Bringing regenerative medicines to the clinic: the future for regulation and reimbursement

Tania Bubela; Christopher McCabe; Peter Archibald; Harold Atkins; Steven E Bradshaw; Panos Kefalas; Michelle Mujoomdar; Claire Packer; James Piret; Mike Raxworthy; Marta Soares; Sowmya Viswanathan

doi:10.2217/rme.15.51

Bringing regenerative medicines to the clinic: the future for regulation and reimbursement

Regen Med. 2015;10(7):897-911. doi: 10.2217/rme.15.51. Epub 2015 Nov 13.

Authors

Affiliations

¹ School of Public Health, 3-279 Edmonton Clinic Health Academy, 11405-87 Avenue, University of Alberta, Edmonton, AB, T6G 1C9, Canada.
² Department of Emergency Medicine, 736 University Terrace, 8303 112 Street, University of Alberta, Edmonton, AB, T6G 2T4, Canada.
³ Centre for Innovative Manufacturing in Regenerative Medicine, Loughborough University, Loughborough, LE11 3GR, UK.
⁴ Ottawa Hospital Research Institute, 501 Smyth Road, Box 926, Ottawa, ON, K1H 8L6, Canada.
⁵ Emedits Global Ltd, 152 City Road, Islington, London, EC1V 2NX, UK.
⁶ Catapult Cell Therapy, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
⁷ CADTH, 865 Carling Avenue, Suite 600, Ottawa, ON, K1S 5S8, Canada.
⁸ The NIHR Horizon Scanning Centre, School of Health & Population Sciences, Public Health building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
⁹ Michael Smith Laboratories, University of British Columbia, 2185 East Mall Vancouver, British Columbia, V6T 1Z4, Canada.
¹⁰ Neotherix Ltd, Research Centre, York Science Park, York, YO10 5DF, UK.
¹¹ Centre for Health Economics, Alcuin 'A' Block, University of York, Heslington, York, YO10 5DD, UK.
¹² Philip S Orsino Cell Therapy Facility, Princess Margaret Cancer Centre, 610 University Avenue, Suite 5-303, Toronto, ON, M5G 2M9, Canada.

PMID: 26565607
DOI: 10.2217/rme.15.51

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.

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.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Animals
Costs and Cost Analysis
Humans
Regenerative Medicine* / economics
Regenerative Medicine* / methods
Regenerative Medicine* / standards
Regenerative Medicine* / trends