1. Pink Sheet

Medicare Coverage For Aduhelm Conditioned On Randomized Trial Would Be ‘Unusual’ – McClellan

 
• By Cathy Kelly

Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.

Medicare Grappling With Difficult Coverage Decision

The Centers for Medicare and Medicaid Services seems unlikely to require a randomized study for Biogen, Inc. and Eisai Co., Ltd.’s Aduhelm as a condition of Medicare reimbursement based on the agency’s past national coverage decisions, former CMS administrator and current Duke Margolis Center for Health Policy director Mark McClellan suggests.

CMS announced on 12 July it is initiating a national coverage analysis for Aduhelm (aducanumab-avwa) and other amyloid-directed monoclonal antibody...

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?

More from Market Access

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.