{"id":"F2025L01177","name":"National Health (Growth Hormone Program) Special Arrangement 2025","slug":"national-health-growth-hormone-program-special-arrangement-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442981,"registerId":"F2025L01177-fast-fetch-1775957899666","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Growth Hormone Program) Special Arrangement 2025","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nNational Health (Growth Hormone Program) Special Arrangement 2025\n\nI, Jonathon Logue, as delegate of the Minister for Health and Ageing, make the following special arrangement.\n\nDated   22 September 2025\n\nJonathon Logue\n\nActing Assistant Secretary  Community Access Programs Branch  Technology Assessment and Access Division  Department of Health, Disability and Ageing\n\n \n\n \n\n \n\nContents\n\nPart 1—Preliminary\n\nDivision 1—General\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Schedule 2\n\n5 Simplified outline\n\n6 Definitions\n\nDivision 2—Special arrangement supplies from hospitals\n\n7 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals\n\nPart 2—Supply of growth hormone pharmaceutical benefits\n\nDivision 1—General\n\n8 Growth hormone pharmaceutical benefits must be supplied only to eligible children and eligible adults\n\nDivision 2—Eligible children\n\nSubdivision A—Supply of growth hormone pharmaceutical benefits for eligible children\n\n9 Supply of growth hormone pharmaceutical benefits for eligible children\n\nSubdivision B—Prescriptions for eligible children\n\n10 Prescriptions for eligible children—general\n\n11 Prescriptions for eligible children—doses\n\n12 Calculate doses by using ideal body weights in certain cases\n\n13 Prescriptions for eligible children—doses: change of treatment category (reclassification)\n\n14 Prescriptions for eligible children—doses: recommenced treatment\n\nDivision 3—Eligible adults\n\nSubdivision A—Supply of growth hormone pharmaceutical benefits for eligible adults\n\n15 Supply of growth hormone pharmaceutical benefits for eligible adults\n\nSubdivision B—Prescriptions for eligible adults\n\n16 Prescriptions for eligible adults\n\nPart 3—Payment for special arrangement supplies of growth hormone pharmaceutical benefits\n\nDivision 1—Supplies by approved hospital authorities for public hospitals\n\n17 Rates of payments for approved hospital authorities for public hospitals\n\n18 Dispensed price for approved hospital authorities for public hospitals\n\nDivision 2—Supplies by other approved suppliers\n\n19 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners\n\n20 Rates of payment for approved hospital authorities for private hospitals\n\n21 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals\n\n22 Mark‑up for ready‑prepared pharmaceutical benefits\n\n23 Dispensing fee\n\nPart 4—Supply to CTG registered patients\n\n24 Application of the CTG Special Arrangement—co‑payment and payment etc.\n\n25 Claims for payment for supply of benefits using the manual system\n\nPart 5—Application, saving and transitional provisions\n\nDivision 1—Provisions relating to this instrument as made\n\n26 Things done under the National Health (Growth Hormone Program) Special Arrangement 2015\n\nSchedule 1—Growth hormone pharmaceutical benefits\n\n1 Growth hormone pharmaceutical benefits for treatment of eligible children\n\n2 Growth hormone pharmaceutical benefits for treatment of eligible adults\n\nSchedule 2—Repeals\n\nNational Health (Growth Hormone Program) Special Arrangement 2015\n\n \n\nPart 1—Preliminary\n\nDivision 1—General\n\n1  Name\n\n (1) This instrument is the National Health (Growth Hormone Program) Special Arrangement 2025.\n\n (2) This instrument may also be cited as PB 112 of 2025.\n\n2  Commencement\n\n (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.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 1 October 2025. 1 October 2025\n\n\nNote: 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.\n\n (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.\n\n3  Authority\n\n  This instrument is made under sections 85A, 99 and 100 of the National Health Act 1953.\n\n4  Schedule 2\n\n  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.\n\n5  Simplified outline\n\nThis 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.\n\nGrowth 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.\n\nThis instrument also deals with payments for supplies of growth hormone pharmaceutical benefits.\n\nNote: 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).\n\n6  Definitions\n\nNote 1: A number of expressions used in this instrument are defined in the Act, including public hospital.\n\nNote 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:\n\n(a) medical practitioner;\n\n(b) private hospital.\n\n  In this instrument:\n\nAct means the National Health Act 1953.\n\napproved ex‑manufacturer price of a listed brand of a pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\napproved hospital authority has the same meaning as in Part VII of the Act.\n\napproved medical practitioner has the same meaning as in Part VII of the Act.\n\napproved pharmacist has the same meaning as in Part VII of the Act.\n\napproved supplier has the same meaning as in Part VII of the Act.\n\nauthorised prescriber:\n\n (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\n\n (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.\n\n \n\n- Authorised prescribers for eligible children\n- Item Column 1Phase of treatment Column 2Authorised prescriber\n- 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\n- 2 a continuing phase of treatment a medical practitioner\n- 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\n\n\nCDC means the Centers for Disease Control and Prevention, US Department of Health and Human Services.\n\nCDC growth charts means the following growth charts:\n\n (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;\n\n (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.\n\nNote: 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).\n\nchanging 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:\n\n (a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or\n\n (b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.\n\nCTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.\n\nCTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.\n\ndispensed price:\n\n (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\n\n (b) for the supply of a growth hormone pharmaceutical benefit by any other approved supplier—has the meaning given by section 21.\n\neligible adult means a person who:\n\n (a) is not an eligible child; or\n\n (b) is 18 years of age or older and has late onset growth hormone deficiency.\n\neligible child means a person:\n\n (a) who has a non‑mature skeleton; or\n\n (b) who:\n\n (i) is less than 18 years of age; and\n\n (ii) has a mature skeleton; and\n\n (iii) has a diagnosis of Prader‑Willi syndrome.\n\ngrowth hormone pharmaceutical benefit has the meaning given by Schedule 1.\n\nideal body weight: see subsection 12(3).\n\nlisted brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\nListing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.\n\nmature skeleton: a person has a mature skeleton if the person is:\n\n (a) a female with a bone age of 13.5 years or more; or\n\n (b) a male with a bone age of 15.5 years or more.\n\nnon‑mature skeleton: a person has a non‑mature skeleton if the person is:\n\n (a) a female with a bone age of less than 13.5 years; or\n\n (b) a male with a bone age of less than 15.5 years.\n\npack quantity has the same meaning as in Part VII of the Act.\n\npercentile means a percentile specified in the CDC growth charts.\n\npharmaceutical benefit has the same meaning as in Part VII of the Act.\n\npharmaceutical 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.\n\npharmaceutical item has the same meaning as in Part VII of the Act.\n\nproportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\nready‑prepared dispensing fee has the same meaning as in the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.\n\nready‑prepared pharmaceutical benefit has the same meaning as in the Listing Instrument.\n\nspecial arrangement supply means a supply of a growth hormone pharmaceutical benefit in accordance with this instrument.\n\nDivision 2—Special arrangement supplies from hospitals\n\n7  Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals\n\n (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.\n\n (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.\n\nPart 2—Supply of growth hormone pharmaceutical benefits\n\nDivision 1—General\n\n8  Growth hormone pharmaceutical benefits must be supplied only to eligible children and eligible adults\n\n  A growth hormone pharmaceutical benefit must not be supplied upon a prescription written for a person if:\n\n (a) the person is not entitled to receive pharmaceutical benefits as mentioned in section 86 of the Act; or\n\n (b) when the prescription is written, the person is not an eligible child or eligible adult.\n\nDivision 2—Eligible children\n\nSubdivision A—Supply of growth hormone pharmaceutical benefits for eligible children\n\n9  Supply of growth hormone pharmaceutical benefits for eligible children\n\n  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:\n\n (a) the growth hormone pharmaceutical benefit is mentioned in clause 1 of Schedule 1; and\n\n (b) the prescription meets the requirements of Subdivision B of this Division; and\n\n (c) the prescription is written by an authorised prescriber for the prescription; and\n\n (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.\n\nNote: 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.\n\nSubdivision B—Prescriptions for eligible children\n\n10  Prescriptions for eligible children—general\n\n (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.\n\n (2) If the growth hormone pharmaceutical benefit has the drug somatrogon or somatropin:\n\n (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\n\n (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\n\n (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\n\n (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.\n\n \n\n- Supply of growth hormone pharmaceutical benefit that has somatrogon or somatropin for an eligible child\n- 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)\n- 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\n- 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\n\n\n (3) If the growth hormone pharmaceutical benefit has the drug mecasermin:\n\n (a) for the purposes of paragraph 9(b), the prescription must be for any of the following phases of treatment of the eligible child:\n\n (i) an initial phase of treatment;\n\n (ii) a continuing phase of treatment; and\n\n (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\n\n (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\n\n (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.\n\n11  Prescriptions for eligible children—doses\n\n (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.\n\n (2) The dose must:\n\n (a) be appropriate for treatment of the eligible child under this instrument; and\n\n (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.\n\n \n\n- Dose of growth hormone pharmaceutical benefits for eligible children\n- 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 …\n- 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.\n- 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.\n- 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.\n- 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.\n- 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.\n- 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.\n\n\n (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:\n\n![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](image.002.png)\n\n (4) The maximum dose may be up to 3% greater than the maximum dose calculated in accordance with the table in subsection (2), if;\n\n (a) the applicable item of the table is item 1, 2, 3 or 4; and\n\n (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.\n\n (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:\n\n (a) the applicable item of the table is item 6; and\n\n (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.\n\n12  Calculate doses by using ideal body weights in certain cases\n\n (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.\n\n (a) item 3 or 4 of the table in subsection 11(2) applies; and\n\n (b) the eligible child has a body mass index greater than the 85th percentile for the eligible child’s age and sex.\n\n (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.\n\n (3) The eligible child’s ideal body weight is:\n\n (a) if the eligible child is:\n\n (i) female with a height less than or equal to 163.3 centimetres; or\n\n (ii) male with a height less than or equal to 176.8 centimetres;\n\n  the 50th percentile weight for the eligible child’s height and sex; or\n\n (b) if the eligible child is:\n\n (i) female with a height greater than 163.3 centimetres; or\n\n (ii) male with a height greater than 176.8 centimetres;\n\n  the number of kilograms worked out by multiplying:\n\n (iii) the 50th percentile body mass index for the eligible child’s age and sex; by\n\n (iv) the square of the eligible child’s height in metres.\n\n13  Prescriptions for eligible children—doses: change of treatment category (reclassification)\n\n (1) This section applies if:\n\n (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\n\n (b) the person is reclassified to a different category of condition.\n\n (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.\n\n14  Prescriptions for eligible children—doses: recommenced treatment\n\n (1) This section applies if:\n\n (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\n\n (b) the person ceases treatment using a growth hormone pharmaceutical benefit, but later recommences such treatment.\n\n (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.\n\nDivision 3—Eligible adults\n\nSubdivision A—Supply of growth hormone pharmaceutical benefits for eligible adults\n\n15  Supply of growth hormone pharmaceutical benefits for eligible adults\n\n  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:\n\n (a) the growth hormone pharmaceutical benefit is mentioned in clause 2 of Schedule 1; and\n\n (b) the prescription meets the requirements of Subdivision B of this Division; and\n\n (c) the prescription is written by an authorised prescriber for the prescription; and\n\n (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.\n\nNote: 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.\n\nSubdivision B—Prescriptions for eligible adults\n\n16  Prescriptions for eligible adults\n\n (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.\n\n (2) The following paragraphs have effect:\n\n (a) for the purposes of paragraph 15(b), the prescription must be for any of the following phases of treatment of the eligible adult:\n\n (i) an initial phase of treatment;\n\n (ii) a continuing phase of treatment;\n\n (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;\n\n (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;\n\n (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.\n\nPart 3—Payment for special arrangement supplies of growth hormone pharmaceutical benefits\n\nDivision 1—Supplies by approved hospital authorities for public hospitals\n\n17  Rates of payments for approved hospital authorities for public hospitals\n\n (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.\n\nNote 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.\n\nNote 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.\n\n (2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017.\n\nNote: 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.\n\n18  Dispensed price for approved hospital authorities for public hospitals\n\n (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:\n\n (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;\n\n (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;\n\n (c) if neither paragraph (a) nor (b) of this subsection applies to the quantity of the benefit supplied—the sum of:\n\n (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and\n\n (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.\n\nNote: 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.\n\nBroken quantities\n\n (2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:\n\n(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\n\n(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for the pack quantity.\n\nRounding\n\n (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).\n\nDivision 2—Supplies by other approved suppliers\n\n19  Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners\n\n (1) This section applies:\n\n (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\n\n (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.\n\n (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.\n\nNote 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.\n\nNote 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.\n\n (3) This section applies despite subsections 99(2) and (2AA) of the Act.\n\n20  Rates of payment for approved hospital authorities for private hospitals\n\n (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.\n\nNote 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.\n\nNote 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.\n\n (2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020.\n\nNote: 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.\n\n21  Dispensed price for approved suppliers other than approved hospital authorities for public hospitals\n\n (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:\n\n (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:\n\n (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and\n\n (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\n\n (iii) the ready‑prepared dispensing fee;\n\n (b) if the quantity (the broken quantity) of the benefit supplied is less than a pack quantity of the benefit—the sum of:\n\n (i) the amount worked out in accordance with subsection (2); and\n\n (ii) the ready‑prepared dispensing fee;\n\n (c) if neither paragraph (a) nor (b) of this subsection applies to the quantity of the benefit supplied—the sum of:\n\n (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and\n\n (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\n\n (iii) the amount worked out in accordance with subsection (2) for the remainder (the broken quantity) of the quantity supplied; and\n\n (iv) the ready‑prepared dispensing fee.\n\nBroken quantities\n\n (2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out by:\n\n (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\n\n (b) applying that percentage to the sum of:\n\n (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and\n\n (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).\n\nRounding\n\n (3) The dispensed price under subsection (1) is to be rounded to the nearest cent (rounding 0.5 cents upwards).\n\n22  Mark‑up for ready‑prepared pharmaceutical benefits\n\n (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:\n\n (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\n\n (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit:\n\n (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\n\n (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.\n\n \n\n- Mark‑up for ready‑prepared pharmaceutical benefits\n- Item If the AEMP or PEMP (as applicable) for the maximum quantity is … the mark‑up for the maximum quantity is …\n- 1 less than $40 10% of the AEMP or PEMP\n- 2 at least $40 but not more than $100 $4\n- 3 more than $100 but not more than $1,000 4% of the AEMP or PEMP\n- 4 more than $1,000 $40\n\n\n (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.\n\nNote: 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.\n\n23  Dispensing fee\n\n  If:\n\n (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\n\n (b) the quantity does not exceed the total quantity or number of units that could be prescribed if the prescription directed a repeated supply;\n\nthe dispensed price for the supply of the benefit includes only one dispensing fee.\n\nNote: See section 49 of the National Health (Pharmaceutical Benefits) Regulations 2017 for the circumstances in which such a supply may be directed.\n\nPart 4—Supply to CTG registered patients\n\n \n\n24  Application of the CTG Special Arrangement—co‑payment and payment etc.\n\n (1) This section applies to a special arrangement supply of a growth hormone pharmaceutical benefit to a CTG registered patient.\n\n (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.\n\n (3) A reference in the CTG Special Arrangement to:\n\n (a) a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the special arrangement supply; and\n\n (b) a CTG supplier is taken to be a reference to the approved supplier who made the special arrangement supply.\n\n (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.\n\nNote: 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.\n\n25  Claims for payment for supply of benefits using the manual system\n\n (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:\n\n (a) by an approved supplier, in respect of a supply made to such a patient; and\n\n (b) using the manual system referred to in section 99AAA of the Act.\n\n (2) This section has effect in addition to section 99AAA of the Act.\n\nPart 5—Application, saving and transitional provisions\n\nDivision 1—Provisions relating to this instrument as made\n\n26  Things done under the National Health (Growth Hormone Program) Special Arrangement 2015\n\n (1) If:\n\n (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\n\n (b) the thing could be done for that particular purpose under this instrument;\n\nthe thing has effect for the purposes of this instrument as if it had been done for that particular purpose under this instrument.\n\n (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.\n\nSchedule 1—Growth hormone pharmaceutical benefits\n\nNote: See the definition of growth hormone pharmaceutical benefit in section 6, and paragraphs 9(a) and 15(a).\n\n \n\n \n\n1  Growth hormone pharmaceutical benefits for treatment of eligible children\n\n (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.\n\n (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:\n\n (a) occurs above the item in the table; and\n\n (b) mentions a listed drug.\n\n \n\n- Growth hormone pharmaceutical benefits for treatment of eligible children\n- Listed drug Form Manner of administration Brand\n- Mecasermin Solution for injection 40 mg in 4 mL (10 mg per mL) Injection Increlex\n- Somatrogon Injection 24 mg in 1.2 mL single use pre‑filled pen Injection Ngenla\n- Injection 60 mg in 1.2 mL single use pre‑filled pen Injection Ngenla\n- Somatropin Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick\n- Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick\n- Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick\n- Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 5\n- Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro\n- Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) Injection Saizen\n- Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 10\n- Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro\n- Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) Injection Saizen\n- Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) Injection Omnitrope Surepal 15\n- Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a pre‑filled pen Injection Norditropin FlexPro\n- Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) Injection Saizen\n\n\nNote: 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.\n\n2  Growth hormone pharmaceutical benefits for treatment of eligible adults\n\n (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.\n\n (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:\n\n (a) occurs above the item in the table; and\n\n (b) mentions a listed drug.\n\n \n\n- Growth hormone pharmaceutical benefits for treatment of eligible adults\n- Listed drug Form Manner of administration Brand\n- Somatropin Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick\n- Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative) Injection Genotropin GoQuick\n- Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen Injection Norditropin FlexPro\n\n\nNote: 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.\n\nSchedule 2—Repeals\n\n \n\nNational Health (Growth Hormone Program) Special Arrangement 2015\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This instrument repeals the 2015 National Health (Growth Hormone Program) Special Arrangement (Schedule 2) and re‑enacts an updated scheme. It retains the core scope — authorising PBS supply and Commonwealth payment for growth hormone pharmaceutical benefits — while adding precise, updated brand/formulation listings (Schedule 1), more granular dosing and ideal‑body‑weight rules (ss11‑12), prescriber authorisation tiers (s6), supplier payment formulas (ss17‑23) and CTG co‑payment modifications (ss24‑25). The text replaces the prior instrument rather than leaving it in force (Schedule 2, item 1)."},"complexity_factors":["Multiple patient categories and eligibility rules (eligible child/adult; mature vs non‑mature skeleton; Prader‑Willi carve‑out) — definitions and thresholds in s6.","Phased treatment model with phase‑specific quantity and repeat limits, differing by drug (somatropin, somatrogon, mecasermin) — ss9‑10,16.","Detailed dosing rules including body‑surface‑area formula, ideal body weight adjustments, BMI percentile triggers and rounding allowances — ss11‑12 (and image formula).","Prescriber authorisation tiers and consultation requirements (specialists, paediatric endocrinology, consultant physicians, nominated specialists) that constrain who may write initial/continuing/recommencement prescriptions — s6 (authorised prescriber table) and ss9,15.","Differentiated payment and dispensed‑price calculations for public hospital authorities, private hospitals, pharmacists and medical practitioners, with broken‑quantity pro‑rations and rounding rules — ss17‑21.","Complex mark‑up table and tiered rules for ready‑prepared benefits and interplay with manufacturer pack quantities and Listing Instrument determinations — s22 and s6 (Listing Instrument reference).","Interaction with other instruments and schemes (Part VII of the National Health Act, Listing Instrument, CTG Special Arrangement), including special modifications for CTG patients and manual claim indicators — ss3,5,24‑25 and s6 references.","Transitional and repeal mechanics replacing the 2015 arrangement and preserving acts done under the old instrument — Schedule 2 and s26.","Operational friction points: packaging/pack‑size constraints affecting allowable dose rounding and permitted quantities (see s11(4)‑(5), s18(1)‑(3), s21)."],"plain_english_summary":"This instrument sets the legal rules for supplying PBS‑funded growth‑hormone medicines to defined eligible children and adults: which brands and formulations may be supplied, who may prescribe, permitted phases and quantities, and how doses are calculated. It also sets the payment rules for suppliers (public and private hospitals, pharmacists, medical practitioners) — the Commonwealth pays the gap between the dispensed price and the permitted patient charge (see ss17,19,20) — and modifies co‑payments for CTG registered patients. It repeals the 2015 Growth Hormone Special Arrangement."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"This instrument appears to maintain the same scope as its predecessor (the 2015 version). It continues to regulate the same program (Growth Hormone Program) for the same beneficiary groups (eligible children and adults with specific growth disorders). While it updates specific products, dosing protocols, and payment mechanics, it does not appear to have expanded beyond the original purpose of subsidising growth hormone therapies through special arrangement supplies under the PBS."},"complexity_factors":["Multiple defined terms (26+ definitions in section 6 alone), including complex medical concepts like 'mature skeleton' (bone age thresholds of 13.5 years for females, 15.5 years for males)","Nested conditional logic for prescribing authority: different authorised prescribers for different phases of treatment (initial, continuing, changing drug, recommencement) and different patient types (children vs adults)","Mathematical formulas for dosing calculations including body surface area calculations and ideal body weight determinations using CDC growth chart percentiles","Cross-references to at least 4 other instruments: National Health Act 1953, National Health (Listing of Pharmaceutical Benefits) Instrument 2024, CTG Special Arrangement 2016, and Commonwealth price determinations","Tiered payment structures with different rules for public hospitals (no mark-up), private hospitals, pharmacists, and medical practitioners","Broken quantity calculations requiring percentage calculations to 2 decimal places for partial pack supplies","Schedule-based product listings with 20+ specific brands/forms for children and 3 for adults, each with specific dosage forms and administration methods","Transitional provisions preserving actions taken under the repealed 2015 instrument"],"plain_english_summary":"This instrument sets the PBS rules for subsidising specified growth‑hormone medicines, defining who can receive them, how they may be prescribed, and how suppliers are paid. It affects eligible children with defined growth disorders, adults with late‑onset deficiency, treating specialists, hospitals, pharmacists and suppliers.\n\nBecause treatment is costly, the rules protect access for patients with proven need, control dosing and prescribing to prevent misuse, and limit government exposure by specifying covered products and payment mechanics."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025","history":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025/history","analysis":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025/analysis","conflicts":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025/conflicts","importantCases":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025/important-cases","documents":"/api/acts/national-health-growth-hormone-program-special-arrangement-2025/documents"}}