For a study comparing health system–level interventions where the primary analyses are patient-centered outcomes, can funding be used to conduct secondary analyses of economic impacts?

Due to the terms of our founding legislation, PCORI is unable to consider any applications that contain cost-effectiveness analysis as one of the aims or goals. Studies that propose to describe or compare costs of care, or to conduct empirical or simulated cost-effectiveness analyses, will be deemed non-responsive and will not advance to Merit Review. We are interested in out-of-pocket costs to patients, which may be proposed for measurement and used as either an outcome or as a mediating variable in analyses. This includes direct measures of adherence and indirect measures including co-payment levels or other assessments of out-of-pocket costs. The potential for replicability or scalability is also critical to demonstrate. For this, we encourage applicants to include cost-related issues, such as resources needed to replicate or disseminate a successful intervention and address reimbursement barriers and how they might be surmounted. Therefore, assessing the cost of an intervention for these purposes is acceptable.