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Sickle Cell Gene Therapy May Need New US-Backed Payment Program, Grogan Suggests

 
• By Cathy Kelly

Former senior advisor to President Trump warns that failure to reform drug pricing practices has seriously handicapped prospects for reimbursing cell and gene therapy under existing US payer programs.

DNA
Major Reimbursement Challenges Ahead For Gene Therapy

Reimbursement for upcoming high-cost cell and gene therapies may need to be handled by government-supported disease specific programs, former US Domestic Policy Council director Joe Grogan suggests, and he say sickle cell disease would be a good candidate for such an initiative.

In a speech to the American Society of Gene and Cell Therapy Policy Summit on 25 September, Grogan painted a somber picture of

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

 
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

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

 
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Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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More from Advanced Technologies

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.