It recommends ezetimibe on its own as an option for treating primary hypercholesterolaemia in adults in whom initial statin therapy is contraindicated or not tolerated.

It also recommends ezetimibe in combination with initial statin therapy as an option when cholesterol concentration is not appropriately controlled after the dose of the statin has been increased, or where a person is unable to have higher doses of the statin because it is likely to cause side effects, and a change to an alternative statin is being considered.

Hypercholesterolaemia is where there are high concentrations of cholesterol in the blood. Primary non-familial hypercholesterolaemia affects around 1.5 million people in England. It can develop when a number of genetic factors interact with dietary and other factors such as smoking and lack of exercise to cause high cholesterol levels. Primary heterozygous-familial hypercholesterolaemia is less common and affects about 106,000 people in England. It is an inherited condition caused by a faulty gene. People with this condition have raised cholesterol levels from birth.

People with hypercholesterolaemia have an increased risk of cardiovascular disease (CVD) because long term raised cholesterol levels accelerate the build-up of fatty deposits in the arteries (atherosclerosis). The narrowing of the arteries can eventually lead to angina, heart attacks and strokes. CVD is the leading cause of death in the UK and accounts for around 1 in 3 of all deaths (180,000) each year.

Meindert Boysen, technology appraisals programme director at NICE, said: “The previous draft recommendations on the use of ezetimibe were based on evidence that looked at the use of ezetimibe for treating hypercholesterolaemia according to the primary and secondary prevention of CVD.

“However, after considering comments received at consultation, the Committee decided that the populations in NICE’s original technology appraisal guidance on ezetimibe were better aligned with the final NICE scope for the review, ezetimibe’s marketing authorisation and current practice.

“The Committee considered that the clinical effectiveness of ezetimibe using the updated evidence base was consistent with that in the original guidance. Taking both of these factors into consideration, the Committee believed that the cost-effectiveness estimates from NICE’s original guidance on ezetimibe were more plausible than the current estimates. The Committee therefore concluded that the recommendations in NICE’s original technology appraisal guidance on ezetimibe are still appropriate.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country. 

Ends

For more information call the NICE press office on 0300 323 0142/ pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

1. The draft guidance on ezetimibe for primary hypercholesterolaemia will be available on the NICE website at http://www.nice.org.uk/guidance/indevelopment/gid-tag326 from 00:01 on 24 December. Embargoed copies are available from the NICE press office on request.
2. Ezetimibe (Ezetrol, Merck Sharp & Dohme) is a cholesterol-absorption inhibitor that blocks the intestinal absorption of dietary and biliary cholesterol and related plant sterols, without affecting the uptake of triglycerides or fat-soluble vitamins. Because of this mechanism of action, ezetimibe can be combined with a statin to provide either a complementary or an alternative mode of cholesterol reduction.
3. Ezetimibe has a marketing authorisation in the UK in combination with a statin as an adjunctive therapy to diet for primary heterozygous-familial or non-familial hypercholesterolaemia that is not appropriately controlled with a statin alone. Ezetimibe monotherapy has a marketing authorisation as an adjunctive therapy to diet for primary heterozygous-familial or non-familial hypercholesterolaemia when a statin is considered inappropriate or is not tolerated.
4. Ezetimibe is taken orally at a dose of 10 mg once daily. It is available in a dose of 10 mg (28‑tablet pack) at a net price per pack of £26.31 (excluding VAT; ‘British national formulary’ September 2015).
5. A fixed-dose combination tablet (Inegy, Merck Sharp & Dohme) containing ezetimibe and simvastatin is available in doses of ezetimibe 10 mg and simvastatin 20 mg (28‑tablet pack) at a net price per pack of £33.42, ezetimibe 10 mg and simvastatin 40 mg (28‑tablet pack) at a net price per pack of £38.98, ezetimibe 10 mg and simvastatin 80 mg (28‑tablet pack) at a net price per pack of £41.21 (excluding VAT; BNF; accessed September 2015). Costs may vary in different settings because of negotiated procurement discounts.

 About primary hypercholesterolaemia

1. Primary hypercholesterolaemia is associated with an underlying genetic cause, which may be caused by a single genetic defect (familial), or more commonly, by the interaction of several genes with dietary and other factors such as smoking or physical inactivity (non-familial).
2. People with hypercholesterolaemia have an increased risk of cardiovascular disease (CVD) because long term raised cholesterol levels accelerate the build-up of fatty deposits in the arteries (atherosclerosis). The narrowing of the arteries can eventually lead to angina, heart attacks and strokes.
3. CVD is the leading cause of death in the UK and accounts for around 1 in 3 of all deaths (180,000) each year and it is a major cause of disability and reduced quality of life.