National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 2) (Cth)
Case
PB 11 of 2022
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 2)
National Health Act 1953
________________________________________________________________________
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 28 February 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
________________________________________________________________________
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 2).
(2)This instrument may also be cited as PB 11 of 2022.
Commencement
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 March 2022 | 1 March 2022 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Authority
This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Schedule
Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 - Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe
omit from the column headed “Responsible Person”: AN substitute: TX
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen
(a)omit:
| MP | C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391 | P12273 | 4 | 2 | 4 |
(b)omit:
| MP | C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391 | P12272 P12315 | 4 | 5 | 4 |
(c)omit:
| MP | C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391 | P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 | 6 | 0 | 6 |
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe
omit:
| MP | C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391 | P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 | 6 | 0 | 6 |
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen
omit from the column headed “Responsible Person” for the brand “Amgevita” (all instances): AN substitute: TX
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe
omit from the column headed “Responsible Person” for the brand “Amgevita” (all instances): AN substitute: TX
Schedule 1, Part 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Aripic Aripiprazole | LR | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Cipla Bisoprolol | LR | MP NP | C5324 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent
(a)omit from the column headed “Form”: Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent substitute: Concentrated injection 60 mg in 1.5 mL, with diluent
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| MSN Cabazitaxel | RQ | MP | C4662 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg
omit:
| a | Candesartan Aspen 4 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
omit:
| a | Candesartan Aspen 8 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg
omit:
| a | Candesartan Aspen 16 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg
omit:
| a | Candesartan Aspen 32 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
omit:
| a | Candesartan Combi Aspen 16/12.5 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
omit:
| a | Candesartan Combi Aspen 32/12.5 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit:
| a | Candesartan Combi Aspen 32/25 | RW | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
(a)omit:
| a | APO-Cefaclor | TX | PDP | 1 | 0 | 1 |
(b)omit:
| a | APO-Cefaclor | TX | MP | 1 | 1 | 1 |
Schedule 1, Part 1, entry for Cefotaxime
omit:
| Powder for injection 2 g (as sodium) | Injection | DBL Cefotaxime | PF | MP NP | C5826 C5881 C5890 | 10 | 0 | 10 |
| PDP | C5519 | 10 | 0 | 10 |
Schedule 1, Part 1, after entry for Chorionic gonadotrophin in the form Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3
insert:
| Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A) | Injection | Brevactid 1500 I.E | DZ | MP | C6991 | 1 | 0 | 1 | C(100) |
| MP | C6979 C6987 C6989 C6990 C6995 | 1 | 5 | 1 |
Schedule 1, Part 1, after entry for Chorionic gonadotrophin in the form Powder for injection 5,000 units with solvent
insert:
| Powder for injection 5,000 units with solvent (s19A) | Injection | Choriomon 5000 I.E | DZ | MP | C6991 | 2 | 0 | 3 | PB(100) |
Schedule 1, Part 1, entry for Clomipramine
omit:
| a | GenRx Clomipramine | GX | MP NP | C6250 C6251 C6299 | 50 | 2 | 50 |
Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit:
| APO-Clopidogrel | TX | MP NP | C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Clopidogrel with aspirin
omit:
| a | APO-Clopidogrel/Aspirin 75/100 | TX | MP NP | C5443 C5488 C5517 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
(c)omit from the column headed “Purposes” (all instances): P6702 P6731 P6947 P9197 P9293 substitute: P12522 P12524 P12530 P12561 P12565 P12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
(c)omit from the column headed “Purposes” (all instances): P6702 P6731 P6947 P9197 P9293 substitute: P12522 P12524 P12530 P12561 P12565 P12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
(c)omit from the column headed “Purposes” (all instances): P6702 P6731 P6947 P9197 P9293 substitute: P12522 P12524 P12530 P12561 P12565 P12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C6702 C6731 C6947 C9197 C9293
(b)insert in numerical order in the column headed “Circumstances” (all instances): C12522 C12524 C12530 C12561 C12565 C12570
(c)omit from the column headed “Purposes” (all instances): P6702 P6731 P6947 P9197 P9293 substitute: P12522 P12524 P12530 P12561 P12565 P12570
Schedule 1, Part 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)
omit:
| a | Entecavir APOTEX | TX | MP NP | C4993 C5036 | 60 | 5 | 30 | D(100) |
Schedule 1, Part 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)
omit:
| a | Entecavir APOTEX | TX | MP NP | C5037 C5044 | 60 | 5 | 30 | D(100) |
Schedule 1, Part 1, after entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4
insert:
| Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 | Injection | Enbrel | PF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | C(100) |
| MP | C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8851 C8873 C8879 C8914 C9064 C9081 C9082 C9084 C9123 C9140 C9162 C9177 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554 C9874 C9905 C11083 C11084 C11107 C11688 C11689 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12354 C12359 C12366 C12389 C12434 C12457 | P8638 P8760 P8851 P8914 P9064 P9082 P9084 P9177 P9386 P9388 P9410 P9428 P9429 P9473 P9501 P9874 P9905 P11083 P11084 P11107 P11688 P11689 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 | 1 | 3 | 1 | |||||
| MP | C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8851 C8873 C8879 C8914 C9064 C9081 C9082 C9084 C9123 C9140 C9162 C9177 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554 C9874 C9905 C11083 C11084 C11107 C11688 C11689 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12354 C12359 C12366 C12389 C12434 C12457 | P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554 P12354 P12359 P12366 P12389 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Etoposide in the form Solution for I.V. infusion 100 mg in 5 mL
omit:
| Pfizer Australia Pty Ltd | PF | MP | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Fenofibrate Cipla | LR | MP NP | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Fenofibrate Cipla | LR | MP | P7640 | 60 | 11 | 60 |
Schedule 1, Part 1, entry for Flecainide in the form Tablet containing flecainide acetate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Flecatab | AF | MP NP | C5550 C5584 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Fluconazole in the form Capsule 200 mg
omit:
| a | APO-Fluconazole | TX | MP NP | C5978 C5989 C6002 C6023 C6030 C7898 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Fosinopril with hydrochlorothiazide
(a)omit:
| a | APO-Fosinopril HCTZ 20/12.5 | TX | MP NP | C4389 | 30 | 5 | 30 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Fosetic 20/12.5”: a
Schedule 1, Part 1, entry for Gabapentin in the form Capsule 100 mg
(a)omit:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
(b)omit:
| a | Gabapentin Aspen 100 | RW | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Gabapentin in the form Capsule 300 mg
(a)omit:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
(b)omit:
| a | Gabapentin Aspen 300 | RW | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Gabapentin in the form Capsule 400 mg
(a)omit:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
(b)omit:
| a | Gabapentin Aspen 400 | RW | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Gabapentin in the form Tablet 600 mg
(a)omit:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
(b)omit:
| a | Gabapentin Aspen 600 | RW | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Gabapentin in the form Tablet 800 mg
(a)omit:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
(b)omit:
| a | Gabapentin Aspen 800 | RW | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, Part 1, after entry for Gemfibrozil
insert:
| Gemtuzumab ozogamicin | Powder for injection 5 mg | Injection | Mylotarg | PF | MP | C12559 C12566 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Imatinib
substitute:
| Imatinib | Capsule 100 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT | LR | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P12525 P12527 P12542 P12543 | 60 | 2 | 60 |
| Imatinib GH | GQ | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| Imatinib-APOTEX | TX | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| IMATINIB-DRLA | RZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| CIPLA IMATINIB ADULT | LR | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Imatinib GH | GQ | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Imatinib-APOTEX | TX | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| IMATINIB-DRLA | RZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Capsule 400 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT | LR | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |
| Imatinib GH | GQ | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| Imatinib-APOTEX | TX | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| IMATINIB-DRLA | RZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| CIPLA IMATINIB ADULT | LR | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| Imatinib GH | GQ | MP | C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| Imatinib-APOTEX | TX | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| IMATINIB-DRLA | RZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP | C9203 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |
| Glivec | AF | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| IMATINIB RBX | RA | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| Imatinib-Teva | SZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 60 | 2 | 60 | |||
| Gilmat | CR | MP | C9203 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Glivec | AF | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| IMATINIB RBX | RA | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Imatinib-Teva | SZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 60 | 5 | 60 | |||
| Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP | C9203 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |
| Glivec | AF | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| IMATINIB RBX | RA | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| Imatinib-Teva | SZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 | 30 | 2 | 30 | |||
| Gilmat | CR | MP | C9203 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| Glivec | AF | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| IMATINIB RBX | RA | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 | |||
| Imatinib-Teva | SZ | MP | C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C9319 C12525 C12527 C12536 C12541 C12542 C12543 | P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
omit:
| a | GenRx Indapamide | GX | MP NP | 90 | 1 | 90 |
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 5 mg
(a)omit from the column headed “Schedule Equivalent” for the brand “Lamictal”: a
(b)omit:
| a | Lamotrigine Aspen 5 | RW | MP NP | C11081 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 25 mg
omit:
| a | Lamotrigine Aspen 25 | RW | MP NP | C11081 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 50 mg
omit:
| a | Lamotrigine Aspen 50 | RW | MP NP | C11081 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 100 mg
omit:
| a | Lamotrigine Aspen 100 | RW | MP NP | C11081 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 200 mg
omit:
| a | Lamotrigine Aspen 200 | RW | MP NP | C11081 | 56 | 5 | 56 |
Schedule 1, Part 1, entry for Methotrexate
(a)omit:
| Injection 7.5 mg in 0.3 mL pre‑filled syringe | Injection | Methoblastin PFS | PF | MP | C7488 C7518 | 4 | 5 | 4 |
(b)omit:
| Injection 10 mg in 0.4 mL pre‑filled syringe | Injection | Methoblastin PFS | PF | MP | C7488 C7518 | 4 | 5 | 4 |
(c)omit:
| Injection 15 mg in 0.6 mL pre‑filled syringe | Injection | Methoblastin PFS | PF | MP | C7488 C7518 | 4 | 5 | 4 |
(d)omit:
| injection 20 mg in 0.8 mL pre‑filled syringe | Injection | Methoblastin PFS | PF | MP | C7488 C7518 | 4 | 5 | 4 |
(e)omit:
| Injection 25 mg in 1 mL pre‑filled syringe | Injection | Methoblastin PFS | PF | MP | C7488 C7518 | 4 | 5 | 4 |
Schedule 1, Part 1, entry for Methoxsalen
substitute:
| Methoxsalen | Solution for blood fraction 20 microgram per mL, 10 mL | Extracorporeal circulation | Uvadex | TQ | MP | C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579 | P10988 P10989 | 1 | 5 | 12 | D(100) |
| MP | C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579 | P12531 P12567 | 2 | 0 | 12 | D(100) | |||||
| MP | C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579 | P10971 P10985 | 2 | 6 | 12 | D(100) | |||||
| MP | C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579 | P12546 P12579 | 12 | 1 | 12 | D(100) |
Schedule 1, Part 1, after entry for Modafinil
insert:
| Molnupiravir | Capsule 200 mg | Oral | Lagevrio | MK | MP | C12582 C12583 C12584 | 40 | 0 | 40 |
Schedule 1, Part 1, entry for Naltrexone
(a)omit:
| a | APO-Naltrexone | TX | MP NP | C5364 | 30 | 1 | 30 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Naltrexone GH”: a
Schedule 1, Part 1, entry for Nilotinib in the form Capsule 150 mg (as hydrochloride monohydrate)
omit from the column headed “Circumstances”: C6958 C6966 C6967 substitute: C12557 C12572
Schedule 1, Part 1, entry for Nilotinib in the form Capsule 200 mg (as hydrochloride monohydrate)
omit from the column headed “Circumstances”: C6954 C6977 substitute: C12522 C12529 C12549 C12563 C12569
Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets
(a)omit:
| a | Brevinor | PF | MP NP | 4 | 2 | 4 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Norimin 28 Day”: a
Schedule 1, Part 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8818 C8863 C8864 C8899
(b)insert in numerical order in the column headed “Circumstances”: C12552 C12553 C12562 C12577
Schedule 1, Part 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8818 C8863 C8864 C8899
(b)insert in numerical order in the column headed “Circumstances”: C12552 C12553 C12562 C12577
(c)omit from the column headed “Purposes”: P8818 P8863 P8864 P8899 substitute: P12552 P12553 P12562 P12577
Schedule 1, Part 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8818 C8863 C8864 C8899
(b)insert in numerical order in the column headed “Circumstances”: C12552 C12553 C12562 C12577
Schedule 1, Part 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8818 C8863 C8864 C8899
(b)insert in numerical order in the column headed “Circumstances”: C12552 C12553 C12562 C12577
(c)omit from the column headed “Purposes”: P8818 P8863 P8864 P8899 substitute: P12552 P12553 P12562 P12577
Schedule 1, Part 1, after entry for Rasagiline
insert:
| Ravulizumab | Solution concentrate for I.V. infusion 300 mg in 3 mL | Injection | Ultomiris | XI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| Solution concentrate for I.V. infusion 1,100 mg in 11 mL | Injection | Ultomiris | XI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)
(a)omit:
| a | APO-Rosuvastatin | TX | MP NP | 30 | 5 | 30 |
(b)omit:
| a | APO-Rosuvastatin | TX | MP | P7598 | 30 | 11 | 30 |
Schedule 1, Part 1, entry for Sildenafil
omit:
| a | APO-Sildenafil PHT | TX | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 90 | D(100) |
Schedule 1, Part 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL
omit:
| a | TOBRAMYCIN WOCKHARDT | WC | MP | C5520 | 56 | 2 | 56 |
Schedule 1, Part 1, entry for Valaciclovir
(a)omit:
| a | APO-Valaciclovir | TX | MP NP | C5940 C5960 C5961 C5962 C5968 | P5960 | 20 | 0 | 10 |
(b)omit:
| a | APO-Valaciclovir | TX | MP NP | C5940 C5960 C5961 C5962 C5968 | P5940 P5961 | 30 | 5 | 30 |
(c)omit:
| a | APO-Valaciclovir | TX | MP NP | C5940 C5960 C5961 C5962 C5968 | P5962 P5968 | 42 | 0 | 42 |
(d)omit:
| a | APO-Valaciclovir | TX | MP | C5975 C9267 | 500 | 2 | 100 | C(100) |
Schedule 1, Part 1, entry for Vedolizumab in the form Injection 108 mg in 0.68 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C12243
(b)insert in numerical order in the column headed “Circumstances”: C12576
(c)omit from the column headed “Purposes”: P12243
(d)insert in numerical order in the column headed “Purposes”: P12576
Schedule 1, Part 1, entry for Vedolizumab in the form Injection 108 mg in 0.68 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C12243
(b)insert in numerical order in the column headed “Circumstances”: C12576
Schedule 1, Part 1, after entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
insert:
| Zanubrutinib | Capsule 80 mg | Oral | Brukinsa | IE | MP | C12495 C12500 C12573 | 120 | 5 | 120 |
Schedule 1, Part 1, entry for Zonisamide in each of the forms: Capsule 25 mg; Capsule 50 mg; and Capsule 100 mg
omit from the column headed “Responsible Person” for the brand “Zonegran”: EI substitute: GH
Schedule 3, after details relevant for Responsible Person code IB
insert:
| IE | BeiGene AUS Pty Ltd | 23 164 802 037 |
Schedule 3, after details relevant for Responsible Person code RO
insert:
| RQ | Reach Pharmaceuticals Pty Ltd | 25 623 897 183 |
Schedule 3,
omit:
| WC | Wockhardt Bio Pty Ltd | 91 607 752 090 |
Schedule 4, Part 1, entry for Cefotaxime
omit:
| C5519 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Schedule 4, Part 1, entry for Dasatinib
(a)omit:
| C6702 | P6702 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have received initial PBS- subsidised second line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenetic response in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and (3) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided. | Compliance with Authority Required procedures |
| C6731 | P6731 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must not have failed PBS-subsidised first line treatment with this drug for this condition; AND Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have failed an adequate trial of PBS-subsidised first line treatment with nilotinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised second line treatment with nilotinib for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of imatinib or nilotinib is defined as:(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or(3) Peripheral basophils greater than or equal to 20%; or(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); ORBlast crisis is defined as either:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or(2) Extramedullary involvement other than spleen and liver; OR(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement | Compliance with Authority Required procedures |
| C6947 | P6947 | Chronic Myeloid Leukaemia (CML) First continuing treatment The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have demonstrated a major cytogenic response; OR Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. First continuing applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) demonstration of continued response to treatment as evidenced by either: (a) a major cytogenetic response [see Note explaining requirements]; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided. | Compliance with Authority Required procedures |
| C9197 | P9197 | Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
| C9293 | P9293 | Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C12522 | P12522 | Chronic Myeloid Leukaemia (CML) Continuing treatment - third-line therapy Patient must have received initial PBS-subsidised treatment with this drug as a third-line therapy for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12522 |
| C12524 | P12524 | Chronic Myeloid Leukaemia (CML) Initial treatment - second-line therapy The condition must be in the chronic phase; OR The condition must be in the accelerated phase; OR The condition must be in the blast phase; AND Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; OR Patient must have failed an adequate trial of PBS-subsidised first-line treatment with nilotinib for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of imatinib or nilotinib is defined as: (i) Lack of response to initial imatinib or nilotinib therapy, defined as either: - failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or - failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR (iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); Blast crisis is defined as either: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or (2) Extramedullary involvement other than spleen and liver; OR (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient's medical records. Pathology report(s) confirming a loss of response to imatinib or nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C12530 | P12530 | Chronic Myeloid Leukaemia (CML) Continuing treatment - second-line therapy Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12530 |
| C12561 | P12561 | Chronic Myeloid Leukaemia (CML) Initial treatment - third-line therapy The condition must be in the chronic phase; OR The condition must be in the accelerated phase; OR The condition must be in the blast phase; AND Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; OR Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND Patient must have failed an adequate trial of PBS-subsidised second-line treatment with nilotinib for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of nilotinib is defined as: (i) Lack of response to second line nilotinib therapy, defined as either: - failure to achieve a haematological response after a minimum of 3 months therapy with nilotinib for patients initially treated in chronic phase; or - failure to achieve any cytogenetic response after a minimum of 6 months therapy with nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with nilotinib; OR ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing nilotinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing nilotinib therapy; OR (iv) Development of accelerated phase or blast crisis in a patient previously prescribed nilotinib for any phase of chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR Blast crisis is defined as either: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or (2) Extramedullary involvement other than spleen and liver; OR (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient's medical records. Pathology report(s) confirming a loss of response to imatinib and nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C12565 | P12565 | Chronic Myeloid Leukaemia (CML) Continuing treatment - first-line therapy The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12565 |
| C12570 | P12570 | Chronic Myeloid Leukaemia (CML) Initial treatment - first-line therapy Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Gemfibrozil
insert:
| Gemtuzumab ozogamicin | C12559 | Acute Myeloid Leukaemia Induction treatment Patient must have confirmed CD33-positive AML prior to initiation of treatment; AND The condition must be de novo; AND The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND Patient must have confirmed intermediate/favourable cytogenetic risk; OR Patient must have unknown cytogenetic risk due to inconclusive test results; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The condition must not be acute promyelocytic leukaemia; AND The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND The treatment must not be used in combination with a tyrosine kinase inhibitor; AND The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND Patient must not receive more than 1 induction cycle under this restriction in a lifetime. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures |
| C12566 | Acute Myeloid Leukaemia Consolidation treatment Patient must have achieved a complete remission following induction treatment with this drug for this condition; AND The treatment must be in combination with standard intensive remission consolidation chemotherapy for this condition, which must include cytarabine and an anthracycline; AND Patient must not receive more than 2 consolidation cycles under this restriction in a lifetime. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 10 9 cells/L with a platelet count of 100 x 10 9 /L or more in the peripheral blood in the absence of transfusion. Progressive disease is defined as the presence of any of the following: a) Leukaemic cells in the CSF; b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; d) Extramedullary leukaemia. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Imatinib
(a)omit:
| C9200 | P9200 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase of chronic myeloid leukaemia; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
(b)omit:
| C9242 | P9242 | Chronic Myeloid Leukaemia (CML) First Continuing The condition must be in the chronic phase of chronic myeloid leukaemia; AND Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have demonstrated a major cytogenic response; OR Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures |
(c)omit:
| C9295 | P9295 | Chronic Myeloid Leukaemia (CML) Subsequent continuing The condition must be in the chronic phase of chronic myeloid leukaemia; AND Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9295 |
(d)omit:
| C10010 | P10010 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). | Compliance with Authority Required procedures |
| C10026 | P10026 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures - Streamlined Authority Code 10026 |
| C10035 | P10035 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. | Compliance with Authority Required procedures |
| C10048 | P10048 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures - Streamlined Authority Code 10048 |
(e)insert in numerical order after existing text:
| C12525 | P12525 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR). | Compliance with Authority Required procedures - Streamlined Authority Code 12525 |
| C12527 | P12527 | Chronic Myeloid Leukaemia (CML) Initial treatment - first-line therapy The condition must be a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C12536 | P12536 | Chronic Myeloid Leukaemia (CML) Continuing treatment - first-line therapy The condition must be in the chronic phase; AND Patient must have received initial continuing PBS-subsidised treatment with this drug as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12536 |
| C12541 | P12541 | Chronic Myeloid Leukaemia (CML) Initial treatment - first-line therapy The condition must be a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C12542 | P12542 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR). | Compliance with Authority Required procedures - Streamlined Authority Code 12542 |
| C12543 | P12543 | Chronic Myeloid Leukaemia (CML) Initial treatment - first-line therapy The condition must be a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Methoxsalen
insert in numerical order after existing text:
| C12531 | P12531 | Chronic graft versus host disease Continuing treatment Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS-listing for the same treatment episode. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see 'Initial treatment' for resuming treatment following relapse. | Compliance with Authority Required procedures - Streamlined Authority Code 12531 |
| C12546 | P12546 | Chronic graft versus host disease Initial treatment in a treatment episode The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; OR The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; OR The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed. Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; AND Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 12546 |
| C12567 | P12567 | Chronic graft versus host disease Continuing treatment Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS-listing for the same treatment episode. Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see 'Initial treatment' for resuming treatment following relapse. | Compliance with Authority Required procedures - Streamlined Authority Code 12567 |
| C12579 | P12579 | Chronic graft versus host disease Initial treatment in a treatment episode The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; OR The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; OR The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed. Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; AND Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 12579 |
Schedule 4, Part 1, after entry for Modafinil
insert:
| Molnupiravir | C12582 | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; OR Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation at the time of prescribing; AND Patient must be aged 65 years or over and at high risk; AND The treatment must be initiated within 5 days of symptom onset. For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions: The patient has received less than 2 doses of SARS-CoV-2 vaccine, The patient is aged 75 years or over, The patient is in residential aged care or residential disability care, Neurological conditions, including stroke and dementia, Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, Congestive heart failure (NYHA Class II or greater), Obesity (BMI greater than 30 kg/m2), Diabetes Types I and II, requiring medication for glycaemic control, Renal failure (eGFR less than 60mL/min), Cirrhosis, or The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 12582 |
| C12583 | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; OR Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation at the time of prescribing; AND Patient must be moderately to severely immunocompromised; AND Patient must be at risk of progression to severe disease due to immunocompromised status; AND The treatment must be initiated within 5 days of symptom onset. Patient must be aged 18 years or over. For the purpose of administering this restriction, "moderately to severely immunocompromised" patients are those with: 1. any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency OR 2. any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (greater than or equal to 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate (more than 0.4mg/kg/week), leflunomide, azathioprine (at least 3mg/kg/day), 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus) OR 3. any significantly immunocompromising condition(s) where, in the last 12 months the patient has received rituximab, 4. Others with very high risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies OR 5. People with severe intellectual or physical disabilities requiring residential care Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 12583 | |
| C12584 | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; OR Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation at the time of prescribing. Patient must identify as Aboriginal or Torres Strait Islander. Patient must be aged 50 or over and at high risk; AND The treatment must be initiated within 5 days of symptom onset. For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions: The patient has received less than 2 doses of SARS-CoV-2 vaccine, The patient is in residential aged care or residential disability care, Neurological conditions, including stroke and dementia, Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, Congestive heart failure (NYHA Class II or greater), Obesity (BMI greater than 30kg/m2), Diabetes Types I and II, requiring medication for glycaemic control, Renal failure (eGFR less than 60mL/min), Cirrhosis, or The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 12584 |
Schedule 4, Part 1, entry for Nilotinib
substitute:
| Nilotinib | C12522 | Chronic Myeloid Leukaemia (CML) Continuing treatment - third-line therapy Patient must have received initial PBS-subsidised treatment with this drug as a third-line therapy for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12522 |
| C12529 | Chronic Myeloid Leukaemia (CML) Initial treatment - second-line therapy The condition must be in the chronic phase; OR The condition must be in the accelerated phase; AND Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; OR Patient must have failed an adequate trial of PBS-subsidised first-line treatment with dasatinib for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of imatinib or dasatinib is defined as: (i) Lack of response to initial imatinib or dasatinib therapy, defined as either: - failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or - failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR (iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR (v) Disease progression (defined as a greater than or equal to. 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy. Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient's medical records. Pathology report(s) confirming a loss of response to imatinib or dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records. | Compliance with Authority Required procedures | |
| C12549 | Chronic Myeloid Leukaemia (CML) Grandfather treatment for patients initiated with nilotinib 200 mg prior to 1 April 2012 as first-line therapy The condition must be in the chronic phase; AND Patient must have received PBS-subsidised treatment with nilotinib 200mg as a first-line therapy for this condition prior to 1 April 2012; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12549 | |
| C12557 | Chronic Myeloid Leukaemia (CML) Initial treatment - first-line therapy Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records. | Compliance with Authority Required procedures | |
| C12563 | Chronic Myeloid Leukaemia (CML) Continuing treatment - second-line therapy Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12563 | |
| C12569 | Chronic Myeloid Leukaemia (CML) Initial treatment - third-line therapy The condition must be in the chronic phase; OR The condition must be in the accelerated phase; AND Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; OR Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND Patient must have failed an adequate trial of PBS-subsidised second-line treatment with dasatinib for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of dasatinib is defined as: (i) Lack of response to second-line dasatinib therapy, defined as either: - failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib for patients initially treated in chronic phase; or - failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib; OR (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib therapy; OR (iv) Development of accelerated phase in a patient previously prescribed dasatinib for the chronic phase of chronic myeloid leukaemia.Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy. Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient's medical records. Pathology report(s) confirming a loss of response to imatinib and dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records. | Compliance with Authority Required procedures | |
| C12572 | Chronic Myeloid Leukaemia (CML) Continuing treatment - first-line therapy The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 12572 |
Schedule 4, Part 1, entry for Ponatinib
(a)omit:
| C8818 | P8818 | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation; AND Patient must have failed an adequate trial of imatinib; OR Patient must have failed an adequate trial of dasatinib; OR Patient must have failed an adequate trial of nilotinib. Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as: 1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: 1. a completed authority prescription form; and 2. a completed Chronic Myeloid Leukaemia - ponatinib Initial PBS authority application form; and 3. a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale and evidence of the T315I mutation. (The date of the relevant pathology report(s) need to be provided); and 4. where there has been a loss of response to imatinib or dasatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
| C8863 | P8863 | Chronic Myeloid Leukaemia (CML) First continuing treatment Patient must have received initial PBS subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have demonstrated a major cytogenetic response; OR Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%. First continuing applications for authorisation must be in writing and must include: 1. a completed authority prescription form; and 2. a completed Chronic Myeloid Leukaemia Continuing PBS authority application Supporting information form; and 3. demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response [see Note explaining definitions of response]; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. | Compliance with Written Authority Required procedures |
| C8864 | P8864 | Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have maintained a major cytogenic response at 12 month intervals; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% at 12 month intervals. | Compliance with Authority Required procedures |
| C8899 | P8899 | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have failed an adequate trial of dasatinib; OR Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND Patient must have failed an adequate trial of nilotinib; OR Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Failure of an adequate trial of dasatinib or nilotinib is defined as: 1. Lack of response to dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: 1. a completed authority prescription form; and 2. a completed Chronic Myeloid Leukaemia - ponatinib Initial PBS authority application form; and 3. a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and 4. where there has been a loss of response to dasatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C12552 | P12552 | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority. Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as: 1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following: (i) date and result of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) date and result of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) date and result of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, date and result(s) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
| C12553 | P12553 | Chronic Myeloid Leukaemia (CML) First continuing treatment Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals. First continuing applications for authorisation must be in writing and must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following: (i) major cytogenetic response (date and result) [see Note explaining definitions of response]; or (ii) a peripheral blood level of BCR-ABL of less than 1% on the international scale (date and result) [see Note explaining definitions of response]. | Compliance with Written Authority Required procedures |
| C12562 | P12562 | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Failure of an adequate trial of dasatinib or nilotinib is defined as: 1. Lack of response to dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following: (i) date and result of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) date and result of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) where there has been a loss of response to dasatinib or nilotinib, date and result(s) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
| C12577 | P12577 | Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Vedolizumab
(a)omit:
| C12243 | P12243 | Severe Crohn disease Initial treatment with subcutaneous form Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 1 (new patient); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 3 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16. Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C12576 | P12576 | Severe Crohn disease Initial treatment with subcutaneous form Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16. Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, after entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
insert:
| Zanubrutinib | C12495 | Mantle cell lymphoma Initial treatment The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be untreated with Bruton tyrosine kinase inhibitor therapy; OR Patient must have developed intolerance to another Bruton tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. | Compliance with Authority Required procedures |
| C12500 | Mantle cell lymphoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; 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 | |
| C12573 | Mantle cell lymphoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received treatment with this drug prior to 1 March 2022; AND The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment 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 the sole PBS-subsidised therapy for this condition; AND Patient must have been untreated with Bruton tyrosine kinase inhibitor therapy at treatment initiation with this drug; OR Patient must have developed intolerance to another Bruton tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 5, after entry for Aflibercept
insert:
| Chorionic gonadotrophin | GRP-21682 | Powder for injection 5,000 units with solvent | Injection | Pregnyl |
| Powder for injection 5,000 units with solvent (s19A) | Injection | Choriomon 5000 I.E | ||
| GRP-21684 | Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 | Injection | Pregnyl | |
| Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A) | Injection | Brevactid 1500 I.E |
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]
omit from the column headed “Brand”: APO-Clopidogrel
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]
omit from the column headed “Brand”: APO-Clopidogrel
Schedule 5, entry for Etanercept
substitute:
| Etanercept | GRP-26051 | Injection 50 mg in 1 mL single use auto-injector, 4 | Injection | Enbrel |
| Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 | Injection | Enbrel | ||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Enbrel | ||
| GRP-26052 | Injection 50 mg in 1 mL single use auto-injector, 4 | Injection | Brenzys Enbrel | |
| Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 | Injection | Enbrel | ||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Brenzys Enbrel |
Schedule 5, entry for Imatinib in the form Tablet 100 mg (as mesilate) [GRP-25645]
insert in alphabetical order in the column headed “Brand”: IMATINIB RBX
Schedule 5, entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-25647]
insert in alphabetical order in the column headed “Brand”: IMATINIB RBX
Schedule 5, omit entry for Methotrexate
Schedule 6, after entry for Etanercept in the form Injection 50 mg in 1 mL single use auto‑injector, 4
insert:
| Etanercept | Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 | Injection |
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Citations
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 2) (Cth)
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