National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 13) (Cth)

Case

PB 120 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 13)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated   22 December 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012).   2

  1. Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 13).

(2)This Instrument may also be cited as PB 120 of 2022.

  1. 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 January 2023 1 January 2023

Note:          This table relates only to the provisions of this instrument as originally made.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.

  1. Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4       Schedules

Each instrument that is specified in a Schedule 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)

  1. Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in each of the forms: Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate); and Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)

omit from the column headed “Schedule Equivalent” (all instances): a

  1. Schedule 1, Part 1, entry for Anastrozole

omit from the column headed “Responsible Person” for the brand “Anastrol”: AS           substitute: TB

  1. Schedule 1, Part 1, after entry for Beclometasone with formoterol and glycopyrronium in the form Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses

insert:

Pressurised inhalation containing beclometasone dipropionate 200 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses Inhalation by mouth Trimbow EU MP NP C12603 1 5 1

  1. Schedule 1, Part 1, entry for Bortezomib in each of the forms: Powder for injection 1 mg; Powder for injection 2.5 mg; Powder for injection 3 mg; Powder for injection 3.5 mg; Solution for injection 2.5 mg in 1 mL; and Solution for injection 3.5 mg in 1.4 mL

insert in numerical order in the column headed “Circumstances” (all instances): C13745

  1. Schedule 1, Part 1, entry for Brolucizumab

(a)omit from the column headed “Circumstances”: C13413

(b)insert in numerical order in the column headed “Circumstances”: C13769

  1. Schedule 1, Part 1, entry for Cemiplimab

(a)omit from the column headed “Circumstances”: C13372

(b)insert in numerical order in the column headed “Circumstances”: C13766

  1. Schedule 1, Part 1, entry for Daratumumab

substitute:

Daratumumab Solution concentrate for I.V. infusion 100 mg in 5 mL Injection Darzalex JC MP C12691 C12844 C12845 C13752 See Note 3 See Note 3 1 PB(100)
Solution concentrate for I.V. infusion 400 mg in 20 mL Injection Darzalex JC MP C12691 C12844 C12845 C13752 See Note 3 See Note 3 1 PB(100)
Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL Injection Darzalex SC JC MP C12691 C12842 C12845 C13744 C13751 C13752 C13774 P12845 1 4 1
MP C12691 C12842 C12845 C13744 C13751 C13752 C13774 P12691 P13774 1 5 1
MP C12691 C12842 C12845 C13744 C13751 C13752 C13774 P12842 1 7 1
MP C12691 C12842 C12845 C13744 C13751 C13752 C13774 P13752 1 8 1
MP C12691 C12842 C12845 C13744 C13751 C13752 C13774 P13744 P13751 1 15 1

  1. Schedule 1, Part 1, entry for Dorzolamide with timolol

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Vizo-PF Dorzolatim AE AO C5038 1 5 1
MP C4343 1 5 1

  1. Schedule 1, Part 1, entry for Doxorubicin - pegylated liposomal

substitute:

Doxorubicin - pegylated liposomal Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL Injection a Caelyx BX MP NP P6234 P6274 P9223 P9287 4
CN6234 CN6274 CN9223 CN9287 		5
CN6234 CN6274 CN9223 CN9287 		1 D(100)
a Liposomal Doxorubicin SUN RA MP NP P6234 P6274 P9223 P9287 4
CN6234 CN6274 CN9223 CN9287 		5
CN6234 CN6274 CN9223 CN9287 		1 D(100)
Caelyx BX MP See Note 3 See Note 3 1 D(100)
Liposomal Doxorubicin SUN RA MP See Note 3 See Note 3 1 D(100)
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL Injection Caelyx BX MP See Note 3 See Note 3 1 D(100)
Liposomal Doxorubicin SUN RA MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Electrolyte replacement, oral

substitute:

Electrolyte replacement, oral Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 Oral O.R.S. AF MP C5889 C6786 P5889 1 0 1
NP C5889 1 0 1
MP C5889 C6786 P6786 30 0 1

  1. Schedule 1, Part 1, omit entry for Ertugliflozin with metformin

  1. Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Escitalopram Sandoz”: C4755  substitute: C4690 C4703 C4755 C4756 C4757

  1. Schedule 1, Part 1, after entry for Famotidine in the form Tablet 40 mg

insert:

Faricimab Solution for intravitreal injection 28.8 mg in 0.24 mL (120 mg per mL) Injection Vabysmo RO MP C13388 C13402 C13406 C13424 C13762 C13770 P13406 P13424 P13762 1 2 1
MP C13388 C13402 C13406 C13424 C13762 C13770 P13388 P13402 P13770 1 5 1

  1. Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

omit:

Irinotecan Kabi PK MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Leflunomide

substitute:

Leflunomide Tablet 10 mg Oral a Arabloc AV MP C13753 C13771 30 5 30
a Arava SW MP C13753 C13771 30 5 30
a Ataris 10 AF MP C13753 C13771 30 5 30
a Leflunomide APOTEX GX MP C13753 C13771 30 5 30
a Leflunomide generichealth HQ MP C13753 C13771 30 5 30
a Leflunomide Sandoz SZ MP C13753 C13771 30 5 30
a Lunava 10 ZP MP C13753 30 5 30
Tablet 20 mg Oral a Arava SW MP C13753 C13771 30 5 30
a Ataris 20 AF MP C13753 C13771 30 5 30
a Leflunomide APOTEX GX MP C13753 C13771 30 5 30
a Leflunomide generichealth HQ MP C13753 C13771 30 5 30
a Leflunomide Sandoz SZ MP C13753 C13771 30 5 30
a Lunava 20 ZP MP C13753 30 5 30

  1. Schedule 1, Part 1, entry for Letrozole

omit:

a Fera AS MP NP C5464 30 5 30

  1. Schedule 1, Part 1, entry for Molnupiravir

omit from the column headed “Circumstances”: C13155 C13156 C13201 C13410  substitute: C13748 C13759 C13760 C13765

  1. Schedule 1, Part 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

substitute:

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL Oral a CellCept RO MP 1 5 1
a Pharmacor Mycophenolate CR MP 1 5 1
a CellCept RO MP P5554 P5795 P9691 P9693 2
CN5554 CN5795 CN9691 CN9693 		5
CN5554 CN5795 CN9691 CN9693 		1 C(100)
a Pharmacor Mycophenolate CR MP P5554 P5795 P9691 P9693 2
CN5554 CN5795 CN9691 CN9693 		5
CN5554 CN5795 CN9691 CN9693 		1 C(100)

  1. Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir

omit from the column headed “Circumstances”: C13155 C13156 C13201 C13410  substitute: C13748 C13759 C13760 C13765

  1. Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL

omit:

Paclitaxel Kabi PK MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

omit:

Paclitaxel Kabi PK MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Paracetamol in the form Tablet 500 mg

(a)omit:

a Mendeleev Paracetamol HX PDP C5846 C5885 P5846 100 0 100

(b)omit:

a Mendeleev Paracetamol HX MP NP C5835 C5865 P5835 100 1 100

(c)omit:

a Mendeleev Paracetamol HX PDP C5846 C5885 P5885 300 0 100

(d)omit:

a Mendeleev Paracetamol HX MP NP C5835 C5865 P5865 300 4 100

  1. Schedule 1, Part 1, entry for Pomalidomide

omit from the column headed “Schedule Equivalent” (all instances): a

  1. Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg

(a)omit:

a Biaxsig AV MP NP PDP 10 0 10

(b)omit:

a Rulide SW MP NP PDP 10 0 10

(c)omit:

a Biaxsig AV MP NP P10404 20
CN10404 		0
CN10404 		10

(d)omit:

a Rulide SW MP NP P10404 20
CN10404 		0
CN10404 		10

  1. Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg

(a)omit:

a Biaxsig AV MP NP PDP 5 0 5

(b)omit:

a Biaxsig AV MP NP P10404 10
CN10404 		0
CN10404 		5

  1. Schedule 1, Part 1, entry for Sunitinib

substitute:

Sunitinib Capsule 12.5 mg Oral a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
Capsule 25 mg Oral a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
Capsule 37.5 mg Oral a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
Capsule 50 mg Oral a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11878 P13152 P13153 28 1 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P4862 28 2 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P11875 28 3 28
a ARX-Sunitinib XT MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib MSN LR MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sunitinib Sandoz SZ MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28
a Sutent PF MP C4862 C7471 C11875 C11878 C13152 C13153 P7471 28 5 28

  1. Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Zoledronic Acid Accord OC MP C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 1 11 1 PB(100)

  1. Schedule 1, Part 2, after entry for Doxepin in the form Tablet 50 mg (as hydrochloride)

insert:

Ertugliflozin with metformin Tablet containing 2.5 mg ertugliflozin with 500 mg metformin hydrochloride Oral Segluromet 2.5/500 MK MP C5631 C7492 C7498 C8249 56 5 56
NP C5631 C7492 C8249 56 5 56
Tablet containing 2.5 mg ertugliflozin with 1 g metformin hydrochloride Oral Segluromet 2.5/1000 MK MP C5631 C7492 C7498 C8249 56 5 56
NP C5631 C7492 C8249 56 5 56
Tablet containing 7.5 mg ertugliflozin with 500 mg metformin hydrochloride Oral Segluromet 7.5/500 MK MP C5631 C7492 C7498 C8249 56 5 56
NP C5631 C7492 C8249 56 5 56
Tablet containing 7.5 mg ertugliflozin with 1 g metformin hydrochloride Oral Segluromet 7.5/1000 MK MP C5631 C7492 C7498 C8249 56 5 56
NP C5631 C7492 C8249 56 5 56

  1. Schedule 1, Part 2, omit entry for Phenelzine

  1. Schedule 1, Part 2, omit entry for Tipranavir

  1. Schedule 4, Part 1, entry for Beclometasone with formoterol and glycopyrronium

insert in numerical order after existing text:

C12603 Severe asthma
Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique.
Patient must be at least 18 years of age.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist. 		Compliance with Authority Required procedures - Streamlined Authority Code 12603

  1. Schedule 4, Part 1, entry for Bortezomib

insert in numerical order after existing text:

C13745 Newly diagnosed systemic light chain amyloidosis
Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total
Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication.

  1. Schedule 4, Part 1, entry for Brolucizumab

(a)omit:

C13413 Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C13769 Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Cemiplimab

(a)omit:

C13372 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 3 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death 1 (PD-1) inhibitor or a programmed cell death ligand 1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must express programmed cell death ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 50% in the tumour sample.
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 13372

(b)insert in numerical order after existing text:

C13766 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 3 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; OR
The condition must have progressed after treatment with tepotinib; AND
Patient must not have received prior treatment with a programmed cell death 1 (PD-1) inhibitor or a programmed cell death ligand 1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must express programmed cell death ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 50% in the tumour sample.
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 13766

  1. Schedule 4, Part 1, entry for Daratumumab

(a)omit:

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

(b)insert in numerical order after existing text:

C13744 P13744 Newly diagnosed systemic light chain amyloidosis
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must be continuing treatment with this drug that was commenced as non-PBS-subsidised supply prior to 1 January 2023; AND
The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND
The condition must have been, prior to the first dose of the non-PBS-subsidised supply, untreated with drug therapy, including this drug, irrespective of whether the diagnosis had been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated.
Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information; AND
Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:
Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the date of the histology result, which was within 4 weeks prior to the commencement of non-PBS-subsidised therapy, (ii) the name of pathologist/pathology provider, (iii) the site of biopsy.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Determine an appropriate number of repeat prescriptions for this authority application in line with either:
(i) Where the patient has received less than 10 non-PBS-subsidised doses, prescribe a number of repeat prescriptions up to the balance of: 15 doses less the number of non-PBS-subsidised doses; or
(ii) Where the patient has received at least 10 non-PBS-subsidised doses, prescribe no more than 5 repeat prescriptions. 		Compliance with Written Authority Required procedures
C13751 P13751 Newly diagnosed systemic light chain amyloidosis
Initial treatment from week 0 to week 24
The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND
The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation.
Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:
Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the date of the histology result, which is no older than 4 weeks at the time of making this authority application, (ii) the name of pathologist/pathology provider, (iii) the site of biopsy.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). 		Compliance with Written Authority Required procedures
C13752 P13752 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, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.
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
C13774 P13774 Newly diagnosed systemic light chain amyloidosis
Continuing treatment from week 25 onwards (administered once every four weeks)
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Doxorubicin - pegylated liposomal

substitute:

Doxorubicin - pegylated liposomal P6234 CN6234 Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 6234
P6274 CN6274 Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 6274
P9223 CN9223 Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 9223
P9287 CN9287 Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 9287

  1. Schedule 4, Part 1, entry for Electrolyte replacement, oral

substitute:

Electrolyte replacement, oral C5889 P5889 For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C6786 P6786 Rehydration in intestinal failure Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Famciclovir

insert:

Faricimab C13388 P13388 Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures
C13402 P13402 Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 13402
C13406 P13406 Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. 		Compliance with Authority Required procedures - Streamlined Authority Code 13406
C13424 P13424 Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures
C13762 P13762 Subfoveal choroidal neovascularisation (CNV)
Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2023; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures
C13770 P13770 Diabetic macular oedema (DMO)
Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2023; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
All reports must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Leflunomide

substitute:

Leflunomide C13753 Severe active rheumatoid arthritis
Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; OR
Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
The treatment must be initiated by a physician.
C13771 Severe active psoriatic arthritis
Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; OR
Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
The treatment must be initiated by a physician.

  1. Schedule 4, Part 1, entry for Molnupiravir

substitute:

Molnupiravir C13748 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m2)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
11. Past COVID-19 infection episode resulting in hospitalisation.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13748
C13759 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset; OR
The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic.
Patient must be at least 70 years of age.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13759
C13760 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 18 years of age.
For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:
1. Any primary or acquired immunodeficiency including:
a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR
2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
a. Chemotherapy or whole body radiotherapy,
b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR
3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR
4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR
5. People with disability with multiple comorbidities and/or frailty.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13760
C13765 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be both: (i) at least 50 years of age, (ii) at high risk.
For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:
1. The patient is in residential aged care,
2. The patient has disability with multiple comorbidities and/or frailty,
3. Neurological conditions, including stroke and dementia and demyelinating conditions,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
5. Heart failure, coronary artery disease, cardiomyopathies,
6. Obesity (BMI greater than 30 kg/m2),
7. Diabetes type I or II, requiring medication for glycaemic control,
8. Renal impairment (eGFR less than 60mL/min),
9. Cirrhosis, or
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13765

  1. Schedule 4, Part 1, entry for Nirmatrelvir and ritonavir

substitute:

Nirmatrelvir and ritonavir C13748 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:
1. The patient is in residential aged care
2. The patient has disability with multiple comorbidities and/or frailty
3. Neurological conditions, including stroke and dementia and demyelinating conditions
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease
5. Heart failure, coronary artery disease, cardiomyopathies
6. Obesity (BMI greater than 30 kg/m2)
7. Diabetes type I or II, requiring medication for glycaemic control
8. Renal impairment (eGFR less than 60mL/min)
9. Cirrhosis
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
11. Past COVID-19 infection episode resulting in hospitalisation.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13748
C13759 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset; OR
The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic.
Patient must be at least 70 years of age.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13759
C13760 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 18 years of age.
For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:
1. Any primary or acquired immunodeficiency including:
a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR
2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
a. Chemotherapy or whole body radiotherapy,
b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR
3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR
4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR
5. People with disability with multiple comorbidities and/or frailty.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13760
C13765 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be both: (i) at least 50 years of age, (ii) at high risk.
For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:
1. The patient is in residential aged care,
2. The patient has disability with multiple comorbidities and/or frailty,
3. Neurological conditions, including stroke and dementia and demyelinating conditions,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
5. Heart failure, coronary artery disease, cardiomyopathies,
6. Obesity (BMI greater than 30 kg/m2),
7. Diabetes type I or II, requiring medication for glycaemic control,
8. Renal impairment (eGFR less than 60mL/min),
9. Cirrhosis, or
10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. 		Compliance with Authority Required procedures - Streamlined Authority Code 13765

  1. Schedule 4, Part 1, omit entry for Tipranavir

  1. Schedule 5, after entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL (s19A)

insert:

Amoxicillin with clavulanic acid GRP-26768 Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral AMCLAVOX DUO FORTE 875/125
APO-AMOXY/CLAV 875/125
APO-Amoxycillin and Clavulanic Acid
APX-Amoxicillin/Clavulanic Acid
AlphaClav Duo Forte
AmoxyClav generichealth 875/125
Amoxyclav AN 875/125
Augmentin Duo forte
Curam Duo Forte 875/125
Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) Oral Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg

  1. Schedule 5, omit entry for Phenelzine

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