EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 1)
PB 4 of 2021
Authority
Subsection 100(1) of the National Health Act 1953 (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).
Purpose
This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No.1) (this Instrument). The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs 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 provides for the addition of brands of the listed drugs bosentan and sildenafil to the Special Arrangement, the addition of two responsible persons to the list of responsible persons and the alteration of responsible person codes for two existing brands of pharmaceutical benefits. It also provides for the alteration of the name of two brands of existing pharmaceutical benefits and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs ambrisentan, bosentan, eltrombopag, macitentan, romiplostim, sildenafil and tadalafil.
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 had already taken place in the decision to list the medication.
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 February 2021.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 1)
Section 1 Name of Instrument
This section provides the name of this Instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No. 1) and may also be cited as
PB 4 of 2021.
Section 2 Commencement
This section provides that this Instrument commences on 1 February 2021.
Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of brands, the alteration of responsible person codes for brands of pharmaceutical benefits, the alteration of brand names of pharmaceutical benefits, the addition of responsible person codes to the list of responsible persons and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT 2010 MADE BY THIS INSTRUMENT
Brands Added
Listed Drug | Form and Brand |
Bosentan | Tablet 62.5 mg (as monohydrate) (Bosentan Cipla) |
Tablet 125 mg (as monohydrate) (Bosentan Cipla) | |
Sildenafil | Tablet 20 mg (as citrate) (Sildenafil PHT APOTEX) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Bosentan | Tablet 62.5 mg (as monohydrate) | From: BOSENTAN DR. REDDY'S |
| Tablet 125 mg (as monohydrate) | From: BOSENTAN DR. REDDY'S |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Ambrisentan | Tablet 5 mg | Volibris | From: GK |
| Tablet 10 mg | Volibris | From: GK |
Addition of Responsible Person Code
Responsible Person and Code |
Apotex Pty Ltd (TY) |
Seekwell Pty Ltd (ZE) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
|
Ambrisentan |
|
Bosentan |
|
Eltrombopag |
|
Macitentan |
|
Romiplostim |
|
Sidenafil |
|
Tadalafil |
|
Document/s incorporated by reference
Listed Drug | Document incorporated | Document access |
Ambrisentan Bosentan Macitentan Selexipag Sildenafil Tadalafil | WHO Functional Classes for pulmonary arterial hypertension (PAH). 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 Functional Class system for PAH is used to define the severity of PAH symptoms and the impact they have on a patient’s day-to-day activities. | The WHO Functional Class system for PAH is available for download for free from the Pulmonary Hypertension Association Australia website: https://www.phaaustralia.com/page/11/classification-of-pulmonary-hypertension |
Ambrisentan Bosentan Macitentan Sildenafil Tadalafil | 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 |
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 this reference does not serve to incorporate a document |
Ambrisentan Bosentan Macitentan Sildenafil Tadalafil | Right heart catherisation (RHC) composite assessment | RHC is a diagnostic procedure used to measure pulmonary artery pressures and thus evaluate whether a patient has pulmonary hypertension or not, and sometimes what is causing the pulmonary hypertension. RHC composite assessment is a range of haemodynamic assessment comprising the measurement of cardiac output, mixed venous oxygen saturation, mean pulmonary arterial pressure, pulmonary artery wedge pressure, right atrial pressure and right ventricular pressure. Measurement must be reported on as part of the authority application for a number of PBS listed drugs. | The RHC composite assessment is part of the standard diagnostic work-up for Pulmonary Arterial Hypertension and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. |
Ambrisentan Bosentan Macitentan Sildenafil Tadalafil | Echocardiography (ECHO) composite assessment | ECHO is an ultrasound of the heart used to estimate the pulmonary artery pressures using mathematical equations and thus evaluate whether a patient has pulmonary hypertension. ECHO composite assessment is a range of haemodynamic assessment comprising the measurement of pulmonary artery systolic pressure, right ventricular systolic pressure, right atrial pressure. Measurement must be reported on as part of the authority application for a number of PBS listed drugs. | The ECHO composite assessment is part of the standard diagnostic work-up for Pulmonary Arterial Hypertension and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. |
Ambrisentan Bosentan Macitentan Sildenafil Tadalafil | Six Minute Walk Test (6MWT) | The 6MWT is an assessment of performance ability in a variety of cardiopulmonary disease. It provides important functional information that is not captured in standardized pulmonary function testing. Measurement must be reported on as part of the authority application for a number of PBS listed drugs. | The 6MWT 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. The 6MWT is part of the standard diagnostic work-up for Pulmonary Arterial Hypertension. |
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 Instrument 2021 (No. 1)
(PB 4 of 2021)
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 2010 (PB 116 of 2010) (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.
The amendments in Schedule 1 involve the addition of brands, the alteration of responsible person codes for brands of pharmaceutical benefits, the alteration of brand names of pharmaceutical benefits, the addition of responsible person codes to the list of responsible persons and the alteration of circumstances for prescribing various pharmaceutical benefits available under the Special Arrangement.
Human Rights Implications
This Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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 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 PBS are evidence-based.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Ben Sladic
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health