Skip to main content
Log in

The Use of Risk-Sharing Contracts in Healthcare: Theoretical and Empirical Assessments

  • Systematic Review
  • Published:
PharmacoEconomics Aims and scope Submit manuscript

Abstract

Objective

The aim of this review is to provide a summary of the literature on risk-sharing agreements, including conceptual, theoretical and empirical (number of agreements and their achievements) perspectives, and stakeholders’  perceptions.

Methods

We conducted a systematic literature search in MEDLINE from 2000 to April 2019, following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology, and completed it with a manual search of other publications (mainly grey literature). The search was restricted to publications with English abstracts; the initial identification of articles was restricted to the title, abstract and key words fields. The geographical scope was not restricted.

Results

Over 20 studies proposed different taxonomies of risk-sharing contracts, which can be summarised as financial and paying-for-performance agreements. Theoretical studies modelling the incentives to implement risk-sharing agreements are scarce; they addressed different types of contracts and regulatory contexts, characterizing the drug prices and the optimal strategies of the involved agents. Empirical studies describing specific agreements are abundant and referred to different geographical contexts; however, few articles showed the economic results and assessed the value of such contracts. Stakeholders’ perceptions of risk-sharing contracting were favourable, but little is known about the economic and clinical advantages of specific agreements. Whether risk-sharing contracts have yielded the desired results for healthcare systems remains uncertain.

Conclusion

Risk-sharing contracts are increasingly used, although the lack of transparency and aggregated registries makes it difficult to learn from these experiences and assess their impact on healthcare systems.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

Data Availability

No underlying data exist for this article as it is based on a review of other published studies.

References

  1. Yu JS, Chin L, Oh J, Farias J. Performance-based risk-sharing arrangements for pharmaceutical products in the United States: a systematic review. J Manag Care Spec Pharm. 2017;23(10):1028–40.

    PubMed  Google Scholar 

  2. Carlson JJ, Sullivan SD, Garrison LP, Neumann PJ, Veenstra DL. Linking payment to health outcomes: a taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy. 2010;96(3):179–90.

    Article  PubMed  Google Scholar 

  3. Garrison LJ, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr P, et al. Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance based risk-sharing arrangements task force. Value Health. 2013;16:703–19.

    Article  PubMed  Google Scholar 

  4. Kanavos P, Ferrario A, Tafuri G, Siviero P. Managing risk and uncertainty in health technology introduction: the role of managed entry agreements. Glob Policy. 2017;8(S2):84–92.

    Article  Google Scholar 

  5. Lu CY, Ritchie J, Williams K, Day R. The views of stakeholders on controlled access schemes for high-cost antirheumatic biological medicines in Australia. Aust N Z Health Policy. 2007;4:26.

    Article  Google Scholar 

  6. Morgan SG, Thomson PA, Daw JR, Friesen M. Canadian policy makers’ views on pharmaceutical reimbursement contracts involving confidential discounts from drug manufacturers. Health Policy. 2013;112:248–54.

    Article  PubMed  Google Scholar 

  7. Zaric GS, O’Brien BJ. Analysis of a pharmaceutical risk sharing agreement based on the purchaser’s total budget. Health Econ. 2005;14:793–803.

    Article  PubMed  Google Scholar 

  8. Barros PP. The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry. Health Econ. 2011;20(4):461–70.

    Article  PubMed  Google Scholar 

  9. Towse A, Garrison LP. Can’t get no satisfaction? Will pay for performance help? Toward an economic framework for understanding performance-based risk-sharing agreements for innovative medical products. Pharmacoeconomics. 2010;28:93–102.

    Article  PubMed  Google Scholar 

  10. Stafinski T, McCabe C, Menon D. Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconomics. 2010;28:113–42.

    Article  PubMed  Google Scholar 

  11. McCabe CJ, Stafinski T, Edlin R, Menon D, Behalf Banff AEDS. Access with evidence development schemes a framework for description and evaluation. Pharmacoeconomics. 2010;28:143–52.

    Article  PubMed  Google Scholar 

  12. Adamski J, Godman B, Ofierska-Sujkowska G, Osinska B, Herholz H, Wendykowska K, et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010;10:153.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Jaroslawski S, Toumi M. Market access agreements for pharmaceuticals in Europe: diversity of approaches and underlying concepts. BMC Health Serv Res. 2011;11:259.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Walker S, Sculpher M, Claxton K, Palmer S. Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions. Value Health. 2012;15(3):570–9.

    Article  PubMed  Google Scholar 

  15. Cook JP, Vernon JA, Manning R. Pharmaceutical risk-sharing agreements. Pharmacoeconomics. 2008;26(7):551–6.

    Article  PubMed  Google Scholar 

  16. Breckenridge A, Walley T. Risk sharing and payment by results. Clin Pharmacol Ther. 2008;83(5):666–7.

    Article  CAS  PubMed  Google Scholar 

  17. Carapinha JL. Setting the stage for risk-sharing agreements: international experiences and outcomes-based reimbursement. S Afr Fam Pract. 2008;50(4):62–5.

    Google Scholar 

  18. Espín J, Oliva J, Rodríguez-Barrios JM. Esquemas innovadores de mejora del acceso al mercado de nuevas tecnologías: Los acuerdos de riesgo compartido. Gac Sanit. 2010;24(6):491–7.

    Article  PubMed  Google Scholar 

  19. Barros PP. Pharmaceutical policies in European countries. Adv Health Econ Health Serv Res. 2010;22:3–27.

    Article  PubMed  Google Scholar 

  20. Klemp M, Frønsdal K, Facey K, on behalf of the HTAi Policy Forum. What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care. 2011;2011(27):77–83.

    Article  Google Scholar 

  21. Campillo-Artero C, Del Llano J, Poveda JL. Contratos de riesgo compartido, ¿con medicamentos huérfanos? Farm Hosp. 2012;36(6):455–63.

    CAS  PubMed  Google Scholar 

  22. Morel T, Arickx F, Befrits G, Siviero P, van der Meijden C, Xoxi E, et al. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet J Rare Dis. 2013;8:198.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Paredes Fernández DM, Lenz Alcayaga RC. Acuerdos de Riesgo Compartido: Lecciones Para su Diseño e Implementación a la Luz de la Experiencia Internacional. Value Health Reg Issues. 2019;20:51–9.

    Article  Google Scholar 

  24. Coulton L, Annemans L, Carter R, Herrera MB, Thabrany H, Lim J, et al. Outcomes-based risk-sharing schemes: is there a potential role in the Asia-Pacific markets? Health Outcomes Res Med. 2012;3(4):e205–19.

    Article  Google Scholar 

  25. Launois R, Ethgen O. Risk-sharing agreements: Choice of study design and assessment criteria [Contrats de risk-sharing: Choix des schémas d’étude et des critères de jugement. Ann Pharm Fr. 2013;71(5):346–57.

    Article  CAS  PubMed  Google Scholar 

  26. Zaric GS, Zhang H, Mahjoub R. Modeling risk sharing agreements and patient access schemes. In: Zaric G, editor. Operations research and health care policy. International series in operations research and management science, vol. 190. New York: Springer; 2013. p. 295–310.

    Google Scholar 

  27. Zhang H, Zaric GS, Huang T. Optimal design of a pharmaceutical price-volume agreement under asymmetric information about expected market size. Prod Oper Manag. 2011;20(3):334–46.

    Article  Google Scholar 

  28. Gavious A, Greenberg D, Hammerman A, Segev E. Impact of a financial risk-sharing scheme on budget-impact estimations: a game-theoretic approach. Eur J Heal Econ. 2014;15(5):553–61.

    Article  Google Scholar 

  29. Zaric GS, Xie B. The impact of two pharmaceutical risk-sharing agreements on pricing, promotion, and net health benefits. Value Health. 2009;12:838–45.

    Article  PubMed  Google Scholar 

  30. Mahjoub R, Odegaard F, Zaric GS. Health-based pharmaceutical pay-for-performance risk-sharing agreements. J Oper Res Soc. 2014;65(4):588–604.

    Article  Google Scholar 

  31. Zhang H, Zaric GS. Using price–volume agreements to manage pharmaceutical leakage and off-label promotion. Eur J Health Econ. 2015;16(7):747–61.

    Article  PubMed  Google Scholar 

  32. Gandjour A. Pharmaceutical risk-sharing agreements. Pharmacoeconomics. 2009;27:431–2.

    Article  PubMed  Google Scholar 

  33. Antonanzas F, Juarez-Castello C, Rodriguez-Ibeas R. Should health authorities offer risk-sharing contracts to pharmaceutical firms? A theoretical approach. Health Econ Policy Law. 2011;6(3):391–403.

    Article  PubMed  Google Scholar 

  34. Levaggi R, Moretto M, Pertile P. The dynamics of pharmaceutical regulation and R&D investments. J Public Econ Theory. 2017;19(1):121–41.

    Article  Google Scholar 

  35. Mahjoub R, Ødegaard F, Zaric GS. Evaluation of a pharmaceutical risk-sharing agreement when patients are screened for the probability of success. Health Econ. 2018;27(1):e15–25.

    Article  PubMed  Google Scholar 

  36. Antonanzas F, Rodríguez-Ibeas R, Juárez-Castelló C. Personalized medicine and pay-for-performance: should pharmaceutical firms be fully penalized when treatment fails? Pharmacoeconomics. 2018;36(7):733–43.

    Article  PubMed  Google Scholar 

  37. Garattini L, Casadei G. Risk sharing agreements: what lessons from Italy? Int J Technol Assess Health Care. 2011;27(2):169–72.

    Article  PubMed  Google Scholar 

  38. Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. Brussels: EMiNet; 2013.

    Google Scholar 

  39. Garattini L, Curto A, Van de Vooren K. Italian risk sharing agreements on drugs: are they worthwhile? Eur J Health Econ. 2015;16:1–3.

    Article  PubMed  Google Scholar 

  40. Carlson JJ, Chen S, Garrison LP. Performance-based risk-sharing arrangements: an updated international review. Pharmacoeconomics. 2017;35(10):1063–72.

    Article  PubMed  Google Scholar 

  41. Ferrario A, Araja D, Bochenek T, Čatic T, Dannkó D, Dimitrova M, et al. The implementation of managed entry agreements in Central and Eastern Europe: findings and implications. Pharmacoeconomics. 2017;35(12):1271–85.

    Article  PubMed  PubMed Central  Google Scholar 

  42. Ferrario A, Kanavos P. Dealing with uncertainty and high prices of new medicines: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015;124:39–47.

    Article  PubMed  Google Scholar 

  43. Lu CY, Lupton C, Rakowsky S, Babar ZUD, Ross-Degnan D, Wagner AK. Patient access schemes in Asia-pacific markets: current experience and future potential. J Pharm Policy Pract. 2015;8(1):6.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Piatkiewicz TJ, Traulsen JM, Holm-Larsen T. Risk-sharing agreements in the EU: a systematic review of major trends. Pharmacoecon Open. 2018;2(2):109–23.

    Article  PubMed  Google Scholar 

  45. Darbà J, Ascanio M. The current performance-linked and risk sharing agreement scene in the Spanish region of Catalonia. Expert Rev Pharmacoecon Outcomes Res. 2019. https://doi.org/10.1080/14737167.2019.1587296.

    Article  PubMed  Google Scholar 

  46. Maskineh C, Nasser SC. Managed entry agreements for pharmaceutical products in middle East and North African countries: payer and manufacturer experience and outlook. Value Health Reg Issues. 2018;16:33–8.

    Article  PubMed  Google Scholar 

  47. Campillo-Artero C, Kovacs F. The use of risk sharing tools for post adoption surveillance of a non-pharmacological technology in routine practice: results after one year. BMC Health Serv Res. 2013;13:181. https://doi.org/10.1186/1472-6963-13-181.

    Article  PubMed  PubMed Central  Google Scholar 

  48. AIFA Agenzia Italiana del Farmaco. http://www.aifa.gov.it/content/comunicazioni-managed-entry-agreements-mea. Accessed 4 Mar 2019.

  49. NICE Patient access schemes liaison unit. https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit. Accessed 5 Mar 2019.

  50. Carlson JJ, Gries KS, Yeung K, Sullivan SD, Garrison LP Jr. Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers. Appl Health Econ Health Policy. 2014;12(3):231–8.

    Article  PubMed  Google Scholar 

  51. Pickin M, Cooper CL, Chater T, O’Hagan A, Abrams KR, Cooper NJ, et al. The multiple sclerosis risk-sharing scheme monitoring study-early results and lessons for the future. BMC Neurol. 2009;9:1.

    Article  PubMed  PubMed Central  Google Scholar 

  52. Fagnani F, Pham T, Claudepierre P, et al. Modeling of the clinical and economic impact of a risk-sharing agreement supporting a treat-to-target strategy in the management of patients with rheumatoid arthritis in France. J Med Econ. 2016;19(8):812–21.

    Article  PubMed  Google Scholar 

  53. Soini E, Asseburg C, Taiha M, Puolakka K, Purcaru O, Luosujärvi R. Modeled health economic impact of a hypothetical certolizumab pegol risk-sharing scheme for patients with moderate-to-severe rheumatoid arthritis in Finland. Adv Ther. 2017;34(10):2316–32.

    Article  PubMed  PubMed Central  Google Scholar 

  54. Calleja MA, Martín M, García C, Rubio-Terrés C, Rubio-Rodríguez D. Análisis del impacto económico del acuerdo de riesgo compartido clínico (ARCC) con certolizumab pegol (Cimzia®) para el tratamiento de la artritis reumatoide. Rev Esp Econ Salud. 2016;11(2):178–91.

    Google Scholar 

  55. Clopes A, Gasol M, Cajal R, Segú L, Crespo R, Mora R, et al. Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer. J Med Econ. 2017;20(1):1–7.

    Article  PubMed  Google Scholar 

  56. Makady A, van Veelen A, de Boer A, Hillege H, Klungel OH, Goettsch W. Implementing managed entry agreements in practice: the Dutch reality check. Health Policy. 2019;123(3):267–74.

    Article  CAS  PubMed  Google Scholar 

  57. Han E, Park SY, Lee EK. Assessment of the price-volume agreement program in South Korea. Health Policy. 2016;120(10):1209–15.

    Article  PubMed  Google Scholar 

  58. Park SY, Han E, Kim J, Lee EK. Factors influencing the difference between forecasted and actual drug sales volumes under the price–volume agreement in South Korea. Health Policy. 2016;120(8):678–774.

    Article  Google Scholar 

  59. Dunlop WCN, Staufer A, Levy P, Edwards GJ. Innovative pharmaceutical pricing agreements in five European markets: a survey of stakeholder attitudes and experience. Health Policy. 2018;122(5):528–32.

    Article  PubMed  Google Scholar 

  60. Rojas P, Antonanzas F. Los contratos de riesgo compartido en el Sistema Nacional de Salud: percepciones de los profesionales sanitarios. Rev Esp Salud Pública. 2018;92(1):1–20.

    Google Scholar 

  61. Kolasa K, Kalo Z, Hornby E. Research Pricing and reimbursement frameworks in Central Eastern Europe: a decision tool to support choices. Expert Rev Pharmacoecon Outcomes Res. 2015;15(1):145–55.

    Article  PubMed  Google Scholar 

  62. Nazareth T, Ko JJ, Sasane R, Frois C, Carpenter S, Demean S, et al. Outcomes-based contracting experience: research findings from US and European stakeholders. J Manag Care Spec Pharm. 2017;23(10):1018–26.

    PubMed  Google Scholar 

  63. Lam MT, De Longhi C, Turnbull J, Lam HR, et al. Has Embase replaced Medline since coverage expansion? J Med Libr Assess. 2018;106(2):227–33.

    Google Scholar 

Download references

Acknowledgements

The authors thank the editor and three anonymous referees for their comments and suggestions.

Author information

Authors and Affiliations

Authors

Contributions

RRI acted as a health economist on this article, summarised the articles, developed the tables and was responsible of the final writing of the text, together with FA. CJC acted as a health economist on this article, collaborated in the search of the final texts, reviewed them and developed the PRISMA summary. RL acted as a health economist on this article and collaborated in the search of the articles and in the literature review. FA acted as a health economist on this article, conceptualised the design of the text, contributed to its writing, and acts as the overall guarantor for the overall content of this article. All authors contributed to the conception and planning of the work and critically revised and approved the final submitted version of the manuscript.

Corresponding author

Correspondence to Fernando Antonanzas.

Ethics declarations

Conflict of interest

F. Antonanzas, C. Juárez-Castelló, R. Lorente and R. Rodríguez-Ibeas have no conflicts of interest directly relevant to the content of this article.

Funding

This study was funded by MINECO Grant (Project ECO2016-78685-R).

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Antonanzas, F., Juárez-Castelló, C., Lorente, R. et al. The Use of Risk-Sharing Contracts in Healthcare: Theoretical and Empirical Assessments. PharmacoEconomics 37, 1469–1483 (2019). https://doi.org/10.1007/s40273-019-00838-w

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40273-019-00838-w

Navigation