Naomi Aronson, Executive Director for Clinical evaluation at the Blue Cross and Blue Shield Association, didn’t mince words in a recent webinar on the use of real-world evidence for coverage, calling for validated outcome measures across multiple conditions, stating that these are “desperately” needed in order to make appropriate coverage decisions. Aronson spoke on a webinar that addressed the use of RWE for coverage, hosted by the Medical Device Innovation Consortium (MDIC).
Aronson went on to describe persistent issues with evidence, including challenges with study populations that differ from the typical population that would receive the intervention in typical clinical care, as well as the use of study comparator treatments that do not reflect the real world. However, it was her opinion that the lack of validated outcome measures was the “largest issue of all”, and suggested that a core set of validated outcome measures for various conditions was sorely needed. Device makers need this if they want to reduce the delay in gaining coverage for their medical device.
Eleanor Perfetto, executive vice president of strategic initiatives at the National Health Council, weighed in, suggesting that outcomes measures need not be completely identical across studies and registries, but acknowledged that a core outcome construct would be beneficial. A related series of core measures and endpoints would solve many challenges.
Perfetto said that adding that these concepts would provide a common platform that would “help us to put our resources in the right place.”
The MDIC webinar also featured Jeff Farkas, senior director of health policy and payment for Dublin-based Medtronic plc, who noted that device makers see private payers as persistently hesitant to make use of RWE for coverage decisions. Gregory Daniel, head of U.S. health care policy at Edwards Lifesciences Corp., said RWE can also be used to support value-based program (VBP) design. Claims data are limited because they do not provide patient-reported outcomes, and discussed the use of electronic health records (EHRs).
Aronson wrapped up by reinforcing that payers and health plans are not wary of real-world evidence, citing their acceptance of these data in organ transplants dating back to the 1980s. However, there is a philosophical roadblock; payers see themselves as purchasers of care, and perceive evidence development as the sponsor’s responsibility. Any deviation from that approach is seen as a case of cost shifting, Aronson said.
To read more, visit https://www.bioworld.com/articles/496573-aronson-says-validated-outcome-measures-are-desperately-needed-for-clinical-evidence
(Source: McCarty M, BioWorld, August 6, 2020)