Focus is on Potential of Real-World Data to Support HTA Decisions
NEW YORK
Flatiron Health is presenting results from its research collaboration with the National Institute for Health and Care Excellence (NICE) at Virtual ISPOR Europe 2021.
In the study Exploring the Potential for EHR-Derived Real-World Data to Reduce Uncertainty in HTA Decision-Making: A Case Study of Long-Term Survival Outcomes, presented in an On-Demand Podium Session, researchers from Flatiron and NICE investigated how real-world data (RWD) may complement findings from clinical trials to reduce uncertainties in Health Technology Appraisal (HTA) decision-making. In this case, the investigators focused on an immunotherapy drug in advanced lung cancer to see if RWD could have been used to address uncertainty regarding long-term survival.
Leveraging Flatiron electronic-health-record (EHR)-derived data from approximately 70,000 U.S. patients with non-small cell lung cancer (NSCLC), the investigators identified a cohort of 1,109 patients with previously untreated, Stage IV NSCLC, with positive or unknown PDL1 status, who initiated first-line pembrolizumab monotherapy between October 2016 and December 2020. They also applied additional lab and ECOG eligibility criteria, using RWD to define a cohort that reflected as much as possible that of the clinical trial. Reported results showed a median real-world median overall survival of 13.8 months.
“This study examined one approach by which we may be able to augment clinical trial data to inform important decisions, such as clinical and cost effectiveness of new technologies and medicines,” said Michael Vasconcelles, MD, Chief Medical Officer and Head of the Medical and Scientific Organization at Flatiron. “I look forward to continuing our research collaboration with NICE to further our understanding of the optimal use of RWD in this regard.”
The three-year Flatiron-NICE research collaboration was launched in July 2020 to explore how RWD may inform the clinical and cost effectiveness of health technologies. Research presented in May at ISPOR 2021 looked at whether RWD available in the U.S. following approval by the Food and Drug Administration could inform NICE technology appraisals for the same medicine and proposed use.
Also at ISPOR Europe, on December 1, scientists from Flatiron, NICE and Roche will conduct a workshop, Policy and Statistical Issues in HTA Review of Histology-Independent Technologies (HIT) in Oncology, offering HTA and industry perspectives about research questions and evidence gaps in health information technology assessments.
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
