National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) IVF/Gift Program (No. PB 38 of 2005) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)

IVF/GIFT PROGRAM

No. PB 38 of 2005

I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons receiving in vitro fertilisation or gamete intra-fallopian transfer treatment:

Commencement

1.    (a)   These Arrangements commence on 1 December 2005.

(b)   The Arrangements made on 29 November 2004 with effect from 1 December 2004 are repealed with effect from the commencement of these Arrangements.

Eligibility for special pharmaceutical products

1. Subject to paragraph 3, patients who are eligible persons within the meaning of the Health Insurance Act 1973 will be provided free of charge with the special pharmaceutical products specified in the Schedule to these Arrangements.

1. Patients are eligible to be provided with special pharmaceutical products under these Arrangements for the following purposes only:

(a) in the case of the special pharmaceutical products specified in Part 1 of the Schedule — for patients who are receiving treatment as described in item 13200 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2005; or

(b) in the case of the special pharmaceutical products specified in Part 2 of the Schedule — for luteal phase support in patients who are receiving treatment as described in item 13200 of the Health Insurance (General Medical Services Table) Regulations 2005, where the luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive beta human chorionic gonadotrophin measurement.

4.    Payment of a medicare benefit for item 13200 or 13203, as the case requires, of the Health Insurance (General Medical Services Table) Regulations 2005, will be evidence of eligibility for the supply of the special pharmaceutical products specified in the Schedule to these Arrangements.

5. The special pharmaceutical products specified in the Schedule to these Arrangements must not be supplied for treatment rendered in conjunction with surrogacy arrangements. This is consistent with rule 26 of the Health Insurance (General Medical Services Table) Regulations 2005, which provides that medicare benefits are not payable under item 13200 or 13203 in these circumstances.

6. In order to obtain the supply of the special pharmaceutical products specified in the Schedule to these Arrangements, a provider is required to notify the Chief Executive Officer of Medicare Australia of the medicare number, within the meaning of subsection 84(1) of the National Health Act 1953, that is applicable to the patient.

THE SCHEDULE

PART 1: Special pharmaceutical products for patients receiving treatment as described in items 13200 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2005

Name of special pharmaceutical product	Form (strength, type, size, etc.)	Proprietary Name	Manufacturer
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL	Pregnyl	Organon (Australia) Pty Limited (OR)
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL	Pregnyl	Organon (Australia) Pty Limited (OR)
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 5,000 units and 3 ampoules solvent 1 mL	Pregnyl	Organon (Australia) Pty Limited (OR)
Follitropin Alfa	Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL	Gonal-f 75	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL	Gonal-f 75	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection 300 I.U. in 0.5 mL multi-dose cartridge	Gonal-f Pen	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL	Gonal-f	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection 450 I.U. in 0.75 mL multi-dose cartridge	Gonal-f Pen	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection 900 I.U. in 1.5 mL multi-dose cartridge	Gonal-f Pen	Serono Australia Pty Ltd (SG)
Follitropin Alfa	Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL	Gonal-f	Serono Australia Pty Ltd (SG)
Follitropin Beta	Solution for injection 100 I.U. in 0.5 mL single use vial	Puregon 100 IU/ 0.5 mL	Organon (Australia) Pty Limited (OR)
Follitropin Beta	Solution for injection 150 I.U. in 0.5 mL single use vial	Puregon 150 IU/ 0.5 mL	Organon (Australia) Pty Limited (OR)
Follitropin Beta	Solution for injection 200 I.U. in 0.5 mL single use vial	Puregon 200 IU/ 0.5 mL	Organon (Australia) Pty Limited (OR)
Follitropin Beta	Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge	Puregon 300 IU/ 0.36 mL	Organon (Australia) Pty Limited (OR)
Follitropin Beta	Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge	Puregon 600 IU/ 0.72 mL	Organon (Australia) Pty Limited (OR)
Follitropin Beta	Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge	Puregon 900 IU/ 1.08 mL	Organon (Australia) Pty Limited (OR)

PART 2: Special pharmaceutical products for luteal phase support in certain patients

Name of special pharmaceutical product	Form (strength, type, size, etc.)	Proprietary Name	Manufacturer
Progesterone	Vaginal gel (prolonged release) 90 mg in single dose pre-filled applicator	Crinone 8%	Serono Australia Pty Ltd (SG)

Dated this twenty third day of  November 2005.

JOAN CORBETT

Assistant Secretary

Pharmaceutical Benefits Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing