Area Drug and Therapeutics Committee Prescribing Supplement No 24 August 2008

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 24 In this issue Drugs currently being considered by SMC advice due on 08 September New drug decisions relevant to Primary Care practitioners New drugs reviewed by the SMC in July 2008 Drugs currently being considered by the SMC with advice due on 08 September 2008 SMC REVIEW INDICATION 498/08 Aripiprazole (Abilify ) Treatment and prevention of manicepisodes in bipolar disorder 494/08 Alemtuzumab (MabCampath ) Treatment of B-cell chronic lymphocytic leukaemia 497/08 Micafungin (Mycamine ) Treatment of invasive candidiasis in adults, elderly and children (including neonates) 493/08 Rituximab (MabThera ) Treatment of stage III to IV follicular lymphoma in combination with chemotherapy 342/07 Pemetrexed (Alimta ) Treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 491/08 Ropinirole prolonged release (Requip XL) Idiopathic Parkinson s disease Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 New Drugs decisions of most relevance to Primary Care in this issue- No 334/06 Lidocaine medicated plaster (Versatis ) following a re-submission to SMC now recommended for restricted use in NHS Scotland and added to the Lanarkshire Joint Formulary only for the treatment of neuropathic pain associated with herpes zoster infection (post-herpetic neuralgia). No 234/06 Buprenorphine transdermal patches (BuTrans ) - following a 2 nd resubmission to SMC this product is not recommended for use in NHS Scotland for the treatment of severe opioid responsive pain and BuTrans will not be added to the Lanarkshire Joint Formulary. No 500/08 Melatonin 2mg prolonged release tablets (Circadin) following a nonsubmission to SMC this product is not recommended for use in NHS Scotland for the short term treatment of primary insomnia in those aged 55+ and melatonin will not be added to the Lanarkshire formulary. No 501/08 Venlafaxine (Efexor XL) following a non-submission to SMC this product is not recommended for use in NHS Scotland for the treatment of moderate to severe generalised social anxiety disorder/social phobia in adults and venlafaxine will not be added to the Lanarkshire Joint Formulary, for this indication. No 434/07 Clobetasol propionate 0.05% shampoo (Etrivex ) following a submission to SMC this product is recommended for use in NHS Scotland for the topical treatment of moderate scalp psoriasis in adults. However this product is not added to the formulary at this time, pending specialist advice on Lanarkshire formulary status. The following new drugs have been reviewed by the Scottish Medicines Consortium in July 2008 : - Colour coding of decisions about new medicines: - Green = accepted for general use in Lanarkshire and added to the Joint Formulary Orange = accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) Light orange = Not added to the formulary due to the specialist nature of the treatment or pending specialist advice on formulary status. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. Red = not accepted for use in Lanarkshire and not added to the Joint Formulary. A request to prescribe a drug in this category must be clinically justified by the prescriber. Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 2

3 No 488/08 No 489/08 Drug/product Indication SMC Lanarkshire and Pegylated interferon ά 2b (ViraferonPeg ) solution for injection in pre-filled pen, in combination with ribavirin (Rebetol ) 200mg capsules. Rabbit anti-human thymocyte immunoglobulin, 25mg powder for solution for infusion (Thymoglobuline ) Treatment of adult patients with chronic hepatitis C who have failed previous treatment. Prevention of graft rejection in renal transplantation Pegylated interferon α 2b (ViraferonPeg ) in combination with ribavirin (Rebetol ) is accepted within NHS Scotland for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alfa (pegylated or non-pegylated) and ribavirin combination therapy or interferon alfa (pegylated or non-pegylated) monotherapy. A sustained virologic response rate of 23% was achieved in a single arm study where relapsed or non-responding patients were treated with peginterferon α 2b and ribavirin. Re-treatment was more cost-effective with patients who had previously responded but relapsed compared to patients who did not respond to initial therapy. Rabbit anti-human thymocyte immunoglobulin, 25mg powder for solution for infusion (Thymoglobuline ) is not recommended for use within NHS Scotland for prevention of graft rejection in renal transplantation. Compared with an alternative agent for induction of immunosuppression it was associated with a lower rate of acute rejection but this did not translate into improved patient or graft survival within the 12-month study period. The manufacturer has not presented a sufficiently robust economic analysis to gain acceptance by SMC. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols Rabbit anti-human thymocyte immunoglobulin is also licensed for the treatment of steroid resistant graft rejection in renal transplantation and for the prevention of graft rejection in heart transplantation. The manufacturer s submission related only to the prevention of graft rejection in renal transplantation. SMC cannot recommend the use of rabbit anti-human thymocyte immunoglobulin for these additional indications. 3

4 No 490/08 No 452/08 Drug/product Indication SMC Lanarkshire and Teriparatide, 750 micrograms/3ml solution for injection prefilled pen (Forsteo ) Trabectedin 0.25mg, 1mg powder for concentrate for solution for infusion (Yondelis ) Treatment of osteoporosis in men at increased risk of fracture. Treatment of patients with advanced soft tissue sarcoma. Teriparatide (Forsteo ) is not recommended for use within NHS Scotland for the treatment of osteoporosis in men at increased risk of fracture. Teriparatide was associated with a greater increase in lumbar spine bone mineral density than placebo. acceptance by SMC. Trabectedin (Yondelis ) is not recommended for use within NHS Scotland for the treatment of patients with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were used, the licensed schedule was superior to the alternative one for the primary endpoint, time to progression. No 334/06 Lidocaine 5% medicated plaster (Versatis ) Resubmission Treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia) acceptance by SMC. Lidocaine 5% medicated plaster (Versatis ) is accepted for restricted use within NHS Scotland for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia). There are only limited comparative data available for lidocaine plasters, the comparative clinical effectiveness remains unclear. It is restricted to use in patients who are intolerant of first-line systemic therapies for post-herpetic neuralgia or where these therapies have been ineffective. Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) 4

5 Recommendation No 434/07 No 234/06 No 499/08 No 500/08 No 501/08 Drug/product Indication SMC Lanarkshire and Clobetasol propionate 0.05% shampoo (Etrivex ) Resubmission Buprenorphine transdermal patches (BuTrans ) 2 nd Resubmission Ibritumomab tiuxetan 1.6mg/ml (Zevalin ) Melatonin 2mg prolonged release tablets (Circadin ) Venlafaxine (Efexor XL ) Topical treatment of moderate scalp psoriasis in adults. Treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics. Consolidation therapy after remission induction in previously untreated patients with follicular lymphoma Short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. Treatment of moderate to severe generalised social anxiety disorder/social phobia in adults. Clobetasol propionate 0.05% shampoo (Etrivex ) is accepted for use within NHS Scotland for the topical treatment of moderate scalp psoriasis in adults. Comparison of clobetasol propionate 0.05% shampoo to another clobetasol formulation demonstrated non-inferiority and costs are similar. Buprenorphine transdermal patches (Butrans ) are not recommended for use within NHS Scotland for the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics. In the patient population considered in this submission, severe osteoarthritis pain in elderly patients whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, buprenorphine transdermal 7-day patch was superior to placebo and similar in efficacy to comparator agents. acceptance by the SMC. The licence holder has indicated their decision to resubmit. Ibritumomab tiuxetan (Zevalin) is not recommended for use within NHSScotland as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. Melatonin prolonged-release tablets (Circadin) are not recommended for use within NHSScotland as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. Venlafaxine extended release capsules (Efexor XL) are not recommended for use within NHSScotland for the treatment of moderate to severe generalised social anxiety disorder/social phobia in adults. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. noted the SMC, not added to the formulary pending specialist advice on formulary status 5