Bringing regenerative medicines to the clinic: the future for regulation and reimbursement
This Open Access Review by authors from Canadian and UK institutes looks at the 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.
Regenerative medicine, likely to be a costly therapeutic option, is coming of age in an era of cost-constrained health systems facing an aging population and high-cost new therapies and technologies that do not necessarily improve health outcomes. Value assessment is must therefore be assessed as part of the clinical translation process: this article therefore discusses topics such as methods to support assessments of value and configuring adaptive licensing frameworks for regulation and reimbursement, specifically reporting on discussions from two workshops sponsored by NICE, University of Alberta, Cell and Gene Therapy Catapult and Centre for Commercialization of Regenerative Medicine (CCRM).
Bubela T, McCabe C, Archibald P et al. Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regen. Med. 10(7), 897–911 (2016).