As part of the NICE’s Single Technology Appraisal process, this assessment critically reviewed the evidence for the clinical and cost-effectiveness of ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia. The evidence was submitted by Merck Sharp & Dohme, the company that manufactures ezetimibe (Ezetrol), and consisted of 25 RCTs of either ezetimibe versus placebo, or ezetimibe plus a statin versus a matching statin dose. The current NICE guidance, based on the results of this appraisal, recommends ezetimibeas an option for treating primary heterozygous-familial or non-familial hypercholesterolaemia in adults in whom initial statin therapy is contraindicated or who cannot tolerate statin therapy. Ezetimibe co-administered with initial statin therapy is recommended as an option for treating primary heterozygous-familial or non-familial hypercholesterolaemia in adults who have started statin therapy when (i) serum total or low-density lipoprotein cholesterol concentration is not appropriately controlled either after appropriate dose titration of initial statin therapy or because dose titration is limited by intolerance to the initial statin therapy, and (ii) a change from initial statin therapy to an alternative statin is being considered.
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