National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026

PB 81 of 2026

Authority

The Pharmaceutical Benefits Scheme (PBS) is established under the National Health Act 1953 (Act) and provides Australians with timely, reliable and affordable access to necessary and cost‑effective medicines.  The Act regulates the listing, pricing, prescribing, supply, and claiming and payment of subsidies for the supply of drugs and medicinal preparations as pharmaceutical benefits.

Subsection 100(1) of the Act provides that the Minister may make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons: who are living in isolated areas; or who are receiving treatment in circumstances in which pharmaceutical benefits (other than pharmaceutical benefits supplied under special arrangements) are inadequate for that treatment; or if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.

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

The National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026 (PB 81 of 2026) (this Instrument) amends the National Health (Growth Hormone Program) Special Arrangement 2025 (PB 112 of 2025) (Growth Hormone Special Arrangement). The purpose of the amendments is to include provision for the PBS-subsidised supply of a new medicine, somapacitan, for the treatment of children with particular conditions, consistent with recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) made in July 2023.

This Instrument provides for the following changes to the Growth Hormone Special Arrangement:

   a minor revision to the definition of ‘authorised prescriber’ to align the specified authorised prescribers for a prescription for ‘a non-PBS subsidised to PBS subsidised supply phase of treatment’ for an eligible child (i.e. an eligible child transitioning to PBS-subsidised growth hormone treatment under the “grandfather” treatment phase) with the eligible prescriber types as specified in the relevant PBS restrictions (legal circumstances);

   the addition of an updated definition of ‘changing drug phase of treatment’ incorporating somapacitan, to allow eligible children to transition from any PBS-subsidised growth hormone to any other where prescribed for the same indication (i.e. from somatropin to somatrogon or somapacitan; from somatrogon to somatropin or somapacitan; or from somapacitan to somatropin or somatrogon);

   the insertion of references to somapacitan to specify the treatment phases, maximum quantities and maximum number of repeats applying to pharmaceutical benefits containing this drug. Prior to these amendments being effective, the Growth Hormone Special Arrangement operates so that only somatrogon and somatropin can be prescribed for the treatment of the relevant conditions in eligible children; and

   the addition of an item to the table incorporating the dosing restrictions with which authorised prescribers must comply when prescribing growth hormone pharmaceutical benefits for eligible children, to specify the maximum dose that applies in respect of PBS-subsidised treatment with somapacitan.

The amendments made by this Instrument are consistent with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) (Listing Instrument) commencing on the same day, which provide for the addition of pharmaceutical benefits containing the drug somapacitan to the Listing Instrument. The Listing Instrument is made under sections 84AF, 84AK, 85, 85A and 88 of the Act.

The amendments made by this Instrument are also consistent with amendments to the Growth Hormone Special Arrangement made by the National Health (Growth Hormone Program) Special Arrangement Amendment (July Update) Instrument 2026 (PB 80 of 2026) (July Update Instrument) commencing on the same day.  The amendments made by the July Update Instrument provide for the addition of pharmaceutical benefits containing the drug somapacitan to Schedule 1 to the Growth Hormone Special Arrangement (specifically to the table in Clause 1, which lists growth hormone pharmaceutical benefits for treatment of eligible children).

Background

Prior to these amendments being effective, somatrogon and somatropin are the only medicines available for supply under the PBS Section 100 Growth Hormone Program for the treatment of a range of paediatric growth hormone deficiency (GHD) conditions.

The Growth Hormone Special Arrangement details the dosing restrictions for children (and adults) with which authorised prescribers must comply when prescribing growth hormone pharmaceutical benefits for each condition during the various phases of treatment. Prior to these amendments being effective, these dosing restrictions apply to somatrogon and somatropin only for paediatric patients.

Somapacitan

At its July 2023 meeting, the PBAC recommended that a new medicine be made available on the Growth Hormone Program to paediatric and adolescent patients who have not reached skeletal maturity – somapacitan (Sogroya®).

The PBAC recommended the listing of somapacitan for the treatment of paediatric patients with: (1) short stature associated with biochemical GHD; and (2) short stature and slow growth.  The PBS restrictions for somapacitan are consistent with the restrictions for somatrogon and somatropin (across the seven applicable treatment phases) where the stated PBS indication is the same.

Somapacitan has different upper dosing limits/requirements to somatrogon and somatropin (as already listed) for the treatment of paediatric patients.

In considering the requested PBS listing of somapacitan, the PBAC noted the consumer comments received, which were supportive of making somapacitan available on the PBS, and which stated that weekly injections (as applies for treatment with somapacitan or somatrogon) have the potential to improve the quality of life for the paediatric population compared to daily injections with somatropin.

Consultation

The amendments made by this Instrument accord with recommendations made by the PBAC.

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation in relation to matters relevant to the Growth Hormone Special Arrangement.

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.

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 these 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.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical condition(s) for which the medicine has been approved for use in Australia and for which listing is sought, and the medicine’s clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies are consulted throughout the process for the listing of their medicines on the PBS and in relation to changes to those listings.  This includes consultation through the PBAC process.

Further consultation on this Instrument was considered unnecessary due to the nature of the consultation that had already taken place throughout the listing process.

This Instrument commences on 1 July 2026.

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

Details of this Instrument are set out in the Attachment.

ATTACHMENT A

DETAILS OF THE NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (SOMAPACITAN) INSTRUMENT 2026

Section 1 Name

This section provides that the name of the Instrument is the National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026 and that it may also be cited as PB 81 of 2026.

Section 2 Commencement

This section provides that this Instrument commences on 1 July 2026.

Section 3 Authority

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

Section 4 Schedules

This section provides that each instrument that is specified in a Schedule to this Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Instrument has effect according to its terms.

Schedule 1 Amendments

Schedule 1 sets out the amendments to the National Health (Growth Hormone Program) Special Arrangement 2025 (Growth Hormone Special Arrangement) made by this Instrument.

Items 1 - 2 – Section 6 (Definitions)

Item 1 omits paragraph ‘(c) a non-PBS subsidised to PBS subsidised supply phase of treatment’ from column 1 of table item 1 of the table in paragraph (b) of the definition of ‘authorised prescriber’, which specifies the authorised prescribers for the various phases of treatment that may apply to the treatment of an eligible child.  Item 2 inserts a corresponding new paragraph ‘(d) a non-PBS subsidised to PBS subsidised supply phase of treatment’ to column 1 of table item 3 of the same table.

Together, these amendments constitute a minor revision to the definition of an ‘authorised prescriber’ in respect of a prescription written for this specific treatment phase (‘non-PBS subsidised to PBS subsidised supply phase of treatment’ or “grandfather” treatment) of an eligible child.  This has the effect that any medical practitioner prescribing in consultation with a nominated specialist or consultant physician in: (a) paediatric endocrinology; or (b) general paediatrics; is an authorised prescriber in respect of the “grandfather” phase of treatment of an eligible child, consistent with the requirements specified in the relevant PBS restrictions (legal circumstances).

Item 3 – Section 6 (Definitions)

Item 3 repeals the previous definition of ‘changing drug phase of treatment’ and substitutes it with an updated definition that incorporates reference to somapacitan but is otherwise consistent with the previous definition.  Read in conjunction with the sets of circumstances in which a prescription for the supply of somapacitan may be written (as specified in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024) that contain reference to ‘change of drug’, this provides for an authorised prescriber to change the pharmaceutical benefit used in the treatment of an eligible child (provided the drug is prescribed for the same indication):

-          from a pharmaceutical benefit that has the drug somapacitan to a pharmaceutical benefit that has the drug somatrogon or somatropin; or

-          from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somapacitan or somatropin; or

-          from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somapacitan or somatrogon.

This provision allows (for example) eligible children to transition from receiving subsidised treatment with somatropin (involving daily injections) to receiving subsidised treatment with somatrogon or somapacitan (involving weekly injections instead) for the same condition.

Items 4 - 6 – Subsection 10(2) (Prescriptions for eligible children—general)

Item 4 omits the reference to ‘somatrogon or somatropin’ in subsection 10(2) and substitutes it with a reference to ‘somapacitan, somatrogon or somatropin’, effectively inserting a reference to ‘somapacitan’ in this subsection.  This has the effect that the provisions in this subsection apply to growth hormone pharmaceutical benefits that have the drug somapacitan (as well as to those that have the drug somatrogon or somatropin) in specifying, in respect of the different phases of treatment of an eligible child:

-          the maximum quantity or number of units of the growth hormone pharmaceutical benefit that may, in the one prescription, be directed by an authorised prescriber to be supplied during the phase of treatment;

-          the total quantity or number of units (including any repeats) of the growth hormone pharmaceutical benefit that may, in prescriptions for the eligible child, be directed by an authorised prescriber to be supplied during the phase of treatment; and

-          the maximum number of occasions on which the supply of the growth hormone pharmaceutical benefit may, in one prescription for the eligible child, be directed to be repeated.

Consistent with the amendments made by Item 4, Item 5 amends the heading of the table in subsection 10(2) to refer to ‘growth hormone pharmaceutical benefit that has somapacitan’ in addition to (growth hormone pharmaceutical benefit that has) ‘somatrogon or somatropin’.  The amended table heading reads ‘supply of growth hormone pharmaceutical benefit that has somapacitan, somatrogon or somatropin for an eligible child’.

Item 6 repeals table item 2 from the table in subsection 10(2) and substitutes it with a revised table item 2 that includes reference to ‘somapacitan’ (along with reference to ‘somatrogon’) in column 1 of this item at paragraph (d), which describes the ‘non-PBS subsidised to PBS subsidised supply’ phase of treatment (commonly referred to as “grandfathering”).  There are no associated changes to column 2 (Maximum quantity or number of units in one prescription) or column 3 (Total quantity or number of units (including any repeats)).

Read in conjunction with the rest of subsection 10(2) (as amended by Item 4), the amendments made by Items 5 and 6 have the effect that the contents of the table in this subsection, which specify the maximum quantity or number of units in one prescription (maximum quantity) and total quantity or number of units (including any repeats) (total quantity) in respect of the different phases of treatment of an eligible child, apply to the supply of a growth hormone pharmaceutical benefit that has somapacitan as well as to the supply of a growth hormone pharmaceutical benefit that has somatrogon or somatropin.  For somapacitan (as for somatrogon and somatropin), the specified quantities are as follows:

Item 7 – Subsection 11(2) (Prescriptions for eligible children—doses)

Item 7 adds a new table item (7) in the table in subsection 11(2), which specifies the maximum dose of growth hormone pharmaceutical benefits that may be prescribed for eligible children for the treatment of specified conditions.

New table item 7 specifies a dose of ‘0.16 mg per kg of the eligible child’s body weight per week’ (0.16 mg/kg/week) as the maximum dose of a growth hormone pharmaceutical benefit that has the drug somapacitan that may be prescribed for an eligible child for the treatment of: (a) short stature associated with biochemical growth hormone deficiency (GHD); or (b) short stature and slow growth.  This means, for example, that for an eligible child with short stature associated with biochemical GHD with a body weight of 32 kilograms, the prescribed dose of somapacitan must not exceed the applicable maximum subsidised dose of 5.12 milligrams (0.16 milligrams multiplied by 32) per week.

ATTACHMENT B

Statement of Compatibility with Human Rights

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

National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026

PB 81 of 2026

This Legislative 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 Legislative Instrument

The National Health (Growth Hormone Program) Special Arrangement Amendment (Somapacitan) Instrument 2026 (PB 81 of 2026) (this Instrument) amends the National Health (Growth Hormone Program) Special Arrangement 2025 (PB 112 of 2025) (Growth Hormone Special Arrangement).  The purpose of the amendments is to include provision for the Pharmaceutical Benefits Scheme (PBS)-subsidised supply of a new medicine, somapacitan, for the treatment of children with particular conditions, consistent with recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) made in July 2023.

The purpose of this instrument is therefore to enable subsidised access to a specific drug for children where indicated for the treatment of paediatric growth hormone deficiency (GHD) conditions, with the drug (somapacitan) promoting linear growth (i.e. an increase in height) and not any non-gender affirming hormones.

Growth hormone is produced by our brain’s pituitary gland and governs our height, bone length and muscle growth.  Our bones need enough growth hormone during our childhood and adolescence in order to lengthen to adult proportions.  Growth hormone prompts our liver to make a substance called insulin-like growth factor-1 (IGF-1).  This and other similar compounds are involved in bone growth.  Taking synthesised growth hormone can help people reach their full height potential.

A person’s age, sex, body weight or surface area, and skeletal maturity are some of the factors taken into consideration when prescribing growth hormone medicines and determining correct dosage.  The Growth Hormone Special Arrangement defines these terms for the purposes of patient eligibility based on clinical evidence and the expert opinion of the PBAC.

There are checks and balances on the provision of subsidised growth hormone medicines to prevent harmful effects on children by restricting who can be an authorised prescriber and providing for a maximum subsidised dose for growth hormone pharmaceutical benefits.

The amendments made by this Instrument will ensure that the appropriate pharmaceutical benefits (as listed in Schedule 1 to the Growth Hormone Special Arrangement from 1 July 2026) are available for eligible children who require treatment with somapacitan in line with their diagnosis and clinical circumstances.  They are consistent with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) (Listing Instrument) in respect of somapacitan, which commence on the same day. 

The Listing Instrument is made under sections 84AF, 84AK, 85, 85A and 88 of the Act.

Human Rights Implications

This Instrument engages Articles 9 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 social security and to the enjoyment of the highest attainable standard of physical and mental health.  It also engages Article 24 of the Convention on the Rights of the Child.  Article 24(1) relevantly provides for the right of the child to the highest attainable standard of health and ensuring no child is deprived of his or her right to access such health care services.  Article 24(2) goes on to provide that States Parties to the Convention shall take appropriate measures to: (b) ensure the provision of necessary medical assistance and health care to all children.

This Instrument assists with the advancement of these rights by ensuring access to PBS-subsidised somapacitan (growth hormone) treatment for paediatric patients in line with their diagnosis and clinical circumstances.

Conclusion

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

Sarah Norris

Assistant Secretary

Community Access Programs Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageinglega