National Health (Growth Hormone Program) Special Arrangement 2025

Mechanically, the National Health (Growth Hormone Program) Special Arrangement 2025 (PB 112 of 2025) is a stand‑alone special arrangement under the National Health Act 1953 that: (a) replaces the 2015 special arrangement (Schedule 2 repeals the 2015 instrument); (b) commences on 1 October 2025 (s 2); and (c) prescribes who may receive listed growth hormone pharmaceutical benefits, who may prescribe them, the permitted phases, quantities and dosing rules for children and adults, and how Commonwealth payments for special arrangement supplies are calculated (Parts 1-4; Schedule 1). The instrument is made under ss 85A, 99 and 100 of the National Health Act 1953 (s 3) and operates subject to Part VII of the Act but takes precedence where it applies (s 5 note).

The instrument does four categories of mechanical work, set out in the simplified outline (s 5) and the operative provisions:

Eligibility and supply controls: it restricts growth hormone pharmaceutical benefits to "eligible children" and "eligible adults" and makes it an offence to supply outside those classes (s 8, definitions in s 6). Schedule 1 lists the precise medicines, brands, forms and manners of administration that constitute growth hormone pharmaceutical benefits for each eligibility class (Schedule 1, cl 1-2).
Prescription and dosing architecture: it defines authorised prescribers by phase of treatment, sets the phases of treatment (initial, continuing, recommencement, changing drug, non‑PBS to PBS supply, reclassified patient phases), constrains the maximum quantity per prescription and total quantities during each phase, and prescribes dosing formulas and rounding allowances (see Div 2 for children, s 9-14; Div 3 for adults, s 15-16; dosing tables s 11).

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Commonwealth Coat of Arms of Australia

National Health (Growth Hormone Program) Special Arrangement 2025

I, Jonathon Logue, as delegate of the Minister for Health and Ageing, make the following special arrangement.

Dated 22 September 2025

Jonathon Logue

Acting Assistant Secretary Community Access Programs Branch Technology Assessment and Access Division Department of Health, Disability and Ageing

Contents

Part 1—Preliminary

Division 1—General

1 Name

2 Commencement

3 Authority

4 Schedule 2

5 Simplified outline

6 Definitions

Division 2—Special arrangement supplies from hospitals

7 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals

Part 2—Supply of growth hormone pharmaceutical benefits

Division 1—General

8 Growth hormone pharmaceutical benefits must be supplied only to eligible children and eligible adults

Division 2—Eligible children

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible children

9 Supply of growth hormone pharmaceutical benefits for eligible children

Subdivision B—Prescriptions for eligible children

10 Prescriptions for eligible children—general

11 Prescriptions for eligible children—doses

12 Calculate doses by using ideal body weights in certain cases

13 Prescriptions for eligible children—doses: change of treatment category (reclassification)

14 Prescriptions for eligible children—doses: recommenced treatment

Division 3—Eligible adults

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible adults

15 Supply of growth hormone pharmaceutical benefits for eligible adults

Subdivision B—Prescriptions for eligible adults

16 Prescriptions for eligible adults

Part 3—Payment for special arrangement supplies of growth hormone pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

17 Rates of payments for approved hospital authorities for public hospitals

18 Dispensed price for approved hospital authorities for public hospitals

Division 2—Supplies by other approved suppliers

19 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

20 Rates of payment for approved hospital authorities for private hospitals

21 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

22 Mark‑up for ready‑prepared pharmaceutical benefits

23 Dispensing fee

Part 4—Supply to CTG registered patients

24 Application of the CTG Special Arrangement—co‑payment and payment etc.

25 Claims for payment for supply of benefits using the manual system

Part 5—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

26 Things done under the National Health (Growth Hormone Program) Special Arrangement 2015

Schedule 1—Growth hormone pharmaceutical benefits

1 Growth hormone pharmaceutical benefits for treatment of eligible children

2 Growth hormone pharmaceutical benefits for treatment of eligible adults

Schedule 2—Repeals

National Health (Growth Hormone Program) Special Arrangement 2015

Part 1—Preliminary

Division 1—General

1 Name

(1) This instrument is the National Health (Growth Hormone Program) Special Arrangement 2025.

(2) This instrument may also be cited as PB 112 of 2025.

2 Commencement

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument 1 October 2025. 1 October 2025

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under sections 85A, 99 and 100 of the National Health Act 1953.

4 Schedule 2

Each instrument that is specified in Schedule 2 to this instrument is amended or repealed as set out in the applicable items in that Schedule, and any other item in that Schedule has effect according to its terms.

5 Simplified outline

This instrument makes a special arrangement for, or in relation to, providing that an adequate supply of growth hormone pharmaceutical benefits will be available to certain persons (eligible children and eligible adults) who are receiving treatment.

Growth hormone pharmaceutical benefits must only be supplied in accordance with this instrument upon a prescription that meets the requirements of Part 2, including requirements relating to the prescriber, quantity or number of units and dose.

This instrument also deals with payments for supplies of growth hormone pharmaceutical benefits.

Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

6 Definitions

Note 1: A number of expressions used in this instrument are defined in the Act, including public hospital.

Note 2: Under subsection 4(1A) of the Act, in the Act a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a) medical practitioner;

(b) private hospital.

In this instrument:

Act means the National Health Act 1953.

approved ex‑manufacturer price of a listed brand of a pharmaceutical benefit has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act.

approved medical practitioner has the same meaning as in Part VII of the Act.

approved pharmacist has the same meaning as in Part VII of the Act.

approved supplier has the same meaning as in Part VII of the Act.

authorised prescriber:

(a) for a prescription for an initial phase of treatment or a continuing phase of treatment of a person who, when the prescription is written, is an eligible adult—means a specialist, or consultant physician, in endocrinology; or

(b) for a prescription for a phase of treatment mentioned in column 1 of an item of the following table of a person who, when the prescription is written, is an eligible child—means a person mentioned in column 2 of the item.

Authorised prescribers for eligible children
Item Column 1Phase of treatment Column 2Authorised prescriber
1 (a) an initial phase of treatment; or(b) a changing drug phase of treatment; or(c) a non‑PBS subsidised to PBS subsidised supply phase of treatment (a) a specialist or consultant physician in paediatric endocrinology; or(b) a specialist or consultant physician in general paediatrics who is prescribing in consultation with a nominated specialist or consultant physician in paediatric endocrinology
2 a continuing phase of treatment a medical practitioner
3 (a) a recommencement phase of treatment; or(b) a continuing treatment as a reclassified patient phase; or(c) a recommencement of treatment as a reclassified patient phase a medical practitioner who is prescribing in consultation with a nominated specialist, or consultant physician, in:(a) paediatric endocrinology; or(b) general paediatrics

CDC means the Centers for Disease Control and Prevention, US Department of Health and Human Services.

CDC growth charts means the following growth charts:

(a) the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development, published by the National Center for Health Statistics of the CDC in May 2002, as existing on the commencement of this instrument;

(b) the CDC Extended BMI‑for‑Age Growth Charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion of the CDC, and published on 15 December 2022, as existing on the commencement of this instrument.

Note: The 2000 CDC Growth Charts for the United States: Methods and Development and the CDC Extended BMI‑for‑Age Growth Charts could in 2025 be viewed on the CDC website (http://www.cdc.gov).

changing drug phase of treatment for an eligible child means a phase of treatment to facilitate a change in the pharmaceutical benefit used in the treatment of the child:

(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or

(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.

CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.

dispensed price:

(a) for the supply of a growth hormone pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 18; and

(b) for the supply of a growth hormone pharmaceutical benefit by any other approved supplier—has the meaning given by section 21.

eligible adult means a person who:

(a) is not an eligible child; or

(b) is 18 years of age or older and has late onset growth hormone deficiency.

eligible child means a person:

(a) who has a non‑mature skeleton; or

(b) who:

(i) is less than 18 years of age; and

(ii) has a mature skeleton; and

(iii) has a diagnosis of Prader‑Willi syndrome.

growth hormone pharmaceutical benefit has the meaning given by Schedule 1.

ideal body weight: see subsection 12(3).

listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

mature skeleton: a person has a mature skeleton if the person is:

(a) a female with a bone age of 13.5 years or more; or

(b) a male with a bone age of 15.5 years or more.

non‑mature skeleton: a person has a non‑mature skeleton if the person is:

(a) a female with a bone age of less than 13.5 years; or

(b) a male with a bone age of less than 15.5 years.

pack quantity has the same meaning as in Part VII of the Act.

percentile means a percentile specified in the CDC growth charts.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical benefit has a drug: a reference in this instrument to a pharmaceutical benefit having a drug is a reference to the pharmaceutical benefit having the drug as mentioned in subsection 84ABA(3) of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

ready‑prepared dispensing fee has the same meaning as in the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

ready‑prepared pharmaceutical benefit has the same meaning as in the Listing Instrument.

special arrangement supply means a supply of a growth hormone pharmaceutical benefit in accordance with this instrument.

Division 2—Special arrangement supplies from hospitals

7 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals

(1) Despite section 94 of the Act, a hospital authority approved for the purpose of its supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which the hospital authority is the governing body or proprietor may also make special arrangement supplies of growth hormone pharmaceutical benefits to patients receiving treatment from that hospital.

(2) In the application of Part VII of the Act, and regulations or other instruments made for the purposes of that Part, to special arrangement supplies of growth pharmaceutical benefits, a reference to a person receiving treatment in or at a hospital is taken to include a reference to a person receiving treatment from the hospital.

Part 2—Supply of growth hormone pharmaceutical benefits

Division 1—General

8 Growth hormone pharmaceutical benefits must be supplied only to eligible children and eligible adults

A growth hormone pharmaceutical benefit must not be supplied upon a prescription written for a person if:

(a) the person is not entitled to receive pharmaceutical benefits as mentioned in section 86 of the Act; or

(b) when the prescription is written, the person is not an eligible child or eligible adult.

Division 2—Eligible children

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible children

9 Supply of growth hormone pharmaceutical benefits for eligible children

A growth hormone pharmaceutical benefit must not be supplied upon a prescription written for treatment of a person who, when the prescription is written, is an eligible child, unless:

(a) the growth hormone pharmaceutical benefit is mentioned in clause 1 of Schedule 1; and

(b) the prescription meets the requirements of Subdivision B of this Division; and

(d) if, under paragraph 85(7)(b) of the Act, a prescription for the supply of the growth hormone pharmaceutical benefit may be written in circumstances that include one or more sets of circumstances relating to a patient—at least one of those sets of circumstances exists in relation to the person.

Note: In the Listing Instrument, as in force on 1 October 2025, a set of circumstances (in which a prescription for the supply of a pharmaceutical benefit may be written) is the set of circumstances mentioned in the table in Part 1 of Schedule 4 to that instrument in relation to a particular circumstances code that is mentioned in the table in Part 1 of Schedule 1 to that instrument in relation to the pharmaceutical benefit.

Subdivision B—Prescriptions for eligible children

10 Prescriptions for eligible children—general

(1) This section applies to a prescription for the supply of a growth hormone pharmaceutical benefit written for a person who, when the prescription is written, is an eligible child.

(2) If the growth hormone pharmaceutical benefit has the drug somatrogon or somatropin:

(a) for the purposes of paragraph 9(b), the prescription must be for a phase of treatment of the eligible child mentioned in column 1 of an item of the following table; and

(b) for the purposes of paragraph 9(b), the maximum quantity or number of units of the growth hormone pharmaceutical benefit that may, in the one prescription, be directed to be supplied during the phase of treatment is the amount mentioned in column 2 of the item; and

(c) for the purposes of paragraph 9(b), 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 to be supplied during the phase of treatment is the amount mentioned in column 3 of the item; and

(d) for the purposes of paragraph 85A(2)(b) of the Act, 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 is one.

Supply of growth hormone pharmaceutical benefit that has somatrogon or somatropin for an eligible child
Item Column 1Phase of treatment Column 2Maximum quantity or number of units in one prescription Column 3Total quantity or number of units (including any repeats)
1 (a) an initial phase of treatment; or(b) a recommencement phase of treatment; or(c) a recommencement of treatment as a reclassified patient phase an amount that is sufficient for 16 weeks of treatment of the eligible child an amount that is sufficient for 32 weeks of treatment of the eligible child
2 (a) a continuing phase of treatment; or(b) a continuing treatment as a reclassified patient phase; or(c) a changing drug phase of treatment; or(d) if the growth hormone pharmaceutical benefit has the drug somatrogon—a non‑PBS subsidised to PBS subsidised supply phase of treatment an amount that is sufficient for 13 weeks of treatment of the eligible child an amount that is sufficient for 26 weeks of treatment of the eligible child

(3) If the growth hormone pharmaceutical benefit has the drug mecasermin:

(a) for the purposes of paragraph 9(b), the prescription must be for any of the following phases of treatment of the eligible child:

(i) an initial phase of treatment;

(ii) a continuing phase of treatment; and

(c) if the one prescription directs the supply of the pharmaceutical benefit to be repeated—for the purposes of paragraph 9(b), each direction for a repeated supply must be a direction for a supply, on one occasion, of the quantity or number of units of the growth hormone pharmaceutical benefit that is sufficient for one month of treatment of the eligible child in that phase; and

11 Prescriptions for eligible children—doses

(1) For the purposes of paragraph 9(b), a prescription for the supply of a growth hormone pharmaceutical benefit for the treatment of a condition of a person who, when the prescription is written, is an eligible child must not prescribe a dose of the growth hormone pharmaceutical benefit other than in accordance with this section.

(2) The dose must:

(a) be appropriate for treatment of the eligible child under this instrument; and

(b) subject to subsections (4) and (5), not exceed the maximum dose calculated in accordance with column 3 of the applicable item of the following table.

Dose of growth hormone pharmaceutical benefits for eligible children
Item Column 1If the growth hormone pharmaceutical benefit has the drug … Column 2and the condition is in the category of… Column 3then the maximum dose is …
1 Somatropin (a) short stature and slow growth; or(b) short stature associated with biochemical growth hormone deficiency; or(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or(d) risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or(e) biochemical growth hormone deficiency and precocious puberty; or(f) hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth 7.5 mg per m2 of the eligible child’s body surface area per week.
2 Somatropin (a) short stature associated with Turner Syndrome; or(b) short stature due to short stature homeobox (SHOX) gene disorders; or(c) short stature associated with chronic renal insufficiency 9.5 mg per m2 of the eligible child’s body surface area per week.
3 Somatropin short stature and poor body composition due to Prader‑Willi Syndrome, if the eligible child has a non‑mature skeleton 7.5 mg per m2 of the eligible child’s body surface area (calculated using the eligible child’s ideal body weight, if section 12 applies) per week.
4 Somatropin short stature and poor body composition due to Prader‑Willi Syndrome, if the eligible child has a mature skeleton 0.04 mg per kg of the eligible child’s body weight (or of the eligible child’s ideal body weight, if section 12 applies) per week.
5 Mecasermin severe primary insulin‑like growth factor 1 deficiency (Primary IGFD) 0.12 mg per kg of the eligible child’s body weight twice daily.
6 Somatrogon (a) short stature associated with biochemical growth hormone deficiency; or(b) short stature and slow growth 0.66 mg per kg of the eligible child’s body weight per week.

(3) For the purposes of items 1 to 3 of the table in subsection (2), the number of m2 of the eligible child’s body surface area is the number calculated using the following formula:

Start formula start square root start fraction Eligible child’s height in centimetres times Eligible child’s body weight in kilograms (or eligible child’s ideal body weight in kilograms, if section 12 applies) over 3600 end fraction end square root end formula

(4) The maximum dose may be up to 3% greater than the maximum dose calculated in accordance with the table in subsection (2), if;

(a) the applicable item of the table is item 1, 2, 3 or 4; and

(b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the maximum dose calculated in accordance with the table.

(5) The dose calculated in accordance with the table in subsection (2) may be rounded up to the nearest 0.2 mg or 0.5 mg (as appropriate) if:

(a) the applicable item of the table is item 6; and

(b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the maximum dose calculated in accordance with the table.

12 Calculate doses by using ideal body weights in certain cases

(1) This section applies in relation to a prescription for the supply of a growth hormone pharmaceutical benefit for the treatment of a person who, when the prescription is written, is an eligible child, if.

(a) item 3 or 4 of the table in subsection 11(2) applies; and

(b) the eligible child has a body mass index greater than the 85th percentile for the eligible child’s age and sex.

(2) Treat a reference in item 4 of the table in subsection 11(2), or subsection 11(3), to the eligible child’s body weight as being a reference to the eligible child’s ideal body weight.

(3) The eligible child’s ideal body weight is:

(a) if the eligible child is:

(i) female with a height less than or equal to 163.3 centimetres; or

(ii) male with a height less than or equal to 176.8 centimetres;

the 50th percentile weight for the eligible child’s height and sex; or

(b) if the eligible child is:

(i) female with a height greater than 163.3 centimetres; or

(ii) male with a height greater than 176.8 centimetres;

the number of kilograms worked out by multiplying:

(iii) the 50th percentile body mass index for the eligible child’s age and sex; by

(iv) the square of the eligible child’s height in metres.

13 Prescriptions for eligible children—doses: change of treatment category (reclassification)

(1) This section applies if:

(a) an approved prescriber prescribes a growth hormone pharmaceutical benefit for the treatment of a condition of a person who, when the prescription is written, is an eligible child; and

(b) the person is reclassified to a different category of condition.

(2) To avoid doubt, a prescription, written after the reclassification, for the supply of a growth hormone pharmaceutical benefit for the treatment of the new category of condition of the person must comply with section 11 in relation to the new category.

14 Prescriptions for eligible children—doses: recommenced treatment

(1) This section applies if:

(a) an approved prescriber prescribes a growth hormone pharmaceutical benefit for the treatment of a condition of a person who, when the prescription is written, is an eligible child; and

(b) the person ceases treatment using a growth hormone pharmaceutical benefit, but later recommences such treatment.

(2) To avoid doubt, a prescription, written after the person ceases treatment as mentioned in paragraph (1)(b) of this section, for the supply of a growth hormone pharmaceutical benefit for the treatment of the person must comply with section 11 when the prescription is written.

Division 3—Eligible adults

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible adults

15 Supply of growth hormone pharmaceutical benefits for eligible adults

A growth hormone pharmaceutical benefit must not be supplied upon a prescription written for a person who, when the prescription is written, is an eligible adult, unless:

(a) the growth hormone pharmaceutical benefit is mentioned in clause 2 of Schedule 1; and

(b) the prescription meets the requirements of Subdivision B of this Division; and

Subdivision B—Prescriptions for eligible adults

16 Prescriptions for eligible adults

(1) This section applies in relation to a prescription for the supply of a growth hormone pharmaceutical benefit for a person who, when the prescription is written, is an eligible adult.

(2) The following paragraphs have effect:

(a) for the purposes of paragraph 15(b), the prescription must be for any of the following phases of treatment of the eligible adult:

(i) an initial phase of treatment;

(ii) a continuing phase of treatment;

(b) for the purposes of paragraph 15(b), the maximum quantity or number of units of the growth hormone pharmaceutical benefit that may, in the one prescription, be directed to be supplied during the phase of treatment is the amount that is sufficient for the first month of treatment of the eligible adult in the phase of treatment;

(c) if the one prescription directs the supply of the pharmaceutical benefit to be repeated—for the purposes of paragraph 15(b), each direction for a repeated supply must be a direction for a supply, on one occasion, of the quantity or number of units of the growth hormone pharmaceutical benefit that is sufficient for one month of treatment of the eligible adult in that phase of treatment;

Part 3—Payment for special arrangement supplies of growth hormone pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

17 Rates of payments for approved hospital authorities for public hospitals

(1) The amount payable under subsection 99(4) of the Act to an approved hospital authority for a public hospital in respect of a special arrangement supply of a growth hormone pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 4 of this instrument in relation to the special arrangement supply of a growth hormone pharmaceutical benefit to a CTG registered patient.

(2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017.

Note: See subsection 99(4) of the Act (read with section 7 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

18 Dispensed price for approved hospital authorities for public hospitals

(1) The dispensed price for a special arrangement supply of a growth hormone pharmaceutical benefit by an approved hospital authority for a public hospital is as follows:

(a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity;

(b) if the quantity (the broken quantity) of the benefit supplied is less than a pack quantity of the benefit—the amount worked out in accordance with subsection (2) for the broken quantity;

(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

(ii) the amount calculated in accordance with subsection (2) for the remainder (the broken quantity) of the quantity supplied that is less than a pack quantity.

Note: No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.

Broken quantities

(2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:

(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for the pack quantity.

Rounding

(3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

Division 2—Supplies by other approved suppliers

19 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

(1) This section applies:

(a) in relation to an approved pharmacist or approved medical practitioner who has made a special arrangement supply of a growth hormone pharmaceutical benefit; and

(b) subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of the supply.

(2) The approved pharmacist or approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 4 of this instrument in relation to the special arrangement supply of a growth hormone pharmaceutical benefit to a CTG registered patient.

(3) This section applies despite subsections 99(2) and (2AA) of the Act.

20 Rates of payment for approved hospital authorities for private hospitals

(1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of a growth hormone pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 4 of this instrument in relation to the special arrangement supply of a growth hormone pharmaceutical benefit to a CTG registered patient.

(2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020.

21 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

(1) The dispensed price for a special arrangement supply of a growth hormone pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital is as follows:

(a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:

(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 22 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

(iii) the ready‑prepared dispensing fee;

(b) if the quantity (the broken quantity) of the benefit supplied is less than a pack quantity of the benefit—the sum of:

(i) the amount worked out in accordance with subsection (2); and

(ii) the ready‑prepared dispensing fee;

(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 22 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

(iii) the amount worked out in accordance with subsection (2) for the remainder (the broken quantity) of the quantity supplied; and

(iv) the ready‑prepared dispensing fee.

Broken quantities

(2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out by:

(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

(b) applying that percentage to the sum of:

(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 22 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).

Rounding

(3) The dispensed price under subsection (1) is to be rounded to the nearest cent (rounding 0.5 cents upwards).

22 Mark‑up for ready‑prepared pharmaceutical benefits

(1) For the purposes of subparagraphs 21(1)(a)(ii) and (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:

(a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) (as applicable) for that quantity; or

(b) if the pack quantity of the benefit is less than the maximum quantity of the benefit:

(i) if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

(ii) if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.

Mark‑up for ready‑prepared pharmaceutical benefits
Item If the AEMP or PEMP (as applicable) for the maximum quantity is … the mark‑up for the maximum quantity is …
1 less than $40 10% of the AEMP or PEMP
2 at least $40 but not more than $100 $4
3 more than $100 but not more than $1,000 4% of the AEMP or PEMP
4 more than $1,000 $40

(2) For the purposes of this section, the maximum quantity of a ready‑prepared pharmaceutical benefit having a pharmaceutical item is the maximum number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion, as determined for the item under paragraph 85A(2)(a) of the Act.

Note: The Listing Instrument, as in force on 1 October 2025, contains the determination of the maximum quantity of a ready‑prepared pharmaceutical benefit having a pharmaceutical item.

23 Dispensing fee

If:

(a) an authorised prescriber writes a prescription for a growth hormone pharmaceutical benefit that, instead of directing a repeated supply of the benefit, directs the supply on one occasion of a quantity or number of units of the benefit; and

(b) the quantity does not exceed the total quantity or number of units that could be prescribed if the prescription directed a repeated supply;

the dispensed price for the supply of the benefit includes only one dispensing fee.

Note: See section 49 of the National Health (Pharmaceutical Benefits) Regulations 2017 for the circumstances in which such a supply may be directed.

Part 4—Supply to CTG registered patients

24 Application of the CTG Special Arrangement—co‑payment and payment etc.

(1) This section applies to a special arrangement supply of a growth hormone pharmaceutical benefit to a CTG registered patient.

(2) Despite section 87 of the Act and sections 17, 19 and 20 of this instrument, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the special arrangement supply with the modification set out in subsection (3) of this section.

(3) A reference in the CTG Special Arrangement to:

(a) a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the special arrangement supply; and

(b) a CTG supplier is taken to be a reference to the approved supplier who made the special arrangement supply.

(4) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the special arrangement supply.

Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the special arrangement supply are instead dealt with under section 25 of this instrument.

25 Claims for payment for supply of benefits using the manual system

(1) A claim for payment of an amount to which an approved supplier is entitled in respect of the special arrangement supply of a growth hormone pharmaceutical benefit must include an indicator that the supply was made to a CTG registered patient, if the claim is made:

(a) by an approved supplier, in respect of a supply made to such a patient; and

(b) using the manual system referred to in section 99AAA of the Act.

(2) This section has effect in addition to section 99AAA of the Act.

Part 5—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

26 Things done under the National Health (Growth Hormone Program) Special Arrangement 2015

(1) If:

(a) a thing was done for a particular purpose under the National Health (Growth Hormone Program) Special Arrangement 2015 as in force immediately before that instrument was repealed; and

(b) the thing could be done for that particular purpose under this instrument;

the thing has effect for the purposes of this instrument as if it had been done for that particular purpose under this instrument.

(2) Without limiting subsection (1), a reference in that subsection to a thing being done includes a reference to a supply of pharmaceutical benefits or a claim for payment being made.

Schedule 1—Growth hormone pharmaceutical benefits

Note: See the definition of growth hormone pharmaceutical benefit in section 6, and paragraphs 9(a) and 15(a).

1 Growth hormone pharmaceutical benefits for treatment of eligible children

(1) A pharmaceutical benefit that consists of a brand mentioned in an item of the following table of the listed drug mentioned in the item in the form mentioned in the item with the manner of administration mentioned in the item is a growth hormone pharmaceutical benefit.

(2) To avoid doubt, if no listed drug is mentioned in an item of the following table, the item is taken to mention the listed drug mentioned in the closest item of the table that:

(a) occurs above the item in the table; and

(b) mentions a listed drug.

Growth hormone pharmaceutical benefits for treatment of eligible children
Listed drug Form Manner of administration Brand
Mecasermin Solution for injection 40 mg in 4 mL (10 mg per mL) Injection Increlex
Somatrogon Injection 24 mg in 1.2 mL single use pre‑filled pen Injection Ngenla
Injection 60 mg in 1.2 mL single use pre‑filled pen Injection Ngenla
Somatropin Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick
Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick
Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 5
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro
Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) Injection Saizen
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 10
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro
Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) Injection Saizen
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 15
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro
Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) Injection Saizen

Note: Each listed drug mentioned in the table has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

2 Growth hormone pharmaceutical benefits for treatment of eligible adults

(2) To avoid doubt, if no listed drug is mentioned in an item of the following table, the item is taken to mention the listed drug mentioned in the closest item of the table that:

(a) occurs above the item in the table; and

(b) mentions a listed drug.

Growth hormone pharmaceutical benefits for treatment of eligible adults
Listed drug Form Manner of administration Brand
Somatropin Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick
Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen Injection Norditropin FlexPro

Schedule 2—Repeals

National Health (Growth Hormone Program) Special Arrangement 2015

1 The whole of the instrument

Repeal the instrument.

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National Health (Growth Hormone Program) Special Arrangement 2025

I, Jonathon Logue, as delegate of the Minister for Health and Ageing, make the following special arrangement.

Dated 22 September 2025

Jonathon Logue

Acting Assistant Secretary Community Access Programs Branch Technology Assessment and Access Division Department of Health, Disability and Ageing

Contents

Part 1—Preliminary

Division 1—General

1 Name

2 Commencement

3 Authority

4 Schedule 2

5 Simplified outline

6 Definitions

Division 2—Special arrangement supplies from hospitals

7 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals

Part 2—Supply of growth hormone pharmaceutical benefits

Division 1—General

8 Growth hormone pharmaceutical benefits must be supplied only to eligible children and eligible adults

Division 2—Eligible children

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible children

9 Supply of growth hormone pharmaceutical benefits for eligible children

Subdivision B—Prescriptions for eligible children

10 Prescriptions for eligible children—general

11 Prescriptions for eligible children—doses

12 Calculate doses by using ideal body weights in certain cases

13 Prescriptions for eligible children—doses: change of treatment category (reclassification)

14 Prescriptions for eligible children—doses: recommenced treatment

Division 3—Eligible adults

Subdivision A—Supply of growth hormone pharmaceutical benefits for eligible adults

15 Supply of growth hormone pharmaceutical benefits for eligible adults

Subdivision B—Prescriptions for eligible adults

16 Prescriptions for eligible adults

Part 3—Payment for special arrangement supplies of growth hormone pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

The instrument organises the program around a small set of legal concepts that determine entitlement, prescribing authority, dosing and payment. The core concepts, defined or operationalised in the text, are:

Eligible child and eligible adult (s 6 definitions). Eligibility is not solely an age test. An "eligible child" is either someone with a non‑mature skeleton or someone under 18 with a mature skeleton plus a diagnosis of Prader‑Willi syndrome (s 6). "Non‑mature" and "mature" skeleton are defined by bone age thresholds (females 13.5 years, males 15.5 years) (s 6). An "eligible adult" is a person who is not an eligible child, or someone aged 18 or more with late onset growth hormone deficiency (s 6).
Growth hormone pharmaceutical benefit (Schedule 1). The instrument defines the set of medicines covered by the arrangement by listing the drugs, forms, manner of administration and brands for children's and adults' treatment (Schedule 1, cl 1-2). If an item omits a drug, it takes the closest above item that does mention a listed drug (Schedule 1 notes).
Phases of treatment and prescribing constraints (Div 2 and 3: ss 9-16). The arrangement distinguishes phases such as initial, continuing, recommencement, changing drug, non‑PBS to PBS subsidised supply, reclassification and recommencement as a reclassified patient. For each phase the instrument prescribes maximum quantity per script and maximum total quantity across prescriptions for the phase (s 10, table). For adults, monthly limits apply (s 16).
Authorised prescribers (definitions s 6). The instrument limits who may write prescriptions depending on phase and patient class. For example, initial and changing drug phases for children require a specialist or consultant physician in paediatric endocrinology, or a general paediatrician prescribing in consultation with a nominated paediatric endocrinologist (s 6 authorised prescriber table). Continuing phases for children may be prescribed by a medical practitioner (s 6 item 2). For eligible adults an "authorised prescriber" is a specialist or consultant physician in endocrinology (s 6).
Dosing methodology and adjustments (s 11-12). The instrument specifies dosing formulas: mg per m^2 per week for several somatropin indications, mg per kg per week for other indications, mecasermin twice daily by weight, and somatrogon weekly by weight (s 11 table). Body surface area is computed by the standard formula given in s 11(3). There are tolerances where pack sizes require rounding or up to 3% in excess (s 11(4)-(5)). If the child’s BMI exceeds the 85th percentile, certain dose calculations must use "ideal body weight" rather than actual weight, with the method for deriving ideal body weight prescribed in s 12(3). The BMI percentiles are sourced from CDC growth charts as defined in s 6.
Supply by hospital authorities (s 7). The instrument overrides the effect of s 94 of the Act to allow approved hospital authorities to make special arrangement supplies to patients receiving treatment in, at, or from the hospital (s 7(1)-(2)).
Dispensed price and payment calculations (Parts 3, ss 17-23). The Commonwealth’s payment to suppliers is the amount, if any, by which the dispensed price exceeds the amount the supplier was entitled to charge under s 87 of the Act (ss 17, 19, 20). The dispensed price formulas differ between approved hospital authorities for public hospitals and other approved suppliers, with explicit guidance on broken quantities, rounding, mark‑ups for ready‑prepared products, and the inclusion of a ready‑prepared dispensing fee for non‑hospital suppliers (ss 18, 21, 22, 23).
Interaction with CTG Special Arrangement (ss 24-25). For CTG registered patients the CTG Special Arrangement’s reduced co‑payment rules and Commonwealth payment provisions apply to these special arrangement supplies, with modifications and a requirement to use an indicator when manual claims are submitted (s 24-25).
Transitional saving for prior actions (s 26). Actions taken under the repealed 2015 instrument are preserved where they could have been done under the new 2025 instrument (s 26).

Operationally, the instrument ties prescribing authority and dosing tightly to patient classification and treatment phase, ties supplier payments to ex‑manufacturer prices and ready‑prepared mark‑ups, and requires reliance on external instruments and resources for pack sizes, maximum quantity determinations and growth chart percentiles (see s 6 references to the Listing Instrument and CDC growth charts).

(Authorities: s 6; ss 9-16; s 11(3); ss 17-23; ss 24-26; Schedule 1.)

The instrument creates legal effects for several distinct groups, with different decision and payment points for each:

Patients classified as eligible children or eligible adults (s 6). Only those persons are legally entitled to receive growth hormone pharmaceutical benefits under a prescription that complies with the instrument (s 8). Children whose bone age meets the "mature skeleton" threshold but who are under 18 are eligible only if they have Prader‑Willi syndrome (s 6). Adults with late onset growth hormone deficiency are explicitly included (s 6).
Prescribers: authorised prescribers vary by phase (s 6 authorised prescriber table; ss 9, 15). Initial, changing drug, non‑PBS to PBS supply phases for children require paediatric endocrinology specialists, or general paediatricians prescribing in consultation with a nominated paediatric endocrinologist (s 6 table item 1). Continuing phases for children may be prescribed by a medical practitioner (s 6 item 2). Recommencement or reclassified patient recommencement prescriptions require a medical practitioner in consultation with a nominated specialist in paediatric endocrinology or general paediatrics (s 6 item 3). For eligible adults, the authorised prescriber for initial and continuing phases is an endocrinology specialist or consultant physician (s 6 authorised prescriber definition).
Approved suppliers: approved hospital authorities for public and private hospitals, approved pharmacists, and approved medical practitioners (s 6 definitions). Section 7 expressly allows approved hospital authorities to make special arrangement supplies to patients receiving treatment in or from the hospital, notwithstanding s 94 of the Act. Payment rules differ by supplier class (ss 17-21).
Pharmacists and dispensing staff: the obligations on quantity per script, repeat limits, the way broken pack quantities are priced and rounding rules (ss 10-11, 18-21) affect operational dispensing and stock management for community pharmacies and hospital pharmacies. Ready‑prepared products attract mark‑ups and a ready‑prepared dispensing fee for non‑hospital suppliers (s 21-22).
Hospital administrators and finance officers: public hospital authorities receive payment under subsection 99(4) of the Act as implemented by ss 17-18, with a dispensed price calculation that forbids mark‑ups on public hospital claims (s 18 note; s 18(1) note). Private hospital authorities also have specific payment rules (s 20).
CTG registered patients and CTG suppliers: for patients registered under subsection 10(2) of the CTG Special Arrangement, the CTG co‑payment reduction rules and Commonwealth payment provisions apply to special arrangement supplies with specified modifications. Approved suppliers who claim under the manual system must include an indicator flagging CTG registration (ss 24-25).
Administrators of the Listing Instrument and Part VII mechanisms: the instrument cross‑references the Listing Instrument for maximum quantities, pack quantities and ready‑prepared classification (s 6 note; s 22(2) note). Those determinations materially control permissible pack sizes and mark‑up bases.

Who pays and who is paid, in practice: the patient is only entitled to pay up to the s 87 charge; the Commonwealth pays suppliers the gap between the dispensed price as calculated by this instrument and the s 87 charge, subject to conditions and CTG modifications (ss 17, 19, 20; s 24). For CTG registered patients certain co‑payment reductions apply under the CTG Special Arrangement as modified (s 24).

The instrument therefore affects clinical practice (who may initiate or continue therapy and how dosing is calculated), pharmacy operations (pack breaks, stock management, claims), hospital supply arrangements, and Commonwealth expenditure through defined dispensed price formulas and mark‑ups.

(Authorities: s 6; ss 7-11; ss 17-25; Schedule 1; s 22 notes.)

The instrument creates prescriptive duties and corresponding rights in the supply, prescribing and payment chain. The primary duties and rights, and the sections that create them, are:

Duty to supply only eligible persons (s 8). A supplier must not supply a growth hormone benefit on a prescription for a person who is not entitled to PBS benefits under s 86 of the Act, or who is not an eligible child or adult when the prescription is written. This is an exclusionary duty that binds all supplies under the arrangement.
Prescription content and prescriber duties (ss 9-16). For eligible children, a prescription must: (a) be for a growth hormone pharmaceutical benefit listed in Schedule 1 (s 9(a)); (b) meet the requirements of Subdivision B (ss 10-14); and (c) be written by an authorised prescriber (s 9(c)). For eligible adults similar constraints apply (s 15). The authorised prescriber rules are precise and vary by phase (s 6). Prescribers must ensure the prescription phase, quantities, repeats and doses comply with the instrument’s tables and dose calculation formulas (s 11).
Duty to calculate doses according to the instrument (s 11). Prescribers must not prescribe doses other than in accordance with s 11. The instrument prescribes specific maximum doses for listed indications and drugs, prescribes the formula for body surface area, permits limited percentage excess when pack sizes prevent exact dosing (s 11(4)), and allows rounding where pack constraints apply for somatrogon (s 11(5)).
Duty to use ideal body weight in specified cases (s 12). If item 3 or 4 of s 11(2) applies and the eligible child has a BMI greater than the 85th percentile, the dose calculation must use ideal body weight as defined in s 12(3). The instrument therefore imposes an evidentiary duty on prescribers to determine BMI percentile and derive ideal body weight correctly.
Right of approved hospital authorities to supply (s 7). Despite s 94 of the Act, hospital authorities approved to supply pharmaceutical benefits to hospital patients may make special arrangement supplies of growth hormone pharmaceutical benefits to patients receiving treatment from that hospital (s 7(1)). This creates a supply right for hospital authorities that might otherwise be limited.
Right to Commonwealth payment for approved suppliers (ss 17, 19, 20). Approved hospital authorities and other approved suppliers are entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price exceeds the amount they were entitled to charge under s 87 of the Act in relation to the supply, subject to the conditions in ss 17, 19 and 20 and the Act (ss 17(1), 19(2), 20(1)). Those entitlements are constrained by the dispensed price formulas (ss 18, 21) and by the conditions that apply under the Act such as s 99AAA and section 98C conditions (s 19(1)(b); s 19 note).
Duty as to broken quantities, rounding and mark‑ups (ss 18-22). Suppliers calculating Commonwealth payment must follow the broken quantity and rounding formulas in ss 18 and 21(2), and apply mark‑ups and ready‑prepared dispensing fees for non‑hospital suppliers per s 21 and s 22. Public hospital suppliers are specifically precluded from adding mark‑ups to the cost for which payment is claimed (s 18 note).
CTG specific duties (ss 24-25). When supplying a CTG registered patient, suppliers must apply the CTG Special Arrangement co‑payment reduction and payment provisions as modified by s 24. Claims submitted using the manual CTG claim route must include an indicator that the supply was made to a CTG registered patient (s 25(1)).
Transitional and saving effect for prior actions (s 26). Acts done under the 2015 instrument that could have been done under the 2025 instrument retain effect as if done under the 2025 instrument (s 26(1)-(2)). That preserves certain rights and positions established prior to repeal.

The instrument also creates limited administrative rights: suppliers may claim Commonwealth payment under the dispensed price formulas (ss 17, 19). Prescribers gain the right to prescribe within the phases they are authorised for, but with constrained repeats and phase duration limits (s 10 tables, s 16 for adults). Patients gain rights to access listed brands and forms when prescriptions meet these requirements, and CTG registered patients gain co‑payment reductions under the CTG Special Arrangement as applied (s 24).

(Authorities: s 8; ss 6, 9-16; ss 17-25; s 26; Schedule 1.)

The instrument itself sets supply and prescribing constraints and payment entitlements, but it does not create standalone civil penalty or criminal penalty provisions within the text provided. Enforcement and penalties therefore flow from the operation of the National Health Act 1953 and related Part VII mechanisms as modified by this instrument. The instrument’s operative provisions create compliance obligations the breach of which can attract existing Act‑level sanctions. Key enforcement touchpoints and mechanisms in the instrument are:

Exclusionary supply rule (s 8). The enforceable duty that growth hormone pharmaceutical benefits must not be supplied unless the person is entitled under s 86 of the Act and is an eligible child or adult means that unlawful supplies can be challenged under the Act’s enforcement mechanisms. The instrument makes compliance with it a precondition of lawful PBS supply.
Conditions on supplier payments (ss 17, 19, 20). The Commonwealth’s payment obligations are limited to amounts calculated under the dispensed price rules in ss 18 and 21, and are subject to conditions determined under s 98C of the Act and s 99AAA of the Act (s 19(1)(b)). Non‑compliance with the conditions of Part VII or these sections may lead to clawbacks or refusal of payment under the Act’s payment control regime.
Interaction with existing Act provisions (s 5 note). The instrument expressly states that Part VII of the Act, and instruments made for the purposes of Part VII, have effect subject to this instrument (s 5 note). That means enforcement bodies applying Part VII will treat this instrument as the operative rule for growth hormone supplies. Any penalties in Part VII or the Health Insurance Act derived mechanisms remain the enforcement avenue.
CTG Special Arrangement application (s 24). For CTG registered patients, the CTG Special Arrangement’s co‑payment and payment rules apply with modifications. The CTG instrument includes its own compliance and payment control rules; where applied, those compliance frameworks would govern CTG‑linked supplies under this instrument as modified.
Claims and manual system indicator (s 25). The instrument requires an indicator on manual CTG claims; incorrect claim documentation may lead to rejected claims or corrective enforcement actions under s 99AAA of the Act.
Transitional saving (s 26). The saving provision reduces short‑term enforcement friction by preserving actions lawfully taken under the 2015 instrument where they are allowable under the 2025 instrument. That both limits immediate retrospective enforcement risk and provides a transitional buffer.

The 2025 instrument therefore operates primarily by creating clear compliance conditions and tying Commonwealth payments to calculated dispensed prices and to the supplier’s adherence to the prescriber, dose and quantity rules. Enforcement will be carried out under the Act’s existing sanctioning and payment control framework rather than by new penalty clauses in the instrument itself. Practically, suppliers should expect payment audits, claim rejections and potential recovery of overpayments where supplies or claims do not meet the detailed requirements in ss 8-25.

(Authorities: s 8; ss 17-21; s 24-25; s 5 note; s 26.)

The instrument cross‑references and modifies the operation of several existing legal instruments and statutory provisions. The interaction points are explicit in the text:

The National Health Act 1953, Part VII. The instrument is made under ss 85A, 99 and 100 of the Act (s 3) and states that Part VII of the Act, and regulations or instruments made for that Part, have effect subject to this instrument (s 5 note). That means where the instrument applies, its provisions displace or override conflicting Part VII provisions for growth hormone special arrangement supplies.
The Listing Instrument (National Health (Listing of Pharmaceutical Benefits) Instrument 2024). The instrument refers to the Listing Instrument for determinations such as maximum quantity of ready‑prepared pharmaceutical benefits and the circumstances codes that allow prescriptions (s 6 notes; s 11(2) note; s 22(2) note). The Listing Instrument’s determinations about maximum quantities and circumstances codes directly control how many units may be prescribed in a phase and what conditions permit prescribing.
Existing Commonwealth price determinations for hospital supplies. The instrument explicitly applies despite the National Health (Commonwealth Price,Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 and the National Health (Commonwealth Price - Pharmaceutical benefits supplied by private hospitals) Determination 2020 in specified respects (ss 17(2) and 20(2) respectively). That is, the dispensed price and payment rules in this instrument govern Commonwealth payments for these special arrangement supplies rather than those existing price determinations.
The Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020 (ready‑prepared dispensing fee). The instrument uses definitions from that Determination such as "ready‑prepared dispensing fee" (s 6 definitions). Where the instrument includes the ready‑prepared dispensing fee in dispensed price calculations for non‑hospital suppliers, it thereby integrates the Determination’s concept into its payment mechanism (s 21(1)(a)(iii), (b)(ii), (c)(iv)).
The CTG Special Arrangement. For CTG registered patients, the CTG Special Arrangement’s co‑payment and payment rules apply with specified modifications (s 24). The instrument modifies references in the CTG instrument so that a "supply under the CTG Special Arrangement" is treated as a "special arrangement supply" under this instrument, and a "CTG supplier" is taken to be the approved supplier who made the special arrangement supply (s 24(3)). However, notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply to these special arrangement supplies where those notes relate to claim procedures (s 24(4) and note).
The National Health (Pharmaceutical Benefits) Regulations 2017. Section 23 notes the relevance of s 49 of those Regulations for circumstances in which a supply may be directed to be made as a single occasion rather than a repeated supply. The instrument therefore expects suppliers and prescribers to consider the Regulations when structuring prescriptions to ensure only one dispensing fee is claimed in the edge case described in s 23.
CDC growth charts and external clinical materials. The instrument defines "CDC growth charts" as the 2000 CDC Growth Charts and the CDC Extended BMI‑for‑Age Growth Charts published in 2002 and 2022 respectively and in effect at commencement (s 6). The instrument requires calculation of BMI percentiles using those charts when determining whether to apply ideal body weight rules (s 12). Reliance on external clinical reference materials means clinical staff and administrators must refer to those external resources when applying the instrument.
Other instruments and Ministerial determinations. The instrument depends on Ministerial declarations under s 85 and determinations about form, manner of administration and brand for listed drugs (Schedule 1 notes). It also references the Act’s definitions for public hospital, approved supplier, medical practitioner and other terms, which derive from Part VII and the Health Insurance Act definitions as applied under s 6 notes.

In short, this instrument sits within the Part VII PBS special arrangement architecture and overrides or modifies particular rules from existing Commonwealth price determinations and the CTG arrangement for the class of growth hormone supplies described. Suppliers and prescribers must therefore operate with awareness of the instrument and the specific external instruments the instrument incorporates by reference or modifies (Listing Instrument, price determinations, CTG Special Arrangement, Regulations, CDC charts).

(Authorities: s 3; s 5 note; s 6 notes; ss 17(2), 20(2); s 21; s 22 note; s 23 note; ss 24-25; Schedule 1 notes.)

This instrument expressly repeals and replaces the earlier National Health (Growth Hormone Program) Special Arrangement 2015 as set out in Schedule 2, item 1 which provides for the repeal of the whole 2015 instrument (Schedule 2). The 2025 instrument itself is presented as the replacement instrument and contains a transitional saving in s 26 to preserve actions done under the 2015 instrument where those actions could have been done under the 2025 instrument.

Specific commencement and amendment mechanics in the instrument are:

Commencement: the whole instrument commences on 1 October 2025 (s 2 table). The instrument notes the commencement table only relates to provisions as originally made and will not be amended in the instrument for later amendments (s 2(2)).
Authority for amendment and repeal: the instrument is made under ss 85A, 99 and 100 of the National Health Act 1953 (s 3). Section 4 instructs that instruments specified in Schedule 2 are amended or repealed as set out in Schedule 2.
Transitional saving: section 26 preserves things done under the 2015 instrument if those things could have been done under this instrument, to avoid retroactive compliance gaps. That includes supplies and claims previously made (s 26(1)-(2)).
External dependence: the instrument depends on other instruments that may be updated independently, such as the Listing Instrument, the Commonwealth price determinations, and the CTG Special Arrangement. The instrument anticipates the Listing Instrument and other instruments as in force on 1 October 2025 (s 6 notes). Any future amendments to those instruments will affect the operation of this instrument to the extent they are cross‑referenced, subject to the Act’s standard legal operation of cross‑references and priority rules.

Because the instrument is an administrative instrument made under the Act, further modification or replacement will follow the Act’s instrument‑making processes. The text does not itself provide a schedule of prior amendments to the 2025 instrument, other than the deliberate repeal of the 2015 instrument in Schedule 2. The transitional provision in s 26 is the only express mechanism preserving prior actions taken under the 2015 arrangement.

(Authorities: s 2; s 3; s 4; Schedule 2; s 26; s 6 notes.)

The instrument text provided does not reference any judicial decisions or litigation concerning either the 2025 instrument or the instrument it replaces. The instrument contains no cited cases and the Schedule 1 notes state only ministerial declarations and determinations under section 85 of the Act. Therefore, there is no litigation history recorded within the instrument itself to report.

Practically, because the instrument creates payment, prescribing and supply rules under the National Health Act 1953, disputes that could give rise to litigation would likely proceed under existing Act dispute and recovery procedures, administrative review channels, or ordinary judicial review if decisions under the instrument were challenged. The instrument, however, contains no express private right of action nor particular judicial remedy provisions. The relevant enforcement and dispute mechanisms remain those set out in the National Health Act 1953 and related instruments, which are not reproduced in this instrument.

Where parties seek to challenge actions under or decisions arising from the instrument, they would need to look to the Act and applicable administrative law pathways. The text preserves prior acts under the 2015 instrument where compatible (s 26), which may reduce immediate legal disputes about continuity for supplies and claims made prior to repeal.

(Authority: the instrument text contains no litigation references; see s 26 for transitional saving.)

The instrument contains precise numeric and reference rules that produce several practical traps for prescribers, suppliers and administrators if overlooked. The following are concrete "gotchas" grounded in the provisions:

Eligibility is not a simple age test (s 6). A person under 18 with a mature skeleton is not automatically excluded from being an eligible child if they have Prader‑Willi syndrome. Conversely, bone age is determinative. Prescribers must document bone age and diagnosis to establish eligibility. Failing to confirm and record bone age as measured against the defined thresholds (female 13.5, male 15.5) risks supplies being out of scope under s 8.
Authorised prescriber varies by treatment phase (s 6 table; ss 9-16). Initial and changing drug phases for children require paediatric endocrinology specialists or a general paediatrician working in consultation with a nominated paediatric endocrinologist. Continuing phases allow general medical practitioners to prescribe. A general practitioner who initiates an initial phase prescription without the required authorisation risks a non‑compliant prescription (s 9, s 10). Reclassification and recommencement have their own consultation requirements (s 13-14).
Dosing calculations require precise formulae and external references (s 11-12). Doses must be calculated in accordance with the instrument’s tables and body surface area formula (s 11(3)). If the child’s BMI is >85th percentile the instrument requires using ideal body weight with a prescribed method (s 12). That triggers two operational needs: access to CDC growth charts for percentile calculation and numeric procedures for deriving ideal body weight for taller children using the 50th percentile BMI for age and sex (s 12(3)(b)(iii)-(iv)). Clinical staff without easy access to those references or without standardised spreadsheet/formula tools risk non‑compliant dose calculations.
Pack size constraints can change allowable doses by up to 3% or require rounding (s 11(4)-(5)). The instrument permits dose increases up to 3% where pack and form cannot accommodate the calculated maximum, and permits rounding up to the nearest 0.2 mg or 0.5 mg for somatrogon when pack constraints apply. Those tolerances are narrow and specific; arbitrary rounding or pack substitution without checking the allowed rounding rules will breach s 11.
Broken quantity price calculations use two‑decimal percentage steps and cent rounding (ss 18(2), 21(2), 18(3), 21(3)). Payment claims for non‑pack quantities require a fraction of the approved ex‑manufacturer price computed to two decimal percentage places and rounded to the nearest cent. Small arithmetic or spreadsheet rounding errors may cause claim rejections or payment adjustments.
Public hospitals and private hospitals have different payment treatments (ss 17-18, 20). Public hospital dispensed price rules exclude mark‑ups and rely strictly on approved ex‑manufacturer or proportional ex‑manufacturer prices with broken quantity proration (s 18). Non‑hospital suppliers, in contrast, may include mark‑ups for ready‑prepared products and a ready‑prepared dispensing fee (s 21). Misclassifying a supplier or using the incorrect dispensed price formula will affect entitlement to Commonwealth payment.
Ready‑prepared mark‑up schedule is discontinuous (s 22). The mark‑up for ready‑prepared pharmaceutical benefits depends on the approved ex‑manufacturer or proportional ex‑manufacturer price range, with discrete steps such as 10% below $40, $4 flat between $40 and $100, 4% between $100 and $1,000, and $40 above $1,000. That structure can produce non‑linear mark‑up outcomes depending on small changes in the AEMP or PEMP. Claims using the wrong mark‑up rule will misstate dispensed price.
CTG supply uses a hybrid claiming approach (ss 24-25). For CTG registered patients, CTG co‑payment and payment provisions apply with modifications. Manual claims must include a CTG indicator (s 25). The instrument also states that notes to certain CTG subsections do not apply (s 24(4)). Suppliers using the CTG route must therefore reconcile the modified CTG application, the instrument’s own payment calculations, and manual claim coding. Failure to include the required indicator on a manual claim may affect payment processing.
Reliance on external instruments and documents creates versioning risk (s 6 notes). The instrument defines CDC growth charts as those existing at commencement and references the Listing Instrument and other determinations "as in force on 1 October 2025" (s 6 notes). If clinicians or suppliers use updated versions of those external documents without checking the legal references, they may misapply percentile cutoffs or maximum quantity determinations.
Reclassification and recommencement rules require recalculation and possible different dosing (ss 13-14). If a patient’s condition is reclassified to a different category of condition, a subsequent prescription must comply with s 11 in relation to the new category. Similarly, recommencement after cessation triggers fresh application of s 11. Administrative systems must track patient phase changes to ensure subsequent prescriptions and claims align with the instrument.
No new penalty clauses in the instrument itself. Enforcement proceeds under the National Health Act 1953 and related instruments. Suppliers and prescribers must therefore be aware that breaches may be treated under the Act’s recovery and enforcement mechanisms even though this instrument contains no express penalty schedule.

Each of these items is grounded in the cited provisions above and can cause rejected claims, recovered payments, or regulatory enquiries when not observed. Practical mitigation requires procedural checklists, standardised dose calculators referencing the specified CDC charts, and clear internal rules for prescriber authorisation by phase.

(Authorities: s 6; ss 9-14; s 11(3)-(5); ss 17-23; ss 24-25; s 26; Schedule 1.)

The instrument creates precise operational requirements for prescribers, suppliers and hospital administrators. Below is a practical, source‑grounded compliance checklist and recommended administrative steps tied to the instrument’s provisions.

Confirm patient eligibility before issuing or filling a prescription (s 8; s 6 definitions)

For children, document bone age to determine mature versus non‑mature skeleton using the thresholds in s 6 (female 13.5 years, male 15.5 years). If a child is under 18 and has a mature skeleton, verify a diagnosis of Prader‑Willi syndrome to be an eligible child (s 6). Keep contemporaneous bone age reports and diagnostic documentation.
For adults, confirm age and, where appropriate, late onset growth hormone deficiency diagnosis as contemplated in the eligible adult definition (s 6).

Authorised prescriber verification by phase (s 6; ss 9, 15)

For eligible children, ensure the prescriber is an authorised prescriber for the phase: initial, changing drug, or non‑PBS to PBS supply phases require a paediatric endocrinology specialist or a general paediatrician prescribing in consultation with a nominated paediatric endocrinologist (s 6 authorised prescriber table). Continuing phases may be prescribed by a medical practitioner (s 6 item 2). For recommencements and reclassified patient recommencements, ensure prescriptions are written by a medical practitioner prescribing in consultation with a nominated specialist in paediatric endocrinology or general paediatrics (s 6 item 3).
For eligible adults, prescriptions for initial and continuing phases must be written by an endocrinology specialist or consultant physician (s 6 authorised prescriber definition).
Maintain records of the consultation where the authorised prescriber requirement is satisfied, including the identity of the nominated specialist and the date of consultation.

Prescribe and dispense only listed products and forms (Schedule 1)

Verify the brand, form, and manner of administration against Schedule 1 before prescribing or dispensing. If an item in Schedule 1 omits a listed drug, follow the Schedule 1 rule that the item is taken to mention the listed drug in the closest above item containing one (Schedule 1 cl 1(2) and 2(2)).

Adhere to phase‑specific quantities and repeat limits (ss 10, 16)

For children using somatrogon or somatropin, ensure initial and recommencement prescriptions provide supplies sufficient for 16 weeks per script and total supplies for the phase do not exceed 32 weeks including repeats (s 10 table). For continuing phases, one prescription may be for 13 weeks and total quantities in the phase may be 26 weeks (s 10 table). For mecasermin, script sizes are monthly with repeats up to five occasions (s 10(3)).
For adults, ensure each prescription supplies one month’s treatment and any repeats are for monthly supplies, with up to 5 repeats per prescription (s 16(2)(b)-(d)).

Calculate doses strictly as required, and record calculations (s 11-12)

Use the dosing table in s 11 to determine maximum dose for the indication and drug. For items requiring body surface area use the formula in s 11(3) and document the height and weight used.
If s 12 applies (item 3 or 4 of s 11(2) and BMI > 85th percentile), calculate ideal body weight using s 12(3). That requires: (a) calculation of BMI percentile using the CDC growth charts as defined in s 6; and (b) if height exceeds 163.3 cm for females or 176.8 cm for males, compute ideal body weight by multiplying the 50th percentile BMI for age and sex by height squared in metres (s 12(3)(b)).
Implement standardised electronic calculators or validated spreadsheets that replicate the body surface area formula, the BMI percentile lookup using the defined CDC charts, and the ideal body weight algorithms. Store the calculation outputs in the patient record.

Apply rounding and pack constraints only as allowed (s 11(4)-(5))

If pack or manufacturer form prevents exact dosing, apply the 3% upper tolerance allowed in s 11(4) where relevant items apply. For somatrogon only, rounding up to nearest 0.2 mg or 0.5 mg is permitted when pack constraints exist (s 11(5)). Document the pack constraint and the rounding justification with manufacturer pack information.

Maintain robust stock and dispensing procedures for broken quantities and ready‑prepared products (ss 18-22)

For public hospital supplies, calculate the dispensed price as the sum of the approved ex‑manufacturer price or proportional ex‑manufacturer price for full pack multiples and prorate broken quantities by percentage to two decimal places and cents rounding to the nearest cent (s 18(1)-(3)).
For other approved suppliers, include applicable mark‑ups for ready‑prepared products per s 22, and add the ready‑prepared dispensing fee where applicable per s 21(1)(a)(iii). If a pack is a broken quantity, apply the proration method in s 21(2) and round results to the nearest cent (s 21(3)).
Implement claim calculation templates that reproduce the two‑decimal percentage proration rule and rounding steps, to avoid arithmetic mismatches that cause audit adjustments.

CTG registered patient handling and claims (ss 24-25)

If the patient is a CTG registered patient, apply the CTG Special Arrangement co‑payment reduction and payment provisions as modified by s 24. Be aware that the instrument treats a "supply under the CTG Special Arrangement" as the special arrangement supply and a "CTG supplier" as the approved supplier making the special arrangement supply (s 24(3)).
When submitting manual claims under s 99AAA of the Act for CTG patients, include the indicator that the supply was made to a CTG registered patient as required by s 25(1). Check whether your claim submission systems have fields for the indicator, and train staff on its use.

Documentation and audit trail (s 26 and general)

Keep copies of prescriptions, authorised prescriber credentials or consultation notes, dose calculations, CDC percentile lookups, bone age reports and diagnostic evidence, pack and manufacturer packaging information where rounding or pack constraints applied, and claim calculation worksheets. These records will support entitlement to Commonwealth payments and defend against potential recoveries or audits.
For supplies made prior to 1 October 2025 under the 2015 instrument, confirm whether actions fall within s 26 transitional saving. Document the rationale why a prior act is preserved under s 26(1).

Ensure internal governance for phase changes and recommencements (ss 13-14)

Develop procedures to flag patients who are reclassified to a new condition category or who recommence treatment after cessation. A new prescription after reclassification or recommencement must comply anew with the dosing and quantity rules in s 11 (ss 13-14). Administrative flags in electronic medical records will reduce the risk of inappropriate repeat authorisations.

Training and version control for external references (s 6 notes)

Ensure clinicians and pharmacy staff use the CDC growth charts versions defined in s 6 for BMI percentiles, and that clinical reference materials used in dose calculations match the instrument’s legal references. If external documents are updated after commencement, document which version was used in each calculation.

Claims accuracy and reconciliation (ss 17-21)

Reconcile claimed dispensed prices with the instrument’s formulas. For hospital suppliers, ensure that mark‑ups are not included on the cost of the pharmaceutical benefit for which payment is claimed (s 18 note). For non‑hospital suppliers, confirm correct mark‑up banding per s 22.

Seek clarification where the Listing Instrument determines maximum quantity or pack definitions (s 6 note; s 22(2) note)

If there is ambiguity about pack quantity or maximum quantity for a particular ready‑prepared pharmaceutical item, consult the Listing Instrument as in force on 1 October 2025 and any subsequent relevant determinations referenced by the Act.

Following this checklist will align clinical, pharmacy and finance practice with the instrument’s requirements and reduce risk of rejected claims, Commonwealth payment adjustments, and regulatory follow up. The operational steps emphasise documentation and reproducible calculations, because the instrument requires precise numeric steps for doses, broken quantities and dispensed price calculations (ss 11, 18, 21).

(Authorities: s 6; ss 9-16; ss 11-12; ss 17-23; ss 24-26; Schedule 1.)

National Health (Growth Hormone Program) Special Arrangement 2025

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