EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 9)
PB 89 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 deletion of the listed drugs daclatasvir, danazol and dipyridamole from the PBS at the request of the pharmaceutical companies. The deletion of forms of the listed drugs dexamethasone and tenofovir with emtricitabine and efavirenz, and for the addition of forms of the listed drugs aflibercept and amino acid formula with vitamins and minerals without phenylalanine to the PBS. It also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs adalimumab, aflibercept, alectinib, apomorphine, brentuximab vedotin, buprenorphine, carfilzomib, cladribine, codeine, codeine with paracetamol, dexamethasone, fentanyl, guselkumab, hydromorphone, ibrutinib, inotuzumab ozogamicin, ipilimumab, lenvatinib, methadone, morphine, nivolumab, oxycodone, oxycodone with naloxone, palbociclib, pembrolizumab, ponatinib, ranibizumab, risperidone, tapentadol, tildrakizumab, tramadol, and venetoclax, and for the alteration of authority requirements for a circumstances codes applicable to the listed drug adalimumab.
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 24 brands and deletion of 8 brands of existing pharmaceutical items;
- the alteration of brand name for 3 existing brands of pharmaceutical items;
- the alteration of responsible person codes for 3 existing brands of pharmaceutical items; and
- the alteration of Section 100 only codes for 6 existing pharmaceutical items.
These changes are summarised, by subject matter, in the Attachment.
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 October 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. 9)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 9) and may also be cited as PB 89 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 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 the deletion of drugs, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of a number of brand names, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the alteration of Section 100 only codes for a number of pharmaceutical benefits, the alteration of authority requirements for a circumstances code applicable to a listed drug and the alteration of 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 Deleted
Listed Drug |
Daclatasvir |
Danazol |
Dipyridamole |
Forms Added
Listed Drug | Form |
Aflibercept | Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe |
Amino acid formula with vitamins and minerals without phenylalanine | Sachets containing oral powder 28 g, 30 (PKU Lophlex) |
Forms Deleted
Listed Drug | Form |
Dexamethasone | Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL |
Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL | |
Tenofovir with emtricitabine and efavirenz | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg |
Brands Added
Listed Drug | Form and Brand |
Buprenorphine | Transdermal patch 15 mg (Bupredermal) |
Transdermal patch 25 mg (Bupredermal) | |
Transdermal patch 30 mg (Bupredermal) | |
Transdermal patch 40 mg (Bupredermal) | |
Gefitinib | Tablet 250 mg (Cipla Gefitinib) |
Hydroxycarbamide | Capsule 500 mg (HYDROXYCARBAMIDE MEDSURGE) |
Icatibant | Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe (Cipla Icatibant) |
Levodopa with carbidopa and entacapone | Tablet 50 mg-12.5 mg (as monohydrate)-200 mg (Carlevent) |
Tablet 75 mg-18.75 mg (as monohydrate)-200 mg (Carlevent) | |
Tablet 100 mg-25 mg (as monohydrate)-200 mg (Carlevent) | |
Tablet 125 mg-31.25 mg (as monohydrate)-200 mg (Carlevent) | |
Tablet 150 mg-37.5 mg (as monohydrate)-200 mg (Carlevent) | |
Tablet 200 mg-50 mg (as monohydrate)-200 mg (Carlevent) | |
Naloxone | Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule (NALOXONE SXP) |
Olmesartan with amlodipine and hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg (Olmekar HCT 20/5/12.5) |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg (Olmekar HCT 40/5/12.5) | |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg (Olmekar HCT 40/5/25) | |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg (Olmekar HCT 40/10/12.5) | |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg (Olmekar HCT 40/10/25) | |
Ondansetron | Tablet (orally disintegrating) 4 mg (Zotren ODT) |
Tablet (orally disintegrating) 8 mg (Zotren ODT) | |
Rizatriptan | Tablet (orally disintegrating) 10 mg (as benzoate) (Rizatriptan-AU) |
Tadalafil | Tablet 20 mg (Tadalca) |
Terbinafine | Tablet 250 mg (as hydrochloride) (NOUMED TERBINAFINE) |
Brands Deleted
Listed Drug | Form and Brand |
Acarbose | Tablet 50 mg (Glucobay 50) |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol (Dronalen Plus) |
Dipyridamole with aspirin | Capsule 200 mg (sustained release)-25 mg (Asasantin SR) |
Icatibant | Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe (Firazyr) |
Mirtazapine | Tablet 45 mg (orally disintegrating) (Remeron SolTab) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin generichealth) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranitidine GH) |
Tablet 300 mg (as hydrochloride) (Ranitidine GH) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Morphine | Injection containing morphine sulfate pentahydrate 10 mg in 1 mL | From: DBL Morphine Pentahydrate |
Injection containing morphine sulfate pentahydrate 15 mg in 1 mL | From: DBL Morphine Pentahydrate | |
Injection containing morphine sulfate pentahydrate 30 mg in 1 mL | From: DBL Morphine Pentahydrate |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Disopyramide | Capsule 100 mg | Rythmodan | From: SW |
Ponatinib | Tablet 15 mg (as hydrochloride) | Iclusig | From: TS |
Tablet 45 mg (as hydrochloride) | Iclusig | From: TS |
Alteration of Section 100 only category
Listed Drug | Form | Brand Name | Section 100 only |
Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL | Movapo | From: D(100) |
Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL | Movapo | From: D(100) | |
Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Apomine Solution for Infusion | From: D(100) | |
Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe | Movapo PFS | From: D(100) | |
Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen | Apomine Intermittent | From: D(100) | |
Movapo Pen | From: D(100) |
Alteration of Authority Requirements
Listed Drug | Circumstances Code | Authority Requirements (part of Circumstances; or Conditions) |
Adalimumab | C6963 | From: Compliance with Authority Required procedures |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Adalimumab |
Aflibercept |
Alectinib |
Apomorphine |
Brentuximab vedotin |
Buprenorphine |
Carfilzomib |
Cladribine |
Codeine |
Codeine with paracetamol |
Dexamethasone |
Fentanyl |
Guselkumab |
Hydromorphone |
Ibrutinib |
Inotuzumab ozogamicin |
Ipilimumab |
Lenvatinib |
Methadone |
Morphine |
Nivolumab |
Oxycodone |
Oxycodone with naloxone |
Palbociclib |
Pembrolizumab |
Ponatinib |
Ranibizumab |
Risperidone |
Tapentadol |
Tildrakizumab |
Tramadol |
Venetoclax |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Adalimumab | Hurley stages. 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. Hurley stages are used to classify the severity of Hidradenitis Suppurativa symptoms. | A description of the Hurley stages is available for download for free from https://www.racgp.org.au/afp/2017/august/hidradenitis-suppurativa-management-comorbidities-and-monitoring/ |
Guselkumab Tildrakizumab | Psoriasis Area Severity Index (PASI). 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 PASI is a widely used tool that enables measurement of the severity and extent of baseline and response of therapy in psoriasis. | The PASI calculation form is available for download for free from the Services Australia website: https://www.servicesaustralia.gov.au/ and forms part of the SA authority application process. |
Palbociclib | The Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. 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 RECIST guidelines are a tool used widely for defining when tumours in cancer patients respond, stabilise and/or progress during treatment. | The RECIST guidelines are available for download for free from the RECIST Working Group website: https://recist.eortc.org/ |
Guselkumab Tildrakizumab | Therapeutic Goods Administration (TGA)‑approved Product Information. 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. This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine. | TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0 |
Pembrolizumab | World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status. 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 WHO/ECOG performance status is a standard medical diagnostic tool used to measure how cancer impacts a patient’s daily living abilities, by evaluating a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). | The WHO/ECOG Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group website: https://ecog-acrin.org/resources/ecog-performance-status |
Diagnostic tools referenced in the Instrument
The following standard medical diagnostic tools are referenced in the Instrument but are not intended to incorporate a document by reference.
Listed Drug | Diagnostic tool | Purpose and use in the Instrument | Reason why this reference does not serve to incorporate a document |
Aflibercept Dexamethasone Ranibizumab | Early treatment diabetic retinopathy study chart (ETDRSC) and Snellen chart | The ETDRSC and Snellen chart are eye charts that are routinely used in clinical practice to measure visual acuity. | Measurement of visual acuity using the ETDRSC and/or Snellen chart is a process for obtaining physiological measurements and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. It is part of the standard diagnostic work-up for macular oedema. |
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. 9)
(PB 89 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. 9) 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).
The amendments in Schedule 1 involve the deletion of drugs, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of a number of brand names, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the alteration of Section 100 only codes for a number of pharmaceutical benefits, the alteration of authority requirements for a circumstances code applicable to a listed drug and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefit0s 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 Connolly
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health