November 2009 PBAC Outcomes - 1st Time Decisions not to Recommend

Aprepitant, pack containing 1 capsule 125 mg and 2 capsules 80 mg, Emend® 

Merck Sharp & Dohme (Australia) Pty Ltd 

Major submission

Anti-nauseant

Extend the current Authority Required listing to include chemotherapy induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy, which includes agents such as oxaliplatin, carboplatin and ifosfamide.

The PBAC rejected the submission on the basis of a high and uncertain cost-effectiveness ratio in the patient population requested.

Sponsor’s comments:  

The Sponsor has no comment.

Botulinum toxin type A purified neurotoxin complex, lyophilised powder for IM injection, 100 units, Botox® 

Allergan Australia Pty Ltd 

Major submission

Hyperhidrosis (treats excessive sweating)

Extend the current Section 100 (Botulinum Toxin Program) listing to include:

Option 1:  severe primary axillary hyperhidrosis in adult and adolescent patients (> 12 years of age) who meet certain criteria and have failed or are intolerant to topical aluminium chloride hexahydrate.

Option 2:  treatment of severe primary axillary hyperhidrosis as per Option 1 but includes a measure of spontaneous resting axillary sweat production in the listing criteria. 

The PBAC rejected the submission on the basis of a high and uncertain cost-effectiveness ratio.

Sponsor’s comments: 

Allergan will continue to work with the PBAC to make the product available for this patient population. 

Everolimus, tablets, 5 mg and 10 mg, Afinitor® 

Novartis Pharmaceuticals Australia Pty Ltd 

Major submission

Anti-cancer drug

Authority Required listing for treatment, as the sole PBS-subsidised therapy, of a patient with Stage IV clear cell variant renal carcinoma after failure of treatment with sorafenib or sunitinib.

Although the PBAC considered there was a clinical need for everolimus, the submission was rejected on the basis of uncertain clinical benefit and a high and uncertain cost-effectiveness ratio.

Sponsor’s comments:

The sponsor will be considering its position regarding any future course of action. 

Ezetimibe, tablet 10 mg, Ezetrol® 

Ezetimibe with simvastatin, tablets,

10 mg-10 mg, 10 mg-20 mg,

10 mg-40 mg and 10 mg-80 mg, Vytorin® 

Merck Sharp & Dohme (Australia) Pty Ltd 

Minor submission 

Lipid lowering drug

Change the current Authority Required (STREAMLINED) listings to Restricted Benefit.

The submission was rejected as the PBAC considered the more restrictive classification remained appropriate for these products.

Sponsor’s comments:

The Sponsor has no comment.

Intravenous Solutions

Glucose, I.V. infusion, 69.5 mmol (anhydrous) per 250 mL (5%), 250 mL, 

Sodium chloride, I.V. infusion, 38.5 mmol per 250 mL (0.9%), 250 mL,

Pharmatel Fresenius Kabi Pty Ltd. 

Minor submission 

Parenteral Nutrition

Electrolyte replacement

Unrestricted listing in the Dental section of the Schedule.

The PBAC did not recommend the addition of these products to the Dental Schedule on the grounds of a lack of demonstrated clinical need.  Listing has proceeded as an unrestricted pharmaceutical benefit under the General Schedule.

Sponsor’s comments:

The Sponsor has no comment.

Imatinib, tablets, 100 mg and 400 mg (as mesylate), Glivec® 

Novartis Pharmaceuticals Australia Pty Ltd 

Major submission

Anti-cancer drug

Extend the current Authority Required listing to include adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour who meets certain criteria.

The PBAC rejected the submission on the basis of uncertain clinical benefit and a high and highly uncertain cost-effectiveness ratio.

Sponsor’s comments:  

The sponsor will be considering its position regarding any future course of action.

Milk powder - nutrient rich, infant formula powder, 400 g, S-26 Gold Premgro® 

Wyeth Australia Pty Ltd 

Minor submission

Medicinal food

Option 1: Authority Required listing for treatment of premature infants born at less than 30 weeks gestation, up to the age of 6 months for whom breast-feeding is not possible. 

Option 2: As above but for premature infants born at less than 33 weeks gestation. 

The PBAC rejected the submission on the basis of limited evidence of long-term clinical benefit and unknown cost-effectiveness.

Sponsor’s comments:

The sponsor has no comment.

Omalizumab (rch), powder for injection, 150 mg, Xolair®. 

Novartis Pharmaceuticals Australia Pty Ltd 

Major submission.

Anti-asthma drug

Option 1:

Section 100 (Highly Specialised Drugs Program) Public and private hospital authority required listing for initial and continuing treatment of uncontrolled severe allergic asthma despite optimised asthma therapy (OAT) in a patient who satisfies certain criteria. 

Option 2:

As per option 1 but without oral corticosteroids (OCS) as part of optimised asthma therapy. 

Although the PBAC considered there was a clinical need for omalizumab, the submission was rejected on the basis of uncertainty in the restrictions, uncertain clinical benefit and a high and unacceptable cost-effectiveness ratio.

Sponsor’s comments:

Novartis is disappointed that the PBAC has rejected the application to list omalizumab on the PBS, but is committed to working with the PBAC to address the issues of concern.

Quetiapine fumarate, tablets, 100 mg, 200 mg and 300 mg (base), Seroquel®

AstraZeneca Pty Ltd

Minor submission

Bipolar disorder

Extend the current Authority Required (Streamlined) listing to include treatment, for up to 6 months, of an episode of acute mania associated with bipolar 1 disorder, in combination with lithium or sodium valproate.

The PBAC considered that this proposal should not have been submitted and evaluated as a minor submission. The PBAC rejected the submission on the basis of considerable uncertainty about the comparison with risperidone and has recommended the data be re-submitted in the form of a major submission to allow full evaluation of the issues identified.

Sponsor’s comments:  

The Sponsor has no comment. 

Quetiapine fumarate, tablets, 100 mg, 200 mg and 300 mg (base), Seroquel® 

AstraZeneca Pty Ltd 

Minor submission

Bipolar disorder

Extend the current Authority Required (Streamlined) listing to include maintenance treatment of bipolar 1 disorder, as monotherapy.

The PBAC considered that this proposal should not have been submitted and evaluated as a minor submission. The PBAC rejected the submission on the basis of considerable uncertainty about the comparison with olanzapine and has recommended the data be re-submitted in the form of a major submission to allow full evaluation of the issues identified.

Sponsor’s comments:

The Sponsor has no comment.