November 2004 PBAC Outcomes - Deferrals

Drug And Form	Drug Use And Type	Listing Requested by Sponsor	PBAC Outcome And Comment
Adalimumab 40 mg per 0.8ml injection, Humira ® Abbott Australasia Pty Ltd	Treatment for rheumatoid arthritis	Remove requirement that patients must be rheumatoid factor positive	The PBAC deferred a decision on amending the listing to allow the sponsor to provide more information to be considered in March 2005 (along with all other biological drugs PBS listed for rheumatoid arthritis).
	Treatment for rheumatoid arthritis	Sponsor's comments	The sponsor looks forward to continuing to work with the PBAC.
Anakinra pre-filled syringe, 100 mg in 0.67 mL, Kineret® Amgen Australia Pty Ltd	Treatment for rheumatoid arthritis	Remove requirement that patients must be rheumatoid factor positive	The PBAC deferred a decision on amending the listing to allow the sponsor to provide more information to be considered in March 2005, (along with all other biological drugs PBS listed for rheumatoid arthritis).
	Treatment for rheumatoid arthritis	Sponsor's comments	The sponsor has no comment
Lamotrigine tablets, 25 mg, 50 mg and 100 mg, Bipolam® GlaxoSmithKline Australia Pty Ltd	Treatment for bipolar disorder	Authority required listing for initial therapy for the prevention of depressive episodes in patients with bipolar disorder who have had least one past manic/hypomanic episode and at least one past depressive episode and have a diagnosis of bipolar disorder using DSM-IV criteria. Continuing therapy for the prevention of depressive episodes in patients with bipolar disorder.	The PBAC deferred a decision on the listing to seek clarification of the incremental cost-effectiveness ratiowith the sponsor.
	Treatment for bipolar disorder	Sponsor's comments	The sponsor will be responding to the PBAC request.
Meloxicam tablets 7.5 mg and 15 mg, Mobic®, Boehringer Ingelheim Pty Limited	Treatment for osteoarthritis and rheumatoid arthritis	Extend listing to include rheumatoid arthritis	The PBAC deferred a decision on the request, pending the results of a review by the Therapeutic Goods Administration (TGA) of cardiovascular adverse effects of COX-2 inhibitors, including meloxicam.
	Treatment for osteoarthritis and rheumatoid arthritis	Sponsor's comments	The sponsor is working with the TGA on the review and looks forward to the PBAC's resolution when the review is complete.
Pemetrexed Disodium powder for injection vial, 500 mg, Alimta® Eli Lilly Australia Pty Ltd	Treatment for non-small cell lung cancer and malignant mesothelioma	Authority required listing for use in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma.	The PBAC deferred a decision on the listing to see the effect of lowering the price on the incremental cost-effectiveness ratio.
		Sponsor's comments	The sponsor is examining the option to put to the PBAC a revised cost effectiveness ratio.