Area Drug and Therapeutics Committee Prescribing

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 103 In this issue Drugs reviewed by the SMC in March 2016 ADTC UPDATES ON DRUGS REVIEWED BY THE SMC The following new drugs have been reviewed by the Scottish Medicines Consortium in March 2016: - 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 = formulary due to the specialist nature of 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. BOTHWELL, G71 8BB

2 No. 1137/16 No. 1131/16 Drug/product SMC Lanarkshire Alendronic acid effervescent tablets (Binosto ) Ataluren (Translarna ) ADVICE: following an abbreviated submission alendronic acid effervescent tablets (Binosto ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of postmenopausal osteoporosis. SMC restriction: for use in patients who are unable to swallow tablets where alendronic acid is the appropriate treatment choice. Alendronic acid 70mg effervescent tablets have demonstrated bioequivalence to alendronic acid 70mg tablets. The effervescent tablet formulation provides an alternative for patients who cannot swallow tablets. It is more expensive than generic alendronic acid tablets but is similar to the cost of existing oral solutions. ADVICE:following a full submission considered under the ultra-orphan process ataluren (Translarna ) is not recommended for use within NHS Scotland. Indication under review: Treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 5 years and older. In a phase IIb, randomised, double-blind study the absolute difference in mean change in 6-minute walking distance from baseline to week 48 for ataluren 40mg/kg/day compared to placebo was 30 metres in the intent-to-treat analysis. 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. formulary after specialist advice on formulary status. Non s 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. BOTHWELL, G71 8BB 2

3 No. 1133/16 Drug/product SMC Lanarkshire Camellia sinensis (green tea) leaf extract (Catephen ) ADVICE: following a full submission camellia sinensis (green tea) leaf extract (Catephen ) is accepted for restricted use within NHS Scotland. Indication under review: Cutaneous treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients from the age of 18 years. SMC restriction: for use in patients not suitable for podophyllotoxin or who have not responded to treatment with podophyllotoxin. Complete clearance of baseline and new warts was achieved in a significantly higher proportion of patients treated for up to 16 weeks with camellia sinensis (green tea) 10% ointment than vehicle ointment, in two phase III randomised double-blind studies. formulary after specialist advice on formulary status. Non s BOTHWELL, G71 8BB 3

4 No. 1130/16 Drug/product SMC Lanarkshire Eculizumab (Soliris ) ADVICE: following a full submission assessed under the ultra orphan process eculizumab (Soliris ) is not recommended for use within NHS Scotland. Indication under review: In adults and children, for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. In a controlled study in patients with transfusion-dependent PNH, eculizumab reduced the rate of haemolysis and improved anaemia compared with placebo. Observational data from a subset of the PNH registry suggest that these benefits may also be achieved in patients with no history of transfusions. Uncontrolled data suggest that eculizumab reduces the incidence of thrombosis in patients with PNH. 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. The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment s cost in relation to its health benefits was not sufficient to gain acceptance by SMC. BOTHWELL, G71 8BB 4

5 No. 872/13 Drug/product SMC Lanarkshire Everolimus (Afinitor ) ADVICE: following a second resubmission assessed under the end of life process: everolimus (Afinitor ) is accepted for use within NHS Scotland. Indication under review: For the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. The addition of everolimus to exemestane treatment significantly increased progression free survival compared with exemestane alone in postmenopausal women with disease progression following a non-steroidal aromatase inhibitor. formulary due to the specialist nature of the treatment. Non s This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of everolimus. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. BOTHWELL, G71 8BB 5

6 No. 1129/16 Drug/product SMC Lanarkshire Isavuconazole (Cresemba ) ADVICE: following a full submission considered under the orphan process isavuconazole (Cresemba ) is accepted for use within NHS Scotland. Indication under review: in adults for the treatment of: invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate A phase III, randomised, double-blind, non-inferiority study demonstrated that, in the treatment of invasive aspergillosis, isavuconazole was non-inferior to a triazole antifungal for all-cause mortality through day 42, and had a similar overall response at the end of treatment. A phase III, open-label, single-arm study demonstrated that, in the treatment of mucormycosis, isavuconazole had a treatment effect on all-cause mortality and overall response. The treatment effect was considered to be comparable to that observed in external control studies of a polyene antifungal. formulary due to the specialist nature of the treatment. Non s This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of isavuconazole. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. BOTHWELL, G71 8BB 6