The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Azelastine and fluticasone nasal spray (Dymista®) has been rejected for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis. It is noted that the combination product is significantly more expensive than the components administered separately.
Imiquimod (Zyclara®) has been rejected for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis. The manufacturer failed to make a submission.
Mannitol (Bronchitol®) has been accepted for restricted use in the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. The restriction recommends use in patients who are not currently using dornase alfa due to lack of response, intolerance or ineligibility and have rapidly declining lung function and in whom other osmotic agents are considered unsuitable.
Saxagliptin (Onglyza®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults as triple oral therapy in addition to a sulphonylurea and metformin to improve glycaemic control when dual therapy, with diet and exercise, does not provide adequate glycaemic control. The restriction places this treatment as an option among other dipeptidyl peptidase-4 inhibitors because indirect comparisons have demonstrated similar efficacy.
Vildagliptin (Galvus®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults as triple oral therapy in addition to a sulphonylurea and metformin to improve glycaemic control when dual therapy, with diet and exercise, does not provide adequate glycaemic control. The restriction places this treatment as an option among other dipeptidyl peptidase-4 inhibitors because a meta-analysis has suggested similar efficacy.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.