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NICE has yesterday published draft guidance recommending ezetimibe (Ezetrol, Merck Sharp & Dohme) as an option for some adults with primary (heterozygous-familial and non-familial) hypercholesterolaemia. The draft guidance updates NICE’s previous guidance on the use of these drugs.

Hypercholesterolaemia is where there are high concentrations of cholesterol in the blood. Primary heterozygous-familial hypercholesterolaemia affects about 120,000 people in the UK and is an inherited condition caused by a faulty gene. People with this condition have raised cholesterol levels from birth. In the more common primary non-familial hypercholesterolaemia, a number of genetic factors interact with dietary and other factors such as smoking and lack of exercise to cause high cholesterol levels.

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.

The draft guidance provisionally recommends ezetimibe on its own for adults with primary heterozygous-familial and non-familial hypercholesterolaemia when a statin is considered inappropriate or is not tolerated, only if:

• they need lipid modification therapy for the primary prevention of cardiovascular disease and have both:

-     type 2 diabetes and

-     a 20% or greater 10‑year risk of developing cardiovascular disease according to the QRISK2 risk assessment tool or

• they need lipid-modification therapy for the secondary prevention of cardiovascular disease.

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said: “Primary hypercholesterolaemia is an important risk factor for developing cardiovascular disease (CVD), the most common cause of death in the UK, as well as being a major cause of morbidity and reduced quality of life. This draft guidance is therefore good news some people with this condition who are aren’t able to take a statin to reduce their cholesterol.”

Yesterday’s draft guidance is different to the original 2007 guidance because it reflects the fact that current clinical practice has a greater emphasis on managing CVD risk rather than meeting target cholesterol levels. 

Consultees, including the company, healthcare professionals and members of the public have until 10 November to comment on the preliminary guidance. Comments received during this consultation will be fully considered by the Committee at its meeting on 18 November and following this meeting the next draft guidance will be issued. 

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. 

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 athttp://www.nice.org.uk/guidance/indevelopment/gid-tag326  from 00:01 on 21 October. 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.
6. The Committee concluded that in the primary prevention population of CVD the most plausible incremental cost-effectiveness ratios (ICERs) were as follows:

• in excess of £31,900 per quality-adjusted life year (QALY) gained for ezetimibe monotherapy compared with no therapy
• in excess of £76,000 per QALY gained for ezetimibe as an add-on to a statin compared with statin therapy alone
• at least £20,300 per QALY gained for ezetimibe monotherapy compared with no treatment in adults with type 2 diabetes.

7. The Committee concluded that in the secondary prevention of CVD population the most plausible ICERs were as follows:

• in excess of £17,300 per QALY gained for ezetimibe monotherapy compared with no therapy
• £115,400 per QALY gained for ezetimibe as an add-on to a statin compared with a statin alone.

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. The prevalence of non-familial hypercholesterolaemia in the UK adult population is estimated to be around 1 in 25, which means that approximately 2,000,000 people are affected. The prevalence of heterozygous familial hypercholesterolaemia in the UK population is estimated to be around 1 in 500, which means that approximately 120,000 people are affected.
3. 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.
4. 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.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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