title: Bringing regenerative medicines to the clinic: the future for regulation and reimbursement.
abstract: 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.
authors.affiliation: School of Public Health, 3-279 Edmonton Clinic Health Academy, 11405-87 Avenue, University of Alberta, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Tania
authors.initials: T
authors.lastname: Bubela
authors.affiliation: Department of Emergency Medicine, 736 University Terrace, 8303 112 Street, University of Alberta, Edmonton, AB, T6G 2T4, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: McCabe
authors.affiliation: Centre for Innovative Manufacturing in Regenerative Medicine, Loughborough University, Loughborough, LE11 3GR, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Archibald
authors.affiliation: Ottawa Hospital Research Institute, 501 Smyth Road, Box 926, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Harold
authors.initials: H
authors.lastname: Atkins
authors.affiliation: Emedits Global Ltd, 152 City Road, Islington, London, EC1V 2NX, UK.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Bradshaw
authors.affiliation: Catapult Cell Therapy, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Panos
authors.initials: P
authors.lastname: Kefalas
authors.affiliation: CADTH, 865 Carling Avenue, Suite 600, Ottawa, ON, K1S 5S8, Canada.
authors.forename: Michelle
authors.initials: M
authors.lastname: Mujoomdar
authors.affiliation: The NIHR Horizon Scanning Centre, School of Health & Population Sciences, Public Health building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Packer
authors.affiliation: Michael Smith Laboratories, University of British Columbia, 2185 East Mall Vancouver, British Columbia, V6T 1Z4, Canada.
authors.forename: James
authors.initials: J
authors.lastname: Piret
authors.affiliation: Neotherix Ltd, Research Centre, York Science Park, York, YO10 5DF, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Raxworthy
authors.affiliation: Centre for Health Economics, Alcuin 'A' Block, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: Marta
authors.initials: M
authors.lastname: Soares
authors.affiliation: Philip S Orsino Cell Therapy Facility, Princess Margaret Cancer Centre, 610 University Avenue, Suite 5-303, Toronto, ON, M5G 2M9, Canada.
authors.forename: Sowmya
authors.initials: S
authors.lastname: Viswanathan
mesh_terms: D000818:Animals; D003365:Costs and Cost Analysis; D006801:Humans; D044968:Regenerative Medicine / Q000191:economics / Q000379:methods / Q000592:standards / Q000639:trends
keywords: access with evidence development; adaptive licensing; advanced-therapy medicinal products; cost–effectiveness modeling; horizon scanning; patent landscaping; regenerative medicine; regulation; reimbursement; value of information