Latest SMC decisions

3 December 2012

The Scottish Medicines Consortium (SMC) has issued its latest set of assessments.

Medicines approved for use within NHS Scotland are as follows:

Aclidinium bromide (Eklira Genuair), for maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease
Colecalciferol (Fultium D3), for the prevention and treatment of vitamin D deficiency and as an adjunct in osteoporosis
Fluticasone/formoterol (Flutiform), for the regular treatment of asthma where the combination of a long-acting β2-agonist and an inhaled corticosteroid is appropriate
Mercaptopurine (Xaluprine) oral solution, for the treatment of acute lymphoblastic leukaemia
Nepafenac (Nevanac), to reduce the risk of postoperative macular oedema associated with cataract surgery in diabetic patients
Velaglucerase (Vpriv), for long-term enzyme replacement therapy in type 1 Gaucher disease.

The following are accepted for restricted use:

Abiraterone (Zytiga), for use in combination with prednisolone after failure of docetaxel-based chemotherapy in patients with metastatic-castration-resistant prostate cancer who have received only one prior chemotherapy regimen
Fingolimod (Gilenya), as a single disease-modifying therapy in highly active relapsing remitting multiple sclerosis (MS) in adults with high disease activity despite treatment with beta-interferon, who have an unchanged or increased relapse rate compared with the previous year, or ongoing severe relapses
Ivabradine (Procoralan), in combination with standard therapy including β-blockers or when β-blockers are contraindicated/not tolerated, for NHYA class II–IV heart failure with systolic dysfunction in patients who are in sinus rhythm and whose resting heart rate remains 75 beats per minute or more despite optimal standard therapy
Tegafur/gimeracil/oteracil (Teysuno), for use in patients with advanced gastric cancer who are unsuitable for the first-line regimen of an anthracycline, fluorouracil and platinum;
Tocilizumab (RoActemra), for use in accordance with British Society for Rheumatology guidance on prescribing TNF blockers in adults with rheumatoid arthritis.

Several medicines were rejected:

Adalimumab (Humira), for moderate to severe active ulcerative colitis
Amifampridine (Firdapse), for Lambert-Eaton myasthenic syndrome
Argatroban (Exembol), indicated in heparin-induced thrombocytopenia type II
Azilsartan medoxomil (Edarbi), used to treat essential hypertension
Azithromycin (Azyter) for antibacterial conjunctivitis
Bevacizumab (Avastin), for epithelial ovarian, fallopian tube, or primary peritoneal cancer
Caffeine citrate (Peyona), for primary apnoea in premature newborns
Interferon beta-1a (Rebif), in patients at high risk of developing MS
Pasireotide (Signifor), for Cushing’s disease
Ranolazine (Ranexa), as an add-on therapy for the symptomatic treatment of stable angina pectoris
Rifaximin (Xifaxanta), for travellers’ diarrhoea
Strontium ranelate (Protelos), in the treatment of osteoporosis in men
Tocofersolan (Vedrop), for children with vitamin E deficiency
Vemurafenib (Zelboraf), a treatment for metastatic melanoma
Zonisamide (Zonegran), for partial seizures in epilepsy.