Nexletol, inclisiran Up for ICER Review

Institute for Clinical and Economic Review (ICER) announced yesterday that it will assess the comparative clinical effectiveness and value of inclisiran (Novartis) and Nexletol (bempedoic acid, Esperion Therapeutics) for treatment of high cholesterol.

ICER, a Boston cost-effectiveness group whose cost-effectiveness studies are increasingly influential in drug price negotiations, says it will assess the two drugs as treatments for heterozygous familial hypercholesterolemia, an inherited condition that leads to high cholesterol levels.

But the larger market for the drugs will be as cholesterol-lowering medications to prevent atherosclerotic cardiovascular disease (ASCVD), and ICER says it will also be assessing them in that context.

The cholesterol-lowering drugs includes statins, ezetimbe (Zetia), and the two PCSK9 inhibitors currently on the market, Repatha (evolocumab) and Praluent (alirocumab). Although it works by a different mechanism than Repatha and Praluent inclisiran is also a PCSK9 inhibitor. Repatha and Praluent have not been widely used and have been disappointing from a a commercial perspective, Inclisiran may have been advantage because it needs to be injected far less often - perhaps only a couple of times a year.

Inclisiran is currently undergoing FDA review, with an anticipated decision expected at the end of this year, according to ICER. The FDA approved Nexletol in February.

ICER's  “open input” period began yesterday on Nexletol and inclisiran began yesterday and will close on June 30, 2020, at 5 p.m. ET. The input period is supposed to allow stakeholders to supply ICER with information that the organization will considered in its evidence report on the two drugs

ICER says its evidence repport on high cholesterol will be reviewed during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) in February 2021.

A draft scoping document, which will provide more detail on ICER’s planned analysis, will be available on July 6, 2020. That document will be open to public comment for three weeks.