The next stage in regulation and reimbursement: Bringing regenerative medicines to the clinic

To fully realize the potential of regenerative medicine, it is crucial to align evidentiary requirements and decision-making considerations among regulatory bodies, health system payers, and developers. This requires coordinated efforts and discussions to ensure significant investments in regenerative medicine are justified.

Discussed in this report are the outcomes of two workshops, which were supported by NICE, University of Alberta, Cell and Gene Therapy Catapult, and Centre for Commercialization of Regenerative Medicine. Discussion of methods to assess the value of regenerative medicine products and services, as well as the interactions between market authorization and reimbursement regulations and practices. Also highlighted are the emerging trends in adaptive licensing practices that could facilitate the development and acceptance of innovative therapies that align with healthcare payer needs.

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