PCORI to fund stud­ies of new hep C drugs

Modern Healthcare - - NEWS - By Jaimy Lee

The Pa­tient-Cen­tered Out­comes Re­search In­sti­tute plans to spend up to $50 mil­lion to fund com­par­a­tive ef­fec­tive­ness re­search for hep­ati­tis C treat­ments just weeks be­fore the third drug in a line of very costly new treat­ments is ex­pected to be ap­proved.

Two new treat­ment reg­i­mens for pa­tients with hep­ati­tis C were ap­proved this year by the Food and Drug Ad­min­is­tra­tion. Both drugs are very ex­pen­sive, rais­ing ques­tions about which of the mil­lions of po­ten­tial pa­tients should re­ceive them. About 3 mil­lion Americans have hep­ati­tis C, which can lead to cir­rho­sis or liver can­cer.

Gilead Sciences’ drug So­valdi, which the FDA ap­proved a year ago, costs $84,000 for a course of treat­ment. Another Gilead drug, Har­voni, which re­ceived ap­proval in Oc­to­ber, costs about $100,000. A new drug from Ab­bVie is ex­pected to re­ceive reg­u­la­tory ap­proval this month.

So­valdi has a cure rate of 95%, higher than the 40% cure rate as­so­ci­ated with pre­vi­ous treat­ments. The So­valdi treat­ment reg­i­men is also shorter than some of the older treat­ments. The drug’s ar­rival on the mar­ket last year trig­gered wide­spread de­bate about whether all pa­tients with hep­ati­tis C should be treated and what role cost plays in mak­ing care de­ci­sions.

The drug reg­i­mens that ex­isted be­fore So­valdi and Har­voni are more com­plex to ad­min­is­ter, have more toxic side ef­fects and have much lower cure rates. But the new treat­ments have not un­der­gone com­par­a­tive ef­fec­tive­ness stud­ies, said Dr. Joe Selby, PCORI’s ex­ec­u­tive di­rec­tor.

“There’s a lot that can be learned about how we ad­min­is­ter th­ese drugs to pa­tients,” he said.

The PCORI fund­ing awards are ex­pected to be an­nounced in Fe­bru­ary. Ar­eas of fo­cus likely will in­clude com­par­ing pa­tients who start treat­ment right after a di­ag­no­sis to those who un­dergo ac­tive surveil­lance un­til the dis­ease be­gins to man­i­fest; study­ing whether there are more side ef­fects or ad­verse events than those re­ported in clin­i­cal tri­als; and how best to treat pa­tients who are at high risk of trans­mit­ting the dis­ease.

There also needs to be bet­ter ev­i­dence to help clin­i­cians un­der­stand how hep­ati­tis C pro­gresses in pa­tients. “Ev­i­dence of the ben­e­fits of treat­ing pa­tients with mild dis­ease is lack­ing, and the new im­ped­i­ment to treat­ment is now the cost of ther­apy,” Dr. Marc Ghany, who works in the Na­tional In­sti­tutes of Health liver dis­eases branch, wrote last week in an ed­i­to­rial in the Jour­nal of the Amer­i­can Med­i­cal As­so­ci­a­tion.

In an in­ter­view, Ghany said the new treat­ments are a ma­jor im­prove­ment. Still, physi­cians and re­searchers want to un­der­stand the long-term safety is­sues. “We need to show that achiev­ing a cure is doable and main­tained long term,” Ghany said.

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