ICER Partners With Aetion, Expands Use of Real-World Evidence

The Institute for Clinical and Economic Review (ICER) announced a new partnership with health care technology company Aetion in a continued effort to expand its use of real-world evidence (RWE) in patient data.

Aetion’s platform will enable ICER to generate decision-grade RWE while advancing standards for the use of transparent, replicable RWE in health technology assessment.

This partnership comes at a time when the FDA and other global entities are considering the use of data gathered outside of clinical trials pertaining to the effectiveness of treatments. Under the 21st Century Cures Act, the FDA is using Aetion technology to analyze insurance claims in an effort to replicate clinical trial results and determine certain situations in which RWE would suffice in replacing clinical trials, reported Reuters.

“ICER has long sought data generated outside clinical trials to enhance our understanding of how medical treatments perform in the real world,” said Pamela Bradt, MD, MPH, ICER’s chief scientific officer in a press release. “Aetion’s rapid-cycle analytics will enable us to quickly generate evidence with the needed rigor and transparency to include in our reviews.

ICER recently committed in 2020 to generating new RWE for assessment processes, as well as pilot formal processes for 24-month re-evaluations of drugs approved by the FDA under accelerated approval pathways.

“While the use of RWE in health technology assessment is not new, improved methods and tools are fueling increased adoption,” said Carolyn Magill, CEO of Aetion in a press release. “Integrating RWE into ICER’s assessments will advance how we as a health care industry—and a society—determine value.”

Aetion has experience partnering with global regulators and biopharma manufacturers, making this partnership more insightful for ICER. The protocols developed through the partnership will be included in the assessments that ICER releases to the public, enabling other stakeholders to replicate the studies.

“Through this partnership we aim to set new standards for how RWE can better inform the consequential decisions that biopharma manufacturers, insurers, and other stakeholders make every single day around drug pricing and patient access,” said Dr Bradt. —Edan Stanley