National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 3)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2023 (No. 3)

PB 21 of 2023

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 for the purposes of the Pharmaceutical Benefits Scheme (PBS), and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the Schedule of Pharmaceutical Benefits (the PBS Schedule) 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 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 deletion of the listed drugs apraclonidine, and interferon beta-1a, and the deletion of forms of the listed drugs etanercept, ethosuximide, oxybutynin, testosterone, and tocilizumab from the PBS Schedule. It also provides for the alteration of circumstances in which prescriptions may be written for the supply of the listed drugs abacavir, calcitonin salmon, fluticasone propionate, lacosamide, methyldopa, nirmatrelvir and ritonavir, nivolumab, oxycodone, ruxolitinib, and sapropterin.

Schedule 1 to this Instrument also provides for the following changes:

•              the addition of 25 brands of existing pharmaceutical items;
•              the deletion of 19 brands of existing pharmaceutical items;
•              the addition of a maximum quantity and number of repeats for 2 existing pharmaceutical items;
•              the addition of 2 pack quantities for existing pharmaceutical items;
•              the deletion of 6 pack quantities of existing pharmaceutical items;
•              the alteration of 1 responsible person name on the list of responsible persons;
•              the addition of 1 responsible person to the list of responsible persons;
•              the addition of 12 pharmaceutical items covered under Supply Only arrangements; and
•              the deletion of 3 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 April 2023.

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 2023 (No. 3)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 3) and may also be cited as PB 21 of 2023.

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 April 2023.

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 deletion of listed drugs, deletion of forms of listed drugs, the addition and deletion of brands, the addition of a maximum quantity and number of repeats for a brand of pharmaceutical benefit, the addition and deletion of pack quantities for brands of pharmaceutical benefits, the alteration of a responsible person name, the addition of a responsible person to the list of responsible persons, the addition and 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

Drugs Deleted

Forms Deleted

Brands Added

Brands Deleted

Addition of Maximum Quantity and Number of Repeats

Addition of Pack Quantity

Deletion of Pack Quantity

Alteration of Responsible Person Name

Addition of Responsible Person

Alteration of Circumstances in Which a Prescription May be Written

Supply Only – Additions

Note: Supply Only benefits are available on the Schedule for dispensing only, for a period of up to 12 months.

Supply Only – Deletions

Documents Incorporated by Reference

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.

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 2023 (No. 3)

(PB 21 of 2023)

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 2023 (No. 3) (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 listed on the Schedule of Pharmaceutical Benefits (the Schedule) 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 brands of existing listed drugs, and ensuring the deletion of listed drugs, forms of listed drugs and brands of listed drugs does not affect access to subsidised medicines. The Pharmaceutical Benefits Scheme (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 Schedule are evidence-based. The Instrument includes the addition of 25 new brands across 24 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, except where indicated for a particular drug or form of drug below. Where the PBAC has identified an unmet clinical need, a Supply Only period has been/will be instituted as outlined below to allow opportunity for patients to transition to an alternative treatment option. The delisting of these items will not affect access to the drugs (or an alternative treatment if required), 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 2023, these amounts are $30.00 for general patients and $7.30 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 ampicillin in the form powder for injection 500 mg (as sodium) (Austrapen) was requested to be delisted from the PBS by the sponsor. The PBAC advised that the delisting of this product may result in an unmet clinical need. The Department sought to retain the product in line with this advice, however the sponsor indicated retention is unviable due to discontinuation from the market and wished to proceed with the delisting. This item will be available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.

The drug apraclonidine in the form eye drops 5 mg (as hydrochloride) per mL, 10 mL (Iopidine 0.5%) was requested to be delisted from the PBS by the sponsor. The PBAC advised that the delisting of this product will not result in an unmet clinical need as alternate agents are available.

The drug cromoglycic acid in the form pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation) (Intal Forte CFC-Free) was requested to be delisted from the PBS by the sponsor due to the discontinuation of the product from 10 February 2022. The PBAC considered that there were several suitable clinical alternatives and advised the delisting of cromoglycic acid would not result in an unmet clinical need. This item was available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.

The drug etanercept in the form injection 50 mg in 1 mL single use dose-dispenser cartridges, 4 (Enbrel) was requested to be delisted from the PBS by the sponsor as a commercial decision. Alternative suitable products  remain listed on the PBS, therefore the delisting of this product will not result in an unmet clinical need.

The drug ethosuximide in the form capsule 250 mg (s19A) (Ethosuximide Essential Generics) was requested to be delisted from the PBS by the sponsor. This item was listed under section 19A of the Therapeutic Goods Act 1989 to address the shortage of ethosuximide in the form capsule 250 mg. The shortage has been resolved and temporary approval for importation and supply of a medicine not on the Australian Register of Therapeutic Goods has lapsed. Patient access has not been affected as the approved form of the drug is now available and remains PBS subsidised and accessible for patients.

The drug heparin in the form injection (preservative-free) 5,000 I.U. (as sodium) in 5 mL (Pfizer Australia Pty Ltd) was requested to be delisted from the PBS by the sponsor. The PBAC noted a lack of suitable clinical alternatives and advised that the delisting of this drug would result in an unmet clinical need. Following this advice, the Department contacted the sponsor to seek to maintain the listing of heparin in the 5 mL form on the PBS. The sponsor had requested the delist of the 0.2 mL and 5 mL forms, before making a final decision to progress the delisting of the 5 mL form (only) of heparin from the PBS. This item was available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.  The sponsor will continue to supply heparin in the 0.2 mL form, which remain available and be subject to 6 months minimum stockholding requirements from 1 July 2023.

The drug hydromorphone in the forms tablet (modified release) containing hydromorphone hydrochloride 4 mg (Jurnista), tablet (modified release) containing hydromorphone hydrochloride 8 mg (Jurnista), tablet (modified release) containing hydromorphone hydrochloride 16 mg (Jurnista), tablet (modified release) containing hydromorphone hydrochloride 32 mg (Jurnista), and tablet (modified release) containing hydromorphone hydrochloride 64 mg (Jurnista) was requested to be delisted from the PBS by the sponsor. The PBAC advised the delisting of these products may result in an unmet clinical need. The Department sought to retain these products on the PBS in line with this advice, however the sponsor advised they wished to proceed with the delisting as the products were being discontinued from manufacture. These items will be available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access these items pending transition to an alternative treatment option.

The drug insulin aspart in the forms injection (human analogue) (fast acting) 100 units per mL, 10 mL vial (Fiasp), and injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5 (Fiasp FlexTouch) was requested to be delisted from the PBS by the sponsor. These items will be available on the Schedule under Supply Only arrangements for a period of up to six months, allowing patients with a pre‑existing valid prescription to access these items pending transition to an alternative treatment option.

The drug interferon beta-1a in the form injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre-filled syringe (Avonex) was requested to be delisted from the PBS by the sponsor. The PBAC considered that while there may be a group of patients who have likely been treated with interferon beta-1a for over 10 years, all patients will be able to switch to interferon beta-1b. The PBAC therefore advised that the delisting of this product will not result in an unmet clinical need.

The drug interferon beta-1a in the forms injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector (Rebif 44), injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe (Rebif 44), and solution for injection 132 micrograms in 1.5 mL multidose cartridge (Rebif 44), was requested to be delisted from the PBS by the sponsor. The PBAC considered that while there may be a group of patients who have likely been treated with interferon beta-1a for over 10 years, all patients will be able to switch to interferon beta-1b. The PBAC therefore advised that the delisting of this product will not result in an unmet clinical need. These items were available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access these items pending transition to an alternative treatment option.

The drug nicotine in the forms gum 2 mg (nicotinell), gum 4 mg (nicotinell), lozenge 2 mg (nicotinell), and lozenge 4 mg (nicotinell) was requested to be delisted from the PBS by the sponsor. The PBAC noted that there are no suitable alternatives on the PBS as these are acute dosing forms of nicotine and advised the delisting of these products may result in an unmet clinical need. The Department sought to retain the product in line with this advice, however the sponsor chose to proceed with the delisting. These items will be available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access these items pending transition to an alternative treatment option.

The drug oxybutynin in the forms tablet containing oxybutynin chloride 5 mg (s19A) (Oxybutynin Chloride (Novitium)), and tablet containing oxybutynin hydrochloride 5 mg (s19A) (Oxybutynin hydrochloride tablets (Niche Generics Limited)) was requested to be delisted from the PBS by the sponsor. These items were listed under section 19A of the Therapeutic Goods Act 1989 to address the shortage of oxybutynin in the form tablet containing oxybutynin hydrochloride 5 mg. The shortage has been resolved and temporary approval for importation and supply of a medicine not on the Australian Register of Therapeutic Goods has lapsed. Patient access has not been affected as the approved form of the drug is now available and remains PBS subsidised and accessible for patients.

The drug pancreatic extract in the form capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity (Creon 40,000) was requested to be delisted from the PBS by the sponsor. The PBAC noted other strengths of this drug would remain listed, the low utilisation of the item in the last financial year and available alternatives. The PBAC advised the delisting of this product would not result in an unmet clinical need. This item was available on the Schedule under Supply Only arrangements for a period of up to 12 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.

The drug testosterone in the form transdermal patches 24.3 mg, 30 (Androderm) was requested to be delisted from the PBS by the sponsor. The PBAC advised that the delisting of this patch would not result in an unmet clinical need given that there are suitable PBS listed alternatives.

The drug tocilizumab in the forms concentrate for injection 80 mg in 4 mL (s19A) (RoActemra), concentrate for injection 200 mg in 10 mL (s19A) (RoActemra), and concentrate for injection 400 mg in 20 mL (s19A) (RoActemra) was requested to be delisted from the PBS by the sponsor. These items were listed under section 19A of the Therapeutic Goods Act 1989 to address the shortage of tocilizumab in the forms concentrate for injection 80 mg in 4 mL, concentrate for injection 200 mg in 10 mL, and concentrate for injection 400 mg in 20 mL. The shortage has been resolved and temporary approval for importation and supply of a medicine not on the Australian Register of Therapeutic Goods has lapsed. Patient access has not been affected as the approved form of the drug is now available and remains PBS subsidised and accessible for patients.

Conclusion

This Instrument is compatible with human rights because it advances the protection of human rights.

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care