March 2005 PBAC Outcomes - Deferrals

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Table containing Deferrals made by the Pharmaceutical Benefits Advisory Committee in March 2005

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:http://www.novartis.com.au
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