July 2009 PBAC Outcomes - Positive Recommendations
| DRUG AND FORM | DRUG USE AND TYPE | LISTING REQUESTED BY SPONSOR | PBAC RECOMMENDATION |
|---|---|---|---|
| AMBRISENTAN, tablets, 5 mg and 10 mg, Volibris® GlaxoSmithKline Australia Pty Ltd Major submission |
Pulmonary arterial hypertension | Section 100 listing for the treatment of primary pulmonary arterial hypertension and pulmonary arterial hypertension associated with connective tissue disease in patients with WHO functional class III or IV symptoms. | Recommended for listing on a cost minimisation basis to bosentan. The equi-effective
doses are ambrisentan 5 mg daily and bosentan 125 mg twice daily. |
| AMINO ACID FORMULA with VITAMINS and MINERALS without VALINE, LEUCINE and ISOLEUCINE,
oral liquid, 125 mL, MSUD Anamix Junior LQ® Nutricia Australia Pty Ltd Minor submission |
Medicinal food | Restricted benefit listing for maple syrup urine disease. | Recommended for listing on the same cost basis per gram of protein as currently listed products for maple syrup urine disease. |
| ARTEMETHER with LUMEFANTRINE tablet, 20 mg – 120 mg, Riamet® Novartis Pharmaceuticals Australia Pty Ltd Minor submission |
Anti-malarial | Restricted benefit or Authority required listing for the treatment of suspected or
confirmed uncomplicated malaria due to Plasmodium falciparum. |
Recommended as an Authority required listing for the treatment of suspected or confirmed malaria due to Plasmodium falciparum on the basis of acceptable cost-effectiveness. |
| BORTEZOMIB, powder for injection, 1 mg, 3.5 mg (solvent required), Velcade® Janssen-Cilag Pty Ltd Major submission |
Anti-cancer drug | Extend the current Authority required listing to include use as first line therapy in combination with a corticosteroid and melphalan or cyclophosphamide in the treatment of multiple myeloma in patients who meet certain criteria. | Recommended on a cost minimisation basis compared with thalidomide. |
| BORTEZOMIB, powder for injection, 3.5 mg, Velcade®, Janssen-Cilag Pty Ltd and expert clinicians Minor submission |
Anti-cancer drug | The following changes to the current restriction were requested:
|
Recommended following discussions with expert clinicians to address barriers to the prescribing of bortezomib. |
| CALCIPOTRIOL with BETAMETHASONE DIPROPIONATE, ointment, 50 mcg – 500 mcg per g (0.005%
- 0.05%), 30 g, Daivobet® CSL Biotherapies (CSL Limited) Major submission |
Psoriasis | Restricted benefit listing for the treatment of chronic stable plaque type psoriasis. | Recommended on a cost minimisation basis compared with the individual components for use in the treatment of chronic stable plaque type psoriasis in a patient not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy. |
| CARBOHYDRATE, FAT, VITAMINS, MINERALS and TRACE ELEMENTS, powder, 400 g, Energivit® Nutricia Australia Pty Ltd Minor submission |
Medicinal food | Notification of minor changes to the current formulation. | The PBAC had no objections to the proposed changes. |
| CARMELLOSE SODIUM with GLYCERIN, eye drops, 5 mg – 9 mg per mL (0.5 % - 0.9 %), single
dose units, 0.4 mL, Optive® Allergan Australia Pty Ltd Minor submission |
Dry eyes | Authority required (Streamlined) listing for severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops. | Recommended on a cost-minimisation basis at the same cost per unit as other carmellose sodium single dose unit products. |
| CHEMOTHERAPY DRUGS: CLADRIBINE, injection 10 mg in 5 mL, Litak®, Orphan Australia Pty Ltd, solution for I.V. infusion 10 mg in 10 mL, Leustatin®, Janssen-Cilag Pty Ltd FOTEMUSTINE, powder for injection 208 mg with solvent, Muphoran®, Servier Laboratories (Australia) Pty Ltd IRINOTECAN HYDROCHLORIDE TRIHYDRATE, I.V. injection, 40 mg in 2 mL, 100 mg in 5 mL, Campostar®, Pharmacia & Upjohn Pty Ltd, 40 mg in 2 mL, 100 mg in 5 mL, Irinotecan Sandoz®, Sandoz Pty Ltd, 40 mg in 2 mL, 100 mg in 5 mL, 500 mg in 25 mL, HH Brand®, Hospira Pty Ltd, 300 mg in 15 mL, Campostar®, Pfizer Pty Ltd RALTITREXED, powder for I.V. infusion, 2 mg, Tomudex®, Hospira Pty Ltd TOPOTECAN, powder for I.V. infusion, 4 mg (base), Hycamtin®, GlaxoSmithKline Australia Pty Ltd |
Anti-cancer drugs | Changes associated with the implementation of the Intravenous Chemotherapy Supply Program. | The PBAC recommended a change from Authority required to Authority required (Streamlined) for these drugs. |
| CIPROFLOXACIN, ear drops, 3 mg per mL (0.3 %), Ciloxan® Alcon Laboratories (Australia) Pty Ltd Minor submission |
Antiinfective | The Paediatric Medicines Advisory Group requested extension of the current Authority required listing to include the treatment of chronic suppurative otitis media with perforation of the tympanic membrane or a grommet in situ in paediatric patients. | Recommended on the basis of a high clinical need and acceptable cost-effectiveness. |
| CLOTRIMAZOLE, cream, 10 mg per g (1 %), Clonea® Alphapharm Pty Ltd Minor submission |
Antifungal | Authority required (Streamlined) listing for the treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person. | The PBAC recommended amending its March 2006 recommendation for listing to allow the cream to be available as a streamlined Authority required benefit. |
| COLCHICINE, tablet, 500 micrograms, Colgout®, Lengout® Aspen Pharmacare Australia Pty Ltd, Lennon Healthcare Minor submission |
Gout | List a new pack size of 30 tablets. | The PBAC recommended the listing of a new pack size following advice of recent reports of a number of recent incidences of colchicine poisonings including two deaths. |
| DORNASE ALFA, solution for inhalation, 2.5 mg (2,500 units) in 2.5 mL, Pulmozyme® Roche Products Pty Ltd Minor submission |
Cystic fibrosis | To request extending availability to children aged less than 5 years of age. | The PBAC considered there is an unmet clinical need in this patient group, noted advice
from the Paediatric Respiratory Medical Group of the Thoracic Society of Australia
and New Zealand and recommended listing subject to certain eligibility criteria and
review following 6 months of treatment. |
| EZETIMIBE with SIMVASTATIN, tablets, 10 mg - 10 mg, 10 mg – 20 mg, Vytorin® Merck Sharp & Dohme (Australia) Pty Ltd and Schering-Plough Pty Ltd Minor submission |
High cholesterol | Authority required (Streamlined) listing for the treatment of homozygous familial hypercholesterolaemia in patients who are eligible for lipid lowering medication in combination with a HMG CoA reductase inhibitor (statin) and for patients eligible for PBS-subsidised lipid-lowering medication where treatment with a statin must be discontinued or reduced to a daily dose of 20 mg or less. | Recommended on a cost-minimisation basis compared with the individual tablets given concomitantly for reasons of financial equity for those patients unable to tolerate high doses of a statin and who require additional lipid-lowering treatment. |
| GEMCITABINE HYDROCHLORIDE, solution concentrate for I.V. infusion, 500 mg (base) in
50 mL, Gemcitabine Ebewe® InterPharma Pty Ltd Minor submission |
Anti-cancer drug | Add a new volume presentation. | Recommended |
| GLICLAZIDE, tablet (modified release), 60 mg, Diamicron MR® Servier Laboratories (Australia) Pty Ltd Minor submission |
Type 2 diabetes | Unrestricted benefit listing. | Recommended on a cost-minimisation basis compared with the 30 mg modified release tablet with the equi-effective doses being one 60 mg modified release tablet and two 30 mg modified release tablets. |
| GLUCOSE INDICATOR—BLOOD, electrode strips, DANA Blood Glucose Test Strip® Diabetes Association of Australia Pty Ltd Minor submission |
Blood glucose monitoring | Unrestricted benefit. | Recommended |
| GLUCOSE INDICATOR—BLOOD, electrode strips, MyGlucoHealth® Entra Health Systems Pty Ltd Minor submission |
Blood glucose monitoring | Unrestricted benefit. | Recommended |
| HYDROXYETHYL STARCH, 130/0.4, I.V infusion, 60 g per 1 L, 500 mL, Voluven® 6% Pharmatel Fresenius Kabi Pty Ltd Major submission |
Hypovolemia | Unrestricted benefit. | Recommended on a cost minimisation basis compared with succinylated gelatin I.V. infusion (Gelofusine®) where one 500 mL bag of hydroxyethyl starch 130/0.4 (HES) is equi-effective to one 500 mL bag of succinylated gelatin. |
| INFLUENZA VACCINE, suspension for injection, pre-filled syringe, 15 mcg/strain/0.1
mL (containing A/New Caledonia/20/99, A/Wisconsin/67/2005, B/Malaysia/2506/2004 like
strains), Intanza® Sanofi Pasteur Pty Ltd Major submission |
Influenza virus | National Immunisation Program listing for vaccination against influenza in patients aged 65 years and older via the intradermal route. | Recommended on a cost-minimisation basis compared with the influenza vaccine given by intramuscular (IM) injection or deep subcutaneous injection (SCI) as the data were insufficient to demonstrate superiority. |
| LERCANIDIPINE HYDROCHLORIDE, tablets, 10 mg, 20 mg, Zanidip® LERCANIDIPINE HYDROCHLORIDE with ENALAPRIL MALEATE, tablets, 10 mg -10 mg, 10 mg – 20 mg, Zan-Extra 10/10®, Zan-Extra 10/20® Solvay Pharmaceuticals Minor submission |
Anti-hypertensive | Decrease in the maximum quantity from 30 tablets to 28 tablets. | Recommended |
| METHYLNALTREXONE BROMIDE, injection, 12 mg in 0.6 mL (base), Relistor® Wyeth Australia Pty Ltd Minor submission |
Constipation | Authority required Palliative Care Schedule listing for initial and continuing treatment of opioid-induced constipation in patients who have failed/unable to tolerate laxative therapies. | Recommended on the basis of a high clinical need, and high and uncertain but acceptable cost-effectiveness compared with placebo. |
| METHYLPHENIDATE HYDROCHLORIDE, tablet (extended release), 18 mg, 27 mg, 36 mg and
54 mg, Concerta®, capsule, 20 mg, 30 mg and 40 mg, (modified release), Ritalin LA® Janssen-Cilag Pty Ltd, Novartis Pharmaceuticals Australia Pty Ltd Minor submission |
Attention Deficit Hyperactivity Disorder (ADHD) | The Paediatric Medicines Advisory Group requested the removal of the age restriction in line with the current listing for atomoxetine. | The PBAC recommended the listings be amended to allow continuing treatment of ADHD beyond the age of 18 years in patients diagnosed between the ages of 6 and 18 years. |
| MONTELUKAST SODIUM, chewable tablets, 4 mg (base), 5 mg (base) and film coated tablets,
10 mg, Singulair® Merck Sharp & Dohme (Australia) Pty Ltd Major submission |
Asthma | The sponsor made the following 3 requests: (i) to change the current Authority required (Streamlined) listing to Restricted benefit; (ii) to extend the current listing to include treatment of residual exercise related asthma symptoms despite receiving optimal dose inhaled corticosteroid therapy; and (iii) to list a new strength (10 mg). |
The PBAC recommended the 5 mg (base) strength tablet for the prevention of exercise-induced
asthma in certain children aged 6 to 14 years on a cost-minimisation basis against
salmeterol, with montelukast 5 mg daily being equivalent to salmeterol 100 micrograms
daily. The PBAC decided not to recommend listing of the 10 mg tablet because of particular
concerns with use beyond the restriction in adults. Extension to the 4 mg tablet
listing was not recommended as the comparator (long acting beta-agonists) is not TGA
approved for use in children aged 2-5 years. |
| MYCOPHENOLATE MOFETIL, capsule, 250 mg, tablet, 500 mg, CellCept® Wyeth Australia Pty Ltd Minor submission |
Transplant rejection | Change the Section 100 listing pack sizes for the 250 mg tablet and 500 mg capsule
presentations from 300 to 100 and 150 to 50 respectively. |
Recommended |
| OESTRADIOL, transdermal patches, 390 micrograms (releasing approximately 25 micrograms
per 24 hours), 585 micrograms (releasing approximately 37.5 micrograms per 24 hours),
780 micrograms (releasing approximately 50 micrograms per 24 hours), 1.17 mg (releasing
approximately 75 micrograms per 24 hours), 1.56 mg (releasing approximately 100 micrograms
per 24 hours), Estradot 25®, Estradot 37.5®, Estradot 50®, Estradot 75®, Estradot 100® transdermal patches, 750 micrograms (releasing approximately 25 micrograms per 24 hours),1.5 mg (releasing approximately 50 micrograms per 24 hours), 3 mg (releasing approximately 100 micrograms per 24 hours), Estraderm MX 25®, Estraderm MX 50®, Estraderm MX 100® transdermal patches, 2 mg (releasing approximately 25 micrograms per 24 hours), 3.8 mg (releasing approximately 50 micrograms per 24 hours), 5.7 mg (releasing approximately 75 micrograms per 24 hours), 7.6 mg (releasing approximately 100 micrograms per 24 hours), Climara 25®, Climara 50®, Climara 75®, Climara 100® transdermal patches, 2 mg (releasing approximately 25 micrograms per 24 hours), 4 mg (releasing approximately 50 micrograms per 24 hours), 8 mg (releasing approximately 100 micrograms per 24 hours), Estraderm 25®, Estraderm 50®, Estraderm 100® OESTRADIOL with NORETHISTERONE ACETATE, transdermal patches, 620 micrograms – 2.7 mg (releasing approximately 50 micrograms – 140 micrograms per 24 hours), 510 micrograms – 4.8 mg (releasing approximately 50 micrograms – 250 micrograms per 24 hours), Estalis continuous 50/140®, Estalis continuous 50/250® OESTRADIOL and OESTRADIOL with NORETHISTERONE ACETATE, pack containing 4 transdermal patches, oestradiol 780 micrograms (releasing approximately 50 micrograms per 24 hours) and 4 transdermal patches oestradiol with northethisterone acetate 620 micrograms -2.7 mg (releasing approximately 50 micrograms-140 micrograms per 24 hours); Estalis sequi 50/140® pack containing 4 transdermal patches, oestradiol 780 micrograms (releasing approximately 50 micrograms per 24 hours) and 4 transdermal patches oestradiol with northethisterone acetate 510 micrograms -4.8 mg (releasing approximately 50 micrograms-250 micrograms per 24 hours), Estalis sequi 50/250® pack containing 4 transdermal patches, oestradiol 4 mg (releasing approximately 50 micrograms per 24 hours) and 4 transdermal patches oestradiol with northethisterone acetate 10 mg - 30 mg (releasing approximately 50 micrograms-250 micrograms per 24 hours), Estracombi® Novartis Pharmaceuticals Australia Pty Ltd and the Department of Health and Ageing Minor submission |
Post-menopausal symptoms - hormone replacement therapy | The PBAC was asked by the Department to consider transferring the Restricted benefit listings of the various transdermal patches (containing oestrogen, and oestrogen and a progestogen in combination) currently available to unrestricted benefit listings. | The PBAC recommended that the listings of the patch forms of hormone replacement therapy containing oestrogen, or a progestogen in combination with an oestrogen, be changed to unrestricted benefit listings. |
| OLANZAPINE (pamoate monohydrate), powder for injection with diluent vial, 210 mg,
300 mg and 405 mg, Zyprexa Relprevv® Eli Lilly Australia Pty Ltd Major submission |
Schizophrenia | Authority required listing for maintenance treatment of schizophrenia in adult patients
sufficiently stabilised during acute treatment with oral olanzapine. |
Recommended on the basis of acceptable cost-effectiveness. The PBAC recommended that consistent with the listing of other long acting injections for schizophrenia, the price advantage for olanzapine injection over the monthly cost of oral olanzapine should be 1:1.79. The equi-effective doses are 10 mg daily oral olanzapine to 300 mg every four weeks olanzapine modified release (MR) injection, 15 mg daily oral olanzapine to 210 mg every two weeks or 405 mg every four weeks olanzapine MR injection and 20 mg daily oral olanzapine to 300 mg every two weeks olanzapine MR injection. |
| PEGFILGRASTIM, injection, 6 mg in 0.6 mL, single use pre-filled syringe, Neulasta® Amgen Australia Pty Ltd Minor submission |
Neutropenia | Extend the current Section 100 Highly Specialised Drugs Program listing to include use as primary prophylaxis of chemotherapy induced neutropenia in patients with inoperable squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx treated with docetaxel, cisplatin and 5-fluorouracil. | The PBAC recommended an extension to the Section 100 listing for pegfilgrastim to include secondary prophylaxis of neutropenia in patients receiving neoadjuvant treatment with docetaxel in combination with cisplatin or fluorouracil with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx on the basis of acceptable cost-effectiveness compared with no prophylaxis. The extension to the listing should also apply to filgrastim. However, the PBAC could not recommend use in primary prophylaxis as no relevant data were presented. |
| PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, turbid liquid suspension for injection
(0.5 mL) in pre-filled syringe or vial, Synflorix® GlaxoSmithKline Australia Pty Ltd Major submission |
Vaccination against childhood infections due to Streptococcus pneumoniae. | National Immunisation Program listing for immunisation of infants and children aged 6 weeks up to 2 years against disease caused by Streptococcus pneumoniae. | Recommended on a cost-minimisation basis against the 7-valent pneumococcal conjugate vaccine (7vPCV – Prevenar®), with the cost of four doses of Synflorix (2, 4, 6 months and a booster) plus an additional administration cost of the booster dose at an existing vaccination point being equivalent to the effective cost of three doses of Prevenar (2, 4 and 6 months). |
| POLYETHYLENE GLYCOL 400, eye drops, 2.5 mg per mL (0.25 %), multidose, 15 mL, Blink® Intensive Tears Protective Eye Drops, 2.5 mg per mL (0.25 %), single dose units 0.4 mL,
20, Blink® Intensive Tears Protective Eye Drops Advanced Medical Optics Australia Pty Ltd Minor submission |
Dry eyes | Restricted benefit listings in the General and Optometrical Schedules for severe dry eye syndrome, including Sjogren’s syndrome for the multi-dose preparation, and an Authority required listing for the preservative free single dose unit product. | Recommended on a cost minimisation basis compared with multi-dose and single dose unit lubricant eye drops. |
| PRAMIPEXOLE HYDROCHLORIDE, tablets, 125 micrograms, 250 micrograms and 1 mg, Sifrol® Boehringer Ingelheim Pty Ltd Major submission |
Parkinson disease | Extend the current Restricted benefit listing to include use as monotherapy for idiopathic
Parkinson disease in patients with motor disability and no evidence of cognitive impairment. |
The PBAC recommended extending the listing to ‘Parkinson disease’ on a cost minimisation basis compared with cabergoline. The equi-effective doses are 2.77 mg pramipexole and 2.90 mg cabergoline. |
| PRASUGREL HYDROCHLORIDE, tablets, 5 mg and 10 mg (base), Effient® Eli Lilly Australia Pty Ltd Major submission |
Antiplatelet drug | Authority required listing for the initial and continuing treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin in patients who are to undergo percutaneous coronary intervention. | Recommended on the basis of acceptable cost effectiveness compared with clopidogrel. |
| SUNITINIB MALATE, capsules, 12.5 mg, 25 mg and 50 mg (base), Sutent® Pfizer Australia Pty Ltd Major submission |
Anti-cancer drug | Authority required listing for initial and continuing treatment of gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance. | Recommended on the basis of high clinical need and a high but acceptable cost-effectiveness ratio compared with best supportive care. |
| TENOFOVIR DISOPROXIL FUMARATE, tablet, 300 mg, Viread® Gilead Sciences Pty Ltd Major submission |
Hepatitis B | Extend the November 2008 PBAC recommendation for a Section 100 listing for treatment
naïve patients who are HBeAg-positive to include treatment of chronic hepatitis B
in treatment naïve HBeAg-negative patients AND patients (HBeAg negative and positive)
who have failed prior anti-hepadnaviral therapy who meet certain criteria. |
Recommended on a cost-minimisation basis compared with entecavir 0.5 mg for treatment of chronic hepatitis B in nucleoside analogue naïve and on a cost-minimisation basis compared with adefovir 10 mg for patients who have failed previous antihepadnaviral therapy. The equi-effective doses are entecavir 0.5 mg once daily and tenofovir 300 mg once daily for long-term therapy in treatment-naïve patients, and adefovir 10 mg and tenofovir 300 mg for long-term therapy for treatment-experienced patients. |
| TERIPARATIDE (rbe), injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled
pen, Forteo® Eli Lilly Australia Pty Ltd Minor submission |
Osteoporosis | Request amending the volume size presentation from 3 mL to 2.4 mL. | Recommended |
| THYROTROPIN ALFA, powder for injection, 0.9 mg, Thyrogen® Genzyme Australasia Pty Ltd Minor submission |
Ablation of thyroid remnant tissue | Requests a change from the current Authority required listing to an Authority required (Streamlined) or a Restricted benefit listing. | The PBAC recommended amending the current Authority required listing to a Streamlined Authority required listing. |
| TIOTROPIUM BROMIDE MONOHYDRATE, cartridge containing solution for inhalation, in cartridge,
2.5 micrograms tiotropium per actuation (for use with inhaler), Spiriva Respimat® Boehringer Ingelheim Pty Ltd Minor submission |
Chronic obstructive pulmonary disease | Restricted benefit listing for a new dosage form for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease. | Recommended on a cost minimisation basis with tiotropium bromide monohydrate capsules containing powder for oral inhalation, with two inhalations of solution for oral inhalation equivalent to a dose of one capsule containing powder for oral inhalation. |
| TOCILIZUMAB, solution for IV infusion, 80 mg in 4 mL, 200 mg in 10 mL, 400 mg in 20
mL, Actemra® Roche Products Pty Ltd Major submission |
Rheumatoid arthritis | Section 100 listing for the treatment of adult patients with severe active rheumatoid
arthritis in combination with methotrexate who meet certain criteria. |
Recommended as a Section 100 item for the treatment of severe, active rheumatoid arthritis in combination with methotrexate in patients who have failed to demonstrate a response to at least one TNF-alfa antagonist treatment on a cost-minimisation basis compared to abatacept. The equi-effective doses are tocilizumab 8 mg/kg administered on days 1 and 29 and then every 28 days and abatacept 10 mg/kg administered on days 1, 15, 29 and then every 28 days. |
| TRIGLYCERIDES—MEDIUM CHAIN, FORMULA, compound powder, 420 g, Caprilon® Nutricia Australia Pty Ltd Minor submission |
Medicinal food | Notification of minor changes to the current formulation. | The PBAC had no objections to the proposed changes. |
| VALSARTAN with HYDROCHLOROTHIAZIDE, tablets, 320 mg -12.5 mg and 320 mg – 25 mg, Co-Diovan® Novartis Pharmaceuticals Australia Pty Ltd Minor submission |
Anti-hypertensive | Restricted benefit listing for treatment of hypertension not adequately controlled
with valsartan 320 mg monotherapy and in patients stabilised on concomitant valsartan
320 mg and hydrochlorothiazide 12.5 mg or 25 mg. |
Recommended on a cost-minimisation basis compared with the corresponding strengths of the hydrochlorothiazide and valsartan components given concomitantly for patients not adequately controlled with either valsartan or hydrochlorothiazide monotherapy. |
| VORICONAZOLE, tablets, 50 mg and 200 mg, Vfend® Pfizer Australia Pty Ltd Minor submission |
Antifungal | Increase the number of repeats available from nil to five. | The PBAC recommended changing the number of repeats allowed for voriconazole 50 mg and 200 mg tablets from nil to two, which would allow for a review of medication every 3 months. |
