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Commonwealth Coat of Arms of Australia
National Health (IVF 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—Payment for special arrangement supplies of IVF pharmaceutical benefits
Division 1—Supplies by approved hospital authorities for public hospitals
8 Rates of payment for approved hospital authorities for public hospitals
9 Dispensed price for approved hospital authorities for public hospitals
Division 2—Supplies by other approved suppliers
10 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners
11 Rates of payment for approved hospital authorities for private hospitals
12 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals
13 Mark‑up for ready‑prepared pharmaceutical benefits
14 Dispensing fee
Part 3—Supply to CTG registered patients
15 Application of the CTG Special Arrangement—co‑payment and payment etc.
Part 4—Claims for payment
16 Claims for payment for supply of benefits
Part 5—Application, saving and transitional provisions
Division 1—Provisions relating to this instrument as made
17 Things done under the National Health (IVF Program) Special Arrangement 2015
Schedule 1—IVF pharmaceutical benefits
Schedule 2—Repeals
National Health (IVF Program) Special Arrangement 2015
Part 1—Preliminary
Division 1—General
1 Name
(1) This instrument is the National Health (IVF Program) Special Arrangement 2025.
(2) This instrument may also be cited as PB 113 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
-
- 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 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 in vitro fertilisation (IVF) pharmaceutical benefits will be available to persons who are receiving IVF treatment from an accredited ART centre (short for accredited assisted reproductive technology centre).
IVF pharmaceutical benefits can only be supplied in accordance with this instrument on the basis of prescription by a medical practitioner practising for such a centre.
This instrument also deals with payments for supplies of IVF 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 the following:
(a) hospital;
(b) public hospital.
Note 2: Under subsection 4(1A) of the Act, a word or phrase used in the Act that is 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 take their meaning from that Act include the following:
(a) medical practitioner;
(b) private hospital.
In this instrument:
accredited ART centre has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.
Act means the National Health Act 1953.
approved ex‑manufacturer price of a listed brand of a pharmaceutical item 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.
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 special arrangement supply of an IVF pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 9; and
(b) for the special arrangement supply of an IVF pharmaceutical benefit by any other approved supplier—has the meaning given by section 12.
IVF pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.
maximum quantity: see subsection 13(2).
pack quantity of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.
pharmaceutical benefit has the same meaning as in Part VII 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 National Health (Listing of Pharmaceutical Benefits) Instrument 2024.
RTAC Accredited Unit number means the number by which the Reproductive Technology Accreditation Committee of the Fertility Society of Australia identifies a person or body as being an accredited ART centre.
special arrangement supply: a supply of an IVF pharmaceutical benefit is a special arrangement supply if the benefit is supplied:
(a) to a person receiving in vitro fertilisation treatment from an accredited ART centre; and
(b) on the basis of a prescription by a medical practitioner practising for such a centre.
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 IVF 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 IVF 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—Payment for special arrangement supplies of IVF pharmaceutical benefits
Division 1—Supplies by approved hospital authorities for public hospitals
8 Rates of payment for approved hospital authorities for public hospitals
(1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an IVF 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 3 of this instrument in relation to the special arrangement supply of an IVF 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 (PB 25 of 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.
9 Dispensed price for approved hospital authorities for public hospitals
(1) The dispensed price for a special arrangement supply of an IVF 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 of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);
(c) if neither paragraph (a) or (b) 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 worked out in accordance with subsection (2) for the remainder 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
10 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 an approved medical practitioner who has made a special arrangement supply of an IVF 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 3 of this instrument in relation to the special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.
(3) This section applies despite subsections 99(2) and (2AA) of the Act.
11 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 an IVF 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 3 of this instrument in relation to the special arrangement supply of an IVF 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 (PB 99 of 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.
12 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals
(1) The dispensed price for a special arrangement supply of an IVF 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 13 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 of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—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) or (b) 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 13 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 of the quantity that is a broken quantity; 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 13 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).
Rounding
(3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).
13 Mark‑up for ready‑prepared pharmaceutical benefits
(1) For the purposes of subparagraphs 12(1)(a)(ii), 12(1)(c)(ii) and 12(2)(b)(ii), the mark‑up for a pack quantity of an IVF pharmaceutical benefit that is 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) 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 National Health (Listing of Pharmaceutical Benefits) Instrument 2024, as in force on 1 October 2025, contains the determination of the maximum quantity of a ready‑prepared pharmaceutical benefit having a pharmaceutical item.
14 Dispensing fee
If a medical practitioner practising for an accredited ART centre:
(a) prescribes an IVF pharmaceutical benefit to a person receiving in vitro fertilisation treatment from the centre; and
(b) 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, not exceeding the total quantity or number of units that could be prescribed if the medical practitioner 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 3—Supply to CTG registered patients
15 Application of the CTG Special Arrangement—co‑payment and payment etc.
(1) This section applies to a special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.
(2) Despite section 87 of the Act and sections 8, 10 and 11 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 16 of this instrument.
Part 4—Claims for payment
16 Claims for payment for supply of benefits
(1) A claim for payment of an amount to which an approved supplier is entitled in respect of the special arrangement supply of an IVF pharmaceutical benefit must include:
(a) the RTAC Accredited Unit number for the accredited ART centre for which the medical practitioner who prescribed the supply of the IVF pharmaceutical benefit was practising; and
(b) an indicator that the supply was made to a CTG registered patient, if the claim is made:
(i) in respect of a supply made to such a patient; and
(ii) 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
17 Things done under the National Health (IVF Program) Special Arrangement 2015
(1) If:
(a) a thing was done for a particular purpose under the National Health (IVF 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 claim for payment being made.
Schedule 1—IVF pharmaceutical benefits
Note: See the definition of IVF pharmaceutical benefit in section 6.
| Listed Drug | Form | Manner of Administration | Brand |
|---|
| Cetrorelix | Powder for injection 250 micrograms (as acetate) with diluent | Injection | Cetrotide |
| Choriogonadotropin alfa | Solution for injection 250 micrograms in 0.5 mL pre‑filled pen | Injection | Ovidrel |
| Choriogonadotropin alfa | Solution for injection 250 micrograms in 0.5 mL pre‑filled syringe (S19A) | Injection | Ovidrel (USA) |
| Chorionic gonadotrophin | Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A) | Injection | Brevactid 1500 I.E |
| Chorionic gonadotrophin | Powder for injection 5,000 units with solvent (s19A) | Injection | Choriomon 5000 I.E |
| Corifollitropin alfa | Solution for injection 100 micrograms in 0.5 mL single dose pre‑filled syringe | Injection | Elonva |
| Corifollitropin alfa | Solution for injection 150 micrograms in 0.5 mL single dose pre‑filled syringe | Injection | Elonva |
| Follitropin alfa | Injection 75 I.U. in 0.125 mL pre‑filled pen | Injection | Bemfola |
| Follitropin alfa | Injection 150 I.U. in 0.25 mL pre‑filled pen | Injection | Bemfola |
| Follitropin alfa | Injection 225 I.U. in 0.375 mL pre‑filled pen | Injection | Bemfola |
| Follitropin alfa | Injection 300 I.U. in 0.5 mL multi‑dose cartridge | Injection | Gonal‑f Pen |
| Follitropin alfa | Injection 300 I.U. in 0.5 mL multi‑dose cartridge | Injection | Ovaleap |
| Follitropin alfa | Injection 300 I.U. in 0.5 mL pre‑filled pen | Injection | Bemfola |
| Follitropin alfa | Injection 450 I.U. in 0.75 mL multi‑dose cartridge | Injection | Gonal‑f Pen |
| Follitropin alfa | Injection 450 I.U. in 0.75 mL multi‑dose cartridge | Injection | Ovaleap |
| Follitropin alfa | Injection 450 I.U. in 0.75 mL pre‑filled pen | Injection | Bemfola |
| Follitropin alfa | Injection 900 I.U. in 1.5 mL multi‑dose cartridge | Injection | Gonal‑f Pen |
| Follitropin alfa | Injection 900 I.U. in 1.5 mL multi‑dose cartridge | Injection | Ovaleap |
| Follitropin alfa with lutropin alfa | Injection 900 I.U. ‑ 450 I.U. in 1.44 mL multi‑dose cartridge | Injection | Pergoveris |
| Follitropin beta | Solution for injection 300 I.U. in 0.36 mL multi‑dose cartridge | Injection | Puregon 300 IU/0.36 mL |
| Follitropin beta | Solution for injection 600 I.U. in 0.72 mL multi‑dose cartridge | Injection | Puregon 600 IU/0.72 mL |
| Follitropin beta | Solution for injection 900 I.U. in 1.08 mL multi‑dose cartridge | Injection | Puregon 900 IU/1.08 mL |
| Follitropin delta | Injection 12 micrograms in 0.36 mL pre‑filled multi‑dose pen | Injection | Rekovelle |
| Follitropin delta | Injection 36 micrograms in 1.08 mL pre‑filled multi‑dose pen | Injection | Rekovelle |
| Follitropin delta | Injection 72 micrograms in 2.16 mL pre‑filled multi‑dose pen | Injection | Rekovelle |
| Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe | Injection | ARX Ganirelix |
| Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe | Injection | Ganirelix Lupin |
| Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe | Injection | GANIRELIX SUN |
| Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe | Injection | Ganirelix Theramex |
| Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe | Injection | Orgalutran |
| Human menopausal gonadotrophin | Powder for injection 600 I.U. with solvent | Injection | Menopur 600 |
| Human menopausal gonadotrophin | Powder for injection 1,200 I.U. with solvent | Injection | Menopur 1200 |
| Lutropin alfa | Powder for injection 75 I.U. with solvent | Injection | Luveris |
| Nafarelin | Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses | Nasal | Synarel |
| Progesterone | Capsule 200 mg | Vaginal | Utrogestan |
| Progesterone | Pessary 100 mg | Vaginal | Oripro |
| Progesterone | Pessary 200 mg | Vaginal | Oripro |
| Progesterone | Vaginal gel (prolonged release) 90 mg in single dose pre‑filled applicator | Vaginal | Crinone 8% |
| Progesterone | Vaginal tablet 100 mg | Vaginal | Endometrin |
| Triptorelin | Injection 100 micrograms (as acetate) in 1 mL pre‑filled syringe | Injection | Decapeptyl |
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.
Schedule 2—Repeals
National Health (IVF Program) Special Arrangement 2015
1 The whole of the instrument
Repeal the instrument