NICE backs use of PCSK9 inhibitors from Sanofi, Amgen

The National Institute for Health and Care Excellence issued final draft guidance Friday backing Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolocumab) for adults with primary hypercholesterolaemia or mixed dyslipidaemia to help reduce their risk of cardiovascular disease. Carole Longson, director of the agency's Centre for Health Technology Evaluation, noted that the two PCSK9 inhibitors are "effective" in reducing levels of LDL-cholesterol when compared with placebo, Merck & Co.'s Zetia (ezetimibe) or statins in people with these conditions.

"However, both drugs are relatively expensive," Longson said, with Praluent costing 4383 pounds ($6357) per year and Repatha priced at 4448 pounds ($6451) annually, compared to Zetia, which costs about 350 pounds ($508). Longson added the guidance recommends Praluent and Repatha "only with the discounts agreed with the companies," although these have not been disclosed.

Both Sanofi and Amgen's injectable therapies have been backed by NICE for people with hypercholesterolaemia or mixed dyslipidaemia whose cholesterol levels are not controlled adequately using other drugs such as statins, or who can't tolerate statins because of their side effects or have another condition which means they can't take them. According to the agency, evidence shows that Praluent reduced levels of LDL-cholesterol by up to 62 percent compared with placebo, and up to 40 percent compared with Zetia, with similar reductions seen with Repatha.

Analysts predict that Praluent, which Sanofi developed with Regeneron Pharmaceuticals, will generate sales of $265 million this year, growing to almost $3 billion by 2022. Meanwhile, Repatha is estimated to record revenue of about $185 million this year, rising to more than $3 billion by 2022. For related analysis, see ViewPoints: A slow start for the PCSK9 inhibitors; can Pfizer – and payers – benefit?

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