a) omit:
| C10011 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must have a mature skeleton.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10027 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child.
Patient must have a mature skeleton.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
(b) omit:
| C10074 | | | Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient aged 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
(c) insert in numerical order after existing text:
| C10113 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must have a mature skeleton; OR
Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10132 | | | Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton, or, in a patient with Prader-Willi syndrome and aged 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient aged 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10133 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child.
Patient must have a mature skeleton; OR
Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
[114] Schedule 4, Part 1, omit entry for Tenofovir with emtricitabine and rilpivirine
[115] Schedule 4, Part 1, omit entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
[116] Schedule 4, Part 1, entry for Teriflunomide
substitute:
Teriflunomide | C10150 | | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10150 |
| C10199 | | | Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10199 |
[117] Schedule 4, Part 1, entry for Trametinib
(a) omit:
| C9643 | P9643 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
| C9645 | P9645 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfathered treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS subsidised treatment within 12 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
| C9646 | P9646 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma. | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C10130 | P10130 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10131 | P10131 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10148 | P10148 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
[118] Schedule 4, Part 1, entry for Vemurafenib
(a) omit:
| C9842 | P9842 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated with adjuvant BRAF inhibitor with MEK inhibitor for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less. | Compliance with Authority Required procedures - Streamlined Authority Code 9842 |
(b) insert in numerical order after existing text:
| C10157 | P10157 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less. | Compliance with Authority Required procedures - Streamlined Authority Code 10157 |
[119] Schedule 4, Part 1, entry for Venetoclax
omit entry for circumstances code “C8579” and substitute:
| C8579 | | | Chronic lymphocytic leukaemia (CLL)
Grandfathered treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first.
A Grandfathered 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 |
[120] Schedule 5, entry for Ramiprilin the form Tablet 5 mg [GRP-15424]
insert in alphabetical order in the column headed “Brand”: Prilace
[121] Schedule 5, entry for Ramiprilin the form Capsule 10 mg [GRP-15431]
insert in alphabetical order in the column headed “Brand”: Prilace
[122] Schedule 5, entry for Ramiprilin the form Tablet 1.25 mg [GRP-15640]
insert in alphabetical order in the column headed “Brand”: Prilace
[123] Schedule 5, entry for Ramiprilin the form Tablet 2.5 mg [GRP-15769]
insert in alphabetical order in the column headed “Brand”: Prilace
1 Name of Instrument