March 2005 PBAC Outcomes - Deferrals

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Drug and form

Drug use and type

Listing requested by Sponsor

PBAC outcome and comment

LETROZOLE tablet 2.5 mg, Femara®

Novartis Pharmaceuticals Australia Pty Ltd

Major submission
Antineoplastic agent Extend the restricted benefit listing for treatment of early-stage hormone-dependent breast cancer in post-menopausal women who have completed standard adjuvant tamoxifen therapy. The PBAC deferred the submission to seek clarification of the incremental cost-effectiveness ratios based on distant recurrence alone.
Sponsor’s comments The sponsor will be responding to the PBAC request and refers you to its own website for further information.
Weblink: https://www.novartis.com/au-en/ 
PIOGLITAZONE tablet 15 mg, 30 mg and 45 mg, Actos®

Eli Lilly Australia Pty Ltd

Minor submission
Antidiabetic drug For the treatment of type 2 diabetes in indigenous Australians. Unrestricted listing for this patient group The PBAC deferred consideration of this matter until a formal process for provision of pharmaceuticals to the indigenous population under the 2004-05 Budget measure has been determined by the Department.
Sponsor’s comments The sponsor needs to clarify this decision with the PBAC.
ROSIGLITAZONE tablet, 4 mg and 8 mg, Avandia®

GlaxoSmithKline Australia Pty Ltd

Minor submission
Antidiabetic drug For the treatment of type 2 diabetes in indigenous Australians. Unrestricted listing for this patient group The PBAC deferred consideration of this matter until a formal process for provision of pharmaceuticals to the indigenous population under the 2004-05 Budget measure has been determined by the Department.
Sponsor’s comments The sponsor has no commen

Last updated
1 March 2005