National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 1) (Cth)
PB 1 of 2022
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 1)
National Health Act 1953
________________________________________________________________________
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 27 January 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
________________________________________________________________________
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 1).
(2)This instrument may also be cited as PB 1 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 February 2022 | 1 February 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Note: This table relates only to the provisions of this instrument as originally made.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Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 Acalabrutinib
insert in numerical order in the column headed “Circumstances”: C12495 C12500 C12501
Schedule 1, Part 1, entry for Adrenaline (epinephrine)
omit:
| Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000) | Injection | ADRENALINE RENAUDIN | LM | PDP MP NP | 5 | 0 | 10 |
| MP NP | 5 | 1 | 10 |
Schedule 1, Part 1, entry for Atazanavir in the form Capsule 200 mg (as sulfate)
(a)omit:
| a | Atazanavir Mylan | AF | MP NP | C4454 C4512 | 120 | 5 | 60 | D(100) |
(b)omit from the column headed “Schedule Equivalent” for the brand “Reyataz”: a
Schedule 1, Part 1, entry for Atazanavir in the form Capsule 300 mg (as sulfate)
(a)omit:
| a | Atazanavir Mylan | AF | MP NP | C4454 C4512 | 60 | 5 | 60 | D(100) |
(b)omit from the column headed “Schedule Equivalent” for the brand “Reyataz”: a
Schedule 1, Part 1, entry for Azacitidine
omit:
| a | Celazadine | CJ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bortezomib Accord | OC | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Bortezomib in each of the forms: Powder for injection 2.5 mg; and Powder for injection 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| DBL Bortezomib | PF | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
substitute:
| Powder for injection 3.5 mg | Injection | Bortezom | CR | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
| Bortezomib Accord | OC | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Bortezomib Juno | JU | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Bortezomib Sandoz | SZ | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Bortezomib-Dr.Reddy's | RI | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| BORTEZOMIB-TEVA | TB | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| DBL Bortezomib | PF | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) | ||
| Velcade | JC | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)
omit:
| a | Bosentan Sandoz | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 60 | D(100 |
Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit:
| Clopidogrel Sandoz | SZ | MP NP | C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL
omit from the column headed “Brand”: Darzalex substitute: Darzalex SC
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | 30 |
Schedule 1, Part 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib ARX | XT | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 30 | 5 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dasatinib Dr.Reddy's | RI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Dimethyl fumarate in the form Capsule (modified release) 120 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Dimethyl Fumarate | CR | MP | C10139 C10140 | 28 | 0 | 14 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Tecfidera”: a
Schedule 1, Part 1, entry for Dimethyl fumarate in the form Capsule (modified release) 240 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Dimethyl Fumarate | CR | MP | C10139 | 56 | 5 | 56 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Tecfidera”: a
Schedule 1, Part 1, entry for Disopyramide
omit from the column headed “Responsible Person”: SW substitute: PB
Schedule 1, Part 1, entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
omit from the column headed “Responsible Person” for the brand “Caelyx” (all instances): JC substitute: BX
Schedule 1, Part 1, entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
omit from the column headed “Responsible Person” for the brand “Caelyx”: JC substitute: BX
Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11443
(b)omit from the column headed “Circumstances”: C11480
(c)insert in numerical order in the column headed “Circumstances”: C12497 C12507
Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11443
(b)omit from the column headed “Circumstances”: C11480
(c)insert in numerical order in the column headed “Circumstances”: C12497 C12507
Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED ESCITALOPRAM | VO | MP NP | C4690 C4703 C4755 C4756 C4757 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Ezetimibe
(a)insert in numerical order in the column headed “Circumstances” for the brand “Ezetimibe GH”: C7990
(b)insert in numerical order in the column headed “Circumstances” for the brand “Ezetimibe Sandoz”: C7990
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZEVYT 10/10 | LR | MP NP | C7958 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZEVYT 10/20 | LR | MP NP | C7958 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZEVYT 10/40 | LR | MP NP | C7957 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | EZEVYT 10/80 | LR | MP NP | C7957 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Fludrocortisone
(a)insert in the column headed “Schedule Equivalent” for the brand “Florinef”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | FLUDROCORTISONE MEDSURGE | DZ | MP NP | 200 | 1 | 100 |
Schedule 1, Part 1, entry for Fulvestrant
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | FULVESTRANT EVER PHARMA | IT | MP | C11473 | 2 | 5 | 2 |
Schedule 1, Part 1, entry for Glatiramer
(a)insert in the column headed “Schedule Equivalent” for the brand “Copaxone”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Glatira | JU | MP | C6860 C7695 | 12 | 5 | 12 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | GLATIRAMER ACETATE-TEVA | EV | MP | C6860 C7695 | 12 | 5 | 12 |
Schedule 1, Part 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 10 mL [Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Revive Tears | PP | MP | C6073 C6098 | P6073 | 1 | 5 | 1 |
| NP | C6073 | 1 | 5 | 1 | ||||
| AO | C6120 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 10 mL [Maximum Quantity: 1; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Revive Tears | PP | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, Part 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 90; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7818
(b)omit from the column headed “Circumstances”: C7865
(c)insert in numerical order in the column headed “Circumstances”: C12495 C12500
Schedule 1, Part 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 120; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7818
(b)omit from the column headed “Circumstances”: C7865
(c)insert in numerical order in the column headed “Circumstances”: C12495 C12500
(d)omit from the column headed “Purposes”: P7818 P7865 substitute: P12495 P12500
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9319
(c)insert in numerical order in the column headed “Purposes”: P9208 P9319
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9319
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9319
(c)insert in numerical order in the column headed “Purposes”: P9208 P9319
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9319
Schedule 1, Part 1, entry for Insulin glargine in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
(a)omit from the column headed “Schedule Equivalent” for the brand “Optisulin SoloStar”: a
(b)omit:
| a | Semglee | AF | MP NP | 5 | 1 | 1 |
Schedule 1, Part 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)
omit:
| a | Isomonit | SZ | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Levothyroxine in the form Tablet containing 50 micrograms anhydrous levothyroxine sodium
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Eltroxin | LT | MP NP | 200 | 1 | 200 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | LEVOXINE | RA | MP NP | 200 | 1 | 200 |
Schedule 1, Part 1, entry for Levothyroxine in the form Tablet containing 75 micrograms anhydrous levothyroxine sodium
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Eltroxin | LT | MP NP | 200 | 1 | 200 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | LEVOXINE | RA | MP NP | 200 | 1 | 200 |
Schedule 1, Part 1, entry for Levothyroxine in the form Tablet containing 100 micrograms anhydrous levothyroxine sodium
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Eltroxin | LT | MP NP | 200 | 1 | 200 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | LEVOXINE | RA | MP NP | 200 | 1 | 200 |
Schedule 1, Part 1, after entry for Levothyroxine in the form Tablet containing 100 micrograms anhydrous levothyroxine sodium
insert:
| Tablet containing 125 micrograms anhydrous levothyroxine sodium | Oral | Eltroxin | LT | MP NP | 200 | 1 | 200 |
Schedule 1, Part 1, entry for Levothyroxine in the form Tablet containing 200 micrograms anhydrous levothyroxine sodium
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Eltroxin | LT | MP NP | 200 | 1 | 200 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | LEVOXINE | RA | MP NP | 200 | 1 | 200 |
Schedule 1, Part 1, entry for Mefenamic acid
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | FEMIN | LI | MP NP | C6213 C6229 | 50 | 2 | 50 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Ponstan”: a
Schedule 1, Part 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Mesalazine 1.2 TAKEDA | NQ | MP NP | C9444 | 120 | 5 | 60 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Mezavant”: a
Schedule 1, Part 1, entry for Methylphenidate in each of the forms: Tablet containing methylphenidate hydrochloride 18 mg (extended release); Tablet containing methylphenidate hydrochloride 27 mg (extended release);Tablet containing methylphenidate hydrochloride 36 mg (extended release); and Tablet containing methylphenidate hydrochloride 54 mg (extended release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | METHYLPHENIDATE-TEVA XR | TB | MP NP | C10717 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED MIRTAZAPINE | VO | MP NP | C5650 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED MIRTAZAPINE | VO | MP NP | C5650 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Nifedipine in the form Tablet 30 mg (controlled release)
omit:
| a | Adefin XL 30 | AF | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Nifedipine in the form Tablet 60 mg (controlled release)
omit:
| a | Adefin XL 60 | AF | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nitrofurantoin BNM | BZ | MP NP MW | 30 | 1 | 30 |
Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Nitrofurantoin BNM | BZ | MP NP MW | 30 | 1 | 30 |
Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)
omit from the column headed “Responsible Person” for the brand “Acimax Tablets” (all instances): AL substitute: FJ
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Oxyndone | TX | MP NP | C10764 C10766 C10771 C10772 | P10766 | 10 | 0 | 20 |
| PDP | C10766 C10768 | P10766 | 10 | 0 | 20 |
Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Oxyndone | TX | MP NP | C10764 C10766 C10771 C10772 | P10764 P10771 P10772 | 20 | 0 | 20 |
| PDP | C10766 C10768 | P10768 | 20 | 0 | 20 |
Schedule 1, Part 1, entry for Pegfilgrastim
omit:
| a | Fulphila | AF | MP | C7822 C7843 C9235 C9303 | 1 | 11 | 1 | D(100) |
Schedule 1, Part 1, entry for Piroxicam in the form Capsule 20 mg
(a)omit:
| a | Feldene | PF | PDP | C6214 | 25 | 0 | 25 |
(b)omit:
| a | Feldene | PF | MP NP | C6214 | 25 | 3 | 25 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
omit:
| a | Rani 2 | AF | MP NP MW | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit:
| a | Rani 2 | AF | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ribavirin
omit:
| Tablet 400 mg | Oral | Ibavyr | IX | MP NP | C5957 C5958 | P5957 | 28 | 2 | 28 |
| MP NP | C5957 C5958 | P5958 | 28 | 5 | 28 | ||||
| Tablet 600 mg | Oral | Ibavyr | IX | MP NP | C5957 C5958 | P5957 | 28 | 2 | 28 |
| MP NP | C5957 C5958 | P5958 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED TELMISARTAN | VO | MP NP | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Topiramate in each of the forms: Tablet 25 mg; Tablet 50 mg; and Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED TOPIRAMATE | VO | MP NP | C5325 C5516 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Topiramate in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED TOPIRAMATE | VO | MP NP | C5516 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Upadacitinib
substitute:
| Upadacitinib | Tablet 15 mg | Oral | Rinvoq | VE | MP | C8638 C9064 C9431 C10340 C10356 C10376 C11488 C11813 C11886 C11944 C11945 C11956 C11978 C12090 C12091 C12142 C12184 C12223 C12246 C12342 C12354 C12366 C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P8638 P9064 P10340 P10376 P11813 P11944 P11945 P11956 P12090 P12091 P12184 P12246 P12504 | 28 | 3 | 28 |
| MP | C8638 C9064 C9431 C10340 C10356 C10376 C11488 C11813 C11886 C11944 C11945 C11956 C11978 C12090 C12091 C12142 C12184 C12223 C12246 C12342 C12354 C12366 C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P12499 P12508 | 28 | 4 | 28 | |||||
| MP | C8638 C9064 C9431 C10340 C10356 C10376 C11488 C11813 C11886 C11944 C11945 C11956 C11978 C12090 C12091 C12142 C12184 C12223 C12246 C12342 C12354 C12366 C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P9431 P10356 P11488 P11886 P11978 P12142 P12223 P12342 P12354 P12366 P12493 P12494 P12496 P12502 | 28 | 5 | 28 | |||||
| Tablet 30 mg | Oral | Rinvoq | VE | MP | C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P12504 | 28 | 3 | 28 | |
| MP | C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P12499 P12508 | 28 | 4 | 28 | |||||
| MP | C12493 C12494 C12496 C12499 C12502 C12504 C12508 | P12493 P12494 P12496 P12502 | 28 | 5 | 28 |
Schedule 1, Part 2, omit entry for Exenatide
Schedule 3, after details relevant for Responsible Person code FI
insert:
| FJ | Pharmaco (Australia) Limited | 89 113 383 501 |
Schedule 3, after details relevant for Responsible Person code LR
insert:
| LT | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
Schedule 4, Part 1, entry for Acalabrutinib
insert in numerical order after existing text:
| C12495 | Mantle cell lymphoma Initial treatment The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be untreated with Bruton tyrosine kinase inhibitor therapy; OR Patient must have developed intolerance to another Bruton tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. | Compliance with Authority Required procedures |
| C12500 | Mantle cell lymphoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures |
| C12501 | Mantle cell lymphoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received treatment with this drug prior to 1 February 2022; AND The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had a WHO performance status of 0 or 1 at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have been untreated with Bruton tyrosine kinase inhibitor therapy at treatment initiation with this drug; OR Patient must have developed intolerance to another Bruton tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Dasatinib
omit entry for circumstances code “C9293” and substitute:
| C9293 | P9293 | Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Dupilumab
(a)omit:
| C11443 | 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 day; 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 PGA, EASI and DLQI scores in the authority application. These baseline scores must have been measured within the past 4 weeks. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records. 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. | Compliance with Authority Required procedures |
(b)omit:
| C11480 | Chronic severe atopic dermatitis Initial treatment of the face and/or hands The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; OR The condition must have affected at least 30% of the face/hands surface area 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 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings for erythema, oedema/papulation, excoriation, lichenification, in the authority application. These 4 symptom sub-score ratings must have been assessed within the past 4 weeks. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| 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 day; 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 |
| C12507 | Chronic severe atopic dermatitis Initial treatment of the face and/or hands The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; OR The condition must have affected at least 30% of the face/hands surface area 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 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for: (i) erythema, (ii) oedema/papulation, (iii) excoriation, (iv) lichenification 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. State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores. The EASI/percentage surface area 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 are in the patient's medical records. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Exenatide
omit:
| C6505 | Diabetes mellitus type 2 The treatment must be in combination with metformin; AND The treatment must be in combination with a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 6505 |
| C6519 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The treatment must be in combination with a sulfonylurea; AND Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR Patient must not have tolerated a combination of metformin and a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 6519 |
Schedule 4, Part 1, entry for Ibrutinib
(a)omit:
| C7818 | P7818 | Mantle cell lymphoma Initial treatment The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
(b)omit:
| C7865 | P7865 | Mantle cell lymphoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C12495 | P12495 | Mantle cell lymphoma Initial treatment The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be untreated with Bruton tyrosine kinase inhibitor therapy; OR Patient must have developed intolerance to another Bruton tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. | Compliance with Authority Required procedures |
| C12500 | P12500 | Mantle cell lymphoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Imatinib
(a)omit entry for circumstances code “C9200” and substitute:
| C9200 | P9200 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase of chronic myeloid leukaemia; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
(b)omit entry for circumstances code “C9203” and substitute:
| C9203 | P9203 | Acute lymphoblastic leukaemia Initial treatment Patient must be newly diagnosed; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL; AND The treatment must be for induction and consolidation therapy; AND The treatment must be in combination with chemotherapy or corticosteroids; AND Patient must not have previously experienced a failure to respond to PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition. A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Ribavirin
(a)omit from the column headed “Purposes Code” for circumstances code “C5957”: P5957
(b)omit:
| C5958 | P5958 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND The treatment must be limited to a maximum duration of 24 weeks. Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Upadacitinib
insert in numerical order after existing text:
| C12493 | P12493 | Chronic severe atopic dermatitis Continuing or resuming treatment with this drug of the whole body Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND Patient must have achieved an adequate response prior to this first continuing treatment authority application; OR Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; OR Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). For the purposes of this restriction, an adequate response to treatment is defined as: (a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and (b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above. State each of the current EASI and DLQI scores for this authority application. | Compliance with Authority Required procedures |
| C12494 | P12494 | Chronic severe atopic dermatitis Continuing or resuming treatment with this drug of the face and/or hands Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND Patient must have achieved an adequate response prior to this first continuing treatment authority application; OR Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; OR Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as: (a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or (ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and (b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above. Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes | Compliance with Authority Required procedures |
| C12496 | P12496 | Chronic severe atopic dermatitis Transitioning from non-PBS to PBS-subsidised supply (treatment of the face and/or hands) - Grandfather arrangements Patient must have been receiving treatment with this therapy for chronic severe atopic dermatitis prior to 1 February 2022; AND The condition must have had at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to commencing non-PBS-subsidised treatment with this therapy; OR The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to commencing non-PBS-subsidised treatment with this therapy; 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, prior to having commenced non-PBS-subsidised treatment with this therapy; OR Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; 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, prior to commencing non-PBS-subsidised treatment with this therapy; AND Patient must not be experiencing an inadequate response to non-PBS-subsidised treatment with this therapy; AND Patient must not have experienced an inadequate response to this therapy in this indication, prior to commencing non-PBS-subsidised treatment with this therapy. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). Patient must be 12 years of age or older. State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for: (i) erythema, (ii) oedema/papulation, (iii) excoriation, (iv) lichenification 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. State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores. The EASI/percentage surface area 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 are in the patient's medical records. 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 |
| C12499 | P12499 | Chronic severe atopic dermatitis Initial treatment with this drug 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 day; 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 Patient must not have experienced an inadequate response to this therapy. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). 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 |
| C12502 | P12502 | Chronic severe atopic dermatitis Transitioning from non-PBS to PBS-subsidised supply (treatment of the whole body) - Grandfather arrangements Patient must have been receiving treatment with this therapy for chronic severe atopic dermatitis prior to 1 February 2022; AND Patient must have had a Physicians Global Assessment (PGA) 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 prior to commencing non-PBS-subsidised treatment with this therapy; AND Patient must have had 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 prior to having commenced non-PBS-subsidised treatment with this therapy; 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, prior to having commenced non-PBS-subsidised treatment with this therapy; OR Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; 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, prior to commencing non-PBS-subsidised treatment with this therapy; AND Patient must not be experiencing an inadequate response to non-PBS-subsidised treatment with this therapy; AND Patient must not have experienced an inadequate response to this therapy in this indication, prior to commencing non-PBS-subsidised treatment with this therapy. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). 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. 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 |
| C12504 | P12504 | Chronic severe atopic dermatitis Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) - whole body, or, face/hands Patient must not be undergoing each of: (i) commencing treatment through this treatment phase listing, (ii) treatment accessed through this treatment phase on more than 2 consecutive occasions; AND Patient must be undergoing existing PBS-subsidised treatment with this therapy where each of the following is true: (i) there is a change in daily dose, (ii) any remaining PBS repeat prescriptions for the strength that the patient is changing from, is marked as 'cancelled'; AND Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). | Compliance with Authority Required procedures |
| C12508 | P12508 | Chronic severe atopic dermatitis Initial treatment with this drug of the face and/or hands The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; OR The condition must have affected at least 30% of the face/hands surface area 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 Patient must not have experienced an inadequate response to this therapy. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist; AND Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). Patient must be 12 years of age or older. State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for: (i) erythema, (ii) oedema/papulation, (iii) excoriation, (iv) lichenification 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. State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores. The EASI/percentage surface area 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 are in the patient's medical records. | Compliance with Written Authority Required procedures |
Schedule 5, omit entry for Adrenaline (epinephrine)
Schedule 5, entry for Clopidogrelin the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]
omit from the column headed “Brand”: Clopidogrel Sandoz
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]
omit from the column headed “Brand”: Clopidogrel Sandoz
Schedule 5, entry for Imatinib
omit:
| GRP-25646 | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA |
| Tablet 100 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva |
Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP- 25647]
insert in alphabetical order in the column headed “Brand”: Imatinib-APOTEX
Schedule 5, entry for Imatinib
omit:
| GRP-25684 | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA Imatinib-APOTEX |
| Tablet 400 mg (as mesilate) | Oral | Gilmat Glivec Imatinib-Teva |
Schedule 5, entry for Nitrofurantoin in the form Capsule 50 mg [GRP-25565]
insert in alphabetical order in the column headed “Brand”: Nitrofurantoin BNM
0
0
0