— ICER adopts Aetion’s Real-World Evidence Platform — advancing standards for the use of transparent, replicable real-world evidence in health technology assessment —
NEW YORK and BOSTON, February 24, 2020 — Today, the Institute for Clinical and Economic Review (ICER) announced it has selected Aetion as a preferred partner and platform to generate decision-grade real-world evidence (RWE). The announcement comes on the heels of ICER’s commitment to expand use of RWE to complement other sources of information used in its value assessments, and it furthers ICER’s mission of catalyzing a movement toward fair pricing, fair access, and future innovation across the entire U.S. health system.
As the leading U.S. health technology assessment (HTA) body, ICER independently evaluates how well new medical interventions improve patients’ lives, and proposes benchmark prices that fairly align with each intervention’s added benefit to patients and the health system. In its updated 2020 Value Assessment Framework, ICER committed to generating new RWE for its assessment process, and to piloting a formal process for using RWE in 24-month re-evaluations of drugs approved by the FDA under accelerated approval pathways.
“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. “Aetion’s rapid-cycle analytics will enable us to quickly generate evidence with the needed rigor and transparency to include in our reviews. 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.”
As Aetion partners with global regulators and biopharma manufacturers to advance RWE standards, its technology will help inform where RWE can support ICER’s assessments. The partnership will advance methods and processes to generate relevant, decision-grade RWE, and ICER will use the Aetion Evidence Platform® to generate RWE for select upcoming assessments and 24-month re-evaluations. The protocols developed will be included in the assessments that ICER releases to the public, enabling other stakeholders to replicate the studies.
“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. “Integrating RWE into ICER’s assessments will advance how we as a health care industry — and a society — determine value. We commend ICER’s commitment to the expanded use of RWE in value assessments.”
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.