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What is PCORI’s official policy on cost and cost-effectiveness analysis?

PCORI’s authorizing law was amended by reauthorization legislation in 2019 to include a new mandate to consider, as appropriate, the full range of clinical and patient-centered outcomes data relevant to patients and stakeholders. The reauthorizing language clarifies that in addition to the relevant health outcomes and clinical effectiveness, relevant outcomes may include the potential burdens and economic impacts of the utilization of medical treatments, items, and services. 

As such, where PCORI previously directed in its past Funding Announcements that proposed studies could not employ direct measurements of cost, PCORI now allows and encourages proposed studies that include collection of data describing these potential burdens and economic impacts when relevant to patients and caregivers or to other stakeholders. However, consistent with past Funding Announcements, PCORI will consider an application nonresponsive if the proposed research conducts a formal cost-effectiveness analysis of alternative approaches to providing care. Research studies also may not directly compare the costs of care between two or more alternative approaches to providing care, or rely on modeling to develop estimates of “total costs of care” designed to enable such comparisons.

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