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New Model For Real World Evidence? Leqembi Registry Data Will Be Bolstered By Medicare Claims

 
• By Cathy Kelly

Senior Centers for Medicare and Medicaid Services official Lee Fleisher described the game plan behind the CMS-facilitated patient registry for the new Alzheimer’s disease treatment, but former CMS official Sean Tunis is still concerned the approach won’t meet data expectations in the planned two-year window.

CMS is Using Its Coverage Clout and Medicare Claims To Generate Real World Evidence. • Source: Shutterstock

The Centers for Medicare and Medicaid Services will link Medicare claims data on Alzheimer's to supplement the data from its bare-bones registry on Eisai Co., Ltd. and Biogen, Inc.’s Leqembi, a new treatment for the disease.

CMS announced specifics on its patient registry after the US Food and Drug Administration’s traditional approval of Leqembi on 6...

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.