EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2022 (No. 10)
PB 85 of 2022
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
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.
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.
Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including medical practitioners (subsection 88(1)), participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.
This legislative instrument is made pursuant to section 88 and subsection 100(2) of the National Health Act 1953 (the Act).
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 decitabine with cedazuridine, mecasermin, somatrogon, and trientine and forms of the listed drugs ethosuximide, fremanezumab, and tenecteplase to the Schedule of Pharmaceutical Benefits. It also provides for the deletion of forms of the listed drug chorionic gonadotrophin and for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs avelumab, brolucizumab, enzalutamide, nivolumab, ofatumumab, pembrolizumab, upadacitinib, and ustekinumab.
Schedule 1 to this Instrument also provides for the following changes:
· the addition of 17 brands of existing pharmaceutical items;
· the deletion of 7 brands of existing pharmaceutical items;
· the alteration of responsible persons code for 1 existing brand of pharmaceutical item; and
· the deletion of 14 pharmaceutical items covered under Supply Only arrangements.
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 2022.
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 2022 (No. 10)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 10) and may also be cited as PB 85 of 2022.
Section 2 Commencement
Subsection 2(1) provides for commencement dates of each of the provisions specified in Column 1 of the table, in accordance with Column 2 of the table. In accordance with Column 2 of the table, Schedule 1 to the Instrument commences on 1 October 2022.
Section 3 Authority
This section specifies that sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 provide the authority for the making of this Instrument.
Section 4 Schedules
Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of listed drugs, the addition and deletion of forms of listed drugs, the addition and deletion of brands, the alteration of responsible person code for a brand of pharmaceutical benefit, the deletion of benefits covered under Supply Only arrangements, 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 SCHEDULE 1 OF THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Decitabine with cedazuridine |
Mecasermin |
Somatrogon |
Trientine |
Forms Added
Listed Drug | Form |
Ethosuximide | Capsule 250 mg (s19A) |
Fremanezumab | Solution for injection 225 mg in 1.5 mL single dose pre-filled pen |
Tenecteplase | Powder for injection 50 mg with solvent (s19A) |
Forms Deleted
Listed Drug | Form |
Chorionic gonadotrophin | Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 |
Powder for injection 5,000 units with solvent |
Brands Added
Listed Drug | Form and Brand |
Bortezomib | Solution for injection 2.5 mg in 1 mL (Bortezomib Accord) |
Solution for injection 3.5 mg in 1.4 mL (Bortezomib Accord) |
Fenofibrate | Tablet 48 mg (Fenofibrate Viatris) |
Tablet 145 mg (Fenofibrate Viatris) |
Lurasidone | Tablet containing lurasidone hydrochloride 40 mg (Lavione) |
Tablet containing lurasidone hydrochloride 80 mg (Lavione) |
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g (Momasone Alcohol Free) |
Moxonidine | Tablet 200 micrograms (Moxonidine Viatris) |
Plerixafor | Injection 24 mg in 1.2 mL (Plerixafor ARX) |
Pomalidomide | Capsule 3 mg (Pomolide; Pomalidomide Sandoz) |
Capsule 4 mg (Pomolide; Pomalidomide Sandoz) |
Pregabalin | Capsule 25 mg (NOUMED PREGABALIN) |
Capsule 75 mg (NOUMED PREGABALIN) |
Capsule 150 mg (NOUMED PREGABALIN) |
Capsule 300 mg (NOUMED PREGABALIN) |
Brands Deleted
Listed Drug | Form and Brand |
Atorvastatin | Tablet 10 mg (as calcium) (ATOMED) |
Tablet 20 mg (as calcium) (ATOMED) |
Tablet 40 mg (as calcium) (ATOMED) |
Tablet 80 mg (as calcium) (ATOMED) |
Cabazitaxel | Concentrated injection 60 mg in 1.5 mL, with diluent (Jevtana) |
Metronidazole | Tablet 200 mg (Metronide 200) |
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g (Momasone) |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Domperidone | Tablet 10 mg | Motilium | From: JC | To: JT |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Avelumab | Ofatumumab |
Brolucizumab | Pembrolizumab |
Enzalutamide | Upadacitinib |
Nivolumab | Ustekinumab |
Supply Only – Deletions
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) (ReddyMax Plus D‑Cal) |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Sachets containing oral powder 34 g, 30 (TYR express 20) (TYR express 20) |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Sachets containing oral powder 34 g, 30 (MSUD express 20) (MSUD express 20) |
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 (restore O.R.S.) |
Enfuvirtide | Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs) (Fuzeon) |
Nifedipine | Tablet 10 mg (Adefin 10) |
| Tablet 20 mg (Adefin 20) |
Rituximab | Solution for I.V. infusion 100 mg in 10 mL (Riximyo; Ruxience; Truxima) |
| Solution for I.V. infusion 500 mg in 50 mL (Riximyo; Ruxience; Truxima) |
Terbutaline | Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses (Bricanyl Turbuhaler) |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Nivolumab Somatrogon | Approved Product Information/Australian Product Information/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. | Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0 |
Decitabine with cedazuridine | International Prognostic Scoring System (IPSS). 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 IPSS is a medical diagnostic tool used to help assess the severity of myelodysplastic syndrome, through the evaluation of the proportion of blast cells in a patient's bonemarrow, the type of chromosomal changes (if any) in the marrow cells, and the presence of one or more low blood cell counts (cytopenias). | The International Prognostic Scoring System (IPSS) is available for download for free from the Blood Journal website: https://ashpublications.org/blood Blood (1997) 89 (6): 2079–2088. |
Mecasermin | Laron syndrome growth charts. 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. These growth charts assist clinicians to determine if a child’s growth is consistent with a diagnosis of primary, hereditary insulin-like growth factor-I (IGF-I) deficiency (Laron syndrome). | The Laron syndrome growth charts appear in the following publication: Laron Z, Lilos P, Klinger B. Growth Curves for Laron syndrome. Arch Dis Child. 1993;68(6):768-770 The literature article can be accessed free of charge from the National Center for Biotechnology Information website: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029371/ |
Mecasermin Somatrogon | The Centers for Disease Control and Prevention (US) Clinical Growth Charts 2000 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. Growth charts (length-for-age and stature-for-age) consist of a series of percentile curves that illustrate the distribution of length/height in children. They are used to track the growth of infants, children, and adolescents. These are tools that contribute to forming an overall clinical impression for the child being measured. | The relevant CDC Clinical Growth Charts (length-for-age and stature-for-age) can be viewed, printed and reproduced via Adobe Acrobat for free from the U.S Department of Health & Human Services website: https://www.cdc.gov/growthcharts/clinical_charts.htm |
Avelumab Enzalutamide Nivolumab 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 |
Decitabine with cedazuridine | World Health Organization (WHO) classification of tumours of haematopoietic and lymphoid tissues. 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 classification of tumours of haematopoietic and lymphoid tissues is a pathologic classification system for hematolymphoid neoplasms which is used as an international standard for oncologists and pathologists in determining diagnostic criteria, pathological features, and associated genetic alterations. | The WHO classification of tumours of haematopoietic and lymphoid tissues is available for download for free from the Radiopaedia website: https://radiopaedia.org/articles/who-classification-of-tumours-of-haematopoietic-and-lymphoid-tissues-1?lang=gb |
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 2022 (No. 10)
(PB 85 of 2022)
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 2022 (No. 10) (the Instrument) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 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).
Human rights implications
The Instrument engages Articles 9 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), specifically the rights to social security and health.
The Right to Social Security
The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The UN Committee on Economic Social and Cultural Rights reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The Committee has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
Analysis
The Instrument advances the right to health and the right to social security by providing new drugs, and new forms and brands of existing listed drugs, and ensuring the deletion of forms and brands of listed drugs does not affect access to PBS medicines. 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 Instrument includes the addition of four new drugs, three new forms across three existing drugs and the addition of 17 new brands across 15 existing forms, which allows for greater patient access to these drugs.
When a sponsor submits a request to delist a drug from the PBS, subsection 101(4AAB) of the National Health Act 1953 requires that the Minister or their delegate obtain advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent and expert advisory body, before varying or revoking declarations under subsection 85(2) so as to delist the drug. In these instances, one of the matters which the PBAC provides advice on is whether the delisting of a drug will result in an unmet clinical need for patients. The PBAC also considers whether the delisting of a form of a drug will result in an unmet clinical need for patients.
Written advice from the PBAC is tabled with the monthly amendments to the Principal Instrument. An unmet clinical need would arise when a currently treated patient population would be left without treatment options once a delisting occurs. Alternative treatment options could include using a different: form, strength or drug. The PBAC considered the delisting of drugs and forms of drugs in the abovementioned instruments, would not result in an unmet clinical need. The delisting of these items will not affect access to the drugs, as affected patients will be able to access alternative medicines through the PBS, and the delisting is unlikely to have an effect on the amount patients pay for those drugs, as co-payment amounts are capped, ensuring their rights to social security are maintained. From 1 January 2022, these fees are up to $42.50 for general patients and up to $6.80 for concession card holders.
Where there are many brands of a listed drug and form, then the delisting of one brand will not adversely affect members of the public as they will be able to obtain any of the other equivalent brands. The delisting of brands in this Instrument will not affect access to the drugs, as affected patients will be able to access equivalent brands, at the same cost. Consequently, the brand delistings in this instrument do not result in an unmet clinical need. Note that delisting of maximum quantities, number of repeats, and pack sizes are equivalent to brand delistings.
The drug chorionic gonadotrophin (Pregnyl®), in the forms injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 and powder for injection 5,000 units with solvent, were requested to be delisted from the PBS by the sponsor due to the discontinuation of the product from manufacture. The PBAC advised that the delisting of human chorionic gonadotrophin would result in an unmet clinical need; however the sponsor confirmed the product has been discontinued and that retention on the PBS was not possible. The Department of Health and Aged Care (Department) and the PBAC sought alternative arrangements for the populations affected by this delisting.
The drug enfuvirtide (Fuzeon®) was requested to be delisted from the PBS by the sponsor due to it being discontinued from manufacture. The PBAC noted the low rate of utilisation and that there were clinical alternatives available. The PBAC advised that the delisting of enfuvirtide would not result in an unmet clinical need.
The drug nifedipine in the forms tablet 10 mg (Adefin® 10) and tablet 20 mg (Adefin® 20) were requested to be delisted from the PBS by the sponsor due to its intention to discontinue supply of the products in Australia. The PBAC advised that the delisting of both forms from the PBS may result in an unmet clinical need. The Department contacted the sponsor and sought to retain the product in line with this advice, however the sponsor indicated retention was not possible due to the product being discontinued from manufacture and that it wished to proceed with the delisting.
The drug terbutaline in the form powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses (Bricanyl® Turbuhaler®) was requested to be delisted from the PBS by the sponsor due to the availability of a new form of Bricanyl® Turbuhaler® which was PBS listed on 1 February 2021. The PBAC noted the sponsor had listed a new terbutaline dosage form to replace the Turbuhaler® and therefore advised that the delisting would not result in an unmet clinical need.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Nikolai Tsyganov
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care