Many sponsors seeking for approval for innovative, first-in-class medical devices have found that Economic and Quality of Life (EQoL) studies can be a valuable asset in the overall commercialization process. As such, many companies will synchronize their efforts to obtain FDA approval, while laying the groundwork for coverage and reimbursement by payers.
While there is no formal requirement for EQoL studies in this pathway, it is advantageous to Sponsors for a credible party to evaluate cost effectiveness and value of new medical therapies, which usually increase overall healthcare costs. This strategy has been shown to be effective for many successful devices. Our EQoL team has led these efforts for such devices as ablation catheters for atrial fibrillation, drug eluting stents (DES) and transcatheter aortic valves.
The EQoL chapter of the DES approval story is a fascinating example of this benefit because, in this case, Medicare created new diagnosis-related codes (DRGs) for DES that were already in effect on the day that the FDA approved the first DES. Prior to this, there was always a lag – often of a year or more – between device approval and reimbursement. In this case, the health economic impact of DES had been established in advance, leading to this simultaneous approval. Our work on the cost-effectiveness of the Cypher DES played a role in this unprecedented event.
In the structural heart space, we have done EQoL work for two transcatheter aortic valve systems, the Edwards Sapien and Medtronic CoreValve devices. We performed both cost effectiveness and quality of life analyses on these devices, published this data and presented it at major meetings.
In so doing, we demonstrated the cost effectiveness of transcatheter aortic valve replacement (TAVR) in both inoperable and high risk patients, which contributed to favorable reimbursement policies for these devices in the US and other markets.
Part of our value-add in this area includes experience with unique methodological approaches for assessing the value of new technologies. In a number of cases we have used a hybrid strategy, combining trial-based analyses with health economic modeling. Such efforts begin with extensive and detailed collection and analysis of health economic data over the course of a trial. Subsequently, trial data are grafted with health economic models, which together enable us to tell a complete and compelling story about the value of interventions from the perspective of patients’ lifetimes.
Matthew Reynolds, MD, MSc, a practicing electrophysiologist with extensive experience in EQoL science, leads The Baim Institute’s EQoL team.