National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2022

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (MARCH UPDATE) INSTRUMENT 2022

PB 14 of 2022

Purpose

This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2022 (PB 14 of 2022) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) Program.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Schedule 1 to this Instrument limits the application of subsection 8(3) and section 23 of the Special Arrangement, which relate to the listed drug eculizumab, to circumstances in which eculizumab is prescribed for the treatment of atypical Haemolytic Uraemic Syndrome (aHUS).  Prior to
1 March 2022, eculizumab could only be prescribed under the Special Arrangement for the treatment of aHUS and therefore the above provisions implicitly applied only to the prescribing of eculizumab for the treatment of aHUS.  In making this limitation explicit, these amendments clarify that the above provisions do not apply to circumstances in which eculizumab may, from 1 March 2022, be prescribed for the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH) (consistent with standard HSD Program parameters). 

Schedule 1 to this Instrument also provides for the addition of the listed drug ravulizumab, the addition of a form for the listed drug etanercept, and the addition of two maximum quantities and number of repeats for the listed drug methoxsalen to the Special Arrangement.  Additionally, it  provides for the deletion of a brand of the listed drugs entecavir, sildenafil, and valaciclovir, and the alteration of circumstances in which a prescription may be written for the supply of the listed drug eculizumab under the Special Arrangement. 

These changes are summarised, by subject matter, in the Attachment.

Authority

Subsection 100(1) of the Act enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.

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 as pharmaceutical benefits.  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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  In addition, an industry nominee has been appointed to the PBAC membership.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (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 were consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that has already taken place in the decision to list the medications outlined under ‘Purpose’.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 March 2022.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT

DETAILS OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (MARCH UPDATE) INSTRUMENT 2022

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2022 and may also be cited as PB 14 of 2022.

Section 2 Commencement

This section provides that this Instrument commences on 1 March 2022.

Section 3 Authority

This section states that this instrument is made under subsection 100(2) of the National Health Act 1953.

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

Item 1 – Section 6

Item 1 amends the definition for “CAR drugs” to add the drug ravulizumab to the list of Complex Authority Required drugs and re-order the list of CAR drugs alphabetically.

Item 2 – Subsection 8(3)

Item 2 amends subsection 8(3) to limit the definition of an eligible patient for an HSD pharmaceutical benefit that contains eculizumab, in circumstances where the person is receiving medical treatment as an admitted patient (inpatient) of a public hospital, to only apply for the treatment of atypical Haemolytic Uraemic Syndrome (aHUS).  This is due to a new listing of eculizumab for the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH), which does not permit an eligible patient to be receiving treatment as an admitted patient (inpatient) of a public hospital.  Item 1 also amends subsection 8(3) to fix a grammatical error by adding the word “and” at the end of paragraph 8(3)(b).

Items 3 and 4 – Section 23

Items 3 and 4 amend section 23 to limit the record keeping requirements for prescriptions for HSD pharmaceutical benefits that contain eculizumab to only apply for the treatment of aHUS.  This is due to a new listing of eculizumab for the treatment of PNH, which does not require the approved hospital authority or the authorised prescriber (whichever applies) to keep a copy of any clinical records relating to the prescription of a pharmaceutical benefit that contains eculizumab for a period of two years.

Items 5 to 17 – Schedules 1, 2 and 3

Items 5 to 17 involve the addition of a listed drug, the addition of a form of a listed drug, the addition of two maximum quantities and number of repeats for a listed drug, the deletion of brands of listed drugs, and the alteration of circumstances for prescribing a listed drug available under the Special Arrangement. These changes are summarised below.

SUMMARY OF CHANGES TO THE HIGHLY SPECIALISED
DRUGS PROGRAM MADE BY THIS INSTRUMENT

Listed Drugs Added

Forms Added

Brands Deleted

Addition of Maximum Quantity and Number of Repeats

Alteration of Circumstances in Which a Prescription May be Written

Documents Incorporated by Reference

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Highly Specialised Drugs Program)
Special Arrangement Amendment (March Update) Instrument 2022

(PB 14 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 purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs Program.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.

Human Rights Implications

This 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 UN Committee on Economic Social and Cultural Rights (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 a new drug, a new form of a drug, and new circumstances  in which two listed drugs may be prescribed (relating to the condition Paroxysmal Nocturnal Haemoglobinuria or PNH in the case of the listed drug eculizumab). The PBS is a benefit scheme which assists with advancement of these human rights 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.

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. PBAC also considers whether the delisting of a form of a drug will result in an unmet clinical need for patients.

Written advice from PBAC is tabled with the monthly amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). 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 the form 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.  

If 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 deletion 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.

Conclusion

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

David Laffan

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health