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Medicare Coverage For Alzheimer’s Drugs: CMS Declines To Revise Restrictions For Class

 
• By Cathy Kelly

Medicare coverage restrictions are more likely to be reconsidered on a case-by-case basis as drugs in the class obtain traditional US Food and Drug Administration approvals in the coming months.

Was the Broad Request For Reconsideration An Overreach? • Source: Shutterstock

The Centers for Medicare and Medicaid Services is not ready to reconsider its national coverage determination that conditions Medicare reimbursement for amyloid-directed Alzheimer’s drugs on use within a study, the agency told the Alzheimer’s Association.

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Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
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No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
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Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
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Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

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No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.