July 2006 PBAC Outcomes - Positive Recommendations
Recommendations made by the PBAC (Pharmaceutical Benefits Advisory Committee) in July 2006 relating to the listing of drugs on the PBS (Pharmaceutical Benefits Scheme)
| Drug and Form | Drug Use and Type | Listing Requested by Sponsor | PBAC Recommendation |
|---|---|---|---|
| Albendazole, tablet, 200 mg,
Zentel® GlaxoSmithKline Australia Pty Ltd Minor submission |
Anthelmintic | Authority Required listing for the treatment of whipworm in an Aboriginal or a Torres Strait Islander person. | The PBAC recommended listing as an Authority Required benefit under the arrangements made for the 2004-05 Budget measure “Improving the capacity of the PBS to meet the needs of Indigenous Australians” for this patient group. |
| Alendronate, tablet, 70mg, Fosamax Once weekly ® , Merck Sharp & Dohme (Australia) Pty Ltd; Alendro
Once Weekly® , Arrow Pharmaceuticals Limited
Alendronate sodium with colecalciferol (vitamin D3), tablet, 70 mg-70 micrograms (2800 i.u.), Fosamax® Plus, Merck Sharp & Dohme (Australia) Pty Ltd Major submission |
Treatment of bone resorptive diseases | Amend Authority Required listing to allow treatment of osteoporosis for patients at high risk of fracture. | The PBAC recommended extending the listing on the basis of acceptable cost-effectiveness
for the initial and continuing treatment as the sole PBS-subsidised anti-resorptive
agent for osteoporosis in patients aged 70 years of age or older and with a BMD T-score
of -3.0 or less.
The initial authority application must state the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement. |
| Amlodipine besylate with atorvastatin calcium, tablets,
5 mg/10 mg, 10 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg, 10 mg/40 mg, 5 mg/80 mg, and 10 mg/80 mg Caduet® Pfizer Australia Pty Ltd Major submission |
Combination product to lower lipid levels and treat hypertension and/or angina | Restricted Benefit listing for use in patients who have hypertension and/or angina
and who meet the criteria set out in the General Statement for Lipid-Lowering Drugs,
and:
(a) who are currently receiving treatment with a dihydropyridine calcium channel blocker; OR (b) whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti-anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate; OR (c) who are intolerant of the side effects of other classes of antihypertensive and/or anti-anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate. |
The PBAC recommended listing as requested on a cost-minimisation basis compared with the corresponding strengths of the amlodipine and atorvastatin constituents. |
| Anticholinesterases: Donepezil hydrochoride, tablets, 5 mg, 10 mg, Aricept® , Pfizer Pty Ltd Galantamine hydrochloride, prolonged release capsules 8 mg (base), 16 mg (base), 24 mg (base), Reminyl®, Janssen-Cilag Pty Ltd Rivastigmine hydrogen tartrate, capsules, 1.5 mg (base), 3 mg (base), 4.5 mg (base), 6 mg (base), oral solution 2 mg (base) per mL, 120 mL, Exelon ®, Novartis Pharmaceuticals Minor submission |
Anti-dementia drugs | Request to amend restrictions:
(1) to allow continuing treatment in patients whose baseline Mini Mental State Examination (MMSE) is greater than 24 points to meet the criteria for continuing treatment either by demonstrating a decrease of at least 4 points from baseline on the Alzheimer’s Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) as currently, OR by demonstrating a 2 point improvement on the MMSE; and (2) to allow assessment by the Standardised Mini-Mental State Examination (SMMSE) and the Rowland Universal Dementia Assessment Scale (RUDAS). |
The PBAC agreed with the requests to allow:
(1) patients with MMSE greater than 24 points to be assessed by an improvement in MMSE of 2 points, or by improvement in the ADAS-COG of 4 points; and (2) patients to be assessed using the SMMSE. However the PBAC did not agree to the use of RUDAS as the Committee considered that the characteristics of the RUDAS as a scale to measure change have not yet been validated, although this work is on-going. |
| Benzathine penicillin, powder for injection, 900 mg (1,200,000i.u.) Pan Benzathine Benzylpenicillin®, Aspen
Australia
Minor submission |
Antibiotic | Unrestricted listing with a maximum quantity of one and Restricted Benefit listing for syphilis with a maximum quantity of 2. | The PBAC had no objection to the Secretariat listing. |
| Ciprofloxacin, ear drops, 0.3% Ciloxan®
Alcon Laboratories (Australia) Pty Ltd Major submission |
Antibiotic | Authority Required listing for the treatment of chronic suppurative otitis media in adults and children one year and over. | The PBAC recommended listing on clinical and cost-effectiveness grounds for use in chronic suppurative otitis media in an Aboriginal and Torres Strait Islander person. |
| Darbepoetin alfa, injection pre-filled syringes, 20 micrograms in 0.5 mL and 50 micrograms in 0.5
mL, Aranesp SureClick® , Amgen Australia Pty Ltd
Minor submission |
Treatment for severe anaemia | Section 100 Highly Specialised Drug listing for treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia. | The PBAC had no objection to the Secretariat listing of these new presentations. |
| Deferasirox, tablets, 125 mg ,
250 mg and 500 mg, Exjade® Novartis Pharmaceuticals Australia Pty Limited Major submission |
Iron chelator | Section 100 Highly Specialised Drug listing for:
Chronic iron overload in paediatric patients age 2 to 5 years, associated with disorders of erythropoiesis, who are intolerant to desferrioxamine or in whom desferrioxamine has proven ineffective. Chronic iron overload in adults, adolescents and children 6 years and older associated with disorders of erythropoiesis; |
The PBAC recommended listing with a restriction consistent with the TGA-approved indication on a cost effectiveness basis versus the comparator, desferrioxamine, noting however that the incremental cost-effectiveness ratio is somewhat uncertain and is likely to be high. |
| Entecavir, tablet, 500 microgram Baraclude®,
Bristol-Myers Squibb Pharmaceuticals Major submission |
Chronic hepatitis B | Section 100 Highly Specialised Drug listing for patients aged 16 years or older with
chronic hepatitis B who satisfy all of the following criteria:
(i) histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy); (ii) abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or HBV DNA positive); (iii) female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception. |
The PBAC recommended the listing of entecavir 500 microgram tablet for the treatment of chronic hepatitis B infection in nucleos(t)ide naïve patients on the basis of acceptable cost-effectiveness compared with lamivudine 100 mg. |
| Entecavir, tablet, 1 mg, Baraclude®, Bristol-Myers Squibb Pharmaceuticals
Major submission |
Chronic hepatitis B | Section 100 Highly Specialised Drug listing for patients aged 16 years or older with
chronic hepatitis B who have failed lamivudine therapy and satisfy all of the following
criteria:
(i) Repeatedly elevated (> 1.2 ULN) serum ALT levels while on concurrent antihepadnaviral therapy of >= 6 months duration in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or serum HBV DNA positive); (ii) Female patients of child-bearing age are not pregnant, not breast- feeding, and are using an effective form of contraception. |
The PBAC recommended the listing of entecavir 1 mg tablet for the treatment of chronic hepatitis B infection in lamivudine resistant patients on a cost minimisation basis compared to adefovir with entecavir 1 mg for 48 weeks considered of equivalent effectiveness to adefovir 10 mg for 48 weeks. |
| Epirubicin hydrochloride, injection,
50 mg (freeze dried), Mayne Pharma Limited Minor submission |
Cytotoxic agent | Unrestricted listing | The PBAC had no objection to the Secretariat listing of this new strength. |
| Etanercept, powder for injection, 25 mg Enbrel®
Wyeth Australia Pty Ltd Minor submission |
Ankylosing spondylitis | Request the removal of HLA-B27 status from eligibility criteria for ankylosing spondylitis. | The PBAC agreed to the request recalling that it had initially recommended inclusion of this requirement in the restriction because HLA-B27 status represents an objective diagnostic criterion for ankylosing spondylitis. The PBAC considered that the current sacro-iliac x-ray criteria will provide an adequate level of certainty of the diagnosis of ankylosing spondylitis for the purposes of the PBS listing restriction. |
| Exemestane, tablet, 25 mg, Aromasin ®
Pfizer Australia Pty Ltd Major submission |
Breast cancer | Extend Restricted Benefit listing to include treatment of hormone-dependent early breast cancer in post-menopausal women following a minimum of 2 years treatment with tamoxifen citrate. | The PBAC recommended listing on a cost-effectiveness basis against tamoxifen for the adjuvant hormonal treatment of early breast cancer. The total duration of PBS-subsidised adjuvant hormonal treatment (tamoxifen + aromatase inhibitors) should not exceed 5 years. |
| Fenofibrate, tablets, 48 mg and 145 mg,Lipidil® , Laboratoires Fournier S.A. Pty Ltd
Minor submission |
Lipid-lowering drug | List on the PBS 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 formulation and strengths of fenofibrate. |
| Fluorouracil, injection, 1 g in 20 mL, Fluorouracil Ebewe® , InterPharma Pty Ltd
Minor submission |
Antineoplastic agent | Unrestricted listing | The PBAC had no objection to the Secretariat listingof this new strength of an already listed drug |
| Glucose indicator – blood, electrode strips, 50, Glucogard 01® , Diacare International Pty Ltd
Minor submission |
Diabetic testing strips | Unrestricted listing | The PBAC agreed to list this new brand of testing strips. |
| Hydroxocobalamin, injection, 1 mg in
1 mL, 3 ampoules, Mayne Pharma Limited Minor submission |
Treatment of vitamin B12 deficiencies | Increase maximum quantity from 2 to 3. | The PBAC had no objection to increasing the maximum quantity due to an extension of the expiry date following from an improvement in the manufacturing process. |
| Ibuprofen, tablet, 400 mg, Brufen® , Abbott Australasia Pty Ltd
Minor submission |
Non-steroidal antiinflammatory drug | Increase maximum quantity for unrestricted listing from 20 to 30. | The PBAC had no objection to the Secretariat listing to the proposed change in pack size. |
| Imiquimod, cream, 5%, Aldara®
3M Health Care Pty Ltd Major submission |
Treatment of basal cell skin cancer | Authority Required listing for treatment of biopsy confirmed primary (previously untreated) superficial basal cell carcinoma (sBCC) in immunocompetent patients who cannot have surgical excision, cryotherapy, nor curettage with diathermy and require drug therapy under certain specified conditions. | The PBAC recommended listing as an authority required benefit for treatment of biopsy confirmed primary (previously untreated) superficial basal cell carcinoma (sBCC) in immunocompetent patients who cannot have surgical excision, cryotherapy, or curettage with diathermy, on the basis of acceptable cost-effectiveness compared to placebo for patients who cannot have surgical excision, cryotherapy or curettage. |
| Infliximab, powder for injection, 100 mg Remicade®
Schering-Plough Pty Ltd Minor submission |
Ankylosing spondylitis | Request the removal of HLA-B27 status from eligibility criteria for ankylosing spondylitis. | The PBAC agreed to the request recalling that it had initially recommended inclusion of this requirement in the restriction because HLA-B27 status represents an objective diagnostic criterion for ankylosing spondylitis. The PBAC considered that the current sacro-iliac x-ray criteria will provide an adequate level of certainty of the diagnosis of ankylosing spondylitis for the purposes of the PBS listing restriction. |
| Infliximab, powder for injection, 100 mg Remicade®
Schering-Plough Pty Ltd Major submission |
Severe plaque psoriasis | Section 100 Highly Specialised Drug listing for the treatment of adult patients with severe plaque psoriasis for whom phototherapy or conventional systemic therapy have been inadequate or are inappropriate. | The PBAC recommended listing for the treatment of severe chronic plaque psoriasis in patients who meet certain criteria on a cost-minimisation basis with efalizumab. The equi-effective doses are infliximab 5mg/kg for 7.25 infusions for 1 year and efalizumab 1 mg/kg/week for 1 year. Restriction to be finalised |
| Letrozole, tablet, 2.5 mg, Femara®
Novartis Pharmaceuticals Australia Pty Limited Major submission |
Breast cancer | Extend Restricted Benefit listing to include the treatment of hormone-dependent early breast cancer in post-menopausal women. | The PBAC recommended listing on a cost-minimisation basis with anastrozole. The equi-effective doses are letrozole 2.5 mg and anastrozole 1 mg. The total duration of PBS-subsidised adjuvant hormonal treatment (tamoxifen + aromatase inhibitors) should not exceed 5 years. |
| Lopinavir with ritonavir, tablet, 200 mg-50 mg, Kaletra® Abbott Australasia Pty Ltd
Minor submission |
Treatment for HIV/AIDS | Section 100 Highly Specialised Drug listing as for other presentations of the same combination. | The PBAC had no objection to the Secretariat listing to add a new formulation of an already listed product to the current Section 100 listing. |
| Morphine hydrochloride, oral solution,1 mg per mL, 500 mL, M.O.S 1® , 5 mg per mL, 250 mL, M.O.S 5® , 5
mg per mL, 500 mL, M.O.S 5®, 10 mg per mL, 250 mL, M.O.S 10 ® , Valeant Pharmaceuticals
Australasia.
Minor submission |
Opioid analgesic | List as per the already listed morphine hydrochloride solution. | The PBAC had no objection to the Secretariat listing of the additional brands of morphine hydrochloride oral solution, noting that this was a temporary measure to ensure the ongoing availability of oral morphine solution under the PBS, following the recall of the current PBS-listed brand of morphine hydrochloride oral solution. |
| Pimecrolimus, cream, 1%
15 g, Elidel® Novartis Pharmaceuticals Australia Pty Ltd Major submission |
Treatment of atopic dermatitis | Extend Authority Required listing to include patients aged over 18 years. | The PBAC recommended listing on the basis of acceptable comparative efficacy and cost- effectiveness over topical corticosteroids (TCS) and vehicle cream in the requested populations. |
| Posaconazole, oral suspension, 40 mg per mL, Noxafil®
Schering-Plough Pty Ltd Major submission |
Anti-fungal agent | Authority Required listing for the treatment of invasive aspergillosis in patients
in patients 13 years or older intolerant to, or with disease refractory to alternative
therapy.
Treatment of fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients 13 years or older intolerant to, or with disease refractory to alternative therapy. |
The PBAC recommended the listing of posaconazole on the grounds of high but acceptable cost-effectiveness compared to a suite of salvage therapies. |
| Risperidone, orally disintegrating tablets, 3 mg and 4 mg, Risperdal® Quicklet®, Janssen-Cilag
Pty Ltd
Minor submission |
Treatment for schizophrenia and bipolar 1 disorder | List as for the 3 mg and 4 mg regular tablets. | The PBAC had no objection to the Secretariat listing to add these higher strength formulations for the treatment of schizophrenia and bipolar I disorder. |
| Ritonavir, oral solution, 600 mg per 7.5 mL (80 mg per mL), 90 mL, Norvir® , Abbott Australasia
Pty Ltd
Minor submission |
Treatment for HIV/AIDS | List as for other presentations of this drug. | The PBAC had no objection to the Secretariat listing to add a new volume of the same concentration to the current Section 100 listing. |
| Rosiglitazone with metformin, tablets, 2 mg/500 mg, 2 mg/1 g, 4 mg/500 mg, and 4 mg/1 g, Avandamet®
GlaxoSmithKline Australia Pty Ltd Major submission |
Oral hypoglycaemics | Authority Required listing: Initiation of therapy, in type 2 diabetic patients who are eligible to treatment with rosiglitazone and metformin. | The PBAC recommended listing of rosiglitazone with metformin fixed dose combination
tablets on the grounds the combination tablets are no worse than concomitant rosiglitazone
and metformin. The equi-effective doses in the context of cost-minimisation were rosiglitazone
4 mg plus metformin 500 mg fixed dose combination tablet compared to rosiglitazone
4 mg and metformin 500 mg.
The PBAC agreed that the combination tablet should be available to the same patient population as had access to individual components. |
| Rosuvastatin, tablets 5 mg, 10 mg, 20 mg, and 40 mg, Crestor®
AstraZeneca Pty Ltd Major submission |
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 recommended listing on a cost-minimisation basis with atorvastatin, with the ratio of equi-effective doses being rosuvastatin to atorvastatin 1:3. |
| Saquinavir mesylate, tablet, 500 mg, Invirase® , Roche Products Pty Ltd
Minor submission |
Treatment for HIV/AIDS | Section 100 Highly Specialised Drug listing | The PBAC had no objection to the Secretariat listing to add a new strength to the current Section 100 listings. |
| Sodium cromoglycate, eye drops, 20 mg per mL (2%), 10mL, Cromolux® , AFT Pharmaceuticals Pty Ltd; Opticrom®
, Aventis Pharma Prty Ltd
Minor submission |
Antiallergic eye drops | The PBAC recommended that sodium cromoglycate eye drops could be transferred from an ‘Authority Required’ to ‘Restricted Benefit’ listing. The Committee further requested the DUSC monitor usage. | |
| Sodium valproate, crushable tablet 100mg, tablets (enteric coated) 200 mg and 500mg, oral liquid 200
mg per 5 mL, 300mL, and syrup, 200 mg per 5 mL, 300 mL, Epilim®, Sanofi-Synthelabo
Australia Pty Ltd; Valpro® , Alphapharm Pty Ltd
Minor submission |
Treatment for epilepsy | Amend CAUTION to: There are reports of fatal hepatotoxicity, particularly in children:
there is increasing evidence of dose related teratogenesis from this drug. |
The PBAC recommended the caution for sodium valproate be amended to replace the current note regarding spina bifida with the new note suggested by the Australian Association of Neurologists. This reflected the finding that with increased experience it has become apparent that spina bifida is not the only teratogenic effect of sodium valproate. |
| Somatropin, 5 mg in 1.5 mL, injection cartridges, Omnitrope® , Sandoz Pty Ltd
Minor submission |
Human growth hormone | List under the Human Growth Hormone Program | The PBAC had no objection to the Secretariat listing to add a new brand to the current Section 100 listings |
| Tramadol, sustained release tablet, 50 mg, Tramal ®, CSL Limited
Minor submission |
Opioid analgesic | Listing as a Restricted Benefit for pain where aspirin and/or paracetamol alone are inappropriate or have failed. | The PBAC had no objection to the Secretariat listing to add a new strength to the current listings for this restriction. |
| Trastuzumab, powder for infusion, 150 mg (Herceptin® )
Roche Products Pty Ltd Major submission |
Breast cancer | Authority Required benefit for adjuvant treatment of patients with HER2-positive early breast cancer. | The PBAC recommended listing for treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery on a cost-effectiveness basis over no treatment. Restriction to be finalised. |
| Travoprost with timolol eye drops,
40 µg-5 mg (base) (0.004%-0.5%) Extravan® Alcon Laboratories (Australia) Pty Ltd Major submisson |
Ocular hypertension (glaucoma) | Restricted Benefit listing for the reduction of elevated intra-ocular pressure (IOP) in patients with ocular hypertension, who are not adequately controlled with timolol maleate 5 mg (base) per mL eye drops or who are insufficiently responsive to prostaglandins or other intraocular pressure lowering medications. | The PBAC recommended listing on a cost minimisation basis with Xalacom® (latanoprost with timolol). The equi-effective doses are the fixed dose combination of travoprost 40µg/mL with timolol 5mg/mL, one drop instilled once daily and the fixed dose combination of latanoprost 50µg/mL and timolol 5mg/mL, one drop instilled once daily. A minor change to the restriction requested was recommended, substituting the words “ prostaglandins or other IOP lowering medications” with “ travaprost”. |
