The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Apixaban (Eliquis®) has been accepted for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors. The risk factors include prior stroke or transient ischaemic attack (TIA), age 75 years or above, hypertension, diabetes mellitus and symptomatic heart failure (NYHA class II or above).
Colecalciferol (Desunin®) has been accepted for the prevention and treatment of vitamin D deficiency in adults and adolescents.
Inhaled mannitol (Bronchitol®) has been rejected for treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. The manufacturer failed to make a sufficiently robust economic case.
Linagliptin (Trajenta®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults. The restriction limits use as monotherapy to patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance and in combination with a sulphonylurea and metformin when glycaemic control remains inadequate despite diet and exercise plus dual therapy.
Linagliptin and Metformin (Jentadueto®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults. It can be used alone in patients who are already treated with both of these medicines or who are inadequately controlled on their maximal tolerated dose of metformin. It can be used in combination with a sulphonylurea as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. The restriction limits use of this product to patients for whom a fixed dose combination of metformin and linagliptin is considered appropriate.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.