National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 9) (Cth)
PB 78 of 2022
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 9)
National Health Act 1953
________________________________________________________________________
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, 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 25 August 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
________________________________________________________________________
Contents
1......... Name......................................................................................................... ………….…1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Listing of Pharmaceutical benefits) Instrument 2012
(PB 71 of 2012). 2
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 9).
(2)This instrument may also be cited as PB 78 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 September 2022 | 1 September 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Note: This table relates only to the provisions of this instrument as originally made.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”: TX substitute: XT
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): TX substitute: XT
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): TX substitute: XT
Schedule 1, Part 1, entry for Alirocumab in each of the forms: Injection 75 mg in 1 mL single use pre-filled pen; and Injection 150 mg in 1 mL single use pre-filled pen
omit from the column headed “Circumstances”: C12055
Schedule 1, Part 1, entry for Apremilast in each of the forms: Pack containing 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg; and
Tablet 30 mg
omit from the column headed “Circumstances”: C11115 substitute: C13243
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bortezomib-AFT | AE | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Brentuximab vedotin
omit from the column headed “Circumstances”: C8722 C8736 C10519 C10524 C10811 C10902 C12085 C12087 C12088 C12141 substitute: C13134 C13179 C13181 C13182 C13208 C13209 C13212 C13231 C13259 C13261
Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent
omit from the column headed “Circumstances” (all instances): C4662 substitute: C13207
Schedule 1, Part 1, after entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent
insert:
| Solution concentrate for I.V. infusion 60 mg in 3 mL | Injection | Cabazitaxel Accord | OC | MP | C13207 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Cabazitaxel in the form Solution concentrate for I.V. infusion 60 mg in 6 mL
omit from the column headed “Circumstances”: C4662 substitute: C13207
Schedule 1, Part 1, entry for Cefazolin in the form Powder for injection 2 g (as sodium)
(a)insert in the column headed “Schedule Equivalent” for the brand “Cephazolin Alphapharm”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Cefazolin-AFT | AE | MP NP | C5826 C5867 C5881 C5890 | 10 | 0 | 5 |
Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 10 mg [Maximum Quantity: 120; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P6676
(b)omit from the column headed “Purposes”: P9763
(c)insert in numerical order in the column headed “Purposes”: P13122 P13168
(d)omit from the column headed “Maximum Quantity”: CN6676
(e)omit from the column headed “Maximum Quantity”: CN9763
(f)insert in numerical order in the column headed “Maximum Quantity”: CN13122 CN13168
(g)omit from the column headed “Number of Repeats”: CN6676
(h)omit from the column headed “Number of Repeats”: CN9763
(i)insert in numerical order in the column headed “Number of Repeats”: CN13122 CN13168
Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 25 mg
substitute:
| Capsule 25 mg | Oral | a | APO-Ciclosporin | TX | MP | 60 | 3 | 30 |
| a | Cyclosporin Sandoz | SZ | MP | 60 | 3 | 30 | ||
| a | Neoral 25 | NV | MP | 60 | 3 | 30 | ||
| a | APO-Ciclosporin | TX | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Cyclosporin Sandoz | SZ | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Neoral 25 | NV | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 50 mg
substitute:
| Capsule 50 mg | Oral | a | APO-Ciclosporin | TX | MP | 60 | 3 | 30 |
| a | Cyclosporin Sandoz | SZ | MP | 60 | 3 | 30 | ||
| a | Neoral 50 | NV | MP | 60 | 3 | 30 | ||
| a | APO-Ciclosporin | TX | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Cyclosporin Sandoz | SZ | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Neoral 50 | NV | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 100 mg
substitute:
| Capsule 100 mg | Oral | a | APO-Ciclosporin | TX | MP | 60 | 3 | 30 |
| a | Cyclosporin Sandoz | SZ | MP | 60 | 3 | 30 | ||
| a | Neoral 100 | NV | MP | 60 | 3 | 30 | ||
| a | APO-Ciclosporin | TX | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Cyclosporin Sandoz | SZ | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
| a | Neoral 100 | NV | MP | P6631 P6638 P6643 P6660 P9694 P9695 P9742 P9764 P13122 P13168 | 120 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 5 CN6631 CN6638 CN6643 CN6660 CN9694 CN9695 CN9742 CN9764 CN13122 CN13168 | 30 | C(100) |
Schedule 1, Part 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL [Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P6676
(b)omit from the column headed “Purposes”: P9763
(c)insert in numerical order in the column headed “Purposes”: P13122 P13168
(d)omit from the column headed “Maximum Quantity”: CN6676
(e)omit from the column headed “Maximum Quantity”: CN9763
(f)insert in numerical order in the column headed “Maximum Quantity”: CN13122 CN13168
(g)omit from the column headed “Number of Repeats”: CN6676
(h)omit from the column headed “Number of Repeats”: CN9763
(i)insert in numerical order in the column headed “Number of Repeats”: CN13122 CN13168
Schedule 1, Part 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg
omit from the column headed “Circumstances”: C7359 C10633 C10650 C10665 substitute: C13186 C13233 C13250 C13251
Schedule 1, Part 1, entry for Dapagliflozin [Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 5]
insertin numerical order in the column headed “Circumstances”: C13230
Schedule 1, Part 1, entry for Dapagliflozin [Authorised Prescriber: NP; Maximum Quantity: 28; Number of Repeats: 5]
insertin numerical order in the column headed “Circumstances”: C13230
Schedule 1, Part 1, entry for Entrectinib
omit from the column headed “Circumstances”: C10633 C10658 substitute: C13184 C13276
Schedule 1, Part 1, omit entry for Eptifibatide
Schedule 1, Part 1, after entry for Gentamicin in the form Injection 80 mg (as sulfate) in 2 mL
insert:
| Gilteritinib | Tablet 40 mg (as fumarate) | Oral | Xospata | LL | MP | C13166 C13167 C13242 | P13166 | 84 | 0 | 84 |
| MP | C13166 C13167 C13242 | P13167 P13242 | 84 | 4 | 84 |
Schedule 1, Part 1, entry for Glatiramer
insert as first entry:
| Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen | Injection | a | Copaxone | TB | MP | C6860 C7695 | 12 | 5 | 12 |
Schedule 1, Part 1, entry for Gliclazide in the form Tablet 60 mg (modified release)
omit from the column headed “Responsible Person” for the brand “ARDIX GLICLAZIDE 60mg MR”: RX substitute: XT
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 2 mg
omit:
| a | Dimirel | AV | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Hydroxycarbamide
omit from the column headed “Responsible Person” for the brand “Hydrea”: BQ substitute: LM
Schedule 1, Part 1, entry for Icatibant
(a)insert in the column headed “Schedule Equivalent” for the brand “Cipla Icatibant”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Fyzant | JU | MP | C7273 C7274 | 1 | 1 | 1 |
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 60; Number of
Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 60; Number of
Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: IMATINIB-DRLA;Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 30; Number of
Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 30; Number of
Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib-APOTEX; Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: IMATINIB-DRLA; Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes” (all instances): P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1,entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes” (all instances): P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Imatinib in the form Tablet 600 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
(c)omit from the column headed “Purposes”: P9208
(d)insert in numerical order in the column headed “Purposes”: P13132
Schedule 1, Part 1, entry for Imatinib in the form Tablet 600 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C13132
Schedule 1, Part 1, entry for Leflunomide in the form Tablet 20 mg
omit:
| a | Arabloc | AV | MP | C5681 C5766 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Molnupiravir
omit from the column headed “Circumstances”: C13107 C13108 C13110 C13112 substitute: C13155 C13156 C13201 C13224
Schedule 1, Part 1, after entry for Nintedanib in the form Capsule 150 mg
insert:
| Niraparib | Capsule 100 mg (as tosilate monohydrate) | Oral | Zejula | GK | MP | C13202 C13204 C13264 C13273 | P13202 | 56 | 2 | 56 |
| MP | C13202 C13204 C13264 C13273 | P13264 | 56 | 5 | 56 | |||||
| MP | C13202 C13204 C13264 C13273 | P13273 | 84 | 2 | 84 | |||||
| MP | C13202 C13204 C13264 C13273 | P13204 | 84 | 5 | 84 |
Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir
omit from the column headed “Circumstances”: C13107 C13108 C13110 C13112 substitute: C13155 C13156 C13201 C13224
Schedule 1, Part 1, omit entry for Norethisterone with mestranol
Schedule 1, Part 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C10914
(b)insert in numerical order in the column headed “Circumstances”: C13226
(c)omit from the column headed “Purposes”: P10914
(d)insert in numerical order in the column headed “Purposes”: P13226
Schedule 1, Part 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10914
(b)insert in numerical order in the column headed “Circumstances”: C13226
Schedule 1, Part 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C10914
(b)insert in numerical order in the column headed “Circumstances”: C13226
(c)omit from the column headed “Purposes”: P10914
(d)insert in numerical order in the column headed “Purposes”: P13226
Schedule 1, Part 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C10914
(b)insert in numerical order in the column headed “Circumstances”: C13226
Schedule 1, Part 1, after entry for Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg
insert:
| Tablet containing oxybutynin chloride 5 mg (s19A) | Oral | Oxybutynin Chloride (Novitium) | QY | MP NP | C6241 | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Pembrolizumab
(a)omit from the column headed “Circumstances”: C9863 C9864
(b)omit from the column headed “Circumstances”: C10679
(c)omit from the column headed “Circumstances”: C10702
(d)omit from the column headed “Circumstances”: C11993
(e)insert in numerical order in the column headed “Circumstances”: C13126 C13213 C13214 C13245
Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pemetrexed-AFT | AE | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, after entry for Polyethylene glycol 400 with propylene glycol in the form Eye drops 4 mg-3 mg per mL, single dose units
0.8 mL, 28
insert:
| Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 30 | Application to the eye | Systane | AQ | AO MP NP | C6172 | 2 | 5 | 1 |
Schedule 1, Part 1, entry for Rituximab
substitute:
| Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | a | Ruxience | PF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) | |||
| a | Truxima | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) | |||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| a | Ruxience | PF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |||
| a | Truxima | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P11225 P11226 substitute: P13127 P13173
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P5917 P5920 substitute: P13128 P13130
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P11225 P11226 substitute: P13127 P13173
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P5917 P5920 substitute: P13128 P13130
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P11225 P11226 substitute: P13127 P13173
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P5917 P5920 substitute: P13128 P13130
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P11225 P11226 substitute: P13127 P13173
Schedule 1, Part 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5917 C5920 C11225 C11226 substitute: C13127 C13128 C13130 C13173
(b)omit from the column headed “Purposes”: P5917 P5920 substitute: P13128 P13130
Schedule 1, Part 1, after entry for Selexipag in the form Tablet 1.6 mg
insert:
| Selinexor | Tablet 20 mg | Oral | Xpovio | TG | MP | C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13115 P13229 P13256 | 16 | 2 | 16 | D(100) |
| MP | C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13116 P13118 P13228 | 20 | 2 | 20 | D(100) | |||||
| MP | C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13159 P13160 P13161 | 32 | 2 | 32 | D(100) |
Schedule 1, Part 1, entry for Siltuximab in each of the forms: Powder for injection 100 mg; and Powder for injection 400 mg
omit from the column headed “Responsible Person”: EY substitute: RJ
Schedule 1, Part 1, entry for Sonidegib in the form Capsule 200 mg
(a)omit from the column headed “Circumstances”: C7540 C7557
(b)insert in numerical order in the column headed “Circumstances”: C13175 C13260
Schedule 1, Part 1, entry for Sunitinib
substitute:
| Sunitinib | Capsule 12.5 mg | Oral | a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 |
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| Capsule 25 mg | Oral | a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| Capsule 37.5 mg | Oral | a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| Capsule 50 mg | Oral | a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11878 P13152 P13153 | 28 | 1 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P4862 | 28 | 2 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P11875 | 28 | 3 | 28 | |||
| a | ARX-Sunitinib | XT | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sunitinib Sandoz | SZ | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 | |||
| a | Sutent | PF | MP | C4862 C7471 C11875 C11878 C13152 C13153 | P7471 | 28 | 5 | 28 |
Schedule 1, Part 1, after entry for Triglycerides, medium chain in the form Oral liquid 225 mL, 15 (betaquik)
insert:
| Oral liquid 225 mL, 15 (K.Quik) | Oral | K.Quik | VF | MP NP | C6147 C6191 | 2 | 5 | 1 |
Schedule 1, Part 1, entry for Valganciclovir in the form Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL
omit from the column headed “Responsible Person”: RO substitute: PB
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”: C12077
(b)omit from the column headed “Circumstances”: C12218
(c)omit from the column headed “Circumstances”: C12244 C12250
(d)insert in numerical order in the column headed “Circumstances”: C13236 C13237
(e)omit from the column headed “Purposes”: P12218
(f)omit from the column headed “Purposes”: P12250
(g)insert in numerical order in the column headed “Purposes”: P13236 P13237
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”: C12077
(b)omit from the column headed “Circumstances”: C12218
(c)omit from the column headed “Circumstances”: C12244 C12250
(d)insert in numerical order in the column headed “Circumstances”: C13236 C13237
(e)omit from the column headed “Purposes”: P12077
(f)omit from the column headed “Purposes”: P12244
Schedule 1, Part 1, entry for Venetoclax in the form Tablet 10 mg
substitute:
| Tablet 10 mg | Oral | Venclexta | VE | MP | C10995 | 14 | 0 | 2 |
Schedule 1, Part 1, entry for Vismodegib
(a)omit from the column headed “Circumstances”: C7540 C7557
(b)insert in numerical order in the column headed “Circumstances”: C13175 C13268
Schedule 1, Part 1, entry for Vorinostat in the form Capsule 100 mg [Maximum Quantity: 120; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C6957 C6964 substitute: C13177 C13246
(b)omit from the column headed “Purposes”: P6964 substitute: P13246
Schedule 1, Part 1, entry for Vorinostat in the form Capsule 100 mg [Maximum Quantity: 120; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6957 C6964 substitute: C13177 C13246
(b)omit from the column headed “Purposes”: P6957 substitute: P13177
Schedule 1, Part 2, after entry for Nifedipine
insert:
| Norethisterone with mestranol | Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets | Oral | Norinyl-1/28 | PF | MP NP | 4 | 2 | 4 |
Schedule 1, Part 2, after entry for Pancreatic extract
insert:
| Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | Ruxience | PF | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) |
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 2 | D(100) | |||
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 2 | D(100) | |||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | a | Riximyo | SZ | MP | C9446 C9611 | 2 | 1 | 1 | D(100) |
| a | Ruxience | PF | MP | C9446 C9611 | 2 | 1 | 1 | D(100) | ||
| a | Truxima | EW | MP | C9446 C9611 | 2 | 1 | 1 | D(100) | ||
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Ruxience | PF | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 2, omit entry for Rivaroxaban
Schedule 3,
omit:
| EY | EUSA Pharma (Australia) Pty Ltd | 14 646 058 728 |
Schedule 3, after details relevant for Responsible Person code TD
insert:
| TG | ANTENGENE (AUS) PTY. LTD. | 30 638 038 990 |
Schedule 4, Part 1, entry for Alirocumab
omit:
| C12055 | Familial heterozygous hypercholesterolaemia Grandfather treatment Patient must have received non-PBS subsidised treatment with this drug for this PBS indication prior to 1 August 2021; AND The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing prior to starting non-PBS-subsidised treatment with this drug for this condition; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease at the time non-PBS-subsidised treatment with this drug for this condition was initiated; OR Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication. Must be treated by a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level must have been measured following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events), must be stated at the time of application, documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment with this drug for this condition was initiated. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin resulted in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must have been treated with the alternative statin (atorvastatin or rosuvastatin) unless there was a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should have occurred after a washout period of at least 4 weeks, or if the creatine kinase (CK) level was elevated, the retrial should not have occurred until CK had returned to normal. In the event of a trial of the alternative statin, the dose of the alternative statin should have been increased not more often than every 4 weeks until the maximum tolerated dose was reached or target LDL-c had been achieved. The following must be stated at the time of application and documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Apremilast
substitute:
| Apremilast | C13243 | Severe chronic plaque psoriasis Patient must have failed to achieve an adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; OR Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; OR Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND The condition must have caused significant interference with quality of life; AND Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist; OR Must be treated by a general practitioner who has been directed to continue treatment (not initiate treatment) by one of the above practitioner types. Patient must be at least 18 years of age. | Compliance with Authority Required procedures - Streamlined Authority Code 13243 |
Schedule 4, Part 1, entry for Brentuximab vedotin
substitute:
| Brentuximab vedotin | C13134 | CD30 positive peripheral T-cell lymphoma, non-cutaneous type Initial treatment Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND The treatment must be for first line therapy for this condition; AND The treatment must be for curative intent; AND The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND The treatment must not be more than 6 treatment cycles under this restriction in a lifetime. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and (b) The date of initial diagnosis of Peripheral T-cell lymphoma. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13179 | CD30 positive cutaneous T-cell lymphoma Initial treatment Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND Patient must have CD30 positivity of at least 3% of malignant cells; AND Patient must have a diagnosis of mycosis fungoides; OR Patient must have a diagnosis of Sezary syndrome; OR Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND Patient must have received prior systemic treatment for this condition; AND The condition must be relapsed or refractory; AND The treatment must not exceed 4 cycles under this restriction in a lifetime; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and (b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and (c) Date of commencement and completion of the most recent prior systemic treatment. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures | |
| C13181 | CD30 positive cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved an objective response with this drug; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria. | Compliance with Authority Required procedures | |
| C13182 | CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND Patient must demonstrate relapsed or chemotherapy-refractory disease; AND Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND The treatment must not exceed 4 cycles under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and (b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and (c) Dates of commencement and completion of front-line curative intent chemotherapy; and (d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures | |
| C13208 | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have undergone a primary autologous stem cell transplant (ASCT) 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 receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime. | Compliance with Authority Required procedures | |
| C13209 | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND Patient must not be suitable for ASCT for this condition; OR Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS upload or mail, it 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). | Compliance with Written Authority Required procedures | |
| C13212 | CD30 positive peripheral T-cell lymphoma, non-cutaneous type Continuing treatment The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as: (a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR (b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable. | Compliance with Authority Required procedures | |
| C13231 | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND Patient must not be suitable for ASCT for this condition; OR Patient must not be suitable for treatment with multi-agent chemotherapy 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 receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime. | Compliance with Authority Required procedures | |
| C13259 | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone a primary autologous stem cell transplant (ASCT); AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS upload or mail, it 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). | Compliance with Written Authority Required procedures | |
| C13261 | CD30 positive systemic anaplastic large cell lymphoma Continuing treatment Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Cabazitaxel
substitute:
| Cabazitaxel | C13207 | Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone; AND The condition must be resistant to treatment with docetaxel; OR Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND The treatment must not be used in combination with a novel hormonal drug; AND Patient must have a WHO performance status of 2 or less; AND Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel. | Compliance with Authority Required procedures - Streamlined Authority Code 13207 |
Schedule 4, Part 1, entry for Ciclosporin
(a)omit:
| P6676 | CN6676 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 6676 |
(b)omit:
| P9763 | CN9763 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9763 |
(c)insert in numerical order after existing text:
| P13122 | CN13122 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13122 |
| P13168 | CN13168 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13168 |
Schedule 4, Part 1, entry for Crizotinib
substitute:
| Crizotinib | C13186 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C13233 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it 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). The following must be documented in the patient's medical records: (a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures | |
| C13250 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it 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). The following must be documented in the patient's medical records: (a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material. | Compliance with Authority Required procedures | |
| C13251 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Dapagliflozin
insert in numerical order after existing text:
| C13230 | Chronic kidney disease Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND Patient must have an estimated glomerular filtration rate of between 25 to 75 mL/min/1.73 m2inclusive prior to initiating treatment with this drug; AND Patient must have a urinary albumin to creatinine ratio of between 200 to 5000 mg/g (22.6-565 mg/mmol) inclusive prior to initiating treatment with this drug; AND Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug. Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13230 |
Schedule 4, Part 1, entry for Dupilumab
omit entry for circumstances code “C12497” and substitute:
| C12497 | Chronic severe atopic dermatitis Initial treatment of the whole body Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND Patient must not have experienced an inadequate response to this biological medicine in this PBS indication. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Patient must be 12 years of age or older. State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application. Acceptable scores can be: (a) current scores; or (b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication. The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records. Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient's medical records. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Entrectinib
substitute:
| Entrectinib | C13184 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it 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). The following must be documented in the patient's medical records: (a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material. | Compliance with Authority Required procedures |
| C13276 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, omit entry for Eptifibatide
Schedule 4, Part 1, after entry for Gentamicin
insert:
| Gilteritinib | C13166 | P13166 | Relapsed or refractory Acute Myeloid Leukaemia Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not be acute promyelocytic leukaemia; AND The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation. The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file. | Compliance with Authority Required procedures |
| C13167 | P13167 | Relapsed or refractory Acute Myeloid Leukaemia Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND The condition must have relapsed or been refractory prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND The condition must not be acute promyelocytic leukaemia; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated. Progressive disease monitoring via a complete blood count must be taken at the end of each cycle. If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. Progressive disease is defined as the presence of any of the following: (a) Leukaemic cells in the CSF; or (b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or (c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or (d) Extramedullary leukaemia. The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file. | Compliance with Authority Required procedures | |
| C13242 | P13242 | Relapsed or refractory Acute Myeloid Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must not be undergoing or have undergone a stem cell transplant. Progressive disease monitoring via a complete blood count must be taken at the end of each cycle. If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. Progressive disease is defined as the presence of any of the following: (a) Leukaemic cells in the CSF; or (b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or (c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or (d) Extramedullary leukaemia. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Imatinib
(a)omit:
| C9208 | P9208 | Malignant gastrointestinal stromal tumour Continuing treatment The condition must be metastatic; OR The condition must be unresectable; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given at a dose not exceeding 600 mg per day. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) | Compliance with Authority Required procedures - Streamlined Authority Code 9208 |
(b)insert in numerical order after existing text:
| C13132 | P13132 | Malignant gastrointestinal stromal tumour Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given at a dose not exceeding 600 mg per day. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) | Compliance with Authority Required procedures - Streamlined Authority Code 13132 |
Schedule 4, Part 1, entry for Molnupiravir
substitute:
| Molnupiravir | C13155 | 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 or nurse practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must 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 at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with: 1. Any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received rituximab; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where 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 or nurse 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 13155 |
| C13156 | 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 or nurse practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be both: (i) at least 50 years of age, (ii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where 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 or nurse 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 13156 | |
| C13201 | 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 or nurse practitioner; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; OR The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic. Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where 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 or nurse 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 13201 | |
| C13224 | 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 or nurse practitioner; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where 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 or nurse 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 13224 |
(b)omit:
| C12218 | P12218 | Severe Crohn disease Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - 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 insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Grandfather treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
(c)omit:
| C12244 | P12244 | Moderate to severe ulcerative colitis Initial PBS-subsidised treatment (Grandfather patient) - 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 previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2021; AND Patient must have previously received induction treatment consisting of at least 2 doses with this drug for this condition in the intravenous form; AND Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non-PBS-subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; 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. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) 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 authority application form must include the following: (i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet to demonstrate response, including the date of assessment; and (ii) If the baseline Mayo or partial Mayo clinic calculation is not available, reason must be provided; and (iii) the date of commencement of this drug. The current Mayo clinic or partial Mayo clinic assessment must be no more than 4 weeks old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria. | Compliance with Written Authority Required procedures |
| C12250 | P12250 | Moderate to severe ulcerative colitis Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - 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 insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Grandfather treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
(d)insert in numerical order after existing text:
| C13236 | P13236 | Severe Crohn disease Balance of supply - 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 insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form. | Compliance with Authority Required procedures |
| C13237 | P13237 | Moderate to severe ulcerative colitis Balance of supply - 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 insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Vismodegib
(a)omit entry for circumstances code “C7491” and substitute:
| C7491 | Metastatic or locally advanced basal cell carcinoma (BCC) Initial treatment or Continuing treatment – balance of supply Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
(b)omit:
| C7540 | Metastatic or locally advanced basal cell carcinoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The condition must remain inappropriate for surgery; AND The condition must remain inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) A completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and c) A confirmation statement from the treating doctor that the disease has not progressed; and d) In patients with locally advanced BCC, a letter from a surgically qualified clinician demonstrating that the condition remains inappropriate for surgery; or a letter from a radiation oncologist demonstrating that the condition remains inappropriate for curative radiotherapy The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. Inappropriate for surgery is defined as: i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or iii/ Medical contraindication to surgery Inappropriate for curative radiotherapy is defined as: i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or ii/ Limitations due to location of tumour; or iii/ Limitations due to cumulative prior radiotherapy dose; or iv/ Progressive disease despite prior irradiation of locally advanced BCC | Compliance with Written Authority Required procedures |
| C7557 | Metastatic or locally advanced basal cell carcinoma Initial treatment The condition must be inappropriate for surgery; AND The condition must be inappropriate for curative radiotherapy; AND Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not receive more than 16 weeks of treatment under this restriction. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) A completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and c) A histological confirmation of BCC and whether the condition is metastatic or locally advanced; and d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery for patients with locally advanced BCC; and e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy for patients with locally advanced BCC; and f) A signed patient acknowledgement. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. Inappropriate for surgery is defined as: i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or iii/ Medical contraindication to surgery Inappropriate for curative radiotherapy is defined as: i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or ii/ Limitations due to location of tumour; or iii/ Limitations due to cumulative prior radiotherapy dose; or iv/ Progressive disease despite prior irradiation of locally advanced BCC. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C13175 | Metastatic or locally advanced basal cell carcinoma (BCC) Initial treatment The condition must be inappropriate for surgery; AND The condition must be inappropriate for curative radiotherapy; AND Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not receive more than 16 weeks of treatment under this restriction. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and (c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Inappropriate for surgery is defined as: (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. Inappropriate for curative radiotherapy is defined as: (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
| C13268 | Metastatic or locally advanced basal cell carcinoma (BCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The condition must remain inappropriate for surgery; AND The condition must remain inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) Confirmation from the treating doctor that the disease has not progressed; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Inappropriate for surgery is defined as: (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. Inappropriate for curative radiotherapy is defined as: (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Vorinostat
substitute:
| Vorinostat | C13177 | P13177 | Cutaneous T-cell lymphoma Initial treatment Patient must have received systemic treatment with chemotherapy; AND Patient must demonstrate relapsed or chemotherapy-refractory disease; AND Patient must be ineligible for stem cell transplant; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it 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). | Compliance with Authority Required procedures |
| C13246 | P13246 | Cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
Schedule 5, after entry for Ondansetron in the form Wafer 8 mg [GRP-17042]
insert:
| Oxybutynin | GRP-26553 | Tablet containing oxybutynin hydrochloride 5 mg | Oral | Ditropan |
| Tablet containing oxybutynin chloride 5 mg (s19A) | Oral | Oxybutynin Chloride (Novitium) |
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