England's NICE backs Merck & Co's Ezetrol for primary hypercholesterolemia

21 October 2015

Medicines watchdog for England and Wales the National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending US pharma giant Merck & Co’s (NYSE: MRK) Ezetrol (ezetimibe) as an option for some adults with primary (heterozygous-familial and non-familial) hypercholesterolemia. The draft guidance updates NICE’s previous guidance on the use of these drugs.

The draft guidance provisionally recommends ezetimibe on its own for adults with primary heterozygous-familial and non-familial hypercholesterolemia when a statin is considered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.

“Primary hypercholesterolemia 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 This draft guidance is therefore good news some people with this condition who aren’t able to take a statin to reduce their cholesterol,” commented Carole Longson, director of the NICE Centre for Health Technology Evaluation.

Today’s draft guidance is different to the original 2007 guidance because it reflects the fact that current clinical practice has a greater emphasis on managing CVD risk rather than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, the NICE pointed out.

ICERs and QALY

The NICE Appraisal Committee concluded that in the primary prevention population of CVD the most plausible incremental cost-effectiveness ratios (ICERs) were as follows:

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