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Payer and Developer perspectives on alternative payment models.

Renita Moradian1, Tsega Meshesha1, Mark Trusheim1

  • 1New Drug Development Paradigms (NEWDIGS) Initiative, Center for Biomedical System Design, Tufts Medical Center Institute for Clinical Research and Health Policy Studies, Boston, MA, USA.

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Summary
This summary is machine-generated.

Most U.S. cell and gene therapy (CGT) developers and payers are using or planning alternative payment models. Key motivations include managing costs and improving patient access, despite administrative and performance measure challenges.

Keywords:
Payersalternative payment modelscell therapydevelopersgene therapymanufacturersoutcomes-based contractsvalue-based payments

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Area of Science:

  • Health Economics and Outcomes Research
  • Pharmaceutical Policy and Management
  • Biotechnology and Therapeutics

Background:

  • Cell and gene therapies (CGT) present unique reimbursement challenges in the U.S. market.
  • High costs and uncertainties associated with CGT necessitate innovative payment solutions.
  • Understanding the perspectives of both developers and payers is crucial for successful reimbursement strategies.

Purpose of the Study:

  • To investigate the adoption and motivations behind alternative payment models (APMs) for CGT in the U.S.
  • To identify perceived barriers and facilitators for implementing APMs in CGT reimbursement.
  • To explore the role of real-world evidence in adjudicating APM contracts.

Main Methods:

  • A literature search was conducted to inform survey development on CGT reimbursement.
  • An online survey was distributed to U.S. CGT developers (n=100) and payers (n=195) between June and August 2022.
  • Analysis of survey responses to identify trends in APM implementation, motivations, and barriers.

Main Results:

  • A significant majority of developers (81%) and payers (84%) have implemented or plan to implement APMs.
  • Payers utilize APMs to mitigate performance and actuarial uncertainties, while developers aim to streamline patient access and budget impact.
  • Common barriers include administrative burden, defining performance measures, and patient mobility; willingness to use real-world evidence was noted.

Conclusions:

  • Early discussions and mutual understanding of motivations are vital for creating effective CGT contracts.
  • APMs are emerging as a key strategy to address reimbursement hurdles for CGT.
  • Further research is needed, considering the study's participant limitations, to refine APM frameworks for CGT.