The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Mexiletine (Namuscla®) has been accepted for restricted use in the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based. As such it would be expected that prescribing would occur in secondary care.
Bempedoic acid (Nilemdo®) has been rejected for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- In combination with a statin, or a statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin
- Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated.
The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.