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Risk-sharing agreements, present and future.

Francisco R Gonçalves1, Susana Santos2, Catarina Silva3,4

  • 1Portuguese Oncology Institute of Porto, 4200-072 Porto, Portugal.

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|May 11, 2018
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Risk-sharing agreements enhance budgetary control for innovative medicines, especially in oncology. While Portugal favors financial agreements, a shift towards clinical outcomes-based models is emerging, though implementation challenges persist.

Keywords:
accessagreementprice per combinationprice per indicationrisk sharing

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Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Oncology therapeutics

Background:

  • Risk-sharing agreements (RSAs) are increasingly used for innovative medicines, particularly in oncology, to manage budgets and uncertainty around clinical benefit.
  • These agreements involve pharmaceutical companies and payers, aiming for controlled spending on high-cost treatments.
  • The oncology field sees significant adoption due to the high cost and evolving evidence base of new cancer drugs.

Purpose of the Study:

  • To review existing types of risk-sharing agreements.
  • To analyze their advantages, disadvantages, and implementation challenges in Portugal.
  • To explore their role in accessing innovative cancer treatments.

Main Methods:

  • A non-systematic literature review of indexed and non-conventional sources was conducted.
  • Analysis focused on the characteristics and trends of risk-sharing agreements.
  • Case study elements related to Portugal's experience were incorporated.

Main Results:

  • A trend towards including medicine use monitoring and real-world outcomes measurement in RSAs.
  • Portugal's agreements are predominantly financial, with a growing interest in clinical outcomes-based models.
  • No universally accepted 'gold standard' methodology for RSAs currently exists.

Conclusions:

  • Risk-sharing agreements offer advantages but face implementation hurdles, including the need for robust data infrastructure.
  • The opportunity cost and implementation expenses of RSAs require further scrutiny.
  • Future healthcare systems need flexible, personalized reimbursement models aligning drug prices with demonstrated value.