EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)SPECIAL ARRANGEMENT AMENDMENT (APRIL UPDATE) INSTRUMENT 2026
PB 35 of 2026
Purpose
This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (April Update) Instrument 2026 (PB 35 of 2026) (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 2024 (PB 26 of 2024), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), and amendments to that instrument, are made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument amends the Special Arrangement for edaravone to be available under HSD Community Access arrangements for both initial and continuing treatment.
Schedule 1 also provides for the addition of the drug zilucoplan, the addition of a form of the listed drug risdiplam, the addition of a brand of the listed drug sildenafil, the deletion of brands of the listed drugs pomalidomide and tenofovir, and the alteration of circumstances in which a prescription may be written for the listed drugs abatacept, ambrisentan, anifrolumab, avatrombopag, benralizumab, bosentan, dupilumab, edaravone, eltrombopag, epoprostenol, iloprost, infliximab, macitentan, mepolizumab, onasemnogene abeparvovec, ravulizumab, riociguat, risdiplam, romiplostim, sildenafil, teduglutide, and tocilizumab under the Special Arrangement. These changes are summarised, by subject matter, in the Attachment.
Authority
Subsection 100(1) of the Act enables the Minister, by legislative instrument, to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may, by legislative instrument, 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).
Background for edaravone amendment
The Special Arrangement is being amended upon a recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to include initial treatment with edaravone for the treatment of amyotrophic lateral sclerosis (ALS). Access to initial treatment with edaravone previously occurred through prescriptions written by a specialist affiliated with a public or private hospital under the HSD Program. Edaravone for both initial and continuing treatment will now be available via the HSD Program Community Access arrangements. Enabling access to edaravone for initial and continuing treatment through the HSD Program Community Access arrangements means that any medical practitioner may prescribe edaravone for both initial and continuing treatment, including for patients receiving treatment in a community setting. Additionally, Community Access prescriptions written by medical practitioners for the initial and continuing treatment of patients receiving treatment in, at, or from a public or private hospital can be dispensed from any Pharmaceutical Benefits Scheme (PBS) Approved Supplier, including community pharmacies. This amendment will enable patients receiving edaravone for initial and continuing treatment to have a greater choice as to where they access their treatment, particularly those patients in rural and remote areas.
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 April 2026.
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 (APRIL UPDATE) INSTRUMENT 2026
Section 1 Name of Instrument
This section provides that the name of the Instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (April Update) Instrument 2026 and may also be cited as PB 35 of 2026.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2026.
Section 3 Authority
This section states that this Instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
This section 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 - Definition of CAR drug
This item amends the definition of CAR drug to add the drug zilucoplan to the list of drugs considered to be CAR drugs.
Item 2 - Definition of community access medication
This item amends the definition of community access medication in Section 6 paragraph (e) of the Special Arrangement to remove the limitation to continuing treatment for the drug edaravone. This will allow the drug edaravone to be prescribed as a community access medication for both initial and continuing treatment.
Item 3 - Definition of authorised prescriber
This item amends the definition of authorised prescriber in paragraph 7(4)(b) of the Special Arrangement. The effect of this amendment is to make a medical practitioner an authorised prescriber for HSD pharmaceutical benefits that have the drug edaravone, regardless of the form of the drug, for both the initial and continuing phase of the patient’s treatment.
The removal of “continuing treatment” in the amended definition of community access medication as it relates to edaravone, and in paragraph 7(4)(b) (as amended), will now allow patients to access edaravone via HSD Community Access arrangements for both the initial and continuing phases of treatment.
The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument) is separately being amended with effect from 1 April 2026 to add the initial treatment phase for treatment with edaravone as a circumstance for which the pharmaceutical benefits listed in Schedule 1 of the Special Arrangement as HSD pharmaceutical benefits can be prescribed under the PBS.
Items 4 to 106 - amendments to Schedules 1, 2 and 3
These items involve the addition of a drug, the addition of a form of a listed drug, the addition and deletion of brands of existing pharmaceutical benefits, and the alteration of circumstances in which a prescription may be written for various listed drugs available under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE HIGHLY SPECIALISEDDRUGS PROGRAM MADE BY THIS INSTRUMENT
Drug Addition
Listed Drug |
Zilucoplan |
Form Addition
Listed Drug | Form |
Risdiplam | Tablet 5 mg |
Brand Addition
Listed Drug | Form and Brand |
Sildenafil | Tablet 20 mg (as citrate) (SILDENAFIL PHT ARX) |
Brand Deletion
Listed Drug | Form and Brand |
Pomalidomide | Capsule 3 mg (Pomalyst) |
| Capsule 4 mg (Pomalyst) |
Tenofovir | Tablet containing tenofovir disoproxil fumarate 300 mg (Viread) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug | Listed Drug |
Abatacept | Infliximab |
Ambrisentan | Macitentan |
Anifrolumab | Mepolizumab |
Avatrombopag | Onasemnogene abeparvovec |
Benralizumab | Ravulizumab |
Bosentan | Riociguat |
Dupilumab | Risdiplam |
Edaravone | Romiplostim |
Eltrombopag | Sildenafil |
Epoprostenol | Teduglutide |
Iloprost | Tocilizumab |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Edaravone | ALS Functional Rating Scale – Revised (ALSFRS-R) score. The ALSFRS-R questionnaire is routinely administered to patients with ALS by neurologists at every clinic visit, typically 3 monthly. It is not proprietary and can be accessed online, being reproduced on multiple medical websites (e.g. https://www.mdcalc.com/calc/10166/revised-amyotrophic-lateral-sclerosis-functional-rating-scale-alsfrs-r). There are also websites that allow the neurologist to input a patient’s ratings to obtain a printable or digital copy of their score (https://neurotoolkit.com/alsfrs-r/). | An ALSFRS-R calculator is available via the MiNDAUS ALS registry: |
Anifrolumab | American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Systemic Lupus Erythematosus (SLE) Classification Criteria 2019 The ACR/EULAR SLE Classification Criteria 2019 provide a comprehensive framework for diagnosing the autoimmune disease systemic lupus erythematosus. | The ACR/EULAR SLE Classification Criteria 2019 is available for download for free from the National Library of Medicine, National Center of Biotechnology Information website: Aringer M et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. |
Abatacept Ambrisentan Anifrolumab Bosentan Dupilumab Epoprostenol Iloprost Infliximab Macitentan Onasemnogene abeparvovec Ravulizumab Riociguat Risdiplam Sildenafil Tocilizumab | Approved Product Information/Australian Product Information/TGA-approved Product Information. 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: |
Benralizumab Dupilumab Mepolizumab | Asthma Control Questionnaire (ACQ-5) and/or Asthma Control Questionnaire interviewer administered version (ACQ-IA). The ACQ-5 and the ACQ-IA are widely used tools for measuring how well a patient’s asthma symptoms are being controlled. | Prescribers can contact the suppliers of these asthma medications directly to obtain free copies of the ACQ calculation sheets. Contact details for the suppliers can be found online at www.pbs.gov.au |
Infliximab | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI is a widely used tool that enables measurement and evaluation of the level of disease activity in Ankylosing Spondylitis. | The BASDAI is available for download for free from the Services Australia website: |
Infliximab | Crohn Disease Activity Index (CDAI). The Crohn’s Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn’s disease. | Crohn Disease Activity Index (CDAI) is available for download for free from the PubMed website: A CDAI score calculation form is included in the Services Australia application form |
Infliximab | Mayo clinic score and partial Mayo clinic score. The Mayo clinic score and the partial Mayo clinic score (an abbreviated form of the Mayo clinic score) are medical diagnostic tools used to measure disease activity, in a standardised way, in Ulcerative Colitis through the evaluation of symptoms. | The Mayo clinic score and the partial Mayo clinic score are available to download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: |
Ravulizumab Zilucoplan | Myasthenia Gravis-Activities of Daily Living (MG-ADL) scoring profile. The MG-ADL is a patient-reported 8-item scale (0-24) focusing on functional disability of generalised Myasthenia Gravis (gMG disease). | The MG-ADL scoring profile is available for download for free from the Myasthenia Gravis Foundation of America website: |
Ravulizumab Zilucoplan | Myasthenia Gravis Composite (MGC) score. The MGC score is a physician and patient assessed outcome measure of signs and symptoms of generalised Myasthenia Gravis (gMG) disease. | The MGC score is available for download for free from the Criteria for Clinical Use of Immunoglobulin in Australia website: |
Ravulizumab Zilucoplan | Myasthenia Gravis Foundation of America (MGFA) Clinical Classification. The MGFA Clinical Classification is a classification system for generalised Myasthenia Gravis (gMG) disease which assists in understanding prognosis and tailoring treatment strategies for patients with gMG. | The Myasthenia Gravis Foundation of America (MGFA) Clinical Classification is available for download for free from the Myasthenia Gravis Foundation of America website: |
Infliximab | Paediatric Ulcerative Colitis Activity Index (PUCAI). The PUCAI is a standard medical diagnostic tool used to measure disease activity in children and adolescents with Ulcerative Colitis through the evaluation of symptoms. | The PUCAI is available for download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: |
Infliximab | Psoriasis Area Severity Index (PASI). 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: |
Anifrolumab | Systemic lupus erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) The SLEDAI-2K is a global index for the assessment of lupus disease activity across clinical and laboratory variables of nine organ systems. | SLEDAI-2K is available for download for free from The Journal of Rhematology website: It can also be accessed by contacting AstraZeneca Medical Information by phone on: Gladman 2002 J. Rheumatol. 29 (2) 288-291 |
Ambrisentan Bosentan Epoprostenol Iloprost Macitentan Riociguat Sildenafil | WHO Functional Classes for pulmonary arterial hypertension (PAH). 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: |
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 |
Infliximab | Bath Ankylosing Spondylitis Metrology Index (BASMI) | The BASMI is a set of 10 questions designed to determine the degree of functional limitation in patients with Ankylosing Spondylitis (AS). BASMI is used to determine the severity of ankylosing spondylitis prior to initiation with a particular biological medicine for this condition. | BASMI is a diagnostic tool rather than a document incorporated. Reference: |
Ambrisentan Bosentan Epoprostenol Iloprost Macitentan Riociguat Sildenafil | 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 Epoprostenol Iloprost Macitentan Riociguat Sildenafil | Right heart catherization (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 Epoprostenol Iloprost Macitentan Riociguat Sildenafil | Six Minute Walk Test (6MWT) | To measure patient motor functioning (physical movement abilities) in any assessment of whether the drug is providing the patient with a clinically meaningful response to treatment. | The PBS restriction requires use of standardised measures of patient motor function in assessing whether their treatment has resulted in a clinically meaningful response, but only where it is practical to do so. Such measures are not limited to this particular instrument. Therefore, the reference does not serve to incorporate a document. |
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 (April Update) Instrument 2026
(PB 35 of 2026)
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 (the Committee) 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
This Instrument advances the right to health and the right to social security by ensuring that the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument), that affect the pharmaceutical benefits that may be supplied under the Special Arrangement, are made concurrently.
The Listing Instrument 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. 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.
This Instrument provides for amendments to the drug edaravone as a result of a recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC). The pharmaceutical benefit edaravone, used for the treatment of amyotrophic lateral sclerosis (ALS) on the Highly Specialised Drugs (HSD) Program, includes the details of the circumstances in which this drug can be prescribed. This amendment will enable patients to access both initial and continuing treatment with edaravone through the HSD Program Community Access arrangements. Enabling access to edaravone for initial and continuing treatment through the HSD Program Community Access arrangements means that any medical practitioner may prescribe edaravone for both treatment phases, including for patients receiving treatment in a community setting. Additionally, Community Access prescriptions written by medical practitioners for both initial and continuing treatment of patients receiving treatment at, or from a public hospital or in, at or from a private hospital can be dispensed from any Pharmaceutical Benefits Scheme (PBS) Approved Supplier, including community pharmacies. This amendment will enable patients receiving initial and continuing treatment with edaravone for ALS to have a greater choice as to where they access their treatment, particularly those in rural and remote areas. This increase in choice promotes Article 12 of the ICESCR.
This Instrument also provides for the addition of the drug zilucoplan, a form of the listed drug risdiplam, and a brand of the listed drug sildenafil.
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.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing