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.
3 Authority
This instrument is made under sections 85A, 99 and 100 of the National Health Act 1953.
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 1 Phase of treatment | Column 2 Authorised 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 has the same meaning as in the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap—PBS Co‑payment Program) Special Arrangement 2026.
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
(c) the prescription is written by an authorised prescriber for the prescription; 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 1 Phase of treatment | Column 2 Maximum quantity or number of units in one prescription | Column 3 Total 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
(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 an amount that is sufficient for the first month of treatment of the eligible child in that phase; 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
(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 5.
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 1 If the growth hormone pharmaceutical benefit has the drug … | Column 2 and the condition is in the category of… | Column 3 then 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:
(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
(c) the prescription is written by an authorised prescriber for the prescription; 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 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;
(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 adult, be directed to be repeated is 5.
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;
(c) if neither paragraph (a) nor (b) of this subsection applies to the quantity of the benefit supplied—the sum of:
(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.
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.
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;
(c) if neither paragraph (a) nor (b) of this subsection applies to the quantity of the benefit supplied—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 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 10(1), (2), (3) and (10) (co‑payment reduction etc.), section 11 (value for safety net purposes) and section 12 (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 special arrangement supply (within the meaning of the CTG Special Arrangement) of a pharmaceutical benefit is taken to be a reference to the special arrangement supply mentioned in subsection (1); and
(b) a CTG supplier is taken to be a reference to the approved supplier who made the special arrangement supply mentioned in subsection (1).
(4) However, the notes to subsections 10(2) and (3) of the CTG Special Arrangement do not apply in relation to the special arrangement supply mentioned in subsection (1).
Note: The notes to subsections 10(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 mentioned in subsection (1) 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.
