November 2007 PBAC Outcomes - 1st time decisions not to recommend

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Drug Name and Sponsor Drug Use and Type Listing requested by Sponsor PBAC Recommendation
Idursulfase-rhu, IV infusion, 6mg/3mL, Elaprase®
Genzyme Australasia Pty Ltd

Major submission
Hunter syndrome (a genetic disorder also known as MPS II)) Section 100 Authority Required for the treatment of Hunter syndrome The PBAC rejected the application on the basis of unacceptable cost-effectiveness. However the Committee indicated that the use of idursulfase for the treatment of MPS II meets the criteria for the Life Saving Drugs Program (LSDP).
Sponsor’s Comments The sponsor agrees that Elaprase is an appropriate drug to be listed under the Life Savings Drug Program.
Influenza vaccine, injection, 0.5mL Fluarix®, Fluvax®, Influvac®,Vaxigrip®,
Influenza Specialist Group

Major submission
Influenza Inclusion on the National Immunisation Program (NIP) for all persons aged 50-64 years old. The PBAC rejected the submission because of uncertainty in clinical benefits in terms of hospitalisation and mortality.
Sponsor’s Comments No comment
Iron sucrose, solution for i.v use, 100 mg/5 mL, Venofer®
Aspen Pharmacare Australia Pty Ltd

Minor submission
Iron deficiency in patients on chronic haemodialysis Seeks a less restrictive listing and inclusion as a Section 100 item benefit The PBAC rejected the submission. The PBAC considered that insufficient data had been provided to recommend first-line listing. Listing under section 100 as a highly specialised drug was rejected because the drug was not considered to be highly specialised.
Sponsor’s Comments No comment
Ivabradine, tablet, 5 and 7.5mg Coralan® Servier Laboratories (Australia) Pty Ltd

Major submission
Angina (heart pain due to lack of oxygen reaching the heart) Authority Required – treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate/contra-indicated to beta blockers. The PBAC rejected the application because of insufficient evidence to support the claim of superiority over the comparators and uncertain cost-effectiveness.
Sponsor’s Comments No comment
Rosiglitazone maleate, tablet, 4 and 8 mg, Avandia®, Rosiglitazone maleate with metformin hydrochloride, tablet, 2mg/1000mg, 2mg/500mg, 4mg/1000mg, 4mg/500mg, Avandamet®,
GlaxoSmithKline Australia Pty Limited

Major submission
Type 2 diabetes Extension of current listing to include use as: monotherapy in type 2 diabetes in patients uncontrolled and contraindicated or intolerant of metformin; and in dual combination therapy with metformin, in uncontrolled type 2 diabetes despite treatment with metformin. The PBAC rejected the submission because of uncertain clinical benefit, concern about the safety of the drug and the resulting uncertain cost-effectiveness.
Sponsor’s Comments The sponsor will be considering its position regarding any future course of action.
Trandolapril with verapamil, sustained release tablet, 4 mg – 240 mg, Tarka®, 
Abbott Australasia Pty Ltd

Minor submission
Anti-hypertensive Requests an amendment to the restriction wording to allow use when a patients is not controlled on either one of the components The PBAC rejected the submission. The current restriction requiring that a patient is stabilised on treatment with trandolapril 4mg and verapamil hydrochloride 240 mg was considered to be clinically appropriate and consistent with other listings.
Sponsor’s Comments No Comment
Zoster virus vaccine, injection, 0.65 mL, Zostavax®,
CSL Biotherapies – CSL Limited

Major submission
Shingles vaccine Inclusion on the National Immunisation Program for prevention/reduction of herpes zoster (shingles) and post-herpetic neuralgia (PHN) pain in people 60 years or over. The PBAC rejected the application on the basis of uncertain cost-effectiveness against the comparator, placebo.
Sponsor’s Comments No comment