Area Drug and Therapeutics Committee Prescribing Supplement No 32 August 2009

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 32 In this issue Drugs currently being considered by SMC advice due on 7 th September 2009 Drug safety update unlicensed and off-label prescribing of medicines New drugs reviewed by SMC in June and July 2009 Drugs currently being considered by the SMC with advice due on 7 th September 2009 SMC REVIEW INDICATION Darunavir (Prezista ) No 566/09 Prasugrel tablets (Efient ) No 562/09 Mecasermin injection (Increlex ) No 563/09 Ranolazine m/r tablets (Ranexa ) No 565/09 Fosamprenavir tablets and suspension (Telzir ) No 431/07 Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1 Antiretroviral treatment Antiplatelet agent acute coronary syndrome Treatment of growth failure in children and adolescents Treatment of stable angina Antiretroviral treatment license extension for children Lamivudine/zidovudine combination (Combivir ) No 569/09 Antiretroviral treatment license extension for children Etanercept (Enbrel ) No 570/09 Chronic severe plaque psoriasis license extension for children Brinzolamide/timolol eye drops (Azarga ) No 568/09 Etoricoxib tablets (Arcoxia ) No 576/09 Drug Safety Update Highlights from the MHRA bulletins: Open angle glaucoma Ankylosing spondylitis Off-label use or unlicensed medicines: prescribers responsibilities A marketing authorisation or product licence defines a medicine s terms of use: its Summary of Product Characteristics outlines, among other things, the indication(s), recommended dose(s), contraindications and special warnings and precautions for use on which the licence is based and it is in line with such use that the benefits of the medicine have been judged to outweigh the potential risks

2 However there may be clinical circumstances when the use of unlicensed medicines or use of medicines outside the terms of the licence (i.e. off-label) may be considered by the prescriber to provide the most appropriate treatment for a patient on the basis of the available evidence. Prescribing an unlicensed medicine or a medicine off-label requires the prescriber to take extreme care and to pay particular attention to the possibility of adverse reactions, problems due to product quality or problems due to inadequate or missing product information. Patients may also be confused as the patient information leaflet will not mention a medicine s off-label use. The following advice should be considered 1 : - Before prescribing an unlicensed medicine, be satisfied that an alternative, licensed medicine would not meet the patient s needs Before prescribing a medicine off-label, be satisfied that such a use would better serve the patient s needs than an appropriately licensed alternative Before prescribing an unlicensed medicine or using a medicine off-label: i) Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy ii) Take responsibility for prescribing the medicine and for overseeing the patient s care, including monitoring and follow-up iii) Record the medicine prescribed and, where common practice is not being followed, the reasons for prescribing this medicine. You may wish to record that you have discussed the issue with the patient. Give patients, or those authorising treatment on their behalf, sufficient information about the proposed treatment, including known serious or common adverse reactions, to enable them to make an informed decision Where current practice supports the use of a medicine outside the terms of its licence, it may not be necessary to draw attention to the licence when seeking consent. However, it is good practice to give as much information as patients or carers require or which they may see as relevant. Explain the reasons for prescribing a medicine off-label or prescribing an unlicensed medicine where there is little evidence to support its use, or where the use of a medicine is innovative. The following new drugs have been reviewed by the Scottish Medicines Consortium in June and July 2009 : - 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 374/07 No 555/09 No 503/08 Drug/product Indication SMC Lanarkshire and ADTC comments Infliximab 100mg powder for concentrate for solution for infusion (Remicade ) Terlipressin acetate 0.12mg/ml solution for injection (Glypressin Solution) Abbreviated Submission Pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion (Caelyx ) Re-submission Treatment of moderately to severely active ulcerative colitis. Treatment of bleeding oesophageal varices. In combination with bortezomib for the treatment of progressive multiple myeloma. Infliximab (Remicade ) is not recommended for use within NHS Scotland for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contra-indications for such therapies. As rescue therapy, infliximab has been shown to reduce the rate of colectomy compared with placebo in two small studies. However its relative efficacy and long-term benefits compared to existing management options remain unclear. The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. Terlipressin acetate 0.12mg/ml solution for injection (Glypressin Solution) is accepted for use in NHS Scotland for the treatment of bleeding oesophageal varices in patients for whom terlipressin is an appropriate choice of therapy. It replaces a formulation that requires reconstitution and is associated with only a modest cost increase. Pegylated liposomal doxorubicin (Caelyx ) is not recommended for use within NHS Scotland in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. Results from an interim analysis showed that pegylated liposomal doxorubicin plus bortezomib significantly increased the time to disease progression compared to bortezomib monotherapy. At the time of the interim analysis only 31% of patients in the combination arm had reached the primary endpoint. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Lanarkshire ADTC endorsed the SMC Lanarkshire ADTC endorsed the SMC Added to the joint formulary Lanarkshire ADTC endorsed the SMC 3

4 No 380/07 Drug/product Indication SMC Lanarkshire and ADTC comments Enoxaparin 20mg, 40mg, 60mg, 80mg, 100mg, 120mg and 150mg prefilled syringes and 300mg multidose vial (Clexane ) Treatment of acute STsegment elevation myocardial infarction (STEMI) Enoxaparin (Clexane ) is accepted for use within NHS Scotland for the treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI) in conjunction with thrombolytic drugs (fibrin or non-fibrin specific). endorsed the SMC Added to the joint formulary No 561/09 No 559/09 Peginterferon alfa-2a, 135 microgram/ml and 180 microgram/ml pre-filled injections of solution for subcutaneous injection (Pegasys ) Calcipotriol and betamethasone dipropionate, 50 micrograms/g micrograms/g gel (Xamiol ) Peginterferon alfa-2a is indicated in combination with ribavirin for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. The topical treatment of scalp psoriasis. In clinical studies using a median of seven days of enoxaparin treatment, enoxaparin demonstrated a reduction in death or non-fatal MI compared to unfractionated heparin. Peginterferon alfa-2a (Pegasys ) is accepted for use within NHS Scotland in combination with ribavirin for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin. Non-responders to previous hepatitis C treatment, predominantly with virus genotype 1, achieved sustained viral responses of 8% and 15% following 48 weeks and 72 weeks of combination treatment respectively. The manufacturer did not provide comparative clinical or cost-effectiveness data versus peginterferon alfa-2b. Calcipotriol and betamethasone dipropionate scalp gel, (Xamiol ) is accepted for use within NHS Scotland for the topical treatment of scalp psoriasis. Short-term comparisons have shown that the combination is more effective than either component used as monotherapy. 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. endorsed the SMC Added to the joint formulary 4

5 Recommendation No 560/09 Drug/product Indication SMC Lanarkshire and ADTC comments Degarelix 120mg, 80mg powder and solvent for solution for injection (Firmagon ) Degarelix is a gonadotropin releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependent prostate cancer. Degarelix (Firmagon ) is not recommended for use within NHS Scotland for the treatment of adult male patients with advanced hormone-dependent prostate cancer. In one study that included patients with all stages of prostate cancer, degarelix was shown to be non-inferior to a luteinising hormone releasing hormone (LHRH) agonist in suppressing testosterone levels over a one year treatment period without an initial testosterone flare. However the benefit relative to current Scottish practice involving use of an LHRH agonist plus a short course of anti-androgen therapy to prevent flare is unclear. endorsed the SMC No 530/09 Etravirine 100mg tablet (Intelence ) Re-submission In combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatmentexperienced adult patients. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Etravirine (Intelence ), in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is accepted for use within NHS Scotland for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients. In HIV-1 infected adults, with resistance to currently available non-nucleoside reverse transcriptase inhibitors (NNRT1s) and at least three primary protease inhibitor (PI) mutations, who were receiving an optimised background regimen that included boosted darunavir plus nucleoside reverse transcriptase inhibitors (NRTIs) and optional enfuvirtide, etravirine achieved significant improvements in virological, immunological and clinical outcomes compared to placebo. 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. 5

6 Recommendation No 557/09 No 548/09 Drug/product Indication SMC Lanarkshire and ADTC comments Histrelin acetate, 50mg subcutaneous implant (Vantas ) Rotigotine, 1mg, 2mg, and 3mg per 24 hours transdermal patch (Neupro ) Palliative treatment of advanced prostate cancer. Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults. Histrelin (Vantas ) subcutaneous implant is accepted for restricted use within NHS Scotland for palliative treatment of advanced prostate cancer. Histrelin is restricted to use in patients with an anticipated life expectancy of at least one year in whom annual administration will offer advantages. In a single-arm study, histrelin provided effective suppression of testosterone levels in patients with advanced prostate cancer. It requires less frequent administration than other leutenising hormone releasing hormone (LHRH) agonists. Other LHRH agonists are available at a lower acquisition cost. Rotigotine (Neupro ) is accepted for use within NHS Scotland for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. It should only be used in patients with a baseline score of 15 points or more on the International Restless Legs Scale (IRLS). Compared with placebo, rotigotine was associated with improvements on a patient-administered scale based on the core clinical features of the syndrome and on the incidence of periodic limb movements during time in bed. 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. noted the SMC Further information required about the IRLS before a formulary decision is made. Other dopamine agonists licensed for use in RLS are available at a lower cost. 6