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Moving Beyond Aduhelm: Cell/Gene Therapy May Be ‘Poster Child’ For What Comes Next

 
• By Kate Rawson

Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.

Is gene therapy where FDA and CMS will be able to connect? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

In the wake of the US Centers for Medicare & Medicaid Services’ limited coverage decision for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, sponsors have been seeking assurances that CMS’ policy not to cover the Alzheimer’s therapy outside of clinical trials – in essence nullifying the US Food & Drug Administration’s Accelerated Approval action in 2021 – was a rare, one-off decision.

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More from Medicare

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

 
• By Cathy Kelly

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

More from Government Payers

UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 
• By Eliza Slawther

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

Dr. Oz Takes Over CMS Amid Major Transformation Of Medicare Part D

 
• By Cathy Kelly

As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.

Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.