Published Aug 2013
Citation
Garrison, LP Jr, Towse A, Briggs A, et al. Performance-based risk-sharing arrangements—good practices for design, implementation, and evaluation: ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force Report. Value Health. 2013;16(5):703-719.
Abstract
There is a significant and growing interest among both payers and
producers of medical products for agreements that involve a “pay-forperformance”
or “risk-sharing” element. These payment schemes—
called “performance-based risk-sharing arrangements” (PBRSAs)—
involve a plan by which the performance of the product is tracked in
a defined patient population over a specified period of time and the
amount or level of reimbursement is based on the health and cost
outcomes achieved. There has always been considerable uncertainty at
product launch about the ultimate real-world clinical and economic
performance of new products, but this appears to have increased in
recent years. PBRSAs represent one mechanism for reducing this
uncertainty through greater investment in evidence collection while
a technology is used within a health care system.
The objective of this
Task Force report was to set out the standards that should be applied
to “good practices”—both research and operational—in the use of a
PBRSA, encompassing questions around the desirability, design, implementation,
and evaluation of such an arrangement. This report
provides practical recommendations for the development and application
of state-of-the-art methods to be used when considering, using,
or reviewing PBRSAs. Key findings and recommendations include the
following. Additional evidence collection is costly, and there are
numerous barriers to establishing viable and cost-effective PBRSAs:
negotiation, monitoring, and evaluation costs can be substantial.
For
good research practice in PBRSAs, it is critical to match the appropriate
study and research design to the uncertainties being addressed. Good
governance processes are also essential. The information generated as
part of PBRSAs has public good aspects, bringing ethical and professional
obligations, which need to be considered from a policy perspective.
The societal desirability of a particular PBRSA is fundamentally an
issue as to whether the cost of additional data collection is justified by
the benefits of improved resource allocation decisions afforded by the
additional evidence generated and the accompanying reduction in
uncertainty.
The ex post evaluation of a PBRSA should, however, be a
multidimensional exercise that assesses many aspects, including not
only the impact on long-term cost-effectiveness and whether appropriate
evidence was generated but also process indicators, such as
whether and how the evidence was used in coverage or reimbursement
decisions, whether budget and time were appropriate, and
whether the governance arrangements worked well. There is an
important gap in the literature of structured ex post evaluation of
PBRSAs. As an innovation in and of themselves, PBRSAs should also be
evaluated from a long-run societal perspective in terms of their impact
on dynamic efficiency (eliciting the optimal amount of innovation).
Keywords: access with evidence development, conditional
licensing, coverage with evidence development, managed entry schemes,
outcomes-based, patient access schemes, pay for performance,
performance-based risk-sharing arrangements, risk-sharing.
Copyright © 2017, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
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