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

Research output: Contribution to journal › Review article › peer-review

40 Citations (Scopus)

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
Pages (from-to)	897-911
Number of pages	15
Journal	Regenerative Medicine
Volume	10
Issue number	7
DOIs	https://doi.org/10.2217/rme.15.51
Publication status	Published - Oct 2015
Externally published	Yes

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

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10.2217/rme.15.51

Cite this

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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.",

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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

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

Abstract

Keywords

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