The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Melatonin prolonged-release (Slenyto®) has been rejected for use in the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The 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 clinical and economic analysis to gain acceptance by SMC.
Dapagliflozin (Forxiga®) has been accepted for use in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥27kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Ospemifene (Senshio®) has been accepted for use in the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.