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Medicare Restrictions On Aduhelm Do Not Signal Broad Concern With Accelerated Approvals – CMS

 
• By Cathy Kelly

CMS chief medical officer Lee Fleisher addresses concerns that the Medicare national coverage determination for Alzheimer’s drugs sets a precedent for accelerated approvals. He and the FDA's Janet Woodcock also discuss prospects for closer collaboration on evidence needs pre-approval.

Concerns persist that the Aduhelm decision sets a precedent. • Source: Alamy

The US Centers for Medicare and Medicaid Services’ national coverage determination limiting Medicare coverage for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa) to situations when patients are enrolled in a clinical trial should not be read as a sign that the agency is cracking down on drugs cleared through the US Food and Drug Administration’s accelerated approval pathway, CMS chief medical officer Lee Fleisher emphasized.

“Our recent decision should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” Fleisher...

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

 
• By Cathy Kelly

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

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.

More from Government Payers

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.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
• By Tim Casey

Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.