PB 60 of 2015
National Health (IVF Program) Special Arrangement 2015
National Health Act 1953
I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 29 June 2015
JULIANNE QUAINE
Assistant Secretary
Pharmaceutical Access Branch
Department of Health
Part 1 - Preliminary
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (IVF Program) Special Arrangement 2015.
(2) This Special Arrangement may also be cited as PB 60 of 2015.
2 Commencement
This Special Arrangement commences on 1 July 2015.
3 Revocation
This Special Arrangement revokes the National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011).
4 Definitions
In this Special Arrangement:
Act means the National Health Act 1953.
approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
approved hospital authority has the same meaning given by subsection 84(1) of the Act.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 10; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 12.
other special arrangement means another Special Arrangement under section 100 of the Act.
Regulations mean the National Health (Pharmaceutical Benefits) Regulations 1960.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:
• Approved ex-manufacturer price
• Approved pharmacist
• Approved medical practitioner
• Brand
• Pack quantity
• Pharmaceutical benefit
• Proportional ex-manufacturer price
Part 2 – Pharmaceutical benefits covered by this Special Arrangement
5 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
(2) Each pharmaceutical benefit is a brand of a listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
6 Application of Part VII of the Act
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies, subject to this Special Arrangement.
Note: See subsection 100(3) of the Act.
7 Section 100 only supply
(1) If the code ‘D(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement, and any other Special Arrangement relating to the listed drug.
(2) A pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical benefits Scheme.
Note: The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
(3) If the code ‘PB(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and with any other Special Arrangement relating to the pharmaceutical benefit.
(4) A pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical benefits Scheme.
Note: The Minister has declared, under paragraph 85(8)(a) of the Act, that this pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
(5) If the code ‘C(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can only be supplied in the circumstances identified in the instrument made under section 85A of the Act and in accordance with this Special Arrangement.
(6) A pharmaceutical benefit mentioned in subsection (5) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has declared, under paragraph 85(8)(b) of the Act, that 1 or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Part 3 – Payment amounts
Division 1 – Payments to suppliers that are approved hospital authorities for public hospitals
8 Payments to approved hospital authorities for public hospitals
(1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 17.
(2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital is to be worked out under Division 1 of Part 4.
(3) 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.
Division 2 – Payments to suppliers that are approved hospital authorities for private hospitals, approved pharmacies or approved medical practitioners
9 Payments to certain suppliers of pharmaceutical benefits
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 17.
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 17.
(3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner is to be worked out under Division 2 of Part 4.
Part 4 – Dispensed price
Division 1—Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital
10 The dispensed price—supply by public hospital
(1) The dispensed price for the supply of a pharmaceutical benefit by a hospital authority for a public hospital is as follows:
(a) if the quantity of the pharmaceutical benefit that is ordered and 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 for each pack quantity;
(b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 11;
(c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of:
(i) the approved ex-manufacturer price or the proportional ex-manufacturer price for each pack quantity; and
(ii) the amount calculated in accordance with section 11 for the remainder of the quantity supplied that is less than a pack quantity.
11 Where quantity is less than a pack quantity
(1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 10(1)(b) and subparagraph 10(1)(c)(ii) is to be calculated 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 for the pack quantity.
Division 2 – Dispensed price for supply of a pharmaceutical benefit by certain suppliers
12 The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner
(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, is as follows:
(a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of:
(i) the approved ex-manufacturer price or of the proportional ex-manufacturer price for each pack quantity, plus the mark-up mentioned in section 13, taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of:
(i) the amount calculated in accordance with section 14; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex-manufacturer price or the proportional ex-manufacturer price for the pack quantity, plus the mark-up mentioned in section 13, taken to the nearest cent, with one half cent being counted as 1 cent; and
(ii) the amount calculated in accordance with section 14 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.
13 Mark-up
For subparagraphs 12(1)(a)(i) and 12(1)(c)(i) and for paragraph 14(a), the mark-up for a pack quantity of a ready-prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark-up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark-up is the amount mentioned in the table below for the approved ex-manufacturer price (AEMP) or for the proportional ex-manufacturer price (PEMP) for that quantity.
(b) if the pack quantity for which a mark-up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark-up is worked out as follows:
(i) if the mark-up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark-up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and
(ii) if the mark-up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark-up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
14 Where quantity is less than a pack quantity
If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraphs 12(1)(b)(i) and 12(1)(c)(ii) is to be calculated by:
(a) adding the mark-up mentioned in section 13 to the approved ex-manufacturer price or the proportional ex-manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
15 Dispensing fee
If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.
Division 3 – Dispensed price – Other matters
16 Rounding up of dispensed price
The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.
Part 5 – Patient contributions
17 Patient contributions
(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority for a public hospital or a private hospital supplies a pharmaceutical benefit to an eligible patient and makes a claim for payment.
(2) The approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
Part 6 – Approved Hospital Authorities
18 Modified application of section 94 approved hospital authorities
(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.
(2) An approved hospital authority may supply pharmaceutical benefits to patients receiving treatment in or at the approved hospital or outside of the approved hospital.
Part 7 - Transitional arrangements
19 Definitions
In this part:
old Arrangement means the National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011), as in force immediately before 1 July 2015.
20 Claim lodged but not determined under the old Arrangement
When a claim for payment has been lodged under the old Arrangement and a decision is outstanding on whether to pay the claim as at 1 July 2015, after the commencement of this Special Arrangement, the claim is to be processed under the old Arrangement.
21 Supply made but not claimed for under old Arrangement
(1) If a claim for payment is lodged for an old supply after commencement of this Special Arrangement, the claim will be processed under the old Arrangement.
(2) In this section:
old supply means a supply of a pharmaceutical benefit that was made under the old Arrangement, but for which no claim has been lodged prior to the commencement of this Special Arrangement.
22 Stock on hand as at 1 July 2015
(1) Where a supplier of pharmaceutical benefits under the old Arrangement holds stock, being pharmaceutical benefits listed in Schedule 1, as at 1 July 2015, that supplier may continue to supply that stock under the old Arrangement until 30 September 2015.
(2) All claims for supply under this section must be processed and, if valid, paid for under the old Arrangement.
23 Repeal of this Part
This Part is repealed on 1 January 2016.
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information
(sections 5 and 7)
Listed Drug
Form
Manner of Administration
Brand
Section 100
only
Cetrorelix
Powder for injection 250 micrograms (as acetate) with diluent
Injection
Cetrotide
D(100)
Choriogonadotropin Alfa
Solution for injection 250 micrograms in 0.5 ml pre-filled pen
Injection
Ovidrel
D(100)
Choriogonadotropin Alfa
Solution for injection 250 micrograms in 0.5 mL pre‑filled syringe
Injection
Ovidrel
D(100)
Chorionic Gonadotrophin
Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL
Injection
Pregnyl
C(100)
Chorionic Gonadotrophin
Powder for injection 5,000 units with solvent
Injection
Pregnyl
PB(100)
Corifollitropin Alfa
Solution for injection 100 micrograms in 0.5mL single dose pre‑filled syringes
Injection
Elonva
D(100)
Corifollitropin Alfa
Solution for injection 150 micrograms in 0.5mL single dose pre‑filled syringes
Injection
Elonva
D(100)
Follitropin Alfa
Injection 300 I.U. in 0.5 mL multi‑dose cartridge
Injection
Gonal‑f Pen
C(100)
Follitropin Alfa
Injection 450 I.U. in 0.75 mL multi‑dose cartridge
Injection
Gonal‑f Pen
C(100)
Follitropin Alfa
Injection 900 I.U. in 1.5 mL multi‑dose cartridge
Injection
Gonal‑f Pen
C(100)
Follitropin Beta
Solution for injection 300 I.U. in 0.36 mL multi‑dose cartridge
Injection
Puregon 300 IU/0.36 mL
C(100)
Follitropin Beta
Solution for injection 600 I.U. in 0.72 mL multi‑dose cartridge
Injection
Puregon 600 IU/0.72 mL
C(100)
Follitropin Beta
Solution for injection 900 I.U. in 1.08 mL multi‑dose cartridge
Injection
Puregon 900 IU/1.08 mL
C(100)
Ganirelix
Injection 250 micrograms (as acetate) in 0.5 mL pre‑filled syringe
Injection
Orgalutran
D(100)
Human Menopausal Gonadotrophin
Powder for injection 600 I.U. with solvent
Injection
Menopur 600
D(100)
Human Menopausal Gonadotrophin
Powder for injection 1,200 I.U. with solvent
Injection
Menopur 1200
D(100)
Nafarelin
Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses
Nasal
Synarel
C(100)
Progesterone
Vaginal gel (prolonged release) 90 mg in single dose pre‑filled applicator
Vaginal
Crinone 8%
D(100)
Progesterone
Vaginal Tablet 100 mg
Vaginal
Endometrin
D(100)
Progesterone
Pessary 100 mg
Vaginal
Oripro
D(100)
Progesterone
Pessary 200 mg
Vaginal
Oripro
D(100)
