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Private Sector Risk-Sharing Agreements in the United States: Trends, Barriers, and Prospects

Louis P. Garrison, Jr, PhD; Josh J. Carlson, PhD; Preeti S. Bajaj, PhD; Adrian Towse, MA, MPhil; Peter J. Neumann, ScD; Sean D. Sullivan, PhD; Kimberly Westrich, MA; and Robert W. Dubois, MD, PhD
Assessment of current trends, success factors, and challenges in the use of risk-sharing agreements in the US private sector.
Due to the confidential nature of agreements and limited number of agreements in the United States, we have few data points to learn from. Thus, it remains to be seen how some of the challenges and opportunities identified will be realized in actual practice.

Finally, we sought to assess the potential for increased use of RSAs in the United States given the shifting incentives in the healthcare system with healthcare reform and the growth of ACOs. However, many of the forthcoming changes have yet to take effect, and until these have been fully implemented, it is challenging to assess whether RSAs may in fact have a great role in the future.


CONCLUSIONS
In summary, there is continued and even growing interest on the part of both manufacturers and payers in RSAs in the United States. Yet, the number of new agreements is still small—mostly exceptional situations. We can ask, “What are the necessary conditions for RSA adoption in the United States?” and the answer seems to be that more robust infrastructure and optimized RSA development and monitoring processes are needed. There is a lot of talk, but improved data systems and changed incentives (via health reform and ACOs) may generate more action.

Acknowledgments

The authors would like to thank the anonymous interviewees and survey respondents who generously shared their expertise, insights, and time, and the National Pharmaceutical Council for providing the funds to conduct this research.

Author Affiliations: Department of Pharmacy, University of Washington (LPG, JJC, PSB, SDS), Seattle, WA; VeriTech Corporation (LPG, JJC, SDS), Mercer Island, WA; Office of Health Economics (AT), London, UK; Director of the Center of the Evaluation of Value & Risk in Health, Tufts Medical Center - Institute for Clinical Research & Health Policy Studies (PJN), Boston, MA; National Pharmaceutical Council (KW, RWD), Washington, DC.

Source of Funding: This research was supported by the National Pharmaceutical Council through a contract with VeriTech Corporation.

Author Disclosures: Dr Bajaj has received payment for services related to data collection, analysis, and preparation for this manuscript. Dr Carlson has been a consultant to Genentech, Pfizer, and Bayer; his employer, the University of Washington, maintains a subscription-based web-enabled database on risk-sharing agreements. Ms Westrich and Dr Dubois are employees of the National Pharmaceutical Council, an industry-funded health policy research group that is not involved in lobbying or advocacy. Dr Neumann is a board member for Merck, Takeda, Bayer, Novo Nordisk, Pacira, and Genentech; and is a consultant for Boston Health Economics and Purdue. Mr Towse has previously received honoraria for an ISPOR conference short course. Drs Sullivan and Garrison report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (LPG, JJC, SDS, AT, KW, RWD); acquisition of data (LPG, PSB, JJC); analysis and interpretation of data (LPG, PSB, JJC, SDS, PJN, AT, KW, RWD); drafting of the manuscript (LPG, PSB, JJC, PJN, KW, RWD); critical revision of the manuscript for important intellectual content (LPG, JJC, AT, SDS, PJN, KW, RWD); obtaining funding (LPG); administrative, technical, or logistic support (PSB); and supervision (LPG, JJC).

Address correspondence to: Louis P. Garrison, Jr, PhD, Pharmaceutical Outcomes Research & Policy Program, University of Washington School of Pharmacy, Box 357630, 1959 NE Pacific St, H-375A, Seattle, WA 98195. E-mail: lgarrisn@u.washington.edu.

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