The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Avanafil (Spedra®) has been rejected for the treatment of erectile dysfunction (ED) in adult men. The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Insulin glargine (Toujeo®) has been accepted for restricted use in the treatment of type 1 or type 2 diabetes mellitus in adults aged 18 years and above. The restriction is as follows:
- Its use should be targeted on patients with Type I diabetes who are at risk of or experience unacceptable frequency and/or severity of nocturnal hypoglycaemia on attempting to achieve better hypoglycaemic control during treatment with established insulins
- It is also acceptable as a once daily insulin therapy for patients who require carer administration of their insulin
- In patients with type 2 diabetes it should be restricted to those who suffer from recurrent episodes of hypoglycaemia or require assistance with their insulin injections
Lisdexamfetamine (Elvanse Adult®) has been accepted for use as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults. Based on clinical judgement, patients should have ADHD of at least moderate severity.
Sitagliptin (Januvia®) has been accepted for use in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Tafluprost / Timolol (Taptiqom®) has been accepted for restricted use in the treatment of raised intraocular pressure in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative-free eye drops. The restriction limits use to patients who have proven sensitivity to preservatives.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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