Pharmaceuticals Value-Based Purchasing

Risk Sharing Agreements in the US

Outcomes-based risk sharing agreements tie reimbursement for medical goods or services to patient outcomes.  Despite the increasing demand from policymakers for value-based payment mechanism, risk-sharing agreements are not that comment.  A paper by Garrison et al. (2015) found that there were only 148 risk sharing agreements (RSAs) worldwide between the late 1990s and 2013 and only 18 of the 148 RSAs occured in the U.S.

RSAs were most often considered when there are treatment alternatives in a given drug therapeutic class. The benefits of RSAs include that:

…they allow payers to ensure that the price of a drug is more closely aligned to its value…payers indicated interest in RSAs for products that are more costly (eg, specialty drugs, biologics, combination products) and for disease areas for which cost consequences are substantial.

If RSAs are selected, RSAs of length 18-36 months are idea because the enable sufficient time for follow-up data collection without committing payers to significant unknown long-term risks.

What are the barriers to adopting outcomes-based RSAs?  Garrison and co-authors interview 16 key stakeholders and found that implementing RSAs is often difficult.

Roughly half of manufacturers and payers expressed interest in outcomes-based RSAs and see value in their use; almost all were optimistic about the use of financial-based RSAs…Outcomes-based agreements…were perceived by interviewees to be difficult to execute and as having high transaction costs. Interview respondents were skeptical about being able to use outcomes-based RSAs, citing challenges in implementing and executing outcomes-based RSAs that would mitigate their potential in the United States, particularly given the fragmented payer system with patient movement across plans, as well as the current lack of data infrastructure that limits feasibility and, to some extent, interest in measuring long-term outcomes.

The authors list the top barriers to RSA use in the US as follows:

  1. Significant additional effort required to establish/execute RSAs (eg, compared to traditional rebates/discounts)
  2. Challenges in identifying/defining meaningful outcomes
  3. Challenges in measuring relevant real-world outcomes
  4. Data infrastructure inadequate for measuring/monitoring relevant outcomes
  5. Difficulty in reaching contractual agreement (eg, on the selection of outcomes, patients, data collection methods)
  6. Implications for federal (Medicaid) best price
  7. Payer concerns about adverse patient selection
  8. Fragmented multi-payer insurance market with and significant patient switching among plans
  9. Challenges in assessing risk upfront due to uncertainties in real-world performance
  10. Lack of control over how product will be used
  11. Significant resources and/or costs associated with ongoing adjudication

Although the US has few RSAs, countries such as Italy and Sweden have a number of RSAs. As payers and provider continue to consolidate, however, the US may have more RSAs in the upcoming years.


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