November 2004 PBAC Outcomes - Positive Recommendations
| Drug And Form | Drug Use And Type | Proposed Listing Or Request | PBAC Outcome And Comment |
|---|---|---|---|
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Acarbose, tablets, 50 mg, 100 mg, Glucobay®, Bayer Australia Limited |
Treatment for type 2 diabetes |
Transfer from authority required to restricted benefit listing with removal of requirement that acarbose cannot be used in combination with insulin |
PBAC recommended transfer to unrestricted listing. The PBAC considered that use in combination with insulin was supported by the data presented and considered that there was no longer any need for a restriction as the clinical place of this product was now well-established and could be determined on an individual patient basis by prescribers. |
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Aciclovir, tablet, 200 mg,Aciclovir-BC® , Biochemie Australia; Acihexal® , Hexal Australia Pty Ltd; Acyclo-V 200® , Alphapharm Pty Ltd; Chem mart aciclovir® , Chem mart Pty Limited; GenRx Aciclovir® , GenRx Pty Ltd; Healthsense aciclovir® , Healthsense; Lovir ® , Douglas Pharmaceuticals Australia Ltd; Terry White Chemists aciclovir ®, Terry White Chemists; Zyclir 200® , Arrow Pharmaceuticals Limited; Zovirax 200 mg® , GlaxoSmithKline Australia Pty Ltd |
Anti-viral therapy |
Define type of microbiological confirmation of diagnosis as viral culture, antigen detection or nucleic acid amplification |
The PBAC recommended the listing be amended to clarify what constitutes microbiological confirmation. The PBAC also recommended the listing be amended to allow patients receiving suppressive therapy who were commenced on treatment prior to 1 May 2004 to receive PBS-subsidised treatment, even if no pathology reports are available . |
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Adalimumab 40 mg per 0.8ml injection, Humira ®; Abbott Australasia Pty Ltd |
Treatment for rheumatoid arthritis |
Remove requirement that patients must be co-prescribed methotrexate. |
The PBAC agreed to remove the requirement that adalimumab be used in combination with methotrexate on the grounds that its use could be limited to the situations where cost-effectiveness had been demonstrated by limiting the maximum quantity, number of repeats and also the number of applications that the HIC would authorise per patient to ensure only fortnightly adalimumab administration is subsidised. |
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Aprepitant capsules, 1 x 125 mg and 2 x 80 mg, Emend® Merck Sharp and Dohme (Australia) Pty Ltd |
Prevention of nausea and vomiting associated with chemotherapy. |
Authority required listing for use where certain very highly emetogenic chemotherapy agents at their higher indicated dose levels are to be administered in isolation, or where concomitant chemotherapy agents are added to certain very highly emetogenic chemotherapy agents at their lower indicated dose level to increase the regimen's emetogenic potential. |
The PBAC recommended listing on the basis of acceptable cost-effectiveness as follows: "Management of nausea and vomiting associated with cytotoxic chemotherapy, being used to treat malignancy, in combination with a 5HT3 antagonist and dexamethasone, where any one of the following chemotherapy agents are to be administered:
Even though there were some uncertainties around the cost-effectiveness of the product, the extent of incremental effectiveness of anti-emetic therapy involving aprepitant was of substantial clinical importance, there were likely to be cost off-sets from reduced use of extended 5HT3 drugs and the total cost to the PBS would be small. |
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Bupropion, tablet (sustained release), 150 mg, Zyban®, GlaxoSmithKline Australia Pty Ltd |
Treatment for smoking cessation |
Amend the listing to allow patients to enrol in a counselling and support program at the point of prescribing, as well as before the consultation. |
The PBAC recommended the additional wording for patients "who are entering a comprehensive support and counselling program during the consultation at which this authority is requested". The PBAC recommended the change to enable patients to enter the sponsor's support program which can not be commenced until the patient is actually prescribed bupropion. |
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Budesonide with Eformoterol Fumarate Dihydrate , 100 micrograms- 6 micrograms, 200 micrograms-6 micrograms, 400micrograms-12 micrograms, powder for oral inhalation in breath actuated device, Symbicort® Turbuhaler, AstraZeneca Pty Ltd. |
Treatment for asthma |
Addition of a new lower strength and amend restriction to "Patients with frequent episodes of asthma who are receiving treatment with optimal doses of budesonide" |
The PBAC recommended listing for the new strength on a cost-minimisation basis compared with the individual components. The PBAC also recommended the requested change to the listing for these products as this more closely reflects appropriate clinical practice. |
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Ciclesonide metered dose inhaler, 80 microgram per actuation and 160 microgram per actuation, Alvesco® Altana Pharma Pty Ltd |
Treatment for asthma |
Unrestricted listing |
The PBAC recommended listing on a cost-minimisation basis with ciclesonide 160 µg (ex-actuation) or 200 micrograms (ex-valve) being equivalent to fluticasone 100 µg (ex-valve). The PBAC considered that this dose relativity reflects the totality of the data available and is consistent with the dose-relativity ratios of the inhaled corticosteroids that have been previously established by the PBAC. |
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Cladribine, solution for IV or SC infusion 10 mg in 5 mL, Litak® Orphan Australia Ltd |
Treatment for hairy cell leukaemia |
Authority required listing for hairy cell leukaemia |
The PBAC recommended listing on a cost-minimisation basis compared to the present 10 mg product. |
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Codeine Phosphate with Paracetamol, tablet 30 mg-500 mg, Codalgin Forte ®, Fawns and McAllan Pty Ltd; Dolaforte® , Chemists' Own Pty Ltd; Dymadon Forte® , GlaxoSmithKline Australia Pty Ltd; Prodeine Forte® , Dakota Pharmaceuticals; Panadeine Forte® , Sanofi-Synthelabo Australia Pty Limited |
Analgesic |
Health Insurance Commission requested a differential listing for a maximum quantity of 60 and no repeats with an authority required restriction for severe non-disabling pain not responding to non-narcotic analgesics. A NOTE to apply limiting approvals for increased maximum quantities of no more than 240 tablets per month. A NOTE to also apply to the unrestricted listing of 20 tablets disallowing any increased maximum quantities or repeats. |
The PBAC recommended the changes as requested to reduce abuse and inappropriate prescribing. |
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Cyclosporin, capsule 10 mg, 25 mg, 50mg and 100 mg and oral liquid 100 mg per mL Neoral®, Novartis Pharmaceuticals Australia Pty Ltd; capsule 25 mg, 50 mg and 100 mg, Cicloral® Hexal Australia Pty Limited; capsule 25 mg, 50 mg and 100 mg, Cysporin® Mayne Pharma Pty Ltd |
Immunosuppressive therapy |
The sponsor requested that the PBAC consider amending the restriction for maintenance therapy to allow review by specialists as well as specialised units in hospitals for use in severe atopic dermatitis, severe psoriasis, nephrotic syndrome and severe active rheumatoid arthritis |
The PBAC recommended the restriction be amended to increase flexibility to allow patients who are stabilised on cyclosporin therapy to be reviewed in the specialist's private rooms, rather than limiting their review, by the same specialist, to the hospital setting.
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Dapsone tablets 25 mg and 100 mg, DAP-25®, DAP-100®, Link Medical Products Pty Ltd |
Treatment for leprosy |
Unrestricted listing |
The PBAC recommended listing as requested on the basis of clinical need for use in patients with severe but uncommon conditions where few other therapeutic alternatives exist and acceptable cost effectiveness (taking into account the previous status of the drug as a PBS item and then an essential drug and the known advantages of the drug and its cost), with the PBPA to negotiate a price in accordance with its usual pricing criteria. |
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Emtricitabine capsule, 200 mg, Emtriva® Gilead Sciences Pty Ltd |
Treatment for HIV infection. |
Section 100 (HSD) for the treatment of HIV infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or (b) viral load of greater than 10,000 copies per mL. |
The PBAC recommended listing on a cost-minimisation basis compared with lamivudine, with the equi-effective doses being emtricitabine 200 mg once daily and lamivudine 150 mg twice daily. |
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Famciclovir, Tablet 250 mg, Famvir®, Novartis Pharmaceuticals |
Anti-viral therapy |
Define type of microbiological confirmation of diagnosis as viral culture, antigen detection or nucleic acid amplification. Allow patients who were commenced on treatment prior to 1 May 2004 to receive PBS-subsidised treatment without requiring a cessation of treatment to obtain a pathology report. |
The PBAC recommended the listing be amended to clarify what constitutes microbiological confirmation. The PBAC also recommended the listing be amended to allow patients receiving suppressive therapy who were commenced on treatment prior to 1 May 2004 to receive PBS-subsidised treatment even if no pathology reports are available . |
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Ferrous Sulfate, solution, 150 mg per 5 mL, 250 mL, AFT Ferrous Sulfate Solution® AFT Pharmaceuticals Pty Ltd |
Iron supplementation |
Unrestricted listing |
The PBAC had no objection to the Secretariat listing of this new product based on the same price as the currently listed product, ferrous gluconate paediatric elixir (Fergon®). |
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Fotemustine powder for injection vial 208 mg and diluent ampoule, Muphoran ® Servier Laboratories (Australia) Pty Ltd |
Treatment for malignant melanoma |
Authority required listing for disseminated malignant melanoma. |
The PBAC recommended listing, as requested, on the basis of acceptable cost-effectiveness. |
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Gemcitabine Hydrochloride powder for I.V. infusion, 200 mg (base) and 1 g (base), Gemzar® Eli Lilly Australia Pty Ltd |
Treatment for breast cancer, lung cancer, pancreatic cancer and bladder cancer. |
Authority required listing for advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline. |
The PBAC recommended listing of gemcitabine for this new restriction on a cost-minimisation basis, comparing the combination of gemcitabine plus paclitaxel with combination capecitabine and docetaxel. |
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Glucose Indicator - Blood, reagent strips, 50, CareSens® , Life Bioscience Pty Ltd |
Testing strips for diabetics |
Unrestricted listing |
The PBAC had no objection to the Secretariat listing of this new product based on the same price as the currently listed blood glucose reagent strips. |
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Glucose Indicator - Blood, electrodestrips, 50, Glucocare Super Sensor®, DiaCare International Pty Ltd |
Testing strips for diabetics |
Unrestricted listing |
The PBAC had no objection to the Secretariat listing of this new product based on the same price as the currently listed blood glucose reagent strips. |
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Iloprost inhalation, 10 micrograms in 1 mL, Ventavis® Schering Pty Ltd |
Treatment for pulmonary hypertension |
Section 100 (HSD) for the treatment of primary pulmonary hypertension or secondary pulmonary hypertension due to connective tissue disease or drug-induced, in patients with NYHA class III or IV symptoms. |
The PBAC recommended listing on a cost-minimisation basis compared with bosentan, with the equi-effective doses being iloprost 2.5-5 micrograms nebulised 6-9 times per day, giving a mean of 7.5 x 20 micrograms (i.e 7.5 x one ampoule) consumed per day, and bosentan 125 mg taken twice daily. The restriction is yet to be finalised |
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Iron as Iron Sucrose (Iron (III) Hydroxide Sucrose Complex) injection, 100 mg elemental iron in 5 mL, Venofer® Baxter Healthcare Pty Ltd |
Treatment for iron deficiency anaemia |
Authority required listing for iron deficiency anaemia, in combination with erythropoietin, in patientsundergoing chronic haemodialysis who have had a documented hypersensitivity reaction to iron polymaltose and in whom continued intravenous iron therapy is appropriate. |
The PBAC recommended listing on the basis of acceptable cost-effectiveness in patients who have failed prior IV iron polymaltose therapy due to hypersensitivity reactions. The Committee considered the product offers clinical benefits for these patients, for whom the number of treatment alternatives is limited. |
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Leuprorelin Acetate, injection 7.5 mg, 22.5 mg and 30 mg pre-filled syringe, Lucrin Depot® Abbott Australasia Pty Ltd |
Treatment for prostate cancer |
Authority required listing for Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate. |
The PBAC had no objection to the Secretariat listing of these new products based on the same price as the currently listed products. |
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Levodopa with Carbidopa and Entacapone tablets, 50 mg/12.5 mg/200 mg, 100 mg/25 mg/200 mg and 150 mg/37.5 mg/200 mg, Stalevo® Novartis Pharmaceuticals Australia Pty Ltd |
Treatment for Parkinson's disease |
Authority required listing for Parkinson's disease in patients who are experiencing motor fluctuations. |
The PBAC recommended listing for patients experiencing motor fluctuations due to end-of-dose effect on a cost-minimisation basis where the equi-effective doses are the 3 strengths of the levodopa-carbidopa-entacapone combination and the concomitant administration of entacapone 200 mg with the corresponding equivalent doses of the levodopa and carbidopa immediate release combination products. |
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Lignocaine Hydrochloride, injection, 100 mg in 5 mL prefilled syringe, Min-I-Jet® Lignocaine hydrochloride, CSL Limited |
Treatment for ventricular arrythmias |
Unrestricted listing |
The PBAC recommended listing at the price requested on the basis of clinical need for the product and acceptable cost effectiveness. The product should also be listed in the Dental Schedule and in Doctor's Bag Supplies. |
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Mesalazine, rectal foam enema, 1 g per applicatorful, 14 applications (equivalent to 7 doses of 2 g mesalazine), aerosol 80 g, Salofalk® , Orphan Australia Pty Ltd. |
Anti-inflammatory agent for rectal use |
Authority required listing for acute episode of mild to moderate ulcerative colitis |
The PBAC had no objection to the Secretariat listing of this new product at the same price per mg as the 2 g enemas. |
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Metformin Hydrochloride with Glibenclamide tablets, 500mg/2.5 mg and 500 mg/5 mg, Glucovance® 500/2.5 and Glucovance® 500/5 Alphapharm Pty Ltd |
Treatment for diabetes |
Unrestricted listing |
The PBAC recommended listing on a cost-minimisation basis compared with the sum of the identical doses of the individual components. |
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Modafinil tablet, 100 mg, Modavigil® CSL Pharmaceuticals |
Treatment for narcolepsy |
Authority required listing for initial and continuing treatment in patients with narcolepsy, where either (i) therapy with dexamphetamine sulfate poses an unacceptable medical risk, including risks related to a psychiatric or cardiac disorder, substance abuse, glaucoma, or other medical conditions in which dexamphetamine sulfate is contraindicated; or (ii) intolerance to dexamphetamine sulfate develops of a severity necessitating treatment withdrawal, who meet certain criteria. |
The PBAC recommended listing on the basis of acceptable cost-effectiveness in the patient group proposed. The PBAC considered that a continuation rule should not be required partly because patients would have to pay the full cost of the polysomnography test for continuing treatment, and that there may be problems with access to sleep laboratories in the time-frames specified for assessment of response.
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| Narcotic Analgesics
Hydromorphone Hydrochloride, tablet 2 mg, 4 mg, 8 mg, oral liquid 1 mg per mL, Dilaudid®, Abbott Australasia Pty Ltd; Methadone Hydrochloride, tablet 10 mg, injection 10 mg in 1 mL, Physeptone®, GlaxoSmithKline Australia Pty Ltd; Morphine Hydrochloride, oral solution, 2 mg per mL, 5 mg per mL, 10 mg per mL, Ordine 2/5/10®, Mundipharma Pty Ltd; Morphine Sulfate, tablet 30 mg, Anamorph®, Fawns and McAllan Pty Ltd Oxycodone, suppository 30 mg, Proladone®, Pharmalab; Oxycodone Hydrochloride, tablet, 5 mg, Endone®, Boots Healthcare Australia Pty Ltd; capsule 5 mg, 10 mg, 20 mg, oral solution 5 mg per 5 mL, OxyNorm®, Mundipharma Pty Ltd; Morphine Sulfate, controlled release tablets (all strengths except the 200mg strength), sachets containing controlled release granules for oral suspension (all strengths except the 200 mg strength) MS Contin®, and controlled release capsules (all strengths), MS Mono®, Mundipharma Pty Ltd; capsules containing sustained release pellets (all strengths), Kapanol®, GlaxoSmithKline Australia Pty Ltd; Oxycodone Hydrochloride, controlled release tablet 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, OxyContin®, Mundipharma Pty Ltd |
Narcotic analgesics |
Request from Health Insurance Commission to amend the NOTE to remove the requirement that increased maximum quantities and repeats will only be granted for chronic severe disabling pain (not associated with proven malignant neoplasia) where patients are initiated in a hospital (in-patient or out-patient). The request arose because of the difficulty the Commission has in administering the requirements of the existing NOTE which do not allow such patients, who are being managed by their medical practitioner, access to increased supply. |
The PBAC agreed to amend the following parts NOTE as follows: Authorities for increased maximum quantities and/or repeats will be granted only for: (i) ....... (as per current); (ii) Chronic severe disabling pain where the authority is requested by a specialist; (iii) Chronic severe disabling pain where the requesting medical practitioner has consulted with another medical practitioner and the clinical need for each authority has been established . The above changes were recommended at the HIC's request, arising The PBAC also noted that the current restrictions did not adequately address the problem of inappropriate prescribing as, once patients were initiated on therapy in the hospital setting, there was no mandatory on-going review of the patient. The PBAC therefore recommended the above NOTE to address these problems and agreed that these changes would largely encourage appropriate prescribing by requiring a second medical opinion for each authority request that is made by a non-specialist. It would also discourage inappropriate prescribing because responsibility has been extended beyond a single prescribing medical practitioner. |
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Omeprazole, tablet, 20 mg, Meprazol ®, Hexal Australia Pty Ltd |
Proton pump inhibitor for ulcer and gastro-oesophageal reflux disease |
Restricted benefit listing for initial treatment of peptic ulcer; gastro-oesophageal reflux disease; Scleroderma oesophagus; Zollinger-Ellison syndrome |
The PBAC had no objection to the Secretariat listing of this new product on the basis of bioequivalence with the omeprazole magnesium 20 mg tablet. |
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Paracetamol sustained release tablet 665 mg, Panadol Extend® GlaxoSmithKline Australia Pty Ltd |
Analgesic |
Restricted benefit listing for the relief of persistent pain associated with osteoarthritis |
The PBAC recommended listing on a cost-minimisation basis at same price per mg of paracetamol as the currently listed immediate release 500 mg tablet formulation. The PBAC considered that any move that would encourage the use of paracetamol at appropriate doses in osteoarthritis should be welcomed . |
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Paracetamol tablet 500 mg, Dymadon P® , Warner Lambert Consumer Healthcare Pty Ltd, Febridol® ,Douglas Medication Systems, Panamax® , Sanofi-Synthelabo Australia Pty Limited, Parahexal® , Hexal Australia Pty Ltd, Paralgin® , Fawns and McAllan Pty Ltd, Parmol® , Arrow Pharmaceuticals Ltd, Tylenol® , Johnson & Johnson Pacific Pty Limited, and Douglas Pharmaceuticals Australia Ltd |
Analgesic |
Restricted benefit listing for chronic arthropathies with a maximum quantity of 300 with 4 repeats. |
The PBAC recommended a differential listing, at the same price per mg as the existing unrestricted benefit listing, to encourage the use of paracetamol at appropriate doses. |
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Pemetrexed Disodiumpowder for injection vial, 500 mg, Alimta® Eli Lilly Australia Pty Ltd |
Treatment for non-small cell lung cancer and malignant mesothelioma |
Authority required listing for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, after prior platinum based chemotherapy. |
The PBAC recommended listing on a cost-minimisation basis compared with docetaxel with the equi-effective doses being those reported in the key trial. Final pricing should also take into account the cost of pre-medication, and the administration of the chemotherapy as practiced in Australia. |
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Pimecrolimus cream, 1 %, Elidel® Novartis Pharmaceuticals Australia Pty Ltd |
Treatment for atopic dermatitis in patients 3 months of age and older |
Authority required listing for the treatment of facial or eyelid atopic dermatitis in patients aged 3 months or older who meet certain criteria, and Authority required listing for short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged 3 months or older who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy. |
The PBAC recommended listing on the basis of acceptable cost-effectiveness in infants, children and adolescent patients (ie patients aged less than 18 years) in the settings proposed when use was limited to 4 x 15 g tubes of the cream per year.
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Pioglitazone Hydrochloridetablets 15 mg, 20 mg and 45 mg, Actos® Eli Lilly Australia Pty Ltd |
Treatment for diabetes |
Remove continuing rule requirements |
The PBAC recommended the change to listing because of widespread stakeholder concern over the complexity of the wording of the restriction and the difficulty the HIC faces in administering the restriction consistently. This change was implemented on 17 November 2004.
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Polyethylene Glycol with Propylene Glycol, eye drops, 0.4%-0.3%, single dose units 0.7 ml, Systane®; Alcon Laboratories (Australia) Pty Ltd |
Eye drops for severe dry eyes |
Authority required listing for severe dry eyes in patients who are sensitive to preservatives in multi-dose eye drops |
The PBAC recommended listing on a cost-minimisation basis compared with hypromellose with dextran 3 mg-1 mg per mL, 0.4 mL, single dose units and other single dose unit tear substitute products. |
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Pravastatin, tablet, 80 mg, Pravachol®, Bristol-Myers Squibb Pharmaceuticals |
Lipid lowering drug |
Restricted benefit listing for use in patients that meet the criteria set out in the general statement for lipid lowering drugs. |
The PBAC had no objection to the Secretariat listing of this new product based on the price of the currently listed strengths. |
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Quinagolide tablets, 3 x 25 µg and 3 x 50 µg (starter pack), and tablet, 75 µg, Norprolac® Starter Pack and Norprolac ® Ferring Pharmaceuticals Pty Ltd |
Treatment for hyperprolactinaemia |
Authority required listing for the treatment of pathological hyperprolactinaemia: where surgery is not indicated; where surgery has already been used with incomplete resolution; where radiotherapy is not indicated; or where radiotherapy has already been used with incomplete resolution |
The PBAC recommended listing on a cost-minimisation basis compared with cabergoline. Based on the weighted average dose across the three studies presented, the equi-effective doses were considered to be 143 micrograms per day of quinagolide until normalised and 1.23 mg per week of cabergoline until normalised (or, alternatively, quinagolide 116.3 micrograms per day is equivalent to cabergoline 1 mg per week). |
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Ribavirin and Peginterferon Alfa-2a, tablet 200 mg and pre-filled syringes 135 µgand 180 µg, Pegasys-RBV® Roche Products Pty Ltd |
Treatment for chronic hepatitis C |
Change the current section 100 (HSD) second criteria from "Abnormal serum ALT levels in conjunction with documented chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV RNA positive)" to " Documented chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV RNA positive)". Replace the NOTE relating to the National Health and Medical Research Council's Taskforce report on hepatitis C, at the request of the Highly Specialised Drug Working Party. |
The PBAC recommended the listing for hepatitis C be amended on the basis of acceptable cost-effectiveness by removing the need for abnormal serum alanine aminotransferase (ALT) for patients who have a documented chronic hepatitis C infection as follows: Treatment of chronic hepatitis C in patients 18 years or older...
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Ribavirin and Peginterferon Alfa-2b, capsule 200 mg and injections 50 µg, 80 µg, 100 µg, 120 µg and 150 µg, Pegatron® Schering Plough Pty Ltd |
Treatment for chronic hepatitis C |
Replace the NOTE relating to the National Health and Medical Research Council's Taskforce report on hepatitis C, at the request of the Highly Specialised Drug Working Party. |
The PBAC recommended the listing be amended for consistency with the changes to Pegasys-RBV®, as above. |
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Risperidone tablets, 0.5 mg and 1 mg, and oral solution, 1 mg in 1 mL, Risperdal® Janssen-Cilag Pty Ltd |
Treatment for behavioural disturbances in dementia and schizophrenia |
Authority required listing for behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful. |
The PBAC recommended listing on the basis of acceptable cost-effectiveness at the price requested. The PBAC was satisfied that the benefits of this drug outweighed the risks associated with treatment of this patient group, but considered that a CAUTION relating to the increased risk of stroke would be appropriate. The PBAC noted that the trials that had given rise to the concerns about increased risk of stroke in the United Kingdom were placebo-controlled and it was quite possible that there would be a similar risk with haloperidol and other traditional antipsychotic drugs used in this patient group. |
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Rituximab solution for infusion, 100 mg in 10 mL and 500 mg in 50mL, Mabthera® Roche Products Pty Ltd |
Treatment for non-Hodgkin's lymphoma |
Change the listing of rituximab to include the treatment of patients aged less than 60 years with previously untreated, CD 20 positive, diffuse large B-cell non-Hodgkin's lymphoma in combination with chemotherapy. |
The PBAC recommended amending the authority required restriction for rituximab to include patients who are aged less than 60 years as follows on the basis of a high, but acceptable, cost-effectiveness ratio . |
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Rosiglitazone tablets, 4mg and 8 mg, Avandia® GlaxoSmithKline Australia Pty Ltd |
Treatment for diabetes |
Extend the listing to include triple therapy for type 2 diabetic patients: Authority required listing for initiation and continuation of triple therapy with metformin and a sulfonylurea in type 2 diabetic patients whose blood glucose concentrations are inadequately controlled, where patients are on maximally tolerated doses of metformin plus sulfonylurea who meet certain criteria. |
The PBAC recommended listing for this indication at the same price as applies to the current restriction for rosiglitazone in dual therapy. |
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Rosiglitazone tablets, 4mg and 8 mg, Avandia® GlaxoSmithKline Australia Pty Ltd |
Treatment for diabetes |
Remove continuing rule requirements |
The PBAC recommended the change to listing because of widespread stakeholder concern over the complexity of the wording of the restriction and the difficulty the HIC faces in administering the restriction consistently. This change was implemented on 17 November 2004.
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Sodium Cromoglycate, oral pressurised inhalation (CFC-free formulation), 1 mg per dose, Intal ®, Aventis Pharma Pty Ltd |
Treatment for asthma |
Unrestricted listing |
The PBAC had no objection to the Secretariat listing of this new product at the same price as the non CFC-free formulation. |
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Temozolomide, capsule, 5 mg, 20 mg, 100 mg and 200 mg, Temodal® , Schering-Plough Pty Ltd |
Treatment for certain types of brain tumour |
Request from clinicians to remove requirement that disease is recurrent. |
The PBAC indicated it had no objection amending the authority required listing for the treatment of glioblastoma to 'Glioblastoma multiforme following standard therapy' providing data supporting this change are submitted to the TGA to amend the approved indication. |
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Tenofovir Disoproxil Fumarate tablet, 300 mg, Viread® Gilead Sciences Pty Ltd |
Treatment for HIV infection |
Widen the listing of tenofovir disoproxil fumarate to that of other nucleoside reverse transcriptase inhibitors (NRTIs) listed on the PBS: Section 100 (HSD) for treatment of HIV infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or (b) viral load of greater than 10,000 copies per mL. |
The PBAC recommended the change to listing on a cost-minimisation basis where tenofovir 300 mg once daily is equi-effective with (but has a better side effect profile than) stavudine 30 mg twice daily (patients < 60 kg) and stavudine 40 mg twice daily (patients ?60 kg). |
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Terbinafine Hydrochloride, tablet, 250 mg (base), Lamisil® Novartis Pharmaceuticals Australia Pty Ltd |
Anti-fungal treatment |
Amend the requirement for pathology report to be no more than 6 months old, following advice form the Health Insurance Commission that this requirement is overly stringent in practice resulting in some patients inappropriately being denied access to therapy. |
The PBAC has no objection to the Secretariat decision to amend the restriction with respect to the age of the pathology report that will be accepted for the purposes of access to treatment be extended from 6 months to 12 months. |
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Timolol Maleate gel, 0.1 %, Nyogel ® Novartis Pharmaceuticals Australia Pty Ltd |
Treatment for glaucoma |
Unrestricted listing |
The PBAC recommended listing on a cost-minimisation basis compared with the standard timolol maleate eye drop formulations with the equi-effective doses being once daily application of the gel and twice daily instillation of the 0.25% standard eye drops. |
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Valaciclovir Hydrochloride, tablet 500 mg (base) Valtrex® GlaxoSmithKline Australia Pty Ltd |
Anti-viral therapy |
Define type of microbiological confirmation of diagnosis as viral culture, antigen detection or nucleic acid amplification. Allow patients who were commenced on treatment prior to 1 May 2004 to receive PBS-subsidised treatment without requiring a cessation of treatment to obtain a pathology report. |
The PBAC recommended the listing be amended to clarify what constitutes microbiological confirmation. The PBAC also recommended the listing be amended to allow patients receiving suppressive therapy who were commenced on treatment prior to 1 May 2004 to receive PBS-subsidised treatment even if no pathology reports are available . |
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Amino Acid Formula with Vitamins and Minerals without Phenylalanineliquid 150 mL, PKU Express Active ® Vitaflo Australia Pty Ltd |
A food for inborn errors of metabolism |
Restricted benefit listing for phenylketonuria |
The PBAC recommended listing on an equivalent cost per gram of protein basis with PKU Express®, Easiphen® and XP Maxamum ®. |
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Amino Acid Formula with Vitamins and Minerals without Phenylalaninepowder, sachets 27.8 g x 30, Lophlex® Nutricia Australia Pty Limited |
A food for inborn errors of metabolism |
Restricted benefit listing for phenylketonuria |
The PBAC recommended listing on an equivalent cost per gram of protein basis with PKU Express®, Easiphen® and XP Maxamum ®. |
