Session (CTI)

PURPOSE: Although the FDA published guidance on communicating HCEI in 2018, HCEI discussions between manufacturers and health care decision-makers (HCDMs) remain challenging. Validating that economic evidence is based on CARSE is critical to bridging any real or perceived evidence credibility gaps. But what options do we have in determining CARSE, and what best practices exist in communicating rigorous HCEI in a relevant and useful way? This workshop will outline approaches to establishing CARSE and propose best practices for engaging HCDMs in productive conversations regarding HCEI from manufacturer, HCDM, and academic perspectives. DESCRIPTION: Dr. Lee will chair and introduce the topic, framing the HCEI opportunity and highlighting common stumbling blocks (10 minutes). Dr. Brixner will compare approaches to CARSE designation and discuss challenges and solutions to meet diverse stakeholder needs (10 minutes). Drs. Gillard and Daw will provide salient manufacturer and HCDM perspectives on the opportunities and challenges in advancing effective HCEI dialogue (20 minutes). Attendees will identify solutions to improve HCDM/manufacturer discussions in a simulated case study (20 minutes). This workshop will be of value to anyone involved in generating and communicating value evidence in US payer contexts.