July 2005 PBAC Outcomes - Deferrals

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Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2005 relating to the listing of drugs on the Pharmaceutical Benefits Scheme (PBS)

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

Drug and form	Drug use and type	Listing requested by Sponsor	PBAC outcome and comment
DOCETAXEL 20 mg and 80 mg Injection, Taxotere® Sanofi Aventis Group Major submission	Anti-cancer drug used for the treatment of breast cancer, ovarian cancer, prostate cancer and lung cancer.	Authority Required listing for the adjuvant treatment of operable node-positive breast cancer in combination with and anthracycline (eg doxorubicin hydrochloride) and cyclophosphamide.	The PBAC deferred the submission to seek clarification about certain aspects of uncertainty with the economic model.
		Sponsor’s comments	The sponsor will be responding to the PBAC’s request.
INSULIN DETEMIR 100 IU per mL, Levemir® Novo Nordisk Pharmaceuticals Pty Ltd Major submission	Long acting insulin used to treat diabetes.	Authority Required listing for the treatment of diabetes mellitus where used as basal insulin in combination with meal-related short-or rapid-acting insulin.	The PBAC deferred the application and resolved to ask the sponsor how it wishes to proceed in the absence of the sponsor’s precondition for listing, namely a recommendation to list insulin glargine.
		Sponsor’s comments	The sponsor is considering its position regarding any future course of action.
LATANOPROST and TIMOLOL, 50 mcg/mL/5 mg/mL, eye drops, Xalacom ® Pfizer Australia Pty Ltd Major submission	Anti glaucoma drug.	Restricted Benefit listing for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medication.	The PBAC deferred a decision on the listing to request that the sponsor provide a meta-analysis of two trials to include the results of a trial that became available at the time of the July PBAC meeting.
		Sponsor’s comments	The sponsor will provide the requested information.