EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 3)
PB 20 of 2020
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
Authority
This Instrument exercises various powers in Part VII of the Act, as set out below:
Pharmaceutical benefits listed on the PBS
Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies. A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)). Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug. A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB). Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.
The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.
Prescribing pharmaceutical benefits
Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.
Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.
Supplying pharmaceutical benefits
Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.
Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.
Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.
Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.
Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.
Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).
Variation and revocation
Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.
Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation. Advice from the PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).
Changes to PB 71 of 2012 made by this Instrument
Schedule 1 to this Instrument provides for the addition of the listed drugs binimetinib, darunavir with cobicistat, emtricitabine and tenofovir alafenamide, and encorafenib, and for the addition of forms of the listed drugs atezolizumab and protein formula with carbohydrate, fat, vitamins and minerals to the PBS. It also provides for the deletion of the listed drugs coal tar, milk powder lactose intolerance formula, and tinidazole, and the deletion of a form of the listed drug atazanavir. Additionally, it alters the circumstances in which a prescription may be written for the supply of the listed drugs amoxicillin, amoxicillin with clavulanic acid, atezolizumab, bortezomib, botulinum toxin type A purified neurotoxin complex, brivaracetam, cefalexin, glecaprevir with pibrentasvir, guselkumab, peginterferon alfa-2a pertuzumab, rituximab, sofosbuvir with velpatasvir and voxilaprevir, tolvaptan, trastuzumab, trastuzumab emtansine and trifluridine with tipiracil (including authority requirements).
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 14 brands and deletion of 22 existing brands of pharmaceutical items;
- the addition of 2 responsible persons to the list of responsible persons;
- the alteration of responsible person codes for 83 existing brands of pharmaceutical items;
- the alteration of authorised prescriber codes for 155 existing brands of pharmaceutical items, including 13 instances where prescriber code alterations were restricted to only some of the listed circumstances codes for the brand;
- the deletion of specific maximum quanity and number of repeats combinations for 50 brands of existing pharmaceutical items and the alteration of the maximum number of repeats applicable under specified circumstances codes for 2 brands of existing pharmaceutical items; and
- the addition of 1 pack quantity for 3 brands of existing pharmacetucial items.
These changes are summarised, by subject matter, in the Attachment.
Changes to HSD medicines for Heptatitis and HIV
Following a recommendation by the PBAC at the March 2019 meeting, the age restrictions, interferon-containing regimens and the determination of patient Hepatitis C virus genotype prior to treatment have been removed from the Hepatitis C General Statement. Pan-genotypic regimens have been added, as well as the requirement for details of previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir (Vosevi®) or glecaprevir with pibrentasvir (Maviret®) for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an non-structural protein 5A (NS5A) inhibitor).
Consultation
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 April 2020.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 3)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3) and may also be cited as PB 20 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2020.
Section 3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions and deletions of drugs, additions and deletions of forms, additions and deletions of brands, alterations of responsible person codes for a number of brands of pharmaceutical benefits, additions of responsible persons to the list of responsible persons, alterations to the authorised prescribers for a number of brands of pharmaceutical benefits (including in some cases restricted to certain circumstances codes), deletions and alterations of maximum quantities and numbers of repeats, additions of pack quantities and alterations to circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.
SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Binimetinib |
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide |
Encorafenib |
Listed Drugs Deleted
Listed Drug |
Coal tar |
Milk powder lactose intolerance formula |
Tinidazole |
Forms Added
Listed Drug | Form |
Atezolizumab | Solution concentrate for I.V. infusion 840 mg in 14 mL |
Protein formula with carbohydrate, fat, vitamins and minerals | Oral liquid 500 mL, 12 (Nutrini Peptisorb Energy) |
Forms Deleted
Listed Drug | Form |
Atazanavir | Capsule 150 mg (as sulfate) |
Brands Added
Listed Drug | Form and Brand |
Fluticasone propionate | Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) (Axotide) |
| Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation) (Axotide) |
Levodopa with carbidopa | Tablet 100 mg-25 mg (as monohydrate) (APO‑Levodopa/Carbidopa; SINADOPA 100/25) |
| Tablet 250 mg-25 mg (as monohydrate) (APO‑Levodopa/Carbidopa; SINADOPA 250/25) |
Mercaptopurine | Tablet containing mercaptopurine monohydrate 50 mg (MERCAPTOPURINE-LINK) |
Olmesartan with amlodipine and hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg (APO‑Olmesartan/Amlodipine/HCTZ 40/5/25 tablet) |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg (APO-Olmesartan/Amlodipine/HCTZ 40/10/12.5) |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg (APO‑Olmesartan/Amlodipine/HCTZ 40/10/25) |
Pegfilgrastim | Injection 6 mg in 0.6 mL single use pre-filled syringe (Fulphila) |
Rasagiline | Tablet 1 mg (as mesilate) (Rasalect) |
Brands Deleted
Listed Drug | Form and Brand |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) (Dronalen Plus D‑Cal) |
Cisplatin | I.V. injection 50 mg in 50 mL (Hospira Pty Limited) |
| I.V. injection 100 mg in 100 mL (Hospira Pty Limited) |
Dexamethasone | Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL (Hospira Pty Limited) |
| Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL (Hospira Pty Limited) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL (Pharmorubicin) |
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL (Pharmorubicin) |
Exemestane | Tablet 25 mg (Estamane; Exemestane AN) |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg (Fludarabine ACT) |
Imatinib | Capsule 100 mg (as mesilate) (IMATINIB AN) |
| Capsule 400 mg (as mesilate) (IMATINIB AN) |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL (Lanpro) |
Mirtazapine | Tablet 15 mg (orally disintegrating) (Remeron SolTab) |
| Tablet 30 mg (orally disintegrating) (Remeron SolTab) |
Temozolomide | Capsule 5 mg (Temozolomide Amneal) |
| Capsule 20 mg (Temolide) |
| Capsule 100 mg (Temolide) |
| Capsule 180 mg (Temozolomide Amneal) |
| Capsule 250 mg (Temolide; Temozolomide Amneal) |
Tenofovir with emtricitabine | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg (Truvada) |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Fosamax Plus | From: MK To: MQ |
| Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Fosamax Plus 70 mg/140 mcg | From: MK To: MQ |
Amlodipine | Tablet 5 mg (as besilate) | Norvasc | From: PF To: UJ |
| Tablet 10 mg (as besilate) | Norvasc | From: PF To: UJ |
Amlodipine with atorvastatin | Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) | Caduet 5/40 | From: PF To: UJ |
| Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) | Caduet 5/80 | From: PF To: UJ |
| Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) | Caduet 10/10 | From: PF To: UJ |
| Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) | Caduet 10/20 | From: PF To: UJ |
| Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) | Caduet 10/40 | From: PF To: UJ |
| Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) | Caduet 10/80 | From: PF To: UJ |
Atorvastatin | Tablet 10 mg (as calcium) | Lipitor | From: PF To: UJ |
| Tablet 20 mg (as calcium) | Lipitor | From: PF To: UJ |
| Tablet 40 mg (as calcium) | Lipitor | From: PF To: UJ |
| Tablet 80 mg (as calcium) | Lipitor | From: PF To: UJ |
Celecoxib | Capsule 100 mg | Celebrex | From: PF To: UJ |
| Capsule 200 mg | Celebrex | From: PF To: UJ |
Eletriptan
| Tablet 40 mg (as hydrobromide) | Relpax | From: PF To: UJ |
| Tablet 80 mg (as hydrobromide) | Relpax | From: PF To: UJ |
Enalapril | Tablet containing enalapril maleate 10 mg | Renitec | From: MK To: AF |
| Tablet containing enalapril maleate 20 mg | Renitec 20 | From: MK To: AF |
Enalapril with hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg | Renitec Plus 20/6 | From: MK To: AF |
Eplerenone | Tablet 25 mg | Inspra | From: PF To: UJ |
| Tablet 50 mg | Inspra | From: PF To: UJ |
Ezetimibe | Tablet 10 mg | Ezetrol | From: MK To: AL |
Ezetimibe and rosuvastatin | Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium) | Rosuzet Composite Pack | From: MK To: AL |
| Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium) | Rosuzet Composite Pack | From: MK To: AL |
| Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium) | Rosuzet Composite Pack | From: MK To: AL |
| Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium) | Rosuzet Composite Pack | From: MK To: AL |
Ezetimibe with atorvastatin | Tablet 10 mg-10 mg | Atozet | From: MK To: AF |
| Tablet 10 mg-20 mg | Atozet | From: MK To: AF |
| Tablet 10 mg-40 mg | Atozet | From: MK To: AF |
| Tablet 10 mg-80 mg | Atozet | From: MK To: AF |
Ezetimibe with simvastatin | Tablet 10 mg-10 mg | Vytorin | From: MK To: AL |
| Tablet 10 mg-20 mg | Vytorin | From: MK To: AL |
| Tablet 10 mg-40 mg | Vytorin | From: MK To: AL |
| Tablet 10 mg-80 mg | Vytorin | From: MK To: AL |
Gabapentin | Capsule 100 mg | Neurontin | From: PF To: UJ |
| Capsule 300 mg | Neurontin | From: PF To: UJ |
| Capsule 400 mg | Neurontin | From: PF To: UJ |
| Tablet 600 mg | Neurontin | From: PF To: UJ |
| Tablet 800 mg | Neurontin | From: PF To: UJ |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL | Xalatan | From: PF To: UJ |
Latanoprost with timolol | Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Xalacom | From: PF To: UJ |
Levodopa with carbidopa | Tablet 100 mg-25 mg (as monohydrate) | Sinemet 100/25 | From: MK To: AL |
| Tablet (modified release) 200 mg‑50 mg (as monohydrate) | Sinemet CR | From: MK To: AL |
| Tablet 250 mg-25 mg (as monohydrate) | Sinemet | From: MK To: AL |
Mirtazapine | Tablet 30 mg | Avanza | From: MK To: AL |
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g | Elocon Alcohol Free | From: MK To: AL |
| Lotion containing mometasone furoate 1 mg per g, 30 mL | Elocon | From: MK To: AL |
| Ointment containing mometasone furoate 1 mg per g, 15 g | Elocon | From: MK To: AL |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Singulair | From: MK To: AF |
| Tablet, chewable, 5 mg (as sodium) | Singulair | From: MK To: AF |
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Olmetec | From: MK To: AL |
| Tablet containing olmesartan medoxomil 40 mg | Olmetec | From: MK To: AL |
Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Olmetec Plus | From: MK To: AL |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Olmetec Plus | From: MK To: AL |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Olmetec Plus | From: MK To: AL |
Phenytoin | Capsule containing phenytoin sodium 30 mg | Dilantin Sodium | From: PF To: UJ |
| Capsule containing phenytoin sodium 100 mg | Dilantin Sodium | From: PF To: UJ |
| Oral suspension 30 mg per 5 mL, 500 mL | Dilantin | From: PF To: UJ |
| Tablet 50 mg | Dilantin Infatabs | From: PF To: UJ |
Pregabalin | Capsule 25 mg | Lyrica | From: PF To: UJ |
| Capsule 75 mg | Lyrica | From: PF To: UJ |
| Capsule 150 mg | Lyrica | From: PF To: UJ |
| Capsule 300 mg | Lyrica | From: PF To: UJ |
Sertraline | Tablet 50 mg (as hydrochloride) | Zoloft | From: PF To: UJ |
| Tablet 100 mg (as hydrochloride) | Zoloft | From: PF To: UJ |
Sildenafil | Tablet 20 mg (as citrate) | Revatio | From: PF To: UJ |
Simvastatin | Tablet 10 mg | Lipex 10 | From: FR To: AL |
|
| Zocor | From: MK To: MQ |
| Tablet 20 mg | Lipex 20 | From: FR To: AL |
|
| Zocor | From: MK To: MQ |
| Tablet 40 mg | Lipex 40 | From: FR To: AL |
|
| Zocor | From: MK To: MQ |
| Tablet 80 mg | Lipex 80 | From: FR To: AL |
|
| Zocor | From: MK To: MQ |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Efexor-XR | From: PF To: UJ |
| Capsule (modified release) 75 mg (as hydrochloride) | Efexor-XR | From: PF To: UJ |
| Capsule (modified release) 150 mg (as hydrochloride) | Efexor-XR | From: PF To: UJ |
Ziprasidone | Capsule 20 mg (as hydrochloride) | Zeldox | From: PF To: UJ |
| Capsule 40 mg (as hydrochloride) | Zeldox | From: PF To: UJ |
| Capsule 60 mg (as hydrochloride) | Zeldox | From: PF To: UJ |
| Capsule 80 mg (as hydrochloride) | Zeldox | From: PF To: UJ |
Addition of Responsible Person Code
Responsible Person and Code |
Teva Pharma Australia Pty Ltd (TI) |
Upjohn Australia Pty Ltd (UJ) |
Alteration of Authorised Prescriber
Listed Drug | Form | Brand Name | Authorised Prescriber |
Abacavir | Oral solution 20 mg (as sulfate) per mL, 240 mL | Ziagen | From: MP To: MP NP |
| Tablet 300 mg (as sulfate) | Ziagen | From: MP To: MP NP |
Abacavir with lamivudine | Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg | Abacavir/Lamivudine GH 600/300 | From: MP To: MP NP |
| Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg | ABACAVIR/LAMIVUDINE 600/300 SUN | From: MP To: MP NP |
|
| Abacavir/Lamivudine Mylan | From: MP To: MP NP |
|
| Kivexa | From: MP To: MP NP |
Abacavir with lamivudine and zidovudine | Tablet containing abacavir 300 mg (as sulfate) with lamivudine 150 mg and zidovudine 300 mg | Trizivir | From: MP To: MP NP |
Adefovir | Tablet containing adefovir dipivoxil 10 mg | APO-Adefovir | From: MP To: MP NP |
|
| Hepsera | From: MP To: MP NP |
Amoxicillin | Capsule 250 mg (as trihydrate) | Alphamox 250 | From: PDP To: MP NP MW PDP |
|
| AMILOXYN | From: PDP To: MP NP MW PDP |
|
| Amoxil | From: PDP To: MP NP MW PDP |
|
| Amoxycillin AN | From: PDP To: MP NP MW PDP |
|
| Amoxycillin Ranbaxy | From: PDP To: MP NP MW PDP |
|
| Amoxycillin Sandoz | From: PDP To: MP NP MW PDP |
|
| APO-Amoxycillin | From: PDP To: MP NP MW PDP |
|
| Cilamox | From: PDP To: MP NP MW PDP |
| Capsule 500 mg (as trihydrate)
| Alphamox 500 | From: PDP To: MP NP MW PDP |
|
| AMILOXYN | From: PDP To: MP NP MW PDP |
|
| Amoxil | From: PDP To: MP NP MW PDP |
|
| Amoxycillin AN | From: PDP To: MP NP MW PDP |
|
| Amoxycillin generichealth 500 | From: PDP To: MP NP MW PDP |
|
| Amoxycillin Ranbaxy | From: PDP To: MP NP MW PDP |
|
| Amoxycillin Sandoz | From: PDP To: MP NP MW PDP |
|
| APO-Amoxycillin | From: PDP To: MP NP MW PDP |
|
| Cilamox | From: PDP To: MP NP MW PDP |
Atazanavir | Capsule 200 mg (as sulfate) | Atazanavir Mylan | From: MP To: MP NP |
|
| Reyataz | From: MP To: MP NP |
| Capsule 300 mg (as sulfate) | Atazanavir Mylan | From: MP To: MP NP |
|
| Reyataz | From: MP To: MP NP |
Atazanavir with cobicistat | Tablet containing 300 mg atazanavir and 150 mg cobicistat | Evotaz | From: MP To: MP NP |
Azithromycin | Tablet 600 mg (as dihydrate) | Zithromax | From: MP To: MP NP |
Bictegravir with emtricitabine with tenofovir alafenamide | Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg | Biktarvy | From: MP To: MP NP |
Cefalexin | Capsule 250 mg (as monohydrate) | APO-Cephalexin | From: PDP To: MP NP MW PDP |
|
| Cefalexin Sandoz | From: PDP To: MP NP MW PDP |
|
| Cephalexin AN | From: PDP To: MP NP MW PDP |
|
| Ibilex 250 | From: PDP To: MP NP MW PDP |
|
| Keflex | From: PDP To: MP NP MW PDP |
| Capsule 500 mg (as monohydrate) | APO-Cephalexin | From: PDP To: MP NP MW PDP |
|
| Cefalexin Sandoz | From: PDP To: MP NP MW PDP |
|
| Cephalex 500 | From: PDP To: MP NP MW PDP |
|
| Cephalexin AN | From: PDP To: MP NP MW PDP |
|
| Cephalexin generichealth | From: PDP To: MP NP MW PDP |
|
| Ibilex 500 | From: PDP To: MP NP MW PDP |
|
| Keflex | From: PDP To: MP NP MW PDP |
Darunavir | Tablet 150 mg (as ethanolate) | Prezista | From: MP To: MP NP |
| Tablet 600 mg (as ethanolate) | Prezista | From: MP To: MP NP |
| Tablet 800 mg (as ethanolate) | Prezista | From: MP To: MP NP |
Darunavir with cobicistat | Tablet containing darunavir 800 mg with cobicistat 150 mg | Prezcobix | From: MP To: MP NP |
Dolutegravir | Tablet 50 mg (as sodium) | Tivicay | From: MP To: MP NP |
Dolutegravir with abacavir and lamivudine | Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg | Triumeq | From: MP To: MP NP |
Dolutegravir with lamivudine | Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg | Dovato | From: MP To: MP NP |
Dolutegravir with rilpivirine | Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride) | Juluca | From: MP To: MP NP |
Doxorubicin - pegylated liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Caelyx | From: MP To: MP NP |
|
| Liposomal Doxorubicin SUN | From: MP To: MP NP |
Efavirenz | Oral solution 30 mg per mL, 180 mL | Stocrin | From: MP To: MP NP |
| Tablet 200 mg | Stocrin | From: MP To: MP NP |
| Tablet 600 mg | Stocrin | From: MP To: MP NP |
Emtricitabine with rilpivirine with tenofovir alafenamide | Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg | Odefsey | From: MP To: MP NP |
Emtricitabine with tenofovir alafenamide | Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg | Descovy | From: MP To: MP NP |
| Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg | Descovy | From: MP To: MP NP |
Enfuvirtide | Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs) | Fuzeon | From: MP To: MP NP |
Entecavir | Tablet 0.5 mg (as monohydrate) | Baraclude | From: MP To: MP NP |
|
| ENTAC | From: MP To: MP NP |
|
| Entecavir Amneal | From: MP To: MP NP |
|
| ENTECAVIR APO | From: MP To: MP NP |
|
| Entecavir APOTEX | From: MP To: MP NP |
|
| Entecavir GH | From: MP To: MP NP |
|
| Entecavir Mylan | From: MP To: MP NP |
|
| ENTECAVIR RBX | From: MP To: MP NP |
|
| Entecavir Sandoz | From: MP To: MP NP |
|
| ENTECLUDE | From: MP To: MP NP |
| Tablet 1 mg (as monohydrate) | Baraclude | From: MP To: MP NP |
|
| ENTAC | From: MP To: MP NP |
|
| Entecavir Amneal | From: MP To: MP NP |
|
| ENTECAVIR APO | From: MP To: MP NP |
|
| Entecavir APOTEX | From: MP To: MP NP |
|
| Entecavir GH | From: MP To: MP NP |
|
| Entecavir Mylan | From: MP To: MP NP |
|
| ENTECAVIR RBX | From: MP To: MP NP |
|
| Entecavir Sandoz | From: MP To: MP NP |
|
| ENTECLUDE | From: MP To: MP NP |
Etravirine | Tablet 200 mg | Intelence | From: MP To: MP NP |
Fosamprenavir | Tablet 700 mg (as calcium) | Telzir | From: MP To: MP NP |
Lamivudine | Oral solution 10 mg per mL, 240 mL | 3TC | From: MP To: MP NP |
| Tablet 100 mg | Zeffix | From: MP To: MP NP |
|
| Zetlam | From: MP To: MP NP |
| Tablet 150 mg
| 3TC | From: MP To: MP NP |
|
| Lamivudine Alphapharm | From: MP To: MP NP |
| Tablet 300 mg | 3TC | From: MP To: MP NP |
|
| Lamivudine Alphapharm | From: MP To: MP NP |
Lamivudine with zidovudine | Tablet 150 mg-300 mg | Combivir | From: MP To: MP NP |
|
| Lamivudine 150 mg + Zidovudine 300 mg Alphapharm | From: MP To: MP NP |
Lopinavir with ritonavir | Oral liquid 400 mg-100 mg per 5 mL, 60 mL | Kaletra | From: MP To: MP NP |
| Tablet 100 mg-25 mg | Kaletra | From: MP To: MP NP |
| Tablet 200 mg-50 mg | Kaletra | From: MP To: MP NP |
Maraviroc
| Tablet 150 mg | Celsentri | From: MP To: MP NP |
| Tablet 300 mg | Celsentri | From: MP To: MP NP |
Nevirapine | Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL | Viramune | From: MP To: MP NP |
| Tablet 200 mg | Nevirapine Alphapharm | From: MP To: MP NP |
| Tablet 400 mg (extended release) | Nevirapine XR APOTEX | From: MP To: MP NP |
|
| Viramune XR | From: MP To: MP NP |
Raltegravir | Tablet 25 mg (as potassium) | Isentress | From: MP To: MP NP |
| Tablet 100 mg (as potassium) | Isentress | From: MP To: MP NP |
| Tablet 400 mg (as potassium) | Isentress | From: MP To: MP NP |
| Tablet 600 mg (as potassium) | Isentress HD | From: MP To: MP NP |
Rifabutin | Capsule 150 mg | Mycobutin | From: MP To: MP NP |
Rilpivirine | Tablet 25 mg (as hydrochloride) | Edurant | From: MP To: MP NP |
Ritonavir | Tablet 100 mg | Norvir | From: MP To: MP NP |
Roxithromycin | Tablet for oral suspension 50 mg | Rulide D | From: PDP To: MP NP PDP |
| Tablet 150 mg | APO-Roxithromycin | From: PDP To: MP NP PDP |
|
| Biaxsig | From: PDP To: MP NP PDP |
|
| Chem mart Roxithromycin | From: PDP To: MP NP PDP |
|
| Roxar 150 | From: PDP To: MP NP PDP |
|
| Roximycin | From: PDP To: MP NP PDP |
|
| Roxithromycin AN | From: PDP To: MP NP PDP |
|
| Roxithromycin Sandoz | From: PDP To: MP NP PDP |
|
| Roxithromycin-GA | From: PDP To: MP NP PDP |
|
| Rulide | From: PDP To: MP NP PDP |
|
| Terry White Chemists Roxithromycin | From: PDP To: MP NP PDP |
| Tablet 300 mg | APO-Roxithromycin | From: PDP To: MP NP PDP |
|
| Biaxsig | From: PDP To: MP NP PDP |
|
| Chem mart Roxithromycin | From: PDP To: MP NP PDP |
|
| Roxar 300 | From: PDP To: MP NP PDP |
|
| Roximycin | From: PDP To: MP NP PDP |
|
| Roxithromycin AN | From: PDP To: MP NP PDP |
|
| Roxithromycin Sandoz | From: PDP To: MP NP PDP |
|
| Roxithromycin-GA | From: PDP To: MP NP PDP |
|
| Rulide | From: PDP To: MP NP PDP |
|
| Terry White Chemists Roxithromycin | From: PDP To: MP NP PDP |
Saquinavir | Tablet 500 mg (as mesilate) | Invirase | From: MP To: MP NP |
Tenofovir | Tablet containing tenofovir disoproxil phosphate 291 mg | Tenofovir GH | From: MP To: MP NP |
| Tablet containing tenofovir disoproxil fumarate 300 mg | Tenofovir APOTEX | From: MP To: MP NP |
|
| Viread | From: MP To: MP NP |
| Tablet containing tenofovir disoproxil maleate 300 mg | Tenofovir Disoproxil Mylan | From: MP To: MP NP |
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat | Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg | Genvoya | From: MP To: MP NP |
Tenofovir with emtricitabine and efavirenz | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg | Atripla | From: MP To: MP NP |
| Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg | Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600 | From: MP To: MP NP |
Tipranavir | Capsule 250 mg | Aptivus | From: MP To: MP NP |
Zidovudine | Capsule 100 mg | Retrovir | From: MP To: MP NP |
| Capsule 250 mg | Retrovir | From: MP To: MP NP |
| Syrup 10 mg per mL, 200 mL | Retrovir | From: MP To: MP NP |
Key:
AO—authorised optometrist; MP—medical practitioner; MW—authorised midwife; NP—authorised nurse practitioner; PDP—participating dental practitioner.
Authorised Nurse Practitioner (NP) Prescribing Added
Listed Drug | Form | Brand Name | Applicable Circumstances or Purposes Codes |
Ganciclovir | Powder for I.V. infusion 500 mg (as sodium) | Cymevene | C5000 |
|
| GANCICLOVIR SXP | C5000 |
Interferon alfa-2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe | Roferon-A | C4993 C5036 |
| Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe | Roferon-A | C4993 C5036 |
Peginterferon alfa-2a | Injection 135 micrograms in 0.5 mL single use pre-filled syringe | Pegasys | P5004 P9603 |
| Injection 180 micrograms in 0.5 mL single use pre-filled syringe | Pegasys | P5004 P9603 |
Tenofovir with emtricitabine | Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg | Tenofovir EMT GH | C6985 C6986 |
| Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg | Tenofovir/Emtricitabine 300/200 APOTEX | C6985 C6986 |
| Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg | Tenofovir Disoproxil Emtricitabine Mylan 300/200 | C6985 C6986 |
Valganciclovir | Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL | Valcyte | C4980 |
| Tablet 450 mg (as hydrochloride) | Valcyte | C4980 |
|
| Valganciclovir Mylan | C4980 |
|
| Valganciclovir Sandoz | C4980 |
Alteration of Maximum Number of Repeats
Listed Drug | Form | Applicable Circumstances Codes | Number of Repeats |
Amoxicillin with clavulanic acid | Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | C5832 C5893 | From: 1 To: 0 |
| Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | C5832 C5893 | From: 1 To: 0 |
Deletion of Maximum Quantity and Number of Repeats
Listed Drug | Form | Brand Name | Maximum Quantity | Number of Repeats |
Amoxicillin | Capsule 250 mg (as trihydrate) | Alphamox 250 | 20 | 1 |
|
| AMILOXYN | 20 | 1 |
|
| Amoxil | 20 | 1 |
|
| Amoxycillin AN | 20 | 1 |
|
| Amoxycillin Ranbaxy | 20 | 1 |
|
| Amoxycillin Sandoz | 20 | 1 |
|
| APO-Amoxycillin | 20 | 1 |
|
| Cilamox | 20 | 1 |
| Capsule 500 mg (as trihydrate) | Alphamox 500 | 20 | 1 |
|
| AMILOXYN | 20 | 1 |
|
| Amoxil | 20 | 1 |
|
| Amoxycillin AN | 20 | 1 |
|
| Amoxycillin generichealth 500 | 20 | 1 |
|
| Amoxycillin Ranbaxy | 20 | 1 |
|
| Amoxycillin Sandoz | 20 | 1 |
|
| APO-Amoxycillin | 20 | 1 |
|
| Cilamox | 20 | 1 |
Cefalexin | Capsule 250 mg (as monohydrate) | APO-Cephalexin | 20 | 1 |
|
| Cefalexin Sandoz | 20 | 1 |
|
| Cephalexin AN | 20 | 1 |
|
| Ibilex 250 | 20 | 1 |
|
| Keflex | 20 | 1 |
| Capsule 500 mg (as monohydrate) | APO-Cephalexin | 20 | 1 |
|
| Cefalexin Sandoz | 20 | 1 |
|
| Cephalex 500 | 20 | 1 |
|
| Cephalexin AN | 20 | 1 |
|
| Cephalexin generichealth | 20 | 1 |
|
| Ibilex 500 | 20 | 1 |
|
| Keflex | 20 | 1 |
Roxithromycin | Tablet for oral suspension 50 mg | Rulide D | 10 | 1 |
| Tablet 150 mg | APO-Roxithromycin | 10 | 1 |
|
| Biaxsig | 10 | 1 |
|
| Chem mart Roxithromycin | 10 | 1 |
|
| Roxar 150 | 10 | 1 |
|
| Roximycin | 10 | 1 |
|
| Roxithromycin AN | 10 | 1 |
|
| Roxithromycin Sandoz | 10 | 1 |
|
| Roxithromycin-GA | 10 | 1 |
|
| Rulide | 10 | 1 |
|
| Terry White Chemists Roxithromycin | 10 | 1 |
| Tablet 300 mg | APO-Roxithromycin | 5 | 1 |
|
| Biaxsig | 5 | 1 |
|
| Chem mart Roxithromycin | 5 | 1 |
|
| Roxar 300 | 5 | 1 |
|
| Roximycin | 5 | 1 |
|
| Roxithromycin AN | 5 | 1 |
|
| Roxithromycin Sandoz | 5 | 1 |
|
| Roxithromycin-GA | 5 | 1 |
|
| Rulide | 5 | 1 |
|
| Terry White Chemists Roxithromycin | 5 | 1 |
Addition of Pack Quantity
Listed Drug | Form | Brand Name | Pack Quantity |
Lenalidomide | Capsule 5 mg | Revlimid | 28 |
| Capsule 10 mg | Revlimid | 28 |
| Capsule 15 mg | Revlimid | 28 |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Amoxicillin |
Amoxicillin with clavulanic acid |
Atezolizumab |
Bortezomib |
Botulinum toxin type A purified neurotoxin complex |
Brivaracetam |
Cefalexin |
Glecaprevir with pibrentasvir |
Guselkumab |
Peginterferon alfa-2a |
Pertuzumab |
Rituximab |
Sofosbuvir with velpatasvir and voxilaprevir |
Tolvaptan |
Trastuzumab |
Trastuzumab emtansine |
Trifluridine with tipiracil |
Document/s incorporated by reference
Listed Drug/s | Document incorporated | Document access |
Botulinum toxin type A purified neurotoxin complex | The Modified Ashworth Scale (MAS). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The MAS measures spasticity in patients with lesions of the Central Nervous System. | The MAS is available for download for free from the Shirley Ryan Ability Lab website: https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3)
(PB 20 of 2020)
This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 3) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
Schedule 1 to this Instrument provides for additions and deletions of drugs, additions and deletions of forms, additions and deletions of brands, alterations of responsible person codes for a number of brands of pharmaceutical benefits, additions of responsible persons to the list of responsible persons, alterations to the authorised prescribers for a number of brands of pharmaceutical benefits (including in some cases restricted to certain circumstances codes), deletions and alterations of maximum quantities and numbers of repeats, additions of pack quantities and alterations to circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.
Human rights implications
This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The pharmaceutical industry now has a nominee on the PBAC membership.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Thea Daniel
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health