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Medicare Premium Hike Will Help Build ‘Contingency Fund’ For Alzheimer’s Drugs

 
• By Cathy Kelly

But CMS cautions that the announcement should not be read as a preview of its upcoming national Medicare coverage decision on Aduhelm and similar treatments.

Big Drug Expenses Ahead For Medicare? • Source: Alamy

The Medicare Part B standard monthly premium will increase $21.60 to $170.10 in 2022, an unprecedented spike in dollar terms, due to factors including the need to set aside reserves to potentially pay for Biogen, Inc.'s and Eisai Co., Ltd.’s high-cost Alzheimer’s drug, Aduhelm, and similar treatments, the Centers for Medicare and Medicaid Services announced 12 November.

Part B premiums will increase 14.5% in 2022, far outstripping earlier estimates. Deductibles will rise by a similar percentage, from...

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Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By Cathy Kelly

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 
• By Alaric DeArment and Cathy Kelly

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

 
• By Cathy Kelly

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 
• By Francesca Bruce

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

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Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.