ADTC UPDATES ON DRUGS REVIEWED BY THE SMC. The following new drugs have been reviewed by the Scottish Medicines Consortium in July 2013: -

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Martha Mathews
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Area Drug and Therapeutics Committee Prescribing Supplement No 72 In this issue Drugs reviewed by the SMC in July 2013 ADTC UPDATES ON DRUGS REVIEWED BY THE SMC The following new drugs have been

1 Area Drug and Therapeutics Committee Prescribing Supplement No 72 In this issue Drugs reviewed by the SMC in July 2013 ADTC UPDATES ON DRUGS REVIEWED BY THE SMC The following new drugs have been reviewed by the Scottish Medicines Consortium in July 2013: - Colour coding of Lanarkshire ADTC 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 = the treatment or pending specialist advice on formulary status. Non 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. 1

2 No 885/13 Drug/product SMC Lanarkshire chloroprocaine hydrochloride, 10mg/mL, solution for injection (Ampres ) ADVICE: following a full submission chloroprocaine hydrochloride (Ampres ) is not recommended for use within NHS Scotland. Indication under review: spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes. In a small, single-centre, randomised, double-blind, controlled study spinal anaesthesia with chloroprocaine injection compared with a hyperbaric formulation of an amide-type local anaesthetic agent was associated with a faster resolution of sensory and motor block, resulting in a shorter time to meet eligibility criteria for discharge. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. 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. No 887/13 elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg film coated tablet (Stribild ) ADVICE: following a full submission elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil (as fumarate) film coated tablet (Stribild ) is accepted for use within NHS Scotland. Indication under review: treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to the three antiretroviral agents in Stribild. Stribild was at least as effective as two other recommended antiretroviral regimens in treatment-naïve HIV-1 infected patients. s of Stribild. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. 2

3 No 835/13 Drug/product SMC Lanarkshire pirfenidone 267mg capsule (Esbriet ) ADVICE: following a resubmission pirfenidone (Esbriet ) is accepted for use within NHS Scotland. Indication under review: In adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Pirfenidone reduced the decline in lung function parameters associated with IPF compared to placebo in a pooled analysis of two similarly designed phase lll studies. of pirfenidone. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. s No 812/12 argatroban, 100mg/ml, concentrate for solution for infusion (Exembol ) ADVICE: following a resubmission argatroban (Exembol ) is accepted for use within NHS Scotland. Indication under review: anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral antithrombotic therapy. Argatroban produces anticoagulant effects in adults with heparin-induced thrombocytopenia type II. However there is limited evidence that the anticoagulant effects are associated with a reduction in thrombosis and deaths due to thrombosis. s 3

4 No 888/13 Drug/product SMC Lanarkshire abatacept 125mg/mL solution for subcutaneous injection in a pre-filled syringe (Orencia ) abatacept 125mg/mL solution for subcutaneous injection (Orencia ) is accepted for use within NHS Scotland. Indication under review: In combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more diseasemodifying anti-rheumatic drugs including methotrexate or a TNF-alpha inhibitor. SMC has previously accepted abatacept 250mg powder for concentrate for solution for infusion (Orencia ) for restricted use in NHS Scotland for this indication. Abatacept 125mg/mL subcutaneous injection (Orencia ) is more expensive on a mg-for-mg basis than abatacept 250mg powder for concentrate for solution for infusion. of abatacept. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. s No 889/13 ursodeoxycholic acid 500mg film-coated tablets (Ursofalk ) ursodeoxycholic acid 500mg film-coated tablets (Ursofalk ) is accepted for use within NHS Scotland. Indication under review: for the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15mm in diameter. The gall bladder must be functioning despite the gallstone(s). For the treatment of primary biliary cirrhosis (PBC), provided there is no decompensated hepatic cirrhosis. s Ursodeoxycholic acid 500mg film-coated tablets have demonstrated bioequivalence to ursodeoxycholic acid 250mg capsules. Relative costs may vary slightly depending on the pack size used. 4

5 No 890/13 Drug/product SMC Lanarkshire calcium polystyrene sulphonate powder for oral/rectal suspension (Sorbisterit ) calcium polystyrene sulphonate powder (Sorbisterit ) is accepted for use within NHS Scotland. Indication under review: treatment of hyperkalaemia, in patients with acute and chronic renal insufficiency, including patients undergoing dialysis treatment. Sorbisterit provides an alternative to the existing proprietary product at a lower cost. The dose of Sorbisterit and the existing proprietary product differ as the strength of the active ingredient varies slightly. the treatment or pending specialist advice on formulary status. Non s 5

Area Drug and Therapeutics Committee Prescribing Supplement No 55 March 2012

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