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As CAR-Ts Proliferate, CMS Seeks To Reserve Medicare Add-On Payments For ‘New’ Therapies

 
• By Cathy Kelly

Products from Bristol-Myers Squibb, Gilead and J&J might be eligible for supplemental reimbursement under hospital payment proposed rule that could help promote uptake.

New Phase Of Medicare Reimbursement Policy For CAR-T Therapies • Source: Alamy

Two recently-approved CAR-T therapies for lymphoma, Bristol Myers Squibb Company’s Breyanzi and Gilead Sciences, Inc.’s Tecartus, face challenges in getting approval for supplemental Medicare reimbursement as novel agents because their indications could be considered the same or similar to older CAR-Ts.

The Centers for Medicare and Medicaid Services discussed applications for new technology add-on payments for Breyanzi (lisocabtagene maraleucel), Tecartus (brexucabtagene autoleucel) and two other chimeric antigen receptor T-cell therapies in the Medicare hospital inpatient prospective payment system

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House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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