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Do Fast Track Regulatory Pathways Mean Quicker Reimbursement For Gene Therapies?

 
• By Francesca Bruce

The norms on securing market access are being rewritten for cell and gene therapies.

Fast Track
Accelerated regulatory pathyways can throw up evidentiary challenges for reimbursement • Source: Alamy

Without caution, fast track regulatory paths can be the “route to non-reimbursement” for cell and gene therapies, according to Eric Faulkner, vice president of global real-world-evidence at Novartis Gene Therapies. He advised that to succeed with payers, companies selling cell and gene therapies need to prove transformative effect and think “outside the box” when it comes to generating evidence and communicating with payers.

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