Open AccessBringing Regenerative Medicines to the Clinic: The Future for Regulation and Reimbursement
Author(s) -
Tania Bubela,
Christopher McCabe,
Peter Archibald,
Harold Atkins,
SE Bradshaw,
Panos Kefalas,
Michelle Mujoomdar,
Claire Packer,
James M. Piret,
Mike Raxworthy,
Marta Soares,
Sowmya Viswanathan
Publication year - 2015
Publication title -
regenerative medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 63
eISSN - 1746-076X
pISSN - 1746-0751
DOI - 10.2217/rme.15.51
Subject(s) - commercialization , reimbursement , regenerative medicine , authorization , business , health technology , medicine , health care , risk analysis (engineering) , marketing , political science , computer science , stem cell , computer security , law , genetics , biology
Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.
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