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