December 2003 PBAC Outcomes - "1st time" decisions not to recommend
| DRUG AND FORM | DRUG USE/TYPE | LISTING REQUESTED BY SPONSOR | PBAC OUTCOME AND COMMENTS |
|---|---|---|---|
|
ADEFOVIR DIPIVOXIL tablet Gilead Sciences Pty Ltd |
Treatment for hepatitis B | Section 100 highly specialised drug listing for the treatment of chronic hepatitis B in patients who have failed with their previous antihepadnaviral therapy and who satisfy specific criteria. | The PBAC rejected the submission because of uncertainty over the extent of clinical
benefit and uncertain cost effectiveness in the lamivudine-resistant hepatitis B population.
Sponsor's comments: The sponsor needs to clarify the decision with the PBAC.
|
| ANAKINRA 100mg per 0.67 mL pre-filled syringe, Kineret®
Amgen Australia Pty Ltd |
Treatment for rheumatoid arthritis | Authority required listing | The PBAC rejected the submission because of uncertain clinical benefit in the requested
populations for listing and uncertain and unacceptable cost-effectiveness.
Sponsor's comments: The sponsor intends to clarify the decision with the PBAC and then consider its course of action. |
| BUPROPION HYDROCHLORIDE tablet 150 mg, Zyban®
GlaxoSmithKline Australia Pty Ltd |
Smoking cessation product | Amend recommended authority required listing to "treatment as short-term adjunctive therapy for nicotine dependence with the goal of maintaining abstinence in patients who have indicated that they are ready to cease smoking and have entered into the SMOKE FREE Clean Start comprehensive support and counselling program. Details of the program must be specified in the authority application" with a maximum quantity of 60 for initiation of treatment and a repeat of 60 for continuation of treatment". | The PBAC rejected the submission because the PBAC did not support mandatory participation in any particular smoking cessation program and considered that a maximum quantity of 30 plus a repeat of 90, as recommended in September 2002, remained appropriate. |
| ENFUVIRTIDE 90mg.mL powder for injection , Fuzeon®
Roche Products Pty Limited |
Treatment for HIV/AIDS | Section 100 highly specialised drug listing | The PBAC rejected the submission because of uncertain and unfavourable cost effectiveness.
Sponsor's comments: The sponsor disagrees with the decision and needs to clarify the decision with the PBAC |
| EZETIMIBE, tablet 10 mg, Ezetrol®
Merck Sharp & Dohme (Australia) Pty Ltd |
Cholesterol lowering drug | Authority required listing: (1) For co-administration with 40 mg or greater of a statin in patients with coronary heart disease and/OR diabetes mellitus whose cholesterol levels remain inadequately controlled; and (2) For initiation by a specialist/consultant physician only for co-administration with statins in patients with Heterozygous Familial Hypercholesterolaemia whose cholesterol levels remain inadequately controlled. |
(1) See 'DECEMBER 2003 PBAC OUTCOMES - Positive Recommendations'
(2) The PBAC rejected the submission because of uncertain extent of clinical benefit and the resulting uncertain cost-effectiveness in the proposed population. Sponsor's comments: The sponsor will be considering its position regarding any future course of action. |
| IMATINIB MESYLATE capsule 100 mg, Glivec®
Novartis Pharmaceuticals Australia Pty Ltd |
Treatment for chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST) | Amend the current recommended authority required listing for continuing treatment
applying to the listing of imatinib as a Section 100 Special Authority for the treatment
of patients with unresectable and/or metastatic malignant GIST as follows: 1. The definition of response be expanded to include patients who have achieved a reduction in tumour size, or at least no tumour growth as assessed by computer tomography (CT scan). 2. Patients whose assessment by CT scan shows tumour growth (of any proportion) but who have not had a deterioration in their performance status (as shown by the ECOG performance scale), may be eligible to continue treatment with imatinib on the PBS if they are able to demonstrate a response as assessed by positron emission tomography (PET scan). |
The PBAC rejected the submission because of issues with the clinical claim and the
resulting cost-effectiveness claim.
Sponsor's comments: The sponsor intends to lodge a re-submission. Please refer to the Novartis Website for further information: |
| LAMOTRIGINE tablets 25 mg, 50 mg and 100 mg, Bipolam®
GlaxoSmithKline Australia Pty Ltd |
Treatment for epilepsy and bipolar disorder | Authority required listing for prevention of depressive episodes in patients with bipolar disorder | The PBAC rejected the submission because of uncertain nature and extent of clinical
benefit and the resulting cost-effectiveness claim.
Sponsor's comments: The sponsor is clarifying the decision with the PBAC and will consider its course of action. |
| MONTELUKAST SODIUM tablets 4 mg and 5 mg (base), Singulair® Merck Sharp and Dohme (Australia) Pty Limited |
Preventer treatment for asthma | Transfer the listing from authority required to restricted benefit listing. | The PBAC rejected the submission because a transfer to restricted benefit listing
would be highly likely to lead to widespread usage outside the restriction and such
use would be inappropriate.
Sponsor's comments: The sponsor will be considering its position regarding any future course of action. |
| OMEPRAZOLE MAGNESIUM tablet 20 mg (base), Losec®
AstraZeneca Pty Ltd |
Treatment for peptic ulcer and gastroesophageal reflux disease | Increase number of repeats from 1 to 2 for peptic ulcer. | The PBAC rejected the submission because it considered the current listing to be consistent
with the dosage instructions in the approved product information for omeprazole magnesium.
Sponsor's comments: The sponsor needs to clarify the decision with the PBAC. |
| PIMECROLIMUS cream 1%, 15 g and 30 g, Elidel®
Novartis Pharmaceuticals Australia Pty Ltd |
Treatment of atopic dermatitis | Authority required listing | The PBAC rejected the submission because of issues with the clinical claim and the
resulting cost-effectiveness claim.
Sponsor's comments:
Please refer to the Novartis Website for further information: |
| RISPERIDONE long-acting intramuscular injection 25mg, 37.5mg and 50mg, Risperdal Consta®
Janssen-Cilag Pty Ltd |
Treatment for schizophrenia | Authority required listing. | The PBAC rejected the submission because of uncertainty in the extent of clinical
benefit in the proposed population and the uncertain cost-effectiveness.
Sponsor's comments: Janssen-Cilag will continue to work with the PBAC to pursue PBS listing for Risperdal Consta. Please call Janssen-Cilag Medical Information on (02) 8875 3367 for information. |
| VALSARTAN tablets 40mg, 80mg and 160mg, Diovan®
Novartis Pharmaceutical Australia Pty Ltd |
For use in the treatment of cardiovascular disease, including hypertension and heart failure. | Authority required listing | The PBAC rejected the submission because of issues with the clinical claim and the
resulting cost-effectiveness claim.
Sponsor's comments: The sponsor intends to clarify the issues with the PBAC and then consider its course of action. |
