SW-3E - Advances in Medical Device RWE Use for Label Expansions and National Coverage Decisions

Background: The US FDA, Centers for Medicare and Medicaid (CMS) and regulatory agencies from many other countries have recently issued Regulatory Guidances for RWE use for medical devices. This symposium will provide examples of using RWE for approval and coverage decisions internationally and a talk by Daniel Canos, Director of OCEA, CDRH, FDA on activities to enhance RWE use for regulatory decisions.

Objectives: To expand understanding of data sources, study design and methods for obtaining label expansions and national coverage for medical devices using RWE by learning from recent successes.

Description: The 1st talk will describe FDA’s priorities, guidance and activities to enhance RWE use for regulatory decisions, given by a Director of a national regulatory agency (TBD)
The 2nd talk by Usha Kreaden from Intuitive Surgical will describe a study for a label change for robotically-assisted prostate removal among prostate cancer patients. The label had a warning that, while robotic surgery is associated with lower procedural complications, the impact on long-term cancer outcomes was not known. Using claims data with 10 years of follow up in partnership with the National Evaluation System for health Technology (NEST), a study was conducted to assess the equivalence of overall mortality rates between robotic and non-robotic prostatectomies that led to FDA’s approval of the label change.
The 3rd talk will describe a label change for a device to treat atrial fibrillation (AF) by cardiac ablation from paroxysmal AF to include persistent AF. This comparative effectiveness study of safety and effectiveness using the EHR databases of Mayo Clinic and Mercy Health in partnership with NEST was accepted by FDA as evidence for the sought indication change. Paul Coplan from J&J MedTech will present this talk.
The 4th talk will describe using RWE for a medical device approval in China. A comparative effectiveness study on lung and gastrointestinal procedure tissue stapler using US RWE was accepted by Chinese authorities as necessary clinical evidence. Shumin Zhang from J&J MedTech will present this talk.
The 5th talk will describe a participant example in CMS’s Pilot for Transitional Coverage for Emerging Technologies (TCET) that tested its processes and concepts. The pilot for renal denervation for uncontrolled hypertension will highlight how CMS’ new RWE framework and updated coverage with evidence development (CED) guidance impacts evidence requirements for national coverage of new technologies. This talk will be given by Lindsay Bockstedt from Medtronic.
The session will be co-moderated by Mary Beth Ritchey and Lisa Weiss, the Medical Device SIG Chair.