Cost regulators for the National Health Service in England and Wales have issued new draft guidelines supporting the use of Merck, Sharp and Dohme’s cholesterol buster Ezetrol.

The Institute has recommended Ezetrol (ezetimibe) for adults with primary (heterozygous-familial and non-familial) hypercholesterolaemia when a statin can’t be taken, but only if patients need lipid modification therapy for the primary prevention of cardiovascular disease and have both type II diabetes and a 20% or greater 10-year risk of developing cardiovascular disease, or they need lipid-modification therapy for secondary prevention of CVD. 

Primary heterozygous-familial hypercholesterolaemia is an inherited condition caused by a faulty gene that affects around 120,000 people in the UK. Non-familial hypercholesterolaemia develops from a mix of genetic traits and other factors such as diet, smoking and lack of exercise, and is thought to affect around 2,000,000 people. In both cases, raised levels of cholesterol put patients at higher risk of developing CVD, the leading cause of death in the country.

Ezetrol is a cholesterol-absorption inhibitor that blocks intestinal absorption of dietary and biliary cholesterol and related plant sterols, but without affecting uptake of triglycerides or fat-soluble vitamins. This means that the drug can be combined with a statin to provide either a complementary or an alternative mode of cholesterol reduction.

The draft guideline differs from that published in 2007 because it reflects the fact that current clinical practice has a greater emphasis on managing CVD risk rather than meeting target cholesterol levels, the Institute notes. Earlier recommendations were centred generally on the reduction of cholesterol, while the updated guidelines distinguish between primary and secondary prevention of heart disease.

NICE’s Committee concluded that in the primary prevention population of CVD the most plausible incremental cost-effectiveness ratios (ICERs) were: in excess of £31,900 per quality-adjusted life year (QALY) gained for Ezetrol compared with no therapy; and in excess of £76,000 per QALY gained for the drug as an add-on to a statin compared with statin therapy alone.

For secondary prevention of CVD the most plausible ICERs were: at least £20,300 per QALY gained for Ezetrol monotherapy compared with no treatment in adults with type II diabetes; in excess of £17,300 per QALY gained for the drug compared with no therapy; and £115,400 per QALY gained for Ezetrol as an add-on to a statin compared with a statin alone.