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

Tania Bubela; Christopher McCabe; Peter Archibald; Harold Atkins; Steven 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

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

Centre for Health Economics

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Journal	REGENERATIVE MEDICINE
DOIs	https://doi.org/10.2217/rme.15.51
Publication status	Published - 13 Nov 2015

Access to Document

10.2217/rme.15.51

http://www.futuremedicine.com/doi/10.2217/rme.15.51

Cite this

@article{ae4c5f68728b4d46bcabee34a788b747,

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.",

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

year = "2015",

month = nov,

day = "13",

doi = "10.2217/rme.15.51",

language = "English",

journal = "REGENERATIVE MEDICINE",

issn = "1746-0751",

publisher = "Future Medicine Ltd.",

}

TY - JOUR

T1 - Bringing regenerative medicines to the clinic:

T2 - the future for regulation and reimbursement

AU - Bubela, Tania

AU - McCabe, Christopher

AU - Archibald, Peter

AU - Atkins, Harold

AU - Bradshaw, Steven

AU - Kefalas, Panos

AU - Mujoomdar, Michelle

AU - Packer, Claire

AU - Piret, James

AU - Raxworthy, Mike

AU - Soares, Marta

AU - Viswanathan, Sowmya

PY - 2015/11/13

Y1 - 2015/11/13

N2 - 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.

AB - 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.

U2 - 10.2217/rme.15.51

DO - 10.2217/rme.15.51

M3 - Article

C2 - 26565607

JO - REGENERATIVE MEDICINE

JF - REGENERATIVE MEDICINE

SN - 1746-0751

ER -