It is a great pleasure to announce that EXCITE International has become a member of the FDA’s Early Payor Feedback Program (EPFP) set up by the Center for Devices and Radiological Health (CDRH). This is a voluntary opportunity for medical device sponsors to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. Other members of the EPFP include Aetna/CVS, Blue Cross Blue Shield Association, CareFirst BlueCross BlueShield (HealthWorx), Center for Medicare & Medicaid Services (CMS), Cigna, Clover Health, Humana, Duke Evidence Synthesis Group, ECRI, Kaiser Permanente, NICE, Premier Inc., United Health Group. EXCITE now becomes an additional resource to companies making an application to CDRH but who wish at the same time to undertake an ETR in preparation for a clinical trial. EXCITE International offers a comprehensive objective evidence-based approach that provides a platform for a clinical trial based on the expectations of payors and internationally renowned clinical experts, in addition to those of CDRH. We are very pleased to become a member of the EPFP.
Link to FDA Early Payor Feedback Program