The National Institute for Health and Care Excellence has backtracked on draft guidance on the drug ezetimibe (Ezetrol) for treating adults with primary hypercholesterolaemia.
NICE is currently in the process of reviewing its existing guidance from 2007 on ezetimibe for heterozygous-familial and non-familial hypercholesterolaemia.
Primary non-familial hypercholesterolaemia affects around 1.5 million people in England, while primary heterozygous-familial hypercholesterolaemia is less common and affects about 106,000.
An earlier draft of the revised guideline, published in the autumn, had recommended that the conditions of use for the drug be tightened for primary hypercholesterolaemia.
It suggested ezetimibe only be considered an option on its own when a statin was considered inappropriate or not tolerated, and the patient needed lipid modification for the primary prevention of cardiovascular disease and had both type 2 diabetes and a 20% or greater 10-year risk of developing CVD, or needed treatment for the secondary prevention of CVD.
“The cost-effectiveness estimates from NICE’s original guidance on ezetimibe were more plausible than the current estimates”
However, NICE has now moved to a less prescriptive position that is closer to the original 2007 guidance. Its latest draft is recommending ezetimibe on its own as an option for treating primary hypercholesterolaemia in adults in whom initial statin therapy is contraindicated or not tolerated.
It is also recommending 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 because it is likely to cause side effects.
In a statement, published today, the institute said the expert guideline committee doing the review had revised its position following comments received during the consultation on the draft version of the proposed new guidance.
As a result, according to the institute, the current draft guideline “in essence reverts to the guidance being reviewed”.
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,” he said.
“The committee considered that the clinical effectiveness of ezetimibe using the updated evidence base was consistent with that in the original guidance,” he added.
“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,” said Mr Boysen.
He said: “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. Final guidance is expected in February.
The charity HEART UK, which had lobbied for a change of position on the drug, welcomed the latest draft guidance.
Its chief executive Jules Payne said: “HEART UK is delighted that NICE has listened to the concerns raised on behalf of healthcare professionals and patients to limit access to this life-saving medication.
“High cholesterol is a major cause of heart attacks in the UK and ezetimibe is a valuable medicine which can be used alongside or instead of statins to help reduce cholesterol for millions of patients across the UK,” she said.
More information on ezetimibe (source: NICE)
Ezetimibe, manufactured by 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.
The drug is taken orally at a dose of 10mg once daily. It is available in a dose of 10mg (28 tablet pack) at a net price per pack of £26.31 (excluding VAT).
A fixed-dose combination tablet (Inegy) containing ezetimibe and simvastatin is also available in doses of ezetimibe 10mg and simvastatin 20mg, 40mg or 80mg.