The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bempedoic acid (Nilemdo®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
- alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Bempedoic acid / ezetimibe (Nustendi®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
- in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Sumatriptan 85mg / naproxen 457mg (Suvexx®) has been rejected for use in the acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a mono-entity product has been insufficient. It is noted this product is available at a considerable cost premium to sumatriptan 100mg and naproxen 500mg tablets taken separately.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.