1. Pink Sheet
  2. >>Market Access

Medicare’s Registry Plans For Leqembi Prompt New Calls For Transparency, Rigor

 
• By Cathy Kelly

Now that it’s clear the Centers for Medicare and Medicaid Services is moving ahead with the patient registry requirement for the Alzheimer’s drug, experts weigh in on how best to collect useful information.    

never too late
Experts Still Hoping To Shape CMS Plans For Registries • Source: Shutterstock

The Centers for Medicare and Medicaid Services should require registries maintained by outside organizations that are tracking patients taking Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi to include all “critical data” that could shed light on safety and outcomes and, importantly, ensure that at least CMS has access to the data, health care providers, patients, physician groups, researchers and policy experts are urging the agency.

Key Takeaways

Two groups of researchers and physicians are advocating that:

  • CMS should require private organizations hosting registries for Leqembi to allow outside researchers access to the data as a condition of coverage.

In two recent letters to CMS and the Department of Health and Human Services, the experts call for transparency and...

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

Global Pharma Guidance Tracker - July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.