ICER, Aetion to Boost Real-World Evidence for Clinical Trials

February 28, 2020 - ICER adopts Aetion’s platform to advance standards for how real-world evidence can inform decision making for clinical trials and enhance overall patient care. 

The Institute for Clinical and Economic Review (ICER) announced this week that it has partnered with Aetion to generate decision-grade real-world evidence (RWE).

The partnership will further ICER’s efforts to expand the use of real-world evidence to complement other sources of information used in its value assessments and enhance its goal to see fair pricing, access, and future innovation across the US health system. 

“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 Pamela Bradt, MD, MPH, ICER’s chief scientific officer.

ICER, the leading US health technology assessment (HTA), evaluates how well new medical interventions boost patients’ lives and create benchmark pricing that aligns with each intervention’s added benefit to patients and the health system, the announcement stated.

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

Aetion’s technology and platform will help support ICER’s 2020 Value Assessment Framework where ICER highlights its efforts to generate real-world evidence that can support its assessment process and boost the 24-month re-evaluations of drugs approved by the FDA under 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. “Integrating RWE into CER’s assessments will advance how we as a healthcare industry, and a society, determine value. We commend ICER’s commitment to the expanded use of RWE in value assessments. 

Real-world evidence is important because it is data obtained during routine clinical practices. The evidence allows researchers to expand decision making and uncover how to better develop care therapies for patients in need. 

The FDA mentioned ways the healthcare space is utilizing real-world data including to monitor postmarket safety and make regulatory decisions, support coverage decisions, develop decision support tools for clinical practices, and support clinical trial designs. 

In August 2019, the FDA Oncology Center for Excellence (OCE) and Syapse signed a multi-year Research Collaboration Agreement (RCA) to use real-world evidence in cancer care.

The partnership intended to work with stakeholders to address important regulatory questions regarding testing and treating patterns, dosing and safety, and outcomes in oncology, focusing on precision medicine. 

The FDA and Syapse will attempt to receive real-world evidence from multiple sources such as clinical data from EHRs and molecular data from testing labs. 

“Advances in real-world evidence presents an opportunity to learn from patients and potentially translate those insights into safer and more effective therapies,” said Sean Khozin, MD, MPH, associate director for oncology regulatory science and informatics in the FDA’s Oncology Center of Excellence. 

Former FDA Commissioner Scott Gottlieb emphasized the importance of using real-world data to advance healthcare during a speech to the Bipartisan Policy Center early last year. 

“RWD is transformed into evidence using transparent data standards so that more of this data can be used to generate the evidence that the agency needs to improve regulatory decision making. Advancing RWD into regulatory-quality real-world evidence is a key strategic priority for the FDA,” he said.