Aetion and NICE announce collaboration to explore use of real-world evidence for comparative effectiveness studies to inform clinical guidance
Collaboration will leverage the Aetion Evidence Platform® to study when and how RWE can support the agency’s decision-making
NEW YORK, NY & MANCHESTER, ENGLAND, October 6, 2021 — Aetion today announced a collaboration with the National Institute for Health and Care Excellence (NICE) to explore how real-world evidence (RWE) can be used to study real-world clinical effectiveness. The collaboration aims to evaluate how RWE studies can be used to fill evidence gaps and reduce uncertainties in NICE guidance development. In addition, the agency will evaluate the appropriate timing post-launch to conduct RWE studies on comparative effectiveness, and pilot tools for planning and reporting on the implementation of RWE studies.
“We are honored to help NICE further advance evidence-based decision-making,” said Carolyn Magill, CEO of Aetion. “Through the scientific rigor embedded in the Aetion Evidence Platform, NICE can more easily integrate high quality RWE into decisions ranging from health technology assessments to clinical guidance development.”
Global regulatory and health technology assessment (HTA) bodies are increasingly using RWE to answer questions on the utilization, safety, and effectiveness of medical treatments and technologies. In April 2021, representatives from NICE, the EMA, and Aetion co-published a paper in the Journal of Comparative Effectiveness Research detailing a structure for organizing the current fragmented RWE recommendations in order to achieve comprehensive guidance.
This collaboration marks Aetion’s first partnership with an international HTA body, and comes on the heels of the company’s research collaboration agreement with the U.S. FDA to use real-world data to study COVID-19, and the company’s selection by the Institute for Clinical and Economic Review as its preferred RWE partner and platform.
“As NICE continues to deliver on our five-year strategic vision, including rapid, robust, and responsive technology evaluation, understanding how to make the best use of RWE is vital in helping us resolve gaps in knowledge and driving forward access to innovations for patients,” said Páll Jónsson, Programme Director – Data, who is leading the collaboration for NICE.
The collaboration will leverage NICE’s leadership in developing evidence-based technology appraisals and clinical guidelines as well as Aetion’s expertise in generating decision-grade RWE. Aetion and NICE will make use of Cegedim Health Data’s The Health Improvement Network® (THIN®) database to power analyses on the Aetion Evidence Platform®.
Aetion is a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) designated research center, and contributes to the ENCePP Working Group 3, whose focus is to inventory EU data sources and define methodological approaches for multi-source studies.
Aetion is a health care analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs health care’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation.
Aetion is based in New York City and backed by investors including New Enterprise Associates (NEA), Warburg Pincus, Flare Capital Partners, Greenspring Associates, Lakestar, B Capital, Foresite Capital, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, EDBI, Johnson & Johnson Innovation—JJDC, Inc., UCB, Amgen Ventures, and Horizon Health Services, Inc. Learn more at aetion.com and follow us at @aetioninc.
NICE’s central role is to improve outcomes for people using England’s National Health Service and other public health and social care services. NICE produces evidence-based guidance and advice for health, public health, and social care practitioners. NICE develops quality standards and performance metrics for those providing and commissioning health, public health and social care services and provides a range of information services for commissioners, practitioners and managers across health and social care. For more information, see www.nice.org.uk or follow @NICEcomms.