将再生医学引入临床：监管与报销的未来

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

作者信息

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

机构信息

School of Public Health, 3-279 Edmonton Clinic Health Academy, 11405-87 Avenue, University of Alberta, Edmonton, AB, T6G 1C9, Canada.

Department of Emergency Medicine, 736 University Terrace, 8303 112 Street, University of Alberta, Edmonton, AB, T6G 2T4, Canada.

出版信息

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

DOI:10.2217/rme.15.51

PMID:26565607

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.

摘要

对再生医学的大量投资需要进行讨论，以便从监管机构、医疗系统支付方和开发者的角度协调证据要求和决策考量。只有通过共同努力，再生医学的潜力才能得以实现。我们报告了由英国国家卫生与临床优化研究所（NICE）、阿尔伯塔大学、细胞疗法加速器和再生医学商业化中心主办的两次研讨会的讨论情况。我们讨论了支持评估再生医学产品和服务价值的方法，以及市场授权与报销法规及实践之间存在的协同作用。我们还讨论了新型适应性许可实践的趋同情况，这可能会促进开发并采用满足医疗保健支付方需求的新型疗法。