Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances?

29 Sep 2022

Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.

After Impact On Cognition Finally Demonstrated In Phase III Trial, will FDA, CMS and sponsors have a meeting of the minds? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Eisai Co., Ltd. and partner Biogen, Inc. plan to seek a revision of the Medicare coverage restrictions facing their Alzheimer’s drug lecanemab, assuming it obtains a traditional approval from the US Food and Drug Administration, on the strength of new Phase III data, which was announced 27 September.

How quickly the Centers for Medicare and Medicaid Services responds to that request may depend in part on whether CMS and FDA engage in much better communication about the drug before it is

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

20 May 2025

• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

20 May 2025

• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

20 May 2025

• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

15 May 2025

• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.