NHS Ayrshire & Arran Formulary Bulletin - NHS Ayrshire and Arran.

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The following products have been recommended for use in NHS Scotland and excluded from the NHS Ayrshire & Arran formulary. Scottish Medicines Consortium advice: recommended for use within NHS Scotland Bemiparin 3,500 IU in 0.2ml solution for injection in prefilled syringes (Zibor®) 204/05 Resubmission 654/10 Resubmission For the prevention of thromboembolic disease in patients undergoing orthopaedic surgery. Bemiparin was associated with a lower incidence of thromboembolic complications than unfractionated heparin and was non-inferior to another low molecular weight heparin. Tapentadol, 50, 100, 150, 200 and 250mg prolonged-release tablets (Palexia® SR) Indication under review: the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. SMC restriction: patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated. Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release has improved gastrointestinal tolerability and similar efficacy compared to another long-acting opioid included as an active control. The manufacturer’s submission related only to the use of tapentadol prolonged release in severe chronic pain. SMC has not yet received a submission for tapentadol immediate release tablets for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. Tapentadol immediate release tablets are not recommended for use in NHS Scotland. 718/11 Calcium carbonate equivalent to 500mg calcium, cholecalciferol (vitamin D3) 800 IU (20 microgram) tablets (Kalcipos-D 500mg/800 IU chewable tablets®) Indications under review: • Prevention and treatment of calcium and vitamin D deficiency in the elderly • Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. This is a new combination product with a different ratio of calcium to cholecalciferol than alternative combination preparations. It is a similar price to an alternative product containing 800IU of cholecalciferol per tablet but is more expensive than some other calcium and cholecalciferol combinations. Any overall budget impact is likely to be small 721/11 Golimumab 50mg solution for injections prefilled pen (auto-injector) or pre-filled syringe (Simponi ®) Indication under review: Treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. SMC restriction: golimumab is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines for anti-TNF_ agents in adults with ankylosing spondylitis. Golimumab is restricted to use at a dose of 50mg only. In a placebo controlled study golimumab 50mg and 100mg were superior to placebo given every four weeks in terms of the proportion of patients who achieved at least 20% improvement in the Assessment in AS International Working group Criteria at week 14. An indirect comparison indicates that golimumab has similar efficacy to two other anti-TNF-α agents used in the treatment of ankylosing spondylitis. The economic case was demonstrated for golimumab when used at a dose of 50mg. The economic case was not demonstrated for the 100mg dose of golimumab. × Exclude ADTC Decision – exclude from the formulary Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit August & September 2011 Page 4 of 8
The following products have not been recommended for use in NHS Scotland and are therefore excluded from the NHS Ayrshire & Arran formulary. Scottish Medicines Consortium advice: not recommended for use within NHS Scotland 647/10 resubmission Glucosamine sulphate 1,500mg powder for oral solution (Glusartel®) Relief of symptoms in mild to moderate osteoarthritis of the knee. In a placebo- and active-comparator study, glucosamine sulphate 1,500mg once daily was significantly better than placebo in the treatment of symptoms associated with osteoarthritis of the knee. Overall the submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC 715/11 Collagenase clostridium histolyticum 0.9mg powder and solvent for solution for injection (Xiapex®) Treatment of Dupuytren’s contracture in adult patients with a palpable cord. Collagenase clostridium histolyticum compared to placebo significantly reduces primary joint contracture in adults with Dupuytren’s contracture and a palpable cord. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. 729/11 Glucosamine sulphate (Dolenio®) Symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. 730/11 Bilastine (Ilaxten®) Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.. 719/11 Abatacept 250mg powder for concentrate for solution for infusion (Orencia ® ) 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 disease-modifying anti-rheumatic drugs including methotrexate or a tumour necrosis factor (TNF)-alpha inhibitor. There is no head to head study comparing abatacept with other biologic or conventional disease-modifying anti-rheumatic drugs. In combination with methotrexate, abatacept reduced the progression of joint damage and improved physical function more than placebo in patients with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy with methotrexate alone. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition, the company did not present a sufficiently robust economic analysis to gain acceptance by SMC. × Exclude ADTC Decision – exclude from the formulary Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran Discontinued Preparations Non-formulary items Cortisone acetate 25mg tablets Digibind injection Predsol-N eye drops and ear drops Area Drug & Therapeutics Committee (ADTC) issues The following guidelines have been approved by the ADTC and are available on the ADTC intranet section within AthenA (accessed via AthenA home page → Policies and patient information tab → Drug & Therapeutic clinical guidelines, or electronically below) ADTC 130: Guidelines for the management of constipation (adults) (new guideline)) Formulary updates • Movicol® oral powder has been replaced with Laxido® Orange oral powder as the brand of choice on the NHS Ayrshire & Arran formulary. • Formulary position of Movicol® Half and Movicol® Paediatric Plain oral powders remain unaffected. NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit August & September 2011 Page 5 of 8
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NHS Ayrshire & Arran Formulary Bulletin - NHS Ayrshire and Arran.

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