March 2005 PBAC Outcomes - 1st time decisions not to recommend

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Table containing 1st time decisions not to recommend, as made by the Pharmaceutical Benefits Advisory Committee in March 2005

Drug and form	Listing requested by Sponsor	Listing requested by Sponsor	PBAC outcome and comments
CETUXIMAB solution for IV infusion, 100 mg in 50 mL, Erbitux® Alphapharm Pty Ltd Major submission	Antineoplastic agent	Authority required listing for Epidermal Growth Factor Receptor expressing metastatic colorectal cancer in patients who have failed irinotecan based therapies, and either failed or are unsuitable for oxaliplatin based therapies, to be used in combination with irinotecan.	The PBAC rejected the submission because of uncertain extent of clinical benefit and uncertain, but unfavourable, cost-effectiveness.
		Sponsor’s comments	The sponsor disagrees with the decision and is working to address the PBAC's concerns.
ETANERCEPT vial powder for injection, 25 mg, Enbrel® Wyeth Australia Pty Ltd Major submission	Used to treat inflammatory diseases such as rheumatoid arthritis.	Change to current PBS eligibility criteria for severe active rheumatoid arthritis (reduction in number of joints affected to qualify for treatment).	The PBAC rejected the submission because of uncertainty of the extent of reduced clinical benefit associated with a smaller reduction in active joint count and the resulting uncertain, but unfavourable, cost-effectiveness.
		Sponsor’s comments	The sponsor will be considering its position regarding any future course of action.
ETANERCEPT vial powder for injection, 25 mg, Enbrel® Wyeth Australia Pty Ltd Major submission	Used to treat inflammatory diseases such as rheumatoid arthritis.	Amend restriction for severe active rheumatoid arthritis.	The PBAC rejected the submission because the evidence available is not sufficiently certain to support the clinical claim.
		Sponsor’s comments	The sponsor has no comment
ETANERCEPT vial powder for injection, 25 mg, Enbrel® Wyeth Australia Pty Ltd Minor submission	Used to treat inflammatory diseases such as rheumatoid arthritis.	Transfer listing from s100 to s85 for severe juvenile chronic arthritis	The PBAC rejected the submission following advice from the Australian Paediatric Rheumatology Group that most patients are treated in paediatric rheumatology centres in outpatients’ departments of public hospitals.
		Sponsor’s comments	The sponsor will be considering its position regarding any future course of action.
LAMOTRIGINE tablet 25 mg, 50 mg and 100 mg, Bipolam® GlaxoSmithKline Australia Pty Ltd Minor submission	Treatment for epilepsy and bipolar disorder	Authority required listing for the long-term prevention of bipolar depression treatment in patients with bipolar disorder.	The PBAC rejected the submission on the basis of unfavourable cost-effectiveness.
		Sponsor’s comments	The sponsor disagrees with the decision.
MOXONIDINE tablet, 200 microgram and 400 microgram, Physiotens® Solvay Pharmaceuticals Major submission	Anti-hypertensive	Restricted benefit listing for hypertension	The PBAC rejected the submission because of doubts overall that moxonidine is no worse than ACE inhibitors in terms of effectiveness and safety and thus uncertain but unfavourable cost-effectiveness.
		Sponsor’s comments	The sponsor disagrees with the decision, and will be considering its position regarding any future course of action.
PEMETREXED powder for IV infusion, 500 mg, Alimta®  Eli Lilly Australia Pty Ltd Re-submission Minor submission	Treatment for mesothelioma and non-small cell lung cancer	Authority required listing for treatment of malignant pleural mesothelioma.	The PBAC rejected the submission on the basis of unfavourable cost-effectiveness and uncertainty about the impact on quality of life.
		Sponsor’s comments	The sponsor disagrees with the decision, and refers you to its website for further information. Weblink: www.lilly.com.au
RITUXIMAB vial, 100 mg in 10 mL, 500 mg in 50 mL, Mabthera® Roche Pharmaceuticals Pty Ltd Major submission	Antineoplastic agent	Authority required listing for previously untreated CD20 positive follicular B-cell non-Hodgkin’s lymphoma, in combination with chemotherapy.	The PBAC rejected the submission because of uncertain clinical benefit and the resulting uncertain cost-effectiveness.
		Sponsor’s comments	The sponsor will be considering its position regarding any future course of action.