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. 

Can an Applicant Resubmit a Proposal for Another Cycle after Removing the Cost-Effectiveness Analysis? If So, Should the Letter of Intent (LOI) Be Resubmitted? 

Yes. Applicants must resubmit a LOI in order to be considered for the next cycle. Be sure to check the Funding Opportunities prior to resubmission to see if any requirements have changed. Also check the resubmission policy for each PCORI Funding Announcement. 

Will a Proposal that Includes a Cost-Effectiveness Analysis as a Secondary Aim Be Deemed Nonresponsive? 

Yes. LOIs that propose to conduct cost-effectiveness analysis in any capacity, if invited to submit a full application, will be asked to remove this aim in their full application.  If this aim is not removed, those applications that conduct cost-effectiveness analysis in any capacity may be deemed nonresponsive, and may not proceed to Merit Review. 

 Secondary outcomes may include changes in healthcare utilization, but the project may not incorporate such outcomes into cost-effectiveness analysis. 

Will A Proposal to Measure Cost Effectiveness as Any One of the Specific Aims and/or to Include It as Any Outcome of the Study Be Deemed Nonresponsive, Even If It Measures Other Outcomes That Are Meaningful to Patients and Other Stakeholders? 

Yes. LOIs that propose to conduct cost-effectiveness analysis in any capacity, if invited to submit a full application, will be asked to remove this aim in their full application.  If this aim is not removed, those applications that conduct cost-effectiveness analysis in any capacity may be deemed nonresponsive, and may not proceed to Merit Review. 

 


Posted: September 1, 2023

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