November 2004 PBAC Outcomes - 1st time decisions not to recommend

1st time Decisions not to Recommend made by the PBAC in November 2004 relating to the listing of drugs on the Pharmaceutical Benefits Scheme
Drug and Form	Drug Use and Type	Listing Requested by Sponsor	PBAC Outcome and Comments
Coal Tar emulsion, 1 g per 100 g, Exorex® penetrating emulsion psoriasis medication Trans Dermal Pharmaceuticals Pty Ltd	Treatment for chronic psoriasis.	Unrestricted listing	The PBAC rejected the application because of uncertain extent of benefit over the appropriate comparator and the resulting uncertain, but unfavourable, cost-effectiveness, and uncertainty over the likely utilisation of the product.
	Treatment for chronic psoriasis.	Sponsor's comment	The sponsor will be making a re-submission to the PBAC.
Efalizumab (rch) powder for injection vial 125 mg and pre-filled syringe diluent, Raptiva® Serono Australia Pty Ltd	Treatment for psoriasis	Authority required listing for initial and continuing treatment by a dermatologist with expertise in the management of psoriasis, of adults 18 years and over with severe plaque psoriasis who meet certain criteria.	The PBAC rejected the application because of unfavourable cost-effectiveness.
	Treatment for psoriasis	Sponsor's comment	The sponsor looks forward to continuing to work with the PBAC.
Gefitinib tablet, 250 mg, Iressa® AstraZeneca Pty Ltd.	A selective inhibitor of epidermal growth factor receptor tyrosine kinase used to treat locally advanced or metastatic non-small cell lung cancer.	Amend authority required restriction to remove requirement for a test for mutations of the epidermal growth factor receptor to t he treatment by a specialist of patients with locally advanced or metastatic non small cell lung cancer with a WHO performance status of ? 2., where disease progression has occurred following prior treatment with at least one chemotherapy agent and the pat ient has a diagnosis of adenocarcinoma or bronchioloalveolar carcinoma	The PBAC rejected the application because it considers the cost-effective way of targeting the drug is by use of the test for mutations of the Epidermal Growth Factor Receptor.
Gefitinib tablet, 250 mg, Iressa® AstraZeneca Pty Ltd.		Sponsor's comment	The sponsor disagrees with the decision and intends to continue to seek wider subsidy for gefitinib. Please refer to the sponsor's website for further information. Weblink:www.astrazeneca.com.au
Imatinib Mesylate tablets 100 mg and 400mg (base), Glivec® Novartis Pharmaceuticals Australia Pty Ltd	Treatment for chronic myeloid leukemia.	Removal of the requirement in the continuation criteria of adult patients with chronic myeloid leukemia (CML) in the chronic phase to achieve a major cytogenetic response (MCR) within 18 months in order for them to be eligible for continued PBS subsidy.	The PBAC rejected the application because of uncertain clinical benefit and thus uncertain but unfavourable cost-effectiveness.
	Treatment for chronic myeloid leukemia.	Sponsor's comment	The sponsor will be considering its position regarding any future course of action.
Laronidase -rch concentrate for solution for infusion, 500 units, Aldurazyme ® Genzyme Australasia Pty Ltd	Replacement therapy in patients with Mucopolysaccharidosis-1	Listing under section 100 of the PBS or under the Life Saving Drugs Program for long term replacement therapy in patients with Mucopolysaccharidosis-I (MPS-I; ? - L-iduronidase deficiency) to treat the non-neurological manifestations of the disease.	The PBAC rejected application for listing on the PBS on the basis of unfavourabl e cost-effectiveness. The PBAC also concluded that laronidase could be considered by the Government for inclusion in the Life Saving Drugs Program.
		Sponsor's comment	The sponsor agrees with the above comment.
Lumiracoxib tablet, 200 mg, Prexige ® Novartis Pharmaceuticals Australia Pty Ltd	A COX-2 inhibitor drug for the treatment for osteoarthritis	Restricted benefit for the symptomatic treatment of osteoarthritis.	The PBAC rejected the application because of insufficient evidence to demonstrate superiority of lumiracoxib over celecoxib in terms of gastrointestinal adverse effects. The PBAC then deferred its consideration of whether to list lumiracoxib on a cost-minimisation basis compared with celecoxib, until the Therapeutic Goods Administration has completed its current review of the cardiovascular safety of the COX-2 inhibitors.
	A COX-2 inhibitor drug for the treatment for osteoarthritis	Sponsor's comment	The sponsor is awaiting the conclusion of the TGA COX-2 review and is considering its course of action.
Mesalazine suppository 1 g, Pentasa® Ferring Pharmaceuticals Pty Ltd	Anti-inflammatory agent for rectal use	Amend authority required restriction to "Treatment of ulcerative proctitis ", remove NOTE preventing authorities for increased quantities or repeats and include provision for 3 repeats.	The PBAC considered that at the current price there was no justification for use in other than the acute setting and there was no need for a repeat in this setting, and therefore rejected the application.
	Anti-inflammatory agent for rectal use	Sponsor's comment	The sponsor has no comment.