Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab

US Exec Ivan Cheung Expects ‘More Open Access’ To Drug

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.

Alzheimer's disease; brain and wooden puzzle on pink background
Eisai will piece together a detailed data package for CMS • Source: Shutterstock

Eisai Co., Ltd. is confident that it has the necessary data to convince the US Centers for Medicare and Medicaid Services to grant broader coverage for its Biogen, Inc.-partnered Alzheimer’s drug candidate lecanemab, if the US Food and Drug Administration approves it next month – setting it up for a potentially much better commercial outlook than the firms’ Aduhelm faced.

Many in the Alzheimer's field, impressed with the quality and amount of data presented from the Phase III Clarity AD clinical trial, are

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

More from Market Access

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By 

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

Will International Prices Influence Medicare Price Negotiation?

 
• By 

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

More from Pink Sheet

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.