November 2005 PBAC Outcomes - Positive Recommendations
Recommendations made by the PBAC (Pharmaceutical Benefits Advisory Committee) in November 2005 relating to the listing of drugs on the PBS (Pharmaceutical Benefits Scheme)
| Drug and Sponsor | Drug use and type | Request of Sponsor | PBAC recommendation and comments |
|---|---|---|---|
| ADEFOVIR DIPIVOXIL tablet 10mg, Hepsera®Gilead Scientific Pty Ltd
Minor submission |
Treatment of hepatitis B | Request to remove requirement for a liver biopsy, as patients will already have had biopsy to receive lamivudine, which they must fail to receive adefovir as a pharmaceutical benefit. | The PBAC agreed to the sponsor’s request to remove the requirement for a second liver biopsy based on adefovir’s listing as second-line to lamivudine therapy which already requires patients to have a diagnosis of hepatitis based on a liver biopsy. |
| ARIPIPRAZOLE tablet
5 mg, Abilify® , Bristol-Myers Squibb Pharmaceuticals Minor submission |
Treatment of schizophrenia | Authority required listing for schizophrenia | The PBAC had no objection to the Secretariat listing of an additional lower strength of aripiprazole to assist with gradual up-titration. |
| BUPRENORPHINE and NALOXONE tablets
2 mg-0.5 mg, 8 mg-2 mg, Suboxone® Reckitt Benckiser (Australia) Pty Limited Major submission |
Detoxification and maintenance treatment of opiate dependence | Section 100 listing for the treatment of opiate dependence, within a framework of medical, social and psychological treatment. Naloxone is included in Suboxone to deter intravenous misuse of the product. | The PBAC recommended listing on a cost-minimisation basis compared to buprenorphine, with the equi-effective doses being determined on a milligram for milligram basis for treatment of opiate dependence, within a framework of medical, social and psychological treatment. |
| CAPECITABINE tablets
500 mg and 150 mg, Xeloda® Roche Products Pty Ltd Major submission |
Treatment of colon cancer | Extend Authority Required restriction to include "adjuvant treatment of patients with Dukes’ C colon cancer." | Listing was recommended on a cost-minimisation basis, concluding that the head-to-head randomised trial comparison presented in the submission indicated that capectabine is no worse than the Mayo Clinic regimen of 5-FU plus leucovorin in terms of disease free survival. The toxicity profile of capecitabine was noted to be different from the comparator but was considered to be no worse overall. |
| CARMUSTINE implant with polifeprosan-20 7.7 mg, Gliadel®
Orphan Australia Pty Ltd Major submission |
Treatment of certain brain tumours | Section 85 Restricted benefit and Section 100 listing for the treatment of newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. | The PBAC recommended listing on a cost-minimisation basis with one pack of eight carmustine 7.7 mg implants being equivalent to a course of temozolomide capsules. Based on the indirect comparison across the two trials provided in the submission, the PBAC concluded that, overall, carmustine is no worse than temozolomide for glioblastoma multiforme, the main indication within the requested restriction. |
| CYCLOSPORIN, capsules, 10 mg, 25 mg, 50 mg,100 mg, Oral Liquid 100 mg per mL, 50 mL,
Neoral®, Novartis Pharmaceuticals Australia Pty Ltd;
capsules 25 mg, 50 mg and 100 mg, Cicloral® , Hexal Australia Pty Ltd; and Cysporin®, Mayne Pharma Pty Ltd Minor submission |
Immunosuppessant | Transfer listing for initiation of therapy from section 100 to section 85 (in addition to maintenance therapy) for dermatitis, psoriasis and rheumatoid arthritis | The PBAC agreed with the request of the High Specialised Drugs Working Party to transfer listing of cyclosporin capsules and oral liquid for the treatment of severe atopic dermatitis, severe psoriasis and severe active rheumatoid arthritis from section 100 to section 85 on the basis that mostly the treatment of these conditions is now by specialists in private practice and outside the hospital setting. |
| DRUGS FOR THE TREATMENT OF BONE DISEASE
ALENDRONATE SODIUM, tablet, equivalent to 70 mg alendronic acid, Fosamax Once Weekly®, Merck Sharp & Dohme (Australia) Pty Ltd; Alendro Once Weekly® Arrow Pharmaceuticals Limited; DISODIUM ETIDRONATE and CALCIUM CARBONATE, pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium), Didrocal® , Pharmacia & Upjohn Pty Ltd; RALOXIFENE HYDROCHLORIDE, tablet, 60 mg, Evista®, Eli Lilly Australia Pty Ltd; RISEDRONATE SODIUM, tablets, 5 mg and 35 mg, Actonel® and Actonel Once-a Week®, Aventis Pharma Pty Ltd Minor submission |
Treatment of osteoporosis | Amend authority required listings to state use should be as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma. | The PBAC recommended a change to the restriction to preclude PBS subsidised use in combination with any other anti-resorptive drugs as there is no evidence of either improved effectiveness or cost-effectiveness of such combination use. |
| EFALIZUMAB injection set containing powder for injection 125 mg and 4 prefilled syringes
solvent, Raptiva®
Serono Australia Pty Ltd Minor submission |
Treatment of psoriasis | Section 85 authority required listing for the treatment of severe chronic plaque psoriasis in patients with severe psoriasis defined as a baseline PASI score > 15 and who are unresponsive to at least two out of three previous systemic therapies comprising phototherapy, methotrexate and cyclosporin. | The PBAC recommended listing on the basis of acceptable cost-effectiveness compared to no systemic treatment in the defined population. The PBAC recommended that the restriction include the requirement for a baseline PASI score of greater than 15 and that this must be assessed following treatment with each of the three nominated therapies (methotrexate, cyclosporin and phototherapy). With respect to the criteria to be met in order to qualify for continuing therapy with efalizumab, the PBAC recommended at least a 75% improvement in the patient’s baseline PASI score following at least 12 weeks of therapy would be required. |
| EPOETIN BETA injections, pre-filled syringe, 1 000 units in 0.3 mL, 2 000 units in
0.3 mL, 3 000 units in 0.3 mL, 5 000 units in 0.3 mL, 10 000 units in 0.6 mL, Neorecormon®,
Roche Pharmaceuticals Pty Ltd Minor submission |
Treatment of severe anaemia | Section 100 item for the 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 recommended listing as previously recommended, on a cost-minimisation basis compared to epoetin alfa, on a unit per unit basis. |
| ESOMEPRAZOLE MAGNESIUM TRIHYDRATE tablet, 20 mg Nexium®
AstraZeneca Pty Ltd Major submission |
Treatment of peptic ulcer and gastro-oesophageal reflux
disease |
Restricted benefit for healing of peptic ulcers associated with non-steroidal anti-inflammatory drugs. | The PBAC recommended listing as a restricted benefit for treatment of gastric ulcer on a cost-minimisation basis, concluding that the indirect comparison via a ranitidine comparator arm presented in the submission indicated that esomeprazole is no worse than omeprazole in the treatment of gastric ulcer. The equi-effective doses are esomeprazole 20 mg daily for 4 to 8 weeks and omeprazole 20 mg daily for 4 to 8 weeks. The PBAC considered it appropriate for the restriction to align as far as possible with the PBS restrictions for the current listed proton pump inhibitors in the treatment of gastrointestinal ulcers. The Committee noted that the majority of gastric ulcers not associated by H. pylori are caused by non-steroidal anti-inflammatory drugs. |
| ETANERCEPT, injection set containing 4 vials powder for injection 50 mg and pre-filled
syringes solvent 1 mL, Enbrel® , Wyeth Australia Pty Ltd
Minor submission |
Treatment of rheumatoid arthritis | Listing as for the 25 mg strength in adults with rheumatoid arthritis and with a history of severe active polyarticular course juvenile chronic arthritis | The PBAC had no objection to the Secretariat listing of higher strength of etanercept for the management of rheumatoid arthritis and patients aged over 18 years of age with a history of severe active polyarticular course juvenile chronic arthritis with onset prior to adulthood. |
| EZETIMIBE tablet, 10 mg, Ezetrol®
Merck Sharp and Dohme (Australia) Pty Limited Major submission |
Lipid-lowering drug | Extend listing to include co-administration with statins in patients with symptomatic cerebrovascular disease (CVD), symptomatic peripheral vascular disease (PVD), or in patients with heterozygous familial hypercholesterolemia (HeFH) | The PBAC recommended the addition of two indications to the current listing for ezetimibe, namely peripheral vascular disease and heterozygous familial hypercholesterolaemia, on the basis of acceptable cost-effectiveness in these patient groups. The PBAC was unable to agree to the addition of cerebrovascular disease because the current General Statement for Lipid-Lowering Drugs does not include this patient group. |
| EZETIMIBE with SIMVASTATIN tablet, 10 mg-40 mg and 10 mg-80 mg, Vytorin®
Merck Sharp & Dohme Pty Ltd Major submission |
Lipid-lowering drug | Extend recommended listing to include co-administration with statins in patients with symptomatic cerebrovascular disease (CVD), symptomatic peripheral vascular disease (PVD), or in patients with heterozygous familial hypercholesterolemia (HeFH) | The PBAC recommended the addition of two indications to the current listing for ezetimibe, namely peripheral vascular disease and heterozygous familial hypercholesterolaemia, on the basis of acceptable cost-effectiveness in these patient groups. The PBAC was unable to agree to the addition of cerebrovascular disease because the current General Statement for Lipid-Lowering Drugs does not include this patient group. |
| FOLLITROPIN BETA, solution for injection 300 i.u., 600 i.u. and 900 i.u in multi-dose
cartridge, Puregon® , Organon (Australia) Pty Limited
Minor submission |
Gonadotrophin | Restricted benefit listing for male infertility | The PBAC had no objection to the Secretariat listing of additional strengths of follitropin beta for the treatment of male infertility. This follows the extension of the TGA-registered indications, to include male infertility, for these strengths of multi-dose cartridges. |
| FOLLITROPIN BETA, solution for injection 900 i.u in multi-dose cartridge, Puregon®
, Organon (Australia) Pty Limited
Minor submission |
Gonadotrophin | Restricted benefit listing for anovulatory infertility | The PBAC had no objection to the Secretariat listing of this new strength of follitropin beta for the treatment of anovulatory infertility and under the section 100 IVF/GIFT program. |
| GRANISETRON HYDROCHLORIDE, tablet, 2 mg, Kytril ®,
Mayne Pharma Pty Ltd Minor submission |
Treatment for nausea and vomiting | Authority required listing for management of nausea and vomiting associated with radiotherapy being used to treat malignancy. | The PBAC had no objection to the Secretariat listing of an oral formulation of granisetron for use in patients being treated for malignancy with radiotherapy. |
| INTESTINAL ANTIINFLAMMATORY AGENTS: AMINOSALICYLIC ACID AND SIMILAR AGENTS :
BALSALAZIDE capsule, 750 mg, Colazide ® Pharmatel Fresenius Kabi MESALAZINE granules, 500 mg and 1 g, Salofalk® Orphan Australia, OLSALAZINE capsule 250 mg and tablet 500 mg, Dipentum® UCB Pharma Minor submission |
Treatment of inflammatory bowel conditions | The PBAC decided to simplify the restrictions relating to this class of drugs at the
July 2005 meeting. The PBAC agreed that the wording be:
Authority required Colitis where hypersensitivity to sulfonamides exists; Colitis where intolerance to sulfasalazine exists. The opinion of the respective sponsors was sought. |
The PBAC recommended that the listings for balsalazide, mesalazine granules and olsalazine
be amended to Authority Required
Ulcerative colitis where hypersensitivity to sulfonamides exists; Ulcerative colitis where intolerance to sulfasalazine exists. NOTE : Not for the treatment of Crohn’s disease The PBAC recommended a change to the restriction to more closely reflect the TGA-approved indications applying to the oral formulations of the aminosalicylic acid derivatives and taking into account comments received by the sponsors. |
| INTESTINAL ANTIINFLAMMATORY AGENTS: AMINOSALICYLIC ACID AND SIMILAR AGENTS:
MESALAZINE tablet250 mg, Mesasal ® GlaxoSmithKline, MESALAZINE tablet500 mg, Salofalk® Orphan Australia Minor submission |
Treatment of inflammatory bowel conditions | The PBAC decided to simplify the restrictions relating to this class of drugs at the
July 2005 meeting. The PBAC agreed that the wording be:
Authority required Colitis where hypersensitivity to sulfonamides exists; Colitis where intolerance to sulfasalazine exists. The opinion of the respective sponsors was sought. |
The PBAC recommended that the listings for mesalazine tablets 250 mg and 500 mg be
amended to Authority Required
Ulcerative colitis where hypersensitivity to sulfonamides exists; Ulcerative colitis where intolerance to sulfasalazine exists; Crohn’s disease where hypersensitivity to sulfonamides exists; Crohn’s disease where intolerance to sulfasalazine exists. The PBAC recommended a change to the restriction to more closely reflect the TGA-approved indications applying to the oral formulations of the aminosalicylic acid derivatives and taking into account comments received by the sponsors. |
| LATANOPROST with TIMOLOL MALEATE eye drops, 50 µg per mL- 5 mg per mL, Xalacom®
Pfizer Australia Pty Limited Minor submission |
Treatment of glaucoma | Listing as a restricted benefit for Reduction of elevated intraocular pressure in
patients with open angle glaucoma who are not adequately controlled with timolol maleate
5mg (base) per mL (0.5%) (bd) eye drops or who are insufficiently responsive to prostaglandins
or other intraocular pressure lowering medication;
Reduction of elevated intra-ocular pressure in patients with ocular hypertension, who are not adequately controlled with timolol maleate 5mg (base) per mL (0.5%) eye drops or who are insufficiently responsive to prostaglandins or other intraocular pressure lowering medication. |
Consistent with its policy on fixed dose combination products, the PBAC recommended listing on a cost-minimisation basis and that latanoprost with timolol maleate should be priced on a mg per mg basis compared to the individual components. |
| LUMIRACOXIB tablet
200 mg, Prexige® Novartis Pharmaceuticals Australia Pty Limited Minor submission |
Treatment of osteoarthritis | Restricted benefit listing for the symptomatic treatment of osteoarthritis. | The PBAC recommended listing for the symptomatic treatment of osteoarthritis only, on a cost-minimisation basis compared to celecoxib with the equi-effective doses being lumiracoxib 200 mg and celecoxib 200 mg. |
| MESALAZINE enema 1 g in 100 mL, 7, Pentasa®,
Ferring Pharmaceuticals Pty Ltd Minor submission |
Treatment of inflammatory bowel conditions | Amend listing to an authority required restriction for acute episode of mild to moderate ulcerative colitis. NOTE: Not for the treatment of Crohn’s disease | The PBAC agreed to change the wording of the restriction as requested by the sponsor following a change to the TGA-approved indication and in light of its recommendation to simplify the wording of the restrictions for this group of drugs. |
| METFORMIN HYDROCHLORIDE extended release tablet
500 mg, Diabex® XR Alphapharm Pty Limited Minor submission |
Oral anti-diabetic agent | Listing as an unrestricted benefit. | The PBAC recommended listing on a cost minimisation basis compared with the immediate release metformin hydrochloride tablet and based on bioequivalent data demonstrating equivalence of this slow release formulation as compared to the immediate release formulation of metformin currently available on the PBS on a mg for mg basis. |
| METHOTREXATE solution concentrate for I.V. infusion 500 mg in 20 mL
Mayne Pharma Pty Ltd Minor submission |
Antimetabolite | Unrestricted listing | The PBAC had no objection to the Secretariat listing of an additional strength of methotrexate solution concentrate. |
| MODAFINIL, tablet, 100 mg, Modavigil ®,
CSL Limited, Australian Association of Neurologists Minor submission |
Treatment for narcolepsy | Request to allow neurologists to initiate treatment. Minor change to sleep latency period from 'less than 8 minutes' to '8 minutes or less'. | The PBAC agreed with the request to allow neurologists to initiate prescribing of modafanil on the basis that narcolepsy is considered to be a neurological condition and that patients may be managed by a neurologist or qualified sleep medicine practitioner. The PBAC also agreed to an administrative change to the restriction requested by Medicare Australia to clarify the "mean sleep latency" as 8 minutes or less. |
| NAPROXEN, oral suspension, 125 mg per 5mL, Naprosyn®,
Roche Products Pty Ltd Minor submission |
Treatment of arthritis | Restore PBS listing. | The PBAC recommended authority required listing for chronic arthopathies (including osteoarthritis) with an inflammatory component and bone pain due to malignant disease in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent. Re-listing was recommended on the basis of clinical need and in recognition of the lack of available paediatric dosage forms for this group of drugs. |
| OLMESARTAN MEDOXOMIL tablets
10 mg, 20 mg and 40 mg, Olmetec® Pfizer Australia Pty Limited Major submission |
Treatment of hypertension. | Unrestricted listing. | The PBAC recommended listing on a cost minimisation basis compared to irbesartan with the equi-effective doses being olmesartan 1 mg and irbesartan 7.5 mg. |
| PEGINTERFERON ALFA-2A 180 mcg and 135 mcg pre-filled syringes, Pegasys ®
Roche Products Pty Ltd Major submission |
Treatment of hepatitis B and C. | Extend Section 100 listing to include treatment of "patients with chronic hepatitis B and compensated liver disease who satisfy all of the Section 100 criteria" with the same restriction as that applying to lamivudine in hepatitis B. | The PBAC recommended listing on the basis of acceptable cost-effectiveness compared to lamivudine, concluding that the two head-to-head trials presented in the submission indicate that a course of peginterferon alfa-2a is more effective than lamivudine in the treatment of hepatitis-B, but has slightly more toxicity. |
| PEGINTERFERON ALFA-2B with RIBAVIRIN, Pegatron ® and PEGINTERFERON ALFA-2B (Peg-Intron®)
Schering-Plough Pty Limited Major submission |
Treatment of hepatitis C | Request for the removal of liver biopsy as eligibility criteria for the treatment of chronic hepatitis C. | The PBAC recommended a change to the restrictions for ribavirin with peginterferon
alfa-2b and peginterferon alfa-2b monotherapy to remove the requirement for liver
biopsy to establish eligibility for PBS subsidised treatment for hepatitis C.
The recommendation is to also apply to the Roche products, peginterferon alfa-2a with ribavirin, Pegasys-RBV® , and peginterferon-alfa-2a, Pegasys® |
| RISEDRONATE SODIUM and CALCIUM CARBONATE tablet 35 mg-1.25 g, Actonel Combi ®
Sanofi Aventis Group Minor submission |
Treatment of osteoporosis | Requests listing of a new risedronate 35 mg tablet presentation incorporating supplemental calcium at the same price and same restriction as currently listed risedronate. | The PBAC recommended listing on a cost-minimisation basis compared to the risedronate 35 mg once weekly preparation currently listed on the PBS. |
| RISPERIDONE tablets
1 mg, 2 mg, 3 mg, 4 mg, and 1 mg per mL oral solution Risperdal® and tablets (orally disintegrating) 1 mg, 2 mg Risperdal Quicklet ®, Janssen-Cilag Pty Ltd Major submission |
Treatment of bipolar 1 disorder, behavioural disturbances in dementia and schizophrenia | Authority required listing for adjunctive therapy to mood stabilisers for the treatment of an episode of acute mania associated with bipolar I disorder. | The PBAC recommended listing on a cost-minimisation basis, concluding that the indirect comparison using placebo as the common comparator, indicted that risperidone was no worse than olanzapine in the treatment of bipolar 1 disorder. The equi-effective doses are risperidone 3.75 mg per day for 2 to 4 months and olanzapine 10.4 mg per day for 2 to 4 months. The PBAC considered it appropriate to include reference to the duration of treatment (up to six months) in restriction wording because of the limitations of the TGA-approved indication for acute mania. |
| RISPERIDONE tablet 500 mg, Risperdal ®, tablet (orally disintegrating) 500 m g Risperdal
Quicklet ®, Janssen-Cilag Pty Ltd
Minor submission |
Treatment of schizophrenia | Extend listing to include listing of schizophrenia in addition to the current restriction for behavioural disturbances. | The PBAC had no objection to the Secretariat’s extension to PBS listing of these currently
listed products for the treatment of schizophrenia. This allows elderly patients with
schizophrenia to be treated with lower doses of risperidone without having to break
the
1 mg tablets. |
| SOMATROPIN, injections, 5 mg, 10 mg and 15 mg, pre-filled multi-dose cartridge, Nordiflex®,
Novo Nordisk Pharmaceuticals Pty Ltd
Minor submission |
Treatment of growth hormone deficiency and short stature in children | Section 100 listing (Human Growth Hormone Program) | The PBAC had no objection to the Secretariat listings of three strengths of somatropin currently listed on the PBS in a new presentation - a pre-filled multi-dose cartridge. |
| SPIRONOLACTONE tablets 25 mg and 100 mg, Aldactone®,
Pfizer Australia Pty Ltd and Spiractin®, Alphapharm Pty Limited Minor submission |
Treatment of heart failure | PBAC requested a review of the listing, specifically of its use in the treatment of cardiac failure not associated with hyperaldosteronism. | The PBAC recommended an amendment to the PBS listings from the current restricted benefit listing to an unrestricted listing, based on the fact that the current restrictions do not reflect current clinical practice. The Committee recommended retaining the current CAUTION notes relating to electrolyte monitoring and contraceptive measures in women of childbearing age. |
| SUMATRIPTAN SUCCINATE, fast disintegrating tablet, 50 mg (base), Imigran FDT ®, GlaxoSmithKline
Australia Pty Ltd
Minor submission |
Treatment of migraine | Amend previous recommendation to allow listing under a separate PBS code. | The PBAC reaffirmed its previous recommended listing on a cost-minimisation basis with reference to the demonstrated bioequivalence to the currently listed sumatriptan tablet 50 mg (base). However the PBAC had no objection to listing under a different item number from the currently listed tablet. |
| TEMOZOLOMIDE capsule, 5 mg, 20 mg, and 100 mg, Temodal®,
Schering-Plough Pty Ltd Minor submission |
Treatment of certain brain tumours | Add note to the restriction for use in gliobastoma multiforme concomitantly with radiotherapy to preclude use in conjunction with PBS-subsidised carmustine wafer. | The PBAC considered that a NOTE should follow the restriction to preclude the PBS-subsidised use of temozolomide in conjunction with carmustine following its recommendation to list carmustine on the PBS. |
| TENOFOVIR DISOPROXIL FUMARATE with EMTRICITABINE, tablet,
300 mg-200 mg, Truvada® Gilead Sciences Pty Ltd Major submission |
HIV infection. | Section 100 listing private hospital authority required for the treatment of HIV infection in patients with CD4 cell counts of less than 500 per cubic millimetre or viral load of greater than 10,000 copies per mL. | Consistent with its policy on fixed dose combination products, the PBAC recommended listing on a cost-minimisation compared to the corresponding strengths of the individual components given concomitantly. Although largely based on pharmacokinetic data rather than clinical data, the data presented indicate that Truvada as requested once daily has similar safety and efficacy compared to concomitant tenofovir 300 mg once daily and emtricitabine 200 mg once daily. |
| TESTOSTERONE UNDECANOATE I.M. injection 1 g, Reandron-1000®
Schering Pty Limited Major submission |
Treatment of androgen deficiency in males. | Authority Required listing as for other testosterone products for androgen deficiency in males who meet certain criteria. | The PBAC recommended listing on a cost-minimisation basis compared to testosterone implant with the equi-effective doses being testosterone intramuscular injection 1000 mg every 12 weeks and testosterone implant (600mg ) every 4 months. |
| TREPROSTINIL SODIUM injections 1mg in 1 mL, 2.5 mg in 1 mL, 5 mg in 1 ml, 10 mg in
1 mL 20 mL multidose vials, Remodulin®
Orphan Australia Pty Ltd Major submission |
Treatment of pulmonary hypertension. | Section 100 listing for the treatment of primary pulmonary hypertension (PPH) or pulmonary arterial hypertension (PAH) associated with connective tissue disease, in patients with disease of WHO Functional Class III or IV severity. | The PBAC recommended listing on a cost-minimisation basis, concluding that the indirect
comparison involving placebo as the common reference submitted indicated that, overall,
treprostinil sodium is no worse than bosentan monohydrate. The equi-effective doses
are trepostinil sodium 9.3 ng/kg/min via continuous subcutaneous infusion and bosentan
250mg twice per day. The PBAC considered that the listing of trepostinil sodium would
provide an additional treatment option to patients with a different mode of administration,
that is by subcutaneous infusion.
The recommended listing is consistent with the TGA approved indication, and will allow for interchangeablility with bosentan and iloprost. The restriction will be posted on the website when finalised. |
| VERTEPORFIN powder for intravenous infusion 15 mg, Visudyne®
Novartis Pharmaceuticals Australia Pty Ltd Major submission |
Treatment of macular degeneration of the retina. | Section 100 Special Program for subfoveal choroidal neovascularisation due to age-related macular degeneration and other macular diseases | The PBAC recommended listing on a cost-effectiveness basis for patients with age-related macular degeneration (AMD) featuring predominantly classic lesions. The PBAC considered that the incremental cost per extra QALY gained was high but acceptable and less uncertain than the estimated cost-effectiveness for the additional patient groups requested for subsidy. |
