FDA de­ci­sions ex­pected soon on pricey new choles­terol drugs

Modern Healthcare - - THE WEEK AHEAD - —Steven Ross John­son

The Food and Drug Ad­min­is­tra­tion may is­sue ap­proval de­ci­sions this month and next for two choles­terol­low­er­ing drugs that could drive the na­tion’s drug costs even higher.

The FDA is ex­pected to de­cide by late July whether to OK Sanofi’s and Re­gen­eron’s choles­terol med­i­ca­tion Praulent, with a de­ci­sion about whether to ap­prove Am­gen’s Repatha ex­pected by the end of Au­gust.

The two drugs be­long to a new class of in­jecta­bles called PCSK9 in­hibitors. Stud­ies show the biologic prod­ucts re­duce lev­els of low-den­sity lipopro­teins by as much as 60% when used in con­junc­tion with statin drugs.

Last month, FDA ad­vi­sory com­mit­tees voted to rec­om­mend lim­ited ap­proval for both Repatha and Praulent for pa­tients with fa­mil­ial hy­per­c­holes­terolemia, which af­fects an es­ti­mated 600,000 Amer­i­cans. But the drugs also may be used for pa­tients who can’t re­duce their LDL ad­e­quately with statins, or who can’t take statins be­cause of side ef­fects.

An anal­y­sis by phar­macy ben­e­fits man­ager Prime Ther­a­peu­tics es­ti­mated the per-pa­tient cost for PCSK9 in­hibitors be­tween $7,000 and $12,000 a year. It’s pro­jected that PCSK9 in­hibitors could cost the coun­try up to $23 bil­lion an­nu­ally.

An ar­ti­cle pub­lished in Health Af­fairs in Fe­bru­ary said the costs as­so­ci­ated with PCSK9 in­hibitors could easily eclipse those of Gilead Sciences’ hep­ati­tis C drug So­valdi, which was priced at $84,000 when first in­tro­duced. “Man­aged phar­macy care, in­deed the healthcare sys­tem, has never seen a chal­lenge like this to our re­silience in ab­sorb­ing costs,” the au­thors con­cluded.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.