The delivery system, payer, manufacturer, or developer of the intervention must cover costs for study interventions. Given the significant treatment costs associated with many of the newly available therapies, the applications must specifically address, in the context of the proposed studies, the support from payers, health plans, industry sponsors, or others in covering the study drugs and non-study protocol–related clinical costs and services rendered in the care processes.
Note that, in general, PCORI will not cover costs for interventions that are being compared in the proposed study (see Appendix 2 Allowable and Unallowable Costs in the Application Guidelines for details). However, in cases where this policy would preclude conducting a comparative clinical effectiveness research (CER) study that addresses the priority questions outlined in this funding announcement, such as research on providing telehealth services in underserved or hard to reach populations or settings, PCORI may consider a waiver on this policy. Request for such a waiver and the accompanying justification must be in the LOI. The waiver must be approved by PCORI staff at the LOI review stage, before a full application is submitted.
The willingness of one or more of the stakeholder groups to cover treatment costs, even when one of the proposed intervention arms is not currently covered by insurance, will be taken as strong endorsement of the study by the health system or payer and of the likelihood that they will implement or use the study’s findings, if definitive. This material support for the study by host delivery system, payer, or developer should be discussed in the application.