Area Drug and Therapeutics Committee Prescribing Supplement No 55 March 2012

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 55 In this issue Drugs reviewed by the SMC in February 2012 ADTC UPDATES ON DRUGS REVIEWED BY THE SMC The following new drugs have been reviewed by the Scottish Medicines Consortium in February 2012: - 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 = of the treatment or pending specialist advice on formulary status. s 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 NHSL Headquarters or prescribing@lanarkshire.scot.nhs.uk 1

2 No 762/12 Drug/product SMC Lanarkshire and ADTC comments asenapine 5mg, 10mg sublingual tablet (Sycrest ) asenapine (Sycrest ) is not recommended for use within NHS Scotland. Indication under review: treatment of moderate to severe manic episodes associated with bipolar I disorder, in adults. Asenapine when used as monotherapy demonstrated superior efficacy to placebo in reducing manic symptoms as measured using the Young Mania Rating Score at three weeks with maintenance of effect at 12 weeks. In addition, asenapine in combination with lithium or valproate demonstrated superior efficacy to lithium or valproate monotherapy. There are no direct comparative data when asenapine is used as add-on treatment. Indirect comparisons with other second generation antipsychotic agents used as monotherapy and as adjunctive therapy suggested equivalent efficacy. No 761/12 bupivacaine HCL 1.0mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2 microgram/ml solution for infusion (Bufyl ) Abbreviated submission The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. ADVICE: following a abbreviated submission bupivacaine HCL 1.0mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2 microgram/ml solution for infusion (Bufyl ) is accepted for use in NHS Scotland. Indication under review: epidural analgesia to relieve pain during labour and to control post operative pain. For patients in whom the combination of bupivacaine and fentanyl is an appropriate choice of therapy, Bufyl provides two fixed-dose, pre-mixed preparations. s 2

3 No 763/12 Drug/product SMC fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya ) fingolimod (Gilenya ) is not recommended for use within NHS Scotland. Indication under review: As single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following adult patient groups: Patients with high disease activity despite treatment with a beta-interferon. These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least one relapse in the previous year while on therapy, and have at least nine T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least one gadolinium-enhancing lesion. A nonresponder could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year. or Patients with rapidly evolving severe RRMS defined by two or more disabling relapses in one year, and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. Fingolimod reduced the annualised relapse rate significantly more than a beta-interferon in patients with clinically active RRMS. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. 3

4 No 764/12 Drug/product SMC abiraterone acetate 250mg tablets (Zytiga ) abiraterone acetate 250mg tablets (Zytiga ) is not recommended for use within NHS Scotland. Indication under review: with prednisone or prednisolone for the treatment of metastatic castrationresistant prostate cancer (mcrpc) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Abiraterone plus prednisone was associated with significantly improved overall survival compared with placebo plus prednisone in patients with mcrpc previously treated with docetaxel. The submitting company s justification of the treatment s costs in relation to its health benefits was not sufficient to gain acceptance by SMC. In addition, the submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. No 476/08 icatibant acetate, 30mg, solution for injection in prefilled syringe (Firazyr ) Resubmission ADVICE: following a resubmission icatibant acetate (Firazyr ) is accepted for use within NHS Scotland. Indication under review: Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency). Icatibant treatment resulted in symptom relief in patients suffering acute abdominal, cutaneous and/or laryngeal attacks of hereditary angioedema. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of icatibant. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland. s 4

5 No 766/12 Drug/product SMC atorvastatin 10 and 20mg chewable tablets (Lipitor ) Abbreviated submission ADVICE: following an abbreviated submission Atorvastatin chewable tablets (Lipitor ) is accepted for use in NHS Scotland Indication under review: as an adjunct to diet for reduction of elevated total cholesterol (total-c), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate; to reduce total-c and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable; prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors. Atorvastatin chewable tablets have demonstrated bioequivalence to atorvastatin film-coated tablets (Lipitor ) and are available at an equivalent cost. However less expensive generic preparations of atorvastatin tablets are expected to become available in the near future. s 5