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.

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.

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.

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.

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.

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.

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.

Sponsor's comment

The sponsor has no comment.