National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 4) (Cth)
Case
PB 33 of 2022
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 4)
National Health Act 1953
________________________________________________________________________
I, CAROLINE TURNOUR, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 28 April 2022
CAROLINE TURNOUR
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
________________________________________________________________________
Name of Instrument
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 4).
(2)This instrument may also be cited as PB 33 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 May 2022 | 1 May 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Note: This table relates only to the provisions of this instrument as originally made.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Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 Abiraterone in each of the forms: Tablet containing abiraterone acetate 250 mg; and Tablet containing abiraterone acetate 500 mg
omit from the column headed “Circumstances”: C12352 substitute: C12700
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
(d)insert in numerical order in the column headed “Purposes”: P11715 P11716
(e)omit from the column headed “Purposes”: P11758
(f)omit from the column headed “Purposes”: P11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 3; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C11715 C11716
(b)omit from the column headed “Circumstances”: C11758
(c)omit from the column headed “Circumstances”: C11789
(d)insert in numerical order in the column headed “Purposes”: P11715 P11716
(e)omit from the column headed “Purposes”: P11758
(f)omit from the column headed “Purposes”: P11789
Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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 | APX-Amoxicillin/Clavulanic Acid | XT | MP NP | C5832 C5893 C10405 | P5832 P5893 | 10 | 0 | 10 |
| MW | C5832 C5893 | 10 | 0 | 10 | ||||
| PDP | C5833 C5894 | 10 | 0 | 10 |
Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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 | APX-Amoxicillin/Clavulanic Acid | XT | MP NP | C5832 C5893 C10405 | P10405 | 20 | 0 | 10 |
Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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 | APX-Amoxicillin/Clavulanic Acid | XT | MP NP | C5832 C5893 C10413 | P5832 P5893 | 10 | 0 | 10 |
| PDP | C5833 C5894 | 10 | 0 | 10 |
Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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 | APX-Amoxicillin/Clavulanic Acid | XT | MP NP | C5832 C5893 C10413 | P10413 | 20 | 0 | 10 |
Schedule 1, Part 1, after entry for Anastrozole
insert:
| Apalutamide | Tablet 60 mg | Oral | Eryland | JC | MP | C12895 | 120 | 5 | 120 |
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”:
| DBL Bortezomib | PF | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses
insert:
| Tablet 500 micrograms (orally disintegrating) | Oral | Jorveza | FD | MP | C12836 C12837 C12909 | 60 | 5 | 60 | |
| Tablet 1 mg (orally disintegrating) | Oral | Jorveza | FD | MP | C12836 C12837 C12909 C12938 | P12836 P12837 P12909 | 60 | 5 | 60 |
| MP | C12836 C12837 C12909 C12938 | P12938 | 90 | 1 | 90 |
Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 8 mg in 0.16 mL pre-filled syringe; Injection (modified release) 16 mg in 0.32 mL pre-filled syringe; Injection (modified release) 24 mg in 0.48 mL pre-filled syringe; and Injection (modified release) 32 mg in 0.64 mL pre-filled syringe
omit from the column headed “Circumstances”: C9212 substitute: C12701
Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 64 mg in 0.18 mL pre-filled syringe; and Injection (modified release) 96 mg in 0.27 mL pre-filled syringe
omit from the column headed “Circumstances”: C9212 substitute: C12915
Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 128 mg in 0.36 mL pre-filled syringe
omit from the column headed “Circumstances”: C9212 substitute: C12915
Schedule 1, Part 1, after entry for Buprenorphine in the form Injection (modified release) 128 mg in 0.36 mL pre-filled syringe
insert:
| Injection (modified release) 160 mg in 0.45 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C12915 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, Part 1, entry for Cabotegravir and rilpivirine
omit from the column headed “Form”: Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3mL
substitute: Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL
Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg
omit from the column headed “Circumstances”: C11196 C11197 C11198 C11291 substitute: C12694 C12849 C12930 C12934
Schedule 1, Part 1, entry for Clopidogrel
substitute:
| Clopidogrel | Tablet 75 mg (as besilate) | Oral | BTC Clopidogrel | JB | MP NP | 28 | 5 | 28 |
| Clopidogrel APOTEX | GX | MP NP | 28 | 5 | 28 | |||
| Clopidogrel GH | GQ | MP NP | 28 | 5 | 28 | |||
| Clovix 75 | RW | MP NP | 28 | 5 | 28 | |||
| Plidogrel | RF | MP NP | 28 | 5 | 28 | |||
| Tablet 75 mg (as hydrogen sulfate) | Oral | Blooms the Chemist Clopidogrel | IB | MP NP | 28 | 5 | 28 | |
| Clopidogrel Sandoz Pharma | HX | MP NP | 28 | 5 | 28 | |||
| Clopidogrel Winthrop | WA | MP NP | 28 | 5 | 28 | |||
| Iscover | AV | MP NP | 28 | 5 | 28 | |||
| Piax | AF | MP NP | 28 | 5 | 28 | |||
| Plavicor 75 | CR | MP NP | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Clopidogrel with aspirin
omit from the column headed “Circumstances” (all instances): C5443 C5488 C5517
Schedule 1, Part 1, entry for Daratumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
omit from the column headed “Circumstances”: C11075 C11076 C11131 C12350 substitute: C12691 C12692 C12844 C12845
Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369 substitute: C12691 C12692 C12842 C12845
(b)omit from the column headed “Purposes”: P11076 substitute: P12845
Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369 substitute: C12691 C12692 C12842 C12845
(b)omit from the column headed “Purposes”: P11075 substitute: P12691
Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 7]
(a)omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369 substitute: C12691 C12692 C12842 C12845
(b)omit from the column headed “Purposes”: P12369 substitute: P12842
Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 8]
(a)omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369 substitute: C12691 C12692 C12842 C12845
(b)omit from the column headed “Purposes”: P12350 substitute: P12692
Schedule 1, Part 1, entry for Darolutamide
omit from the column headed “Circumstances”: C12398 substitute: C12895
Schedule 1, Part 1, entry for Desmopressin
omit:
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL | Nasal | Desmopressin Acetate (Medsurge) | DZ | MP | C5266 C5267 C5342 | P5267 P5342 | 1 | 5 | 1 |
| NP | C5267 C5342 | 1 | 5 | 1 | |||||
| MP | C5266 C5267 C5342 | P5266 | 2 | 5 | 1 |
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]
omit from the column headed “Circumstances”: C11425 C11479
Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
omit from the column headed “Circumstances”: C11425 C11479
Schedule 1, Part 1, after entry for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor
insert:
| Elotuzumab | Powder for injection 300 mg | Injection | Empliciti | BQ | MP | C12847 C12891 | See Note 3 | See Note 3 | 1 | D(100) |
| Powder for injection 400 mg | Injection | Empliciti | BQ | MP | C12847 C12891 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Enzalutamide
omit from the column headed “Circumstances”: C12371 substitute: C12937
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 1 mg
omit:
| a | Diapride 1 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 2 mg
omit:
| a | Diapride 2 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 3 mg
omit:
| a | Diapride 3 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Glimepiride in the form Tablet 4 mg
omit:
| a | Diapride 4 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Hydroxychloroquine
substitute:
| Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg | Oral | a | APO- Hydroxychloroquine | TX | MP NP | 100 | 1 | 100 |
| a | Hequinel | RW | MP NP | 100 | 1 | 100 | |||
| a | Hydroxychloroquine GH | GQ | MP NP | 100 | 1 | 100 | |||
| a | Plaquenil | SW | MP NP | 100 | 1 | 100 |
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)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 GH; 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”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
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)insert in numerical order in the column headed “Circumstances”: C9208
(b)insert in numerical order in the column headed “Circumstances”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)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 GH; 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”: C9238
(c)insert in numerical order in the column headed “Circumstances”: C9278
(d)insert in numerical order in the column headed “Circumstances”: C9319
(e)insert in numerical order in the column headed “Purposes”: P9238
(f)insert in numerical order in the column headed “Purposes”: P9278
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”: C9319
(b)insert in numerical order in the column headed “Circumstances”: C12685
(c)omit from the column headed “Purposes”: P9319
(d)insert in numerical order in the column headed “Purposes”: P12685
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”: C9319
(b)insert in numerical order in the column headed “Circumstances”: C12685
Schedule 1, Part 1, entry for Metoprolol
substitute:
| Metoprolol | Tablet containing metoprolol tartrate 50 mg | Oral | a | APO-Metoprolol | TX | MP NP | 100 | 5 | 100 |
| a | Betaloc | AP | MP NP | 100 | 5 | 100 | |||
| a | Metoprolol Sandoz | SZ | MP NP | 100 | 5 | 100 | |||
| a | Metrol 50 | RW | MP NP | 100 | 5 | 100 | |||
| a | Minax 50 | AF | MP NP | 100 | 5 | 100 | |||
| Mistrom | ZS | MP NP | 100 | 5 | 100 | ||||
| a | NOUMED METOPROLOL | VO | MP NP | 100 | 5 | 100 | |||
| Tablet containing metoprolol tartrate 100 mg | Oral | a | APO-Metoprolol | TX | MP NP | 60 | 5 | 60 | |
| a | Betaloc | AP | MP NP | 60 | 5 | 60 | |||
| a | Metoprolol Sandoz | SZ | MP NP | 60 | 5 | 60 | |||
| a | Metrol 100 | RW | MP NP | 60 | 5 | 60 | |||
| a | Minax 100 | AF | MP NP | 60 | 5 | 60 | |||
| Mistrom | ZS | MP NP | 60 | 5 | 60 | ||||
| a | NOUMED METOPROLOL | VO | MP NP | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Molnupiravir
substitute:
| Molnupiravir | Capsule 200 mg | Oral | Lagevrio | MK | MP NP | C12839 C12923 C12936 | 40 | 0 | 40 |
Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)
(a)omit:
| a | Momex SR 10 | RW | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Momex SR 10 | RW | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)
(a)omit:
| a | Momex SR 30 | RW | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Momex SR 30 | RW | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)
(a)omit:
| a | Momex SR 60 | RW | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Momex SR 60 | RW | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)
(a)omit:
| a | Momex SR 100 | RW | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 |
(b)omit:
| a | Momex SR 100 | RW | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 |
Schedule 1, Part 1, entry for Netupitant with Palonosetron
omit from the column headed “Responsible Person”: MF substitute: JZ
Schedule 1, Part 1, entry for Nintedanib in each of the forms: Capsule 100 mg; and Capsule 150 mg
omit from the column headed “Circumstances”: C6950 C6961 C6975 substitute: C12650 C12651 C12653 C12654 C12655 C12661
Schedule 1, Part 1, after entry for Nintedanib in the form Capsule 150 mg
insert:
| Nirmatrelvir and ritonavir | Pack containing 4 tablets nirmatrelvir 150 mg and 2 tablets ritonavir 100 mg, 5 | Oral | Paxlovid | HD | MP NP | C12839 C12923 C12936 | 1 | 0 | 1 |
Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; and Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED OLANZAPINE | VO | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 7.5 mg; and Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED OLANZAPINE | VO | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, Part 1, after entry for Omeprazole in the form Tablet 20 mg (as magnesium)
insert:
| Onasemnogene abeparvovec | Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |
| Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL | Injection | Zolgensma | NV | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Osimertinib in each of the forms: Tablet 40 mg; and Tablet 80 mg
omit from the column headed “Circumstances”: C11176
Schedule 1, Part 1, entry for Palonosetron
omit from the column headed “Responsible Person” for the brand “Aloxi”: MF substitute: JZ
Schedule 1, Part 1, entry for Peginterferon alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe: and Injection 180 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Responsible Person”: RO substitute: XO
Schedule 1, Part 1, entry for Pirfenidone in each of the forms: Capsule 267 mg; and Tablet 267 mg
omit from the column headed “Circumstances”: C6950 C6961 C6975 substitute: C12650 C12651 C12661
Schedule 1, Part 1, entry for Pirfenidone in the form Tablet 801mg
omit from the column headed “Circumstances”: C6961 substitute: C12661
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)
omit:
| a | QUEPINE XR | RF | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 150 mg (as fumarate)
omit:
| a | QUEPINE XR | RW | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)
omit:
| a | QUEPINE XR | RF | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
omit:
| a | Quetiapine GH 200 | GQ | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)
omit:
| a | QUEPINE XR | RF | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)
omit:
| a | QUEPINE XR | RF | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
omit:
| a | Ausran | RW | MP NP MW | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit:
| a | Ausran | RW | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Rasagiline
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Alziras | RW | MP NP | C5339 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Risdiplam
omit from the column headed “Pack Quantity”: See Note 3 substitute: 1
Schedule 1, Part 1, after entry for Ruxolitinib in the form Tablet 20 mg
insert:
| Sacituzumab govitecan | Powder for injection 180 mg | Injection | Trodelvy | GI | MP | C12656 C12669 C12670 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Selexipag in the form Tablet 200 micrograms [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11241
(b)omit from the column headed “Purposes”: P11241
Schedule 1, Part 1, entry for Selexipag in the form Tablet 200 micrograms [Maximum Quantity: 140; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C11241
(b)omit from the column headed “Purposes”: P11241
Schedule 1, Part 1, entry for Selexipag in each of the forms: Tablet 400 micrograms; and Tablet 600 micrograms
omit from the column headed “Circumstances”: C11241
Schedule 1, Part 1, entry for Selexipag in the form Tablet 800 micrograms [Maximum Quantity: 60; Number of Repeats: 3]
omit from the column headed “Circumstances”: C11241
Schedule 1, Part 1, entry for Selexipag in the form Tablet 800 micrograms [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11241
(b)omit from the column headed “Purposes”: P11241
Schedule 1, Part 1, entry for Selexipag in each of the forms: Tablet 1 mg; Tablet 1.2 mg; Tablet 1.4 mg; and Tablet 1.6 mg
omit from the column headed “Circumstances”: C11241
Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg
(a)omit:
| a | Lipex 10 | AL | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Simvastatin generichealth | GQ | MP NP | 30 | 5 | 30 |
(c)omit:
| a | Zocor | MQ | MP NP | 30 | 5 | 30 |
(d)omit:
| a | Lipex 10 | AL | MP | P7598 | 30 | 11 | 30 |
(e)omit:
| a | Simvastatin generichealth | GQ | MP | P7598 | 30 | 11 | 30 |
(f)omit:
| a | Zocor | MQ | MP | P7598 | 30 | 11 | 30 |
Schedule 1, Part 1, entry for Simvastatin in the form Tablet 20 mg
(a)omit:
| a | Simvastatin generichealth | GQ | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Simvastatin generichealth | GQ | MP | P7598 | 30 | 11 | 30 |
Schedule 1, Part 1, entry for Simvastatin in the form Tablet 40 mg
(a)omit:
| a | Simvastatin generichealth | GQ | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Simvastatin generichealth | GQ | MP | P7598 | 30 | 11 | 30 |
Schedule 1, Part 1, entry for Somatropin
substitute:
| Somatropin | Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) |
| Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 7 | D(100) | |
| Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative) | Injection | Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 | See Note 3 | See Note 3 | 1 | D(100) | |
| Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative) | Injection | Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 | See Note 3 | See Note 3 | 1 | D(100) | |
| Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative) | Injection | Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 | See Note 3 | See Note 3 | 1 | D(100) | |
| Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative) | Injection | Genotropin GoQuick | PF | MP | C11102 C11104 C12588 C12601 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 1 | D(100) | |
| Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative) | Injection | Genotropin GoQuick | PF | MP | C11102 C11104 C12588 C12601 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen | Injection | Norditropin FlexPro | NO | MP | C11102 C11104 C12588 C12601 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) | Injection | Omnitrope Surepal 5 | SZ | MP | C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932 | See Note 3 | See Note 3 | 1 | D(100) | |
| Scitropin A | SA | MP | C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) | Injection | Saizen | SG | MP | C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) | Injection | Omnitrope Surepal 10 | SZ | MP | C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932 | See Note 3 | See Note 3 | 1 | D(100) | |
| SciTropin A | SA | MP | C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen | Injection | Norditropin FlexPro | NO | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative) | Injection | NutropinAq | IS | MP | C11102 C11104 C12588 C12601 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) | Injection | Saizen | SG | MP | C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) | Injection | Omnitrope Surepal 15 | SZ | MP | C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen | Injection | Norditropin FlexPro | NO | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 | See Note 3 | See Note 3 | 1 | D(100) | |
| Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) | Injection | Saizen | SG | MP | C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, after entry for Triglycerides - medium chain, formula in the form Oral liquid 500 mL, 8 (Nutrini Peptisorb)
insert:
| Oral liquid 500 mL, 12 (Nutrini Peptisorb) | Oral | Nutrini Peptisorb | SB | MP NP | C4660 | 12 | 5 | 1 |
Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED VALACICLOVIR | VO | MP NP | C5940 C5961 | 30 | 5 | 30 |
Schedule 1, Part 1, after entry for Varenicline in the form Tablet 1 mg (as tartrate)
insert:
| Tablet 1 mg (as tartrate) (s19A) | Oral | APO-Varenicline (Canada) | XT | MP NP | C6885 C7483 | P6885 | 56 | 2 | 56 |
| MP NP | C6885 C7483 | P7483 | 112 | 0 | 56 |
Schedule 1, Part 2, after entry for Calcipotriol with betamethasone
insert:
| Clopidogrel | Tablet 75 mg (as besilate) | Oral | BTC Clopidogrel | JB | MP NP | C4165 C4166 | 28 | 5 | 28 |
| Clopidogrel APOTEX | GX | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Clopidogrel GH | GQ | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Clovix 75 | RW | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Plidogrel | RF | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Tablet 75 mg (as hydrogen sulfate) | Oral | Blooms the Chemist Clopidogrel | IB | MP NP | C4165 C4166 | 28 | 5 | 28 | |
| Clopidogrel Sandoz Pharma | HX | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Clopidogrel Winthrop | WA | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Iscover | AV | MP NP | C4165 C4166 | 28 | 5 | 28 | |||
| Piax | AF | MP NP | C4165 C4166 | 28 | 5 | 28 |
Schedule 1, Part 2, after entry for Enfuvirtide
insert:
| Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200mg | Oral | a | APO- Hydroxychloroquine | TX | MP | C10417 C10418 | 100 | 1 | 100 |
| a | Hequinel | RW | MP | C10417 C10418 | 100 | 1 | 100 | |||
| a | Hydroxychloroquine GH | GQ | MP | C10417 C10418 | 100 | 1 | 100 | |||
| a | Plaquenil | SW | MP | C10417 C10418 | 100 | 1 | 100 |
Schedule 3, after details relevant for Responsible Person code HB
insert:
| HD | Department of Health | 83 605 426 759 |
Schedule 3, after details relevant for Responsible Person code JX
insert:
| JZ | Juniper Biologics Pty Ltd | 97 655 479 897 |
Schedule 3, after details relevant for Responsible Person code XN
insert:
| XO | Echo Therapeutics Pty Ltd | 92 628 298 699 |
Schedule 4, Part 1, entry for Abiraterone
substitute:
| Abiraterone | C12700 | Castration resistant metastatic carcinoma of the prostate The treatment must be used in combination with a corticosteroid; AND The treatment must not be used in combination with chemotherapy; AND Patient must have a WHO performance status of 2 or less; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C11758 | P11758 | Severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 6 to 17 years inclusive. 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)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. The authority application must be made in writing and must include: (1) two completed authority prescription forms; 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 PCDAI assessment must be no more than 4 weeks old at the time of application. A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
(b)omit:
| C11789 | P11789 | Severe Crohn disease Initial treatment - Initial 1 (new patient) Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment and which is no more than 4 weeks old at the time of application; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 6 to 17 years inclusive. 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)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. The authority application must be made in writing and must include: (1) two completed authority prescription forms; 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). If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website ( An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, after entry for Anastrozole
insert:
| Apalutamide | C12895 | Castration resistant non-metastatic carcinoma of the prostate The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. Patient must be undergoing concurrent treatment with androgen deprivation therapy. Prescribing instructions: Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application. The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Budesonide
insert in numerical order after existing text:
| C12836 | P12836 | Eosinophilic oesophagitis First continuing treatment - Confirmation of remission Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND Patient must have documented evidence of having achieved histologic remission while receiving initial PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2hpf on oesophageal biopsy; AND Patient must not receive more than 26 weeks of treatment under this restriction. Must be treated by a gastroenterologist. Histologic assessment should be based on the peak eosinophils count derived from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction). The histologic assessment should, where possible, be performed by the same physician who confirmed the diagnosis of eosinophilic oesophagitis in the patient. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted and submitted after the patient has completed 8 weeks of the initial treatment course and no later than 2 weeks prior to the patient completing the PBS-subsidised initial treatment course, to avoid an interruption to supply. Where a histologic assessment is not undertaken and the results submitted, the patient will be not be eligible for ongoing treatment. | Compliance with Authority Required procedures |
| C12837 | P12837 | Eosinophilic oesophagitis Subsequent continuing treatment - Maintenance of remission Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition under the - Transitioning from non-PBS to PBS-subsided treatment - Grandfather treatment restriction; AND The condition must not have progressed while being treated with this drug. Must be treated by a gastroenterologist or in consultation with a gastroenterologist. | Compliance with Authority Required procedures |
| C12909 | P12909 | Eosinophilic oesophagitis Transitioning from non-PBS to PBS-subsidised treatment - Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with a corticosteroid for this condition prior to 1 May 2022; AND Patient must be receiving non-PBS treatment with a corticosteroid for this condition at the time of application; AND Patient must have had, prior to commencement of non-PBS-subsidised treatment with a corticosteroid, a history of symptoms of oesophageal dysfunction; AND Patient must have had, prior to commencement of non-PBS-subsidised treatment with a corticosteroid, eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2hpf; AND Patient must have documented evidence that they are currently in histologic remission, where remission is defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf); corresponding to less than 16 eosinophils per mm2hpf on oesophageal biopsy. Must be treated by a gastroenterologist. 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 subsequent continuing treatment criteria. Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation. Histologic assessment should be based on the peak eosinophils count derived from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction). The histologic assessment should, where possible, be performed by the same physician who confirmed the diagnosis of eosinophilic oesophagitis in the patient. This assessment, which will be used to determine eligibility for continuing treatment, should have been conducted after the patient has completed 8 weeks of the initial treatment course and no later than 2 weeks prior to the patient completing the initial treatment course, to avoid an interruption to supply. Where a histologic assessment is not undertaken and the results submitted, the patient will not be eligible for ongoing treatment. | Compliance with Authority Required procedures |
| C12938 | P12938 | Eosinophilic oesophagitis Initial treatment - Induction of remission Patient must have a history of symptoms of oesophageal dysfunction; AND Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2hpf; AND Patient must not receive more than 90 days of treatment under this restriction. Must be treated by a gastroenterologist. Applications for treatment of this condition must be received within 12 weeks of biopsy. Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation. Diagnostic sensitivity increases with the number of biopsies and is optimised after taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction). A histologic assessment of the oesophageal biopsy should be planned for approximately 8 weeks after the initiation of the first PBS-subsidised treatment with this drug under this restriction, and no later than 2 weeks prior to the patient completing the PBS-subsidised initial treatment course, to determine the patient's eligibility for continuing therapy and to avoid an interruption to supply. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Buprenorphine
insert in numerical order after existing text:
| C12701 | Opiate dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment. |
| C12915 | Opiate dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone. |
Schedule 4, Part 1, entry for Carfilzomib
substitute:
| Carfilzomib | C12694 | Multiple myeloma Initial treatment - once weekly treatment regimen The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received this drug for this condition; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 12694 |
| C12849 | Multiple myeloma Continuing treatment - once weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not develop disease progression while receiving treatment with this drug for this condition; AND Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 12849 | |
| C12930 | Multiple myeloma Continuing treatment - twice weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not develop disease progression while receiving treatment with this drug for this condition; AND Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 12930 | |
| C12934 | Multiple myeloma Initial treatment - twice weekly treatment regimen The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received this drug for this condition; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 12934 |
Schedule 4, Part 1, entry for Clopidogrel
omit:
| C5436 | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events Patient must be in one whom low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding. | Compliance with Authority Required procedures - Streamlined Authority Code 5436 |
| C5459 | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events Patient must have a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin. | Compliance with Authority Required procedures - Streamlined Authority Code 5459 |
| C5508 | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events Patient must have a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs). | Compliance with Authority Required procedures - Streamlined Authority Code 5508 |
| C5517 | Prevention of recurrence of myocardial infarction or unstable angina Patient must have a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin. | Compliance with Authority Required procedures - Streamlined Authority Code 5517 |
| C5524 | Prevention of recurrence of myocardial infarction or unstable angina Patient must be in one whom low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding. | Compliance with Authority Required procedures - Streamlined Authority Code 5524 |
| C5525 | Prevention of recurrence of myocardial infarction or unstable angina Patient must have a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs). | Compliance with Authority Required procedures - Streamlined Authority Code 5525 |
Schedule 4, 1, omit entry for Clopidogrel with aspirin
Schedule 4, Part 1, entry for Daratumumab
substitute:
| Daratumumab | C12691 | P12691 | Relapsed and/or refractory multiple myeloma Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C12692 | P12692 | Relapsed and/or refractory multiple myeloma Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly) The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised). Patient must be undergoing treatment with this drug in one of the following situations: (i) for the first time, (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures | |
| C12842 | P12842 | Relapsed and/or refractory multiple myeloma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have been on treatment with this drug in the subcutaneous form for this condition prior to 1 November 2021; AND Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures | |
| C12844 | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2021; AND Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures | ||
| C12845 | P12845 | Relapsed and/or refractory multiple myeloma Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Darolutamide
substitute:
| Darolutamide | C12895 | Castration resistant non-metastatic carcinoma of the prostate The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. Patient must be undergoing concurrent treatment with androgen deprivation therapy. Prescribing instructions: Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application. The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading. | Compliance with Authority Required procedures |
| C12927 | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND Patient must have had a lapse in treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Patient must be aged 3 years or older. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Recent growth data (height and weight, not older than three months); AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
| C12928 | Growth retardation secondary to an intracranial lesion, or cranial irradiation Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have had an intracranial lesion which is under appropriate observation and management; OR Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Patient must be aged 3 years or older. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR (b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months; AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12929 | Short stature associated with chronic renal insufficiency Initial treatment Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND Patient must have a current height at or below the 1stpercentile for age and sex; OR Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a specialist or consultant physician in paediatric endocrinology; OR Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND 3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR (b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND 6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12932 | Short stature and slow growth Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. Patient must be aged 3 years or older. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
Schedule 5, entry for Clopidogrel
omit:
| GRP-15475 | Tablet 75 mg (as besilate) | Oral | BTC Clopidogrel Clopidogrel APOTEX Clopidogrel GH Clovix 75 Plidogrel |
| Tablet 75 mg (as hydrogen sulfate) | Oral | Blooms the Chemist Clopidogrel Clopidogrel Sandoz Pharma Clopidogrel Winthrop Iscover Piax |
Schedule 5, entry for Desmopressin [GRP-24629]
omit:
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL | Nasal | Desmopressin Acetate (Medsurge) |
Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-25645]
insert in alphabetical order in the column headed “Brand”: Imatinib GH
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 GH
Schedule 5, after entry for Ondansetron in the form Wafer 8 mg [GRP-17042]
insert:
| Palbociclib | GRP-25965 | Capsule 125 mg | Oral | Ibrance |
| Tablet 125 mg | Oral | Ibrance | ||
| GRP-25966 | Capsule 100 mg | Oral | Ibrance | |
| Tablet 100 mg | Oral | Ibrance | ||
| GRP-25967 | Capsule 75 mg | Oral | Ibrance | |
| Tablet 75 mg | Oral | Ibrance |
Schedule 5, after entry for Tocilizumab
insert:
| Varenicline | GRP-26245 | Tablet 1 mg (as tartrate) | Oral | Champix |
| Tablet 1 mg (as tartrate) (s19A) | Oral | APO-Varenicline (Canada) |
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Citations
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 4) (Cth)
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