March 2011 PBAC Outcomes - Positive Recommendations
PDF Printable Version of March 2011 PBAC Outcomes Positive Recommendations (102 kb)
DRUG AND FORM | DRUG USE AND TYPE | LISTING REQUESTED BY SPONSOR | PBAC RECOMMENDATION |
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Azacitidine, powder for injection, 100 mg, Vidaza® Celgene Pty Ltd Minor submission (out-of-session) |
Myelodysplastic syndrome |
To ratify the Secretariat proposed maximum quantity and repeats for the Section 100 (Highly Specialised Drug) Streamlined Authority listing for Public hospitals and the Authority Required listing for Private hospitals. |
The PBAC recommended a maximum quantity of 14 vials which would allow daily dosing of 75 mg/m2 for a patient up to 2.2 m2 (165 mg) and a repeat of 2 for initial PBS subsidised treatment and 5 for continuing PBS subsidised treatment. |
bDMARD Restrictions for Rheumatoid Arthritis: Abatacept, powder for infusion 250 mg, Orencia®, Bristol-Myers Squibb Pharmaceuticals Pty Ltd Adalimumab, injection, 40 mg in 0.8 mL, pre-filled syringe and pre-filled pen, Humira®, Abbott Australasia Pty Ltd Certolizumab pegol, injection, 200 mg in 1 mL, single use pre-filled syringe, Cimzia®, UCB Australia Pty Ltd Etanercept, powder for injection, 25 mg (with pre-filled solvent syringe 1 mL), injection, 50 mg in 1 mL single use pre-filled syringe and single use pre-filled auto-injection, Enbrel®, Wyeth Australia Pty Limited Golimumab, injection, 50 mg in 0.5 mL, pre-filled syringe and single use pre-filled
pen, Simponi®, Schering-Plough Pty Ltd Tocilizumab, solution for I.V. infusion, 80 mg in 4 mL, 200 mg in 10 mL and 400 mg in 20 mL, Actemra®, Roche Products Pty Ltd Minor submission (out-of-session) |
Rheumatoid arthritis |
To ratify the change proposed by the PBAC Chair that both the full |
The PBAC agreed that both the full 6-month trial of DMARD therapy immediately prior to an initial application for bDMARD therapy and the time-period that patients can cease therapy with a bDMARD before being required to requalify for treatment under the Initial 1 treatment restriction be set at 2 years for consistency. |
Buprenorphine with naloxone, soluble film (sublingual), 2 mg (as hydrochloride) - 0.5 mg (as hydrochloride), 8 mg (as hydrochloride) - 2 mg (as hydrochloride), Suboxone® Reckitt Benckiser (Australia) Pty Ltd Minor submission |
Opiate Dependence |
Requests the same Section 100 (Opiate Dependence Treatment Program) Restricted benefit listing as the sublingual tablets for the new sublingual soluble film form. |
The PBAC recommended listing on a cost-minimisation basis compared with the currently listed sublingual tablets. |
Calcium folinate, injection, (equivalent to 1000 mg folinic acid in 100 mL), Calcium Folinate Ebewe® Interpharma Pty Ltd Minor submission (out-of-session) |
Used in chemotherapy protocols |
Unrestricted benefit listing of an additional higher strength of an existing product. |
The PBAC recommended listing on a cost-minimisation basis compared with calcium folinate 100 mg in 10 mL. |
Capecitabine, tablets, 150 mg and Roche Products Pty Ltd Major submission |
Anti–cancer drug |
Change the current Authority Required restriction for the adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour to include ‘either as monotherapy or in combination with oxaliplatin’ or remain unchanged. Change the wording of the current restriction for oxaliplatin adjuvant treatment to “adjuvant treatment of stage III (Dukes C) colon cancer, in combination with a fluoropyrimidine agent” instead of in combination with 5 – fluorouracil and folinic acid. |
The PBAC recommended the listing of capecitabine in combination with oxaliplatin (XELOX) on the PBS for the adjuvant treatment of stage III (Dukes C) colon cancer on a cost-minimisation basis compared with modified FOLFOX-6. |
Dabigatran etexilate, capsules, 110 mg and 150 mg (as mesilate), Pradaxa® Boehringer Ingelheim Pty Ltd Major submission |
Anti-thrombotic and anti-coagulant |
Extend the current Authority Required listing to include the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation who are at moderate to high risk of developing stroke or systemic embolism, who meet certain criteria. The submission requests an Authority Required (STREAMLINED) listing for this indication. |
The PBAC recommended an Authority required (STREAMLINED) listing of dabigatran 150 mg and an extension to the listing of dabigatran 110 mg on the basis of acceptable cost effectiveness. |
Dalteparin sodium, injection, 2,500 units (anti-Xa) in 0.2 mL, 5,000 units (anti-Xa) in 0.2 mL, 12,500 units (anti-Xa) in 0.5 mL, single dose pre-filled syringe, Fragmin® Pfizer Australia Pty Ltd Minor submission |
Anti-coagulant |
Requests maximum quantities of the 2,500 and 5,000 strengths be increased from 10 to 20 with Nil repeats. Unrestricted benefit listing for a new 12,500 strength. |
Recommended.
The PBAC recommended listing on a cost-minimisation basis compared with the currently listed dalteparin injections. |
Desmopressin acetate, wafer, 240 micrograms (base), Minirin® Melt Ferring Pharmaceuticals Pty Ltd Minor submission (out-of-session) |
Nocturnal enuresis |
Authority Required (STREAMLINED) listing of a higher strength desmopressin wafer under the same listings conditions. |
Recommended.
|
Docetaxel, solution concentrate for I.V. infusion, 140 mg in 7 mL, Oncotaxel® Generic Health Pty Ltd Minor submission (out-of-session) |
Anti-cancer drug |
New presentation (anhydrous concentrate only currently listed) and a new higher strength of docetaxel under the same listing conditions as the currently listed products. |
Recommended. |
Docetaxel, concentrate injection, 160 mg in 16 mL, DBL Docetaxel® Hospira Pty Ltd Minor submission (out-of-session) |
Anti-cancer drug |
New presentation (anhydrous concentrate only currently listed) and a new higher strength of docetaxel under the same listing conditions as the currently listed products. |
Recommended. |
Donepezil hydrochloride, tablets (disintegrating), 5 mg and 10 mg, Pfizer Australia Pty Ltd Minor submission (out-of-session) |
Alzheimer disease |
Authority required listing for an oral disintegrating tablet under the same listing conditions as the currently listed tablets. |
The PBAC recommended listing on a cost-minimisation basis compared with the PBS listed 5 mg and 10 mg tablets. |
Eltrombopag, tablets, GlaxoSmithKline Australia Pty Ltd Minor submission |
Idiopathic thrombocytopenia purpura (ITP) – a bleeding disorder |
Resubmission for a Section 100 (Highly Specialised Drugs Program) Public and Private hospital authority required listing for severe thrombocytopenia in adult patients with severe chronic immune (idiopathic) thrombocytopenic purpua (ITP) meeting certain criteria. |
The PBAC recommended listing on the basis of acceptable cost effectiveness compared with romiplostim (less effective and less expensive), restricted to the same population as romiplostim. |
Enoxaparin, injection, 80 mg (8,000 i.u. anti-Xa) in 0.8 mL, 100 mg (10,000 i.u. anti-Xa) in 1 mL, pre-filled syringe, Enoxaparin® Sanofi-Aventis Australia Pty Ltd |
Anti-coagulant |
Restricted benefit listing of the 80 mg and 100 mg strengths for haemodialysis. |
The PBAC recommended listing on the basis of clinical need. |
Ezetimibe, tablet, 10 mg, Ezetrol® Ezetimibe with simvastatin, tablet, 10 mg-10 mg and 10 mg-20 mg, Vytorin®, Merck Sharp & Dohme (Australia) Pty Ltd Minor submission |
High cholesterol levels |
Requests a change to the restriction wording recommended at the November 2010 PBAC meeting to allow treatment of a patient with inadequate control after at least 3 months of treatment with 40 mg or greater of a statin, or at a maximum tolerated dose of a statin.
|
The PBAC re-affirmed that the amended restriction wording of the definition of inadequate control with a statin to “at a maximum tolerated dose of a statin” as recommended at the November 2010 meeting remains appropriate. The PBAC recommended that the restriction wording for ezetimibe (and ezetimibe with
simvastatin), for the restriction with streamlined authority code 2669 (and 3194)
be amended to remove the daily dose statement of “to a dose of 20 mg or less per day
as follows: |
Fentanyl, transdermal patch, 1.28 mg (releasing approximately 12 micrograms per hour),1.28 mg (releasing approximately 12.5 micrograms per hour), 2.55 mg (releasing approximately 25 micrograms per hour), 5.10 mg (releasing approximately 50 micrograms per hour), 7.65 mg (releasing approximately 75 micrograms per hour),10.20 mg (releasing approximately 100 micrograms per hour), Denpax® Alphapharm Pty Ltd Minor submission |
Severe pain |
Restricted Benefit listing of a different brand of fentanyl patch which releases the same amount of fentanyl per hour but has a different amount of drug in the reservoir compared with the originator brand (Durogesic®) |
The PBAC recommended listing on a cost-minimisation basis compared with Durogesic® brand of fentanyl patches. |
Ferrous fumarate, tablet, 200mg, , (equivalent to 65.7mg elemental iron), Ferro-Tab® AFT Pharmaceuticals Pty Ltd Minor submission |
Iron supplement |
Unrestricted benefit listing as an additional option for the treatment of anaemia. |
The PBAC recommended listing as an additional option for the treatment of anaemia. |
Fingolimod, capsule, 0.5 mg (as hydrochloride), Gilenya® Novartis Pharmaceuticals Major submission |
Multiple sclerosis |
Authority Required listing for the initial and continuing treatment of clinically |
After a revised offer from the sponsor, the PBAC recommended out-of-session listing on the basis of an acceptable cost-effectiveness ratio compared with interferon beta-1a. |
Fluorouracil, injection, 2500 mg in 50 mL, Fluorouracil Ebewe® Interpharma Pty Ltd Minor submission (secretariat listing) |
Anti-cancer drug |
Unrestricted listing of a higher strength of fluorouracil. |
The PBAC recommended listing on a cost-minimisation basis compared with the 1000 mg in 20 mL presentation. |
Fluorouracil, injection, 5000 mg in 100 mL, Fluorouracil Ebewe® Interpharma Pty Ltd Minor submission (out-of-session) |
Anti-cancer drug |
Unrestricted listing of a higher strength of fluorouracil. |
The PBAC recommended listing on a cost-minimisation basis compared with the |
Fosaprepitant, powder for I.V. infusion, 150 mg, (as dimeglumine), Emend IV® Merck Sharp and Dohme Pty Ltd Minor submission |
Anti-emetic |
Authority required (STREAMLINED) listing for management of nausea and vomiting associated with cytotoxic chemotherapy (moderately emetogenic, highly emetogenic and combination anthracycline/cyclophosphamide regimens for breast cancer). |
The PBAC recommended an Authority Required listing on a cost-minimisation basis compared with aprepitant, pack containing 1 capsule 125 mg and 2 capsules 80mg. The PBAC considered that 5 repeats was appropriate which would allow up to 6 cycles of chemotherapy to be administered per script of fosaprepitant. The PBAC recommended that 5 repeats should also be allowed for aprepitant. |
Imatinib, tablet, 100mg and 400 mg, (as mesylate), Glivec® Novartis Pharmaceuticals Australia Pty Ltd Minor submission |
Anti-cancer drug |
Resubmission for an Authority Required listing for the adjuvant treatment of an adult patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg/day for a period of 12 months. |
The PBAC recommended listing on the basis of an acceptable cost-effectiveness ratio compared with placebo. |
Interferon beta-1a, injection, 44 micrograms (12,000,000 i.u) in 0.5mL, single dose auto-injector, RebiDose® Merck Serono Australia Pty Ltd Minor submission (out-of-session) |
Multiple Sclerosis |
Authority Required listing of a new presentation of a pre-filled syringe, each pre-assembled in a disposable RebiDose autoinjector and ready for use. |
The PBAC recommended the listing of a new form of injector for interferon beta-1a on a cost-minimisation basis with the 44 micrograms in 0.5 mL single dose pre-filled syringe under the current listing conditions. |
Lacosamide, oral solution 15 mg per mL, 200 mL, Vimpat® UCB Australia Pty Ltd Minor submission (secretariat listing) |
Epilepsy |
Authority Required Continuing treatment, in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent, of partial epileptic seizures in a patient aged 16 years or older, who has previously been treated with PBS-subsidised lacosamide. Note |
The PBAC recommended the listing of a |
Methylprednisolone, powder for injection, 40 mg and 1 g (as sodium succinate), Methylpred® Aspen Pharmacare Australia Pty Ltd Minor submission (secretariat listing) |
Anti-inflammatory |
Unrestricted benefit |
The PBAC recommended the listing of a new presentation of methyprednisolone powder for injection (without diluent) on a cost-minimisation basis compared with methylprednisolone powder for injection with diluent. |
Pegfilgrastim, injection 6 mg in 0.6 mL, single use pre-filled syringe, Neulasta® Filgrastim, injection, 300 micrograms in 0.5 mL and 480 micrograms in 1.6 mL; Amgen Australia Pty Ltd Filgrastim, injection, 120 micrograms in 0.2 mL single use pre-filled syringe, Hospira Australia Pty Ltd Minor submission |
Bone marrow cell stimulator |
Requests to extend the current Section 100 (HSD) Authority required listing to include primary prophylaxis of febrile neutropenia in Hodgkin Disease patients treated with escalated BEACOPP chemotherapy. |
The PBAC recommended listing on the basis of clinical need and acceptable cost-effectiveness. The PBAC also recommended that any new PBS eligible patient population should flow on to filgrastim, as reaffirmed by the PBAC at the July 2008 meeting (allowing flexibility in treatment options for chemotherapy induced neutropenia). |
Phenoxymethylpenicillin, powder for oral liquid, 125 mg per 5 mL and 250 mg per 5 mL (as potassium salt), 100 mL, Phenoxymethylpenicillin-AFT® AFT Pharmaceuticals Pty Ltd Minor submission (secretariat listing) |
Antibiotic |
Unrestricted benefit Dental Listing |
The PBAC recommended the listing of two new strengths of phenoxymethylpenicillin on a cost-minimisation basis compared with phenoxymethylpenicillin 150 mg (as benzathine) per 5 mL, 100 mL. |
Risedronate sodium, tablet, 35 mg (enteric coated), Actonel EC® Risedronate sodium and Calcium carbonate, pack containing 4 tablets risedronate sodium 35 mg (enteric coated) and 24 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium), Actonel EC Combi® Risedronate sodium with Calcium carbonate and Colecalciferol, pack containing 4 tablets risedronate sodium 35 mg (enteric coated) and 24 sachets containing granules of calcium carbonate 2.5 g (equivalent to 1 g calcium) with colecalciferol 22 micrograms, Actonel EC Combi D® Sanofi-Aventis Australia Pty Ltd |
Osteoporosis |
Authority Required (STREAMLINED) listing of a new enteric coated formulation under the same listing conditions as risedronate 35 mg tablet products. |
The PBAC recommended the listing on a cost-minimisation basis with the PBS listed
products containing risedronate sodium |
Risperidone, powder for I.M. injection, 25 mg, 37.5 mg and Janssen – Cilag Pty Ltd Major submission |
Bipolar disorder |
Extend the current Authority Required (STREAMLINED) listing to include maintenance treatment, in combination with a mood stabiliser, of treatment refractory bipolar 1 disorder. |
The PBAC recommended listing on a cost-minimisation basis with oral olanzapine. The PBAC agreed that the restriction should specify use in combination with lithium or sodium valproate for consistency with the TGA approved indication and that the requested listing for treatment of treatment refractory disease, without further qualification, was appropriate. |
Rosiglitazone, tablet 4mg and 8mg (as maleate), Avandia®; ROSIGLITAZONE with METFORMIN, tablet, 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride, 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride, 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride, 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride, Avandamet®, GlaxoSmithKline Australia Pty Ltd |
Diabetes |
Response from sponsor regarding PBAC’s decision to change the current Authority Required (STREAMLINED) listing to Authority Required. |
The PBAC considered that the listing should be changed to an Authority Required and that this would highlight that there was still concern regarding the side effects and safety of rosiglitazone and that it should not be prescribed without due consideration of the risk versus the benefit. |
Sirolimus, tablet, 0.5 mg, Rapamune® Wyeth Australia Pty Ltd Minor submission (out-of-session) |
Immunosuppressant |
Section 100 - Private Hospital Authority Required Section 85 – General Schedule |
The PBAC recommended listing of a new lower strength of sirolimus on a cost-minimisation basis compared with sirolimus 1 mg tablets. |
Somatropin, injection, 10 mg (30 i.u), vial with diluent in single use syringe (with preservative), Zomacton® Ferring Pharmaceuticals Pty Ltd Minor submission (out-of-session) |
Growth hormone deficiency |
Section 100 (Human Growth Hormone) Restricted Benefit listing of a new higher strength of somatropin for the treatment of short stature in accordance with the “Guidelines for the Availability of Human Growth Hormone (hGH) as a Pharmaceutical Benefit”. |
Recommended |
Telmisartan with amlodipine, tablets, Boehringer Ingelheim Pty Ltd Major submission |
Antihypertensive |
Restricted Benefit listing for the treatment of hypertension in a patient who is not adequately controlled with either of the drugs in the combination. |
The PBAC recommended listing, in accordance with the Combination Product Guidelines, on a cost-minimisation basis compared with the corresponding strengths of the constituent components, telmisartan and amlodipine, given concomitantly. |
Tobramycin, nebuliser solution single dose units, 300 mg in 5 mL, 56, Tobi® Novartis Pharmaceuticals Australia Pty Ltd Major submission |
Inhaled antibiotic for the treatment of lung infections in patients with cystic fibrosis |
Resubmission seeking a Section 100 listing for treatment of a patient with cystic fibrosis and pulmonary infection with Pseudomonas aeruginosa initiated by a specialist physician or paediatrician in consultation with a cystic fibrosis clinic/centre and who met certain criteria. |
The PBAC recommended the listing of tobramycin solution for inhalation (TSI) on the PBS with an Authority Required (STREAMLINED) listing for the management of proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis on the basis of acceptable cost effectiveness compared with placebo. |
Varenicline, box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack; tablet, Champix® Pfizer Australia Pty Ltd Minor submission |
Smoking Cessation |
Requests to amend the NOTE of the current restriction to allow re-treatment 6 months from the commencement of a course of varenicline with another course of PBS-subsidised smoking cessation treatment. |
The PBAC reiterated its intention that only one course of varenicline of up to 24 weeks of continuous therapy should be subsidised under the PBS per year, and recommended that a NOTE stipulating this be re-instated in the restriction. |
Zonisamide, capsule, 25 mg, 50 mg, Eisai Australia Pty Ltd Dutasteride, capsule 500 micrograms, Avodart®, GlaxoSmithKline Australia Pty Ltd Pancreatic extract, granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g, Creon Micro®, Abbott Products Pty Ltd Minor submission |
Epilepsy
Benign Prostatic Hyperplasia
Cystic Fibrosis |
Seeks PBAC advice on suitability for inclusion in the PBS medicines for prescribing by nurse practitioners. |
Recommended for prescribing by nurse practitioners within collaborative arrangements as continuing therapy only (NP-CTO). |