Payer and Developer perspectives on alternative payment models

ABSTRACT

Objective

To understand the use of alternative payment models to address the reimbursement challenges of cell and gene therapies (CGT) in the U.S.A..

Methods

A literature search focused on CGT reimbursement in the U.S. market was conducted to identify information gaps and inform survey development. U.S. developers (n = 100) and payers (n = 195) were invited to complete an online survey between June and August 2022.

Results

The overall response rate was 16%; payer respondents represented 98 plans covering 338 million lives. Most developers (81%) and payers (84%) had implemented or were planning to implement at least one alternative payment model. Payers pursued these models to ‘reduce product performance uncertainties’ (81%), ‘align therapy costs with benefits’ (58%), and ‘manage actuarial uncertainty’ (54%). Developers aimed to ‘streamline patient access’ (92%) and ‘mitigate budget impact’ (77%). Common perceived barriers included increased administrative burden (developers 79% and payers 67%), defining performance measures (developers 71%, payers 83%) and addressing patient mobility (developers 71% and payers 63%). Both parties expressed a willingness to use real-world evidence for contract adjudication.

Conclusion

Although limited by the number of participants, this survey indicates early discussions coupled with understanding motivations are essential for developing contracts that appeal to both parties and ensure patient access.

KEYWORDS:

• Payers
• manufacturers
• developers
• alternative payment models
• outcomes-based contracts
• value-based payments
• gene therapy
• cell therapy

Declaration of interest

R Moradian served as a Graduate Research Assistant for the FoCUS program at NEWSDIGS for the duration of the survey project. T Meshesha is currently employed as Program Manager for the FoCUS Project at NEWDIGS. M Trusheim receives consultancy fees for his role as Strategic Director of the FoCUS Project at NEWDIGS. J Barlow receives consultancy fees for her role as a Senior Advisor of the FoCUS Project at NEWDIGS and serves as Chief Clinical Officer at Real Endpoints LLC (Florham Park, NJ, U.S.A.).

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

R Moradian designed the study/survey, conducted research, analyzed data and wrote the manuscript. T Meshesha conducted research, analyzed data and wrote the manuscript. M Trusheim designed the study/survey, analyzed data, and wrote the manuscript. J Barlow designed the study/survey, conducted research, analyzed data, and wrote the manuscript.

Acknowledgments

Medical writing support was provided by Diana Steinway, Appa Communications (Leuven, Belgium). We extend our heartfelt appreciation to all the individuals who participated in the surveys and contributed to our research. Your valuable insights and participation have been instrumental in advancing our work. Thank you for being an essential part of the NEWDIGS community.

Informed consent statement

Informed consent was obtained from all participants involved in the study.

Additional information

Funding

This research was wholly funded by the Center for Biomedical Innovation New Drug Development Paradigms (NEWDIGS) Initiative at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. It received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.