December 2003 PBAC Outcomes - Positive Recommendations
| DRUG AND FORM | DRUG USE/TYPE | PROPOSED LISTING OR REQUEST | PBAC RECOMMENDATION |
|---|---|---|---|
| ADALIMUMAB 40 mg per 0.8ml injection, Humira®
Abbott Australasia Pty Ltd
|
Treatment for rheumatoid arthritis | Authority required listing as for etanercept (Enbrel®). | The PBAC recommended listing on the basis of cost-minimisation against etanercept.
The equi-effective doses are adalimumab 40 mg every second week and etanercept 25
mg twice weekly.
Link to draft restriction recommended by the PBAC. |
| ARIPIPRAZOLE, tablets 10 mg, 15 mg, 20 mg and 30 mg, Abilify®
Bristol-Myers Squibb Pharmaceuticals |
Drug used to treat schizophrenia
|
Authority required listing for schizophrenia |
The PBAC recommended listing on a cost-minimisation basis against olanzapine. The equi-effective doses are 23.1 mg per day of aripiprazole and 16.3 mg per day of olanzapine. |
| BOSENTAN tablet 62.5 mg and 125 mg, Tracleer® Actelion Pharmaceuticals Australia Pty Ltd |
Treatment for pulmonary hypertension | Section 100 for treatment by a clinician from a designated hospital of certain patients who have failed to respond to calcium channel blocker therapy and who have Class III or Class IV primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma. | The PBAC recommended listing on the basis of an acceptable, but high, cost-effectiveness ratio. The PBAC noted that the proposed pricing arrangements made the incremental cost per extra life-year gained sufficiently favourable to allow a recommendation to list this product when considered in the context of the risk-sharing agreement (which includes a patient registry to examine survival that will be funded to run for three years), the proposal to limit prescribing to clinicians from designated hospitals and the proposed inclusion of the continuation rule in the restriction. |
| CALCIUM FOLINATE injection 50 mg in 5 mL, Leucovorin Calcium DBL® Mayne Pharma Pty Ltd |
Used in combination with certain anti-cancer drugs | Unrestricted listing | The PBAC recommended listing at the price requested (which is equivalent on a mg per mg basis to the 3 mg strength which was deleted from the PBS) on the basis of clinical need for the product. |
| CISAPRIDE tablets 5 mg and 10 mg and oral suspension 1 mg per mL, 200 mL, Prepulsid®
Janssen-Cilag Pty Ltd |
Treatment to increase gastrointestinal motility | Amend authority required listing to treatment of gastroparesis where the diagnosis
has been made or confirmed by a specialist physician using gastric emptying scintigraphy
and the patient does not have a contraindication to cisapride; AND (a) treatment with domperidone or metoclopramide is not tolerated; or (b) treatment with domperidone or metoclopramide is ineffective. |
The PBAC had no objection to the Secretariat decision to amend the authority required
restriction (at the sponsor's request), to limit the use of cisapride and allow some
maintenance of stock as a result of the worldwide discontinuation of the product.
|
| CLONAZEPAM tablets 500 µg and 2 mg, Rivotril® - Roche Products Pty Ltd; and Paxam® - Alphapharm Pty Ltd, oral liquid 2.5 mg per mL, 10 mL, Rivotril® - Roche Products Pty Ltd |
Treatment for epilepsy | Extend the listing to include use under the Palliative Care Program | The PBAC recommended listing under the Palliative Care Program with an authority required
restriction for "Initial supply (for up to four months) for palliative care patients
for the prevention of epilepsy. Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred." |
| DARBEPOETIN ALFA injections, Aranesp®
Amgen Australia Pty Ltd
|
Treatment for anaemia caused by kidney failure | Review of the section 100 restriction to minimise usage outside the intended population. | The PBAC recommended a change to listing as follows: " Treatment of anaemia requiring
transfusion, defined as a haemoglobin level less than 100 g per L, where intrinsic
renal disease, as assessed by a nephrologist, is the primary cause of the anaemia."
|
| ENOXAPARIN SODIUM injection 20 mg (2,000 IU anti-Xa) in 0.2 mL pre-filled syringe, Clexane® Aventis Pharma Pty Limited |
Antithrombotic agent |
Request to extend the listing to include listing as a restricted benefit for haemodialysis with a maximum quantity of 20, as for the 40 mg and 60 mg strengths. |
The PBAC agreed to this request on the basis of clinical need. |
EPOETIN ALFA injections, Eprex® Janssen-Cilag Pty Ltd |
Treatment for anaemia caused by kidney failure |
Review of the section 100 restriction to minimise usage outside the intended population. |
The PBAC recommended a change to listing as follows: " Treatment of anaemia requiring transfusion, defined as a haemoglobin level less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia." |
EPOETIN ALFA injection 20,000 units in 0.5 mL, pre-filled syringe, Eprex® Janssen-Cilag Pty Ltd |
Treatment for anaemia caused by kidney failure |
List as for other strengths of epoetin alfa injections |
The PBAC had no objection to the Secretariat decision to list this new strength. |
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 20mg tablets x 14 , clarithromycin 500mg tablets x14 , and amoxycillin 500mg capsules x 28, triple combination pack Nexium Hp7® AstraZeneca Pty Ltd |
Treatment for peptic ulcer |
Restricted benefit listing for eradication of Helicobacter pylori associated with peptic ulcer disease and healing of duodenal ulcer associated with helicobacter pylori. |
The PBAC recommended listing on a cost-minimisation basis against both omeprazole and clarithromycin and amoxycillin (Klacid Hp7) and omeprazole magnesium and clarithromycin and amoxycillin (Losec Hp7), as a restricted benefit for " Eradication of Helicobacter pylori associated with peptic ulcer disease." The request for listing in the healing of duodenal ulcer associated with Helicobacter pylori was not accepted because the PBAC considered the length of treatment provided by this preparation is not sufficient to allow ulcer healing. |
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: co-administration with statins in patients with Heterozygous Familial Hypercholesterolaemia whose cholesterol levels remain inadequately controlled.
|
(1) The PBAC recommended listing on the basis of acceptable cost-effectiveness as requested. A particular matter that the PBAC wished to continue to monitor is the extent to which future randomised trials reporting major cardiovascular outcomes where cholesterol therapy is titrated to achieve reductions to target levels demonstrate further reductions in major cardiovascular endpoints beyond that achieved with non-titrated therapy or monotherapy. (2) See 'DECEMBER 2003 PBAC OUTCOMES - "1st time" Decision not to Recommend' |
GATIFLOXACIN SESQUIHYDRATE tablet 400 mg, Tequin® Bristol-Myers Squibb Pharmaceuticals |
Antibiotic |
Extension to the recommended authority required listing for "Radiologically confirmed, community acquired pneumonia in patients greater than 12 years old with a history of immediate hypersensitivity to penicillin". |
The PBAC recommended the extension to the restriction as requested. |
LAMIVUDINE tablet 300 mg, 3TC® GlaxoSmithKline Australia Pty Ltd |
Nucleoside reverse transcriptase inhibitor used to treat HIV/AIDS and hepatitis B |
Section 100 listing for treatment of HIV infection in patients with CD4 cell counts of less than 500 per cubic millimetre, or viral load of greater than 10,000 copies per mL. |
The PBAC had no objection to the Secretariat decision to list this new strength of lamivudine at the same price per month of treatment as the 150 mg tablet. |
MESALAZINE suppository 1 g and enema 1 g per 100 mL, Pentasa® Ferring Pharmaceutical Pty Ltd |
Anti-inflammatory agent for rectal use |
Authority required listing for the suppository for acute episodes of mild to moderate ulcerative proctitis and for the enema for acute episodes of mild to moderate ulcerative proctosigmoiditis |
The PBAC recommended listing of the enema on a cost-minimisation basis against mesalazine enema 2 g (Salofalk?). The PBAC recommended listing of the suppository on a cost-minimisation basis against hydrocortisone acetate rectal foam, taking into account the dose of hydrocortisone used in the trial presented of 356 mg per day compared with that of the listed strength of hydrocortisone foam of 90 mg per day. |
METOPROLOL SUCCINATE tablets controlled release 23.75 mg, 47.5 mg, 95 mg and 190 mg, Toprol-XL® AstraZeneca Pty Ltd |
Treatment for heart failure |
Authority required listing for moderate to severe heart failure in patients stabilised on conventional therapy which must include an ACE-inhibitor if tolerated. |
The PBAC recommended listing on a cost-minimisation basis against carvedilol and bisoprolol. The equi-effective doses are 138 mg per day of metoprolol controlled release, 37 mg per day carvedilol and 7.4mg per day bisoprolol. |
OXALIPLATIN powder for injection 50 mg and 100 mg, Eloxatin® Sanofi-Synthelabo Australia Pty Limited |
Treatment for colorectal cancer. |
Authority required listing for the treatment of advanced colorectal cancer in combination with 5-fluorouracil and folinic acid. |
The PBAC recommended listing for metastatic colorectal cancer in combination with 5-fluorouracil and folinic acid on the basis of acceptable cost-effectiveness. The PBAC considered that an overall survival gain of between 2 to 3 months was indirectly demonstrated. |
PERINDOPRIL ERBUMINE tablet 8 mg, Coversyl® Servier Laboratories (Australia) Pty Ltd |
An ACE inhibitor used to treat hypertension and heart failure |
Unrestricted listing |
The PBAC recommended listing on the basis that pricing should be in accordance with the usual Pricing Authority criteria. |
PROGESTERONE pessary 100mg and 200mg Orion Laboratories Pty Ltd
|
For use in the IVF/GIFT program |
Listing under section 100 IVF/GIFT Program for luteal phase support in patients who are receiving medical treatment as described in item 13200 of the Medicare Benefits Schedule. |
The PBAC recommended listing on a cost-minimisation basis compared with progesterone vaginal gel. The equi-effective doses are 200 mg per day for the pessary and 90 mg per day for the gel. |
SIROLIMUS, tablet 1 mg and oral solution 1 mg per mL, Rapamune® Wyeth Australia Pty Limited |
For prophylaxis of rejection in kidney transplant |
Section 100 listing for management of kidney transplant recipients where cessation of cyclosporin therapy is considered appropriate and cessation is intended within 4 months; and management of kidney transplant recipients with biopsy proven calcineurin inhibitor-related nephrotoxicity. |
The PBAC recommended listing on a cost-minimisation basis compared with tacrolimus with the same restrictions as tacrolimus. The PBAC considered that sirolimus is no worse than tacrolimus in respect to effectiveness and toxicity, and has similar effectiveness and is associated with less nephrotoxicity than cyclosporin. |
VALGANCICLOVIR tablet 450mg, Valcyte® Roche Products Pty Ltd |
Anti-viral preparation |
To extend the current section 100 listing to include the "prophylaxis of cytomegalovirus (CMV) infection and disease in solid organ transplant patients at risk of cytomegalovirus disease ‿. |
The PBAC recommended listing on a cost-minimsation basis against oral ganciclovir. The equi-effective doses are valganciclovir 900 mg per day for 90 days and oral ganciclovir 300mg per day for 90 days. |
VORICONAZOLE tablet, 50 mg & 200 mg; powder for infusion, 200 mg, Vfend® Pfizer Pty Ltd |
Treatment for severe fungal infections |
Request to amend the restriction by inclusion of the descriptor "immunocompromised" for treatment of aspergillosis; and to change the relativity for the tablet, which was recommended on a cost-minimisation basis compared with oral itraconazole, to approval on a cost-effectiveness basis at the price requested in June 2003. |
The PBAC agreed to the inclusion of the word "immunocompromised" in the restriction for treatment of aspergillosis. The PBAC also now accepts that voriconazole tablets 50 mg and 200 mg are acceptably cost effective at the price requested, but the cost-effectiveness ratios were considered high. |
