Positive Recommendations made by the PBAC in December 2002

Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2002

Table containing Positive PBAC Recommendations made in December 2002
Drug and form Drug use / type Proposed listing or request PBAC Recommendation
Anastrozole tablet 1 mg, Arimidex®

AstraZeneca Pty Ltd

Change to restriction and advice on therapeutic relativity

Treatment for breast cancer Restricted benefit listing for treatment of hormone-dependent advanced breast cancer in post-menopausal women. Accepted as being of similar safety and efficacy to letrozole (Femara®) in this patient group.
Choriogonadotrophin-alfa (rch), powder for injection vial with diluent, Ovidrel® Serono Australia Pty Ltd

New listing

For use in assisted reproduction techniques (eg IVF) Restricted benefit listing "to trigger ovulation and luteinisation in the treatment of anovulatory infertility in females under 41 years of age with no more than 2 live children by their present union". Also under the Section 100 IVF/GIFT Program Recommended for listing on a cost-minimisation basis compared with the urinary-derived product, with advice to the Pricing Authority that some flexibility in the cost-minimisation basis for pricing is warranted, based on a theoretical advantage of recombinant products over urinary-derived products.
Erythromycin lactobionate, IV infusion, 1 g (base), Erythrocin® IV Abbott Australasia

New listing

Antibiotic Unrestricted listing Recommended for listing as requested on the basis of the price being acceptable (in accord with the usual Pricing Authority criteria) relative to the 300 mg strength of erythromycin lactobionate injection.
Etanercept powder for injection 25 mg, Enbrel® Wyeth Australia Pty Limited

New listing

Treatment for rheumatoid arthritis Section 100 listing for the treatment of adult patients with severe active rheumatoid arthritis, who have a record of rheumatoid factor positive status and who have failed other treatment options;

For the treatment of juvenile patients aged 4 to 17 years with active polyarticular-course juvenile chronic arthritis, who have failed other treatment regimens

Recommended for listing for both adults and children, on the basis of high but acceptable cost-effectiveness ratios. Although the PBAC had no objection if the Government wished to negotiate a price volume agreement in order to share with the sponsor any risk of etanercept usage beyond the recommended restriction (and thus to support the sponsor's efforts to promote the use of etanercept within this restriction), it was considered that this risk would be limited by the wording and HIC reinforcement of the restriction, and would be further reduced by adopting a collaborative approach with the relevant expert and educational groups.
Fluticasone propionate with salmeterol xinafoate, 100 ?g-50 ?g, 250 ?g-50 ?g, 500 ?g per dose (60 doses) accuhaler and 50 ?g-25 ?g, 125 ?g-25 ?g and 250 ?g-25 ?g per dose (120 doses) metered dose inhaler, Seretide®
GlaxoSmithKline Australia

Amend listing

Asthma inhaler Amend restricted benefit listing to "patients with frequent episodes of asthma who are receiving treatment with optimal doses of inhaled fluticasone propionate". Recommended on the basis of accepted clinical practice. The Pricing Authority should take account that appreciable use outside the current tighter restriction is evidenced by changes in utilisation patterns within the asthma treatment market.
Naproxen oral suspension 125 mg in 5 mL, 500 mL, Link Medical Products Pty Ltd


Non-steroidal antiinflammatory drug Unrestricted listing Re-listing was recommended as requested on the basis of clinical need.
Progesterone prolonged release vaginal gel 8% (delivering 80 mg), single dose applicators, Crinone® - Serono Australia Pty Ltd

New listing

For use in assisted reproduction techniques (eg IVF) Section 100 under the IVF/GIFT Program. Recommended for listing on a cost-minimisation basis where 90 mg progesterone gel is equivalent to the most widely used dose of human chorionic gonadotrophin (hCG) in Australia (4,500 iu).