CER Daily Newsfeed

Using Real-World Evidence to Improve Healthcare Decision Making

(July/August 2025, Rob Abbott, ISPOR: Value & Outcomes Spotlight) comments “...I also want to call out the Real-World Evidence Transparency Initiative Partnership, a joint collaboration and ongoing effort between ISPOR, ISPE, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council. The objective of this initiative is to establish a culture of transparency for study analysis and reporting of hypotheses evaluating RWE studies on treatment effects. An important output of the Transparency Initiative is the Real-World Evidence Registry, a fit-for-purpose platform that enables researchers to register their study designs before they begin work to facilitate the transparency needed to elevate the trust in the study results.” Full

Setting a New Pace: Real-World Evidence is Finding Its Footing in HEOR

(July/August 2025, Beth Fand Incollingo, ISPOR: Value & Outcomes Spotlight) reports “...[Mark McClellan, MD, PhD], who served as former commissioner of both the FDA and the Centers for Medicare & Medicaid Services (CMS), noted that ‘there’s a lot going on at CMS around advancing real-world data interoperability to support better patient-care decisions, such as protocols to slow the progression of diabetes or coronary artery disease.’ He added that the FDA can turn to RWE18 to resolve critical epidemiology questions, such as which subpopulations should be eligible to receive specific vaccines.” Full

Duke-Margolis 2025 RWE Policy Series: Integrating Research into Care and Advancing Payer-Focused Evidence Frameworks

(8/18, Katie McCool, The Evidence Base) reports “...On aligning RWE with timely coverage decisions, Jaksa called for stakeholders to ‘come together to figure out… what evidence gaps can we quickly knock out,’ while [AMCP’s Cate Lockhart] suggested creating alerts for payers when ‘there’s some new evidence… that might be useful for you.’ [CMMI’s Kate Davidson] pointed to leveraging patient-generated health data to ‘provide patients with… shared decision making with the providers’ and align incentives between patients and providers.” Full

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review: Industry Groups Call For Changes

(8/18, Lisa Takagi, Pink Sheet) reports “...While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.” Subscription Required

Using Real-World Evidence to Improve Healthcare Decision Making

(July/August 2025, Rob Abbott, ISPOR: Value & Outcomes Spotlight) comments “...I also want to call out the Real-World Evidence Transparency Initiative Partnership, a joint collaboration and ongoing effort between ISPOR, ISPE, the Duke-Margolis Center for Health Policy, and the National Pharmaceutical Council. The objective of this initiative is to establish a culture of transparency for study analysis and reporting of hypotheses evaluating RWE studies on treatment effects. An important output of the Transparency Initiative is the Real-World Evidence Registry, a fit-for-purpose platform that enables researchers to register their study designs before they begin work to facilitate the transparency needed to elevate the trust in the study results.” Full

Setting a New Pace: Real-World Evidence is Finding Its Footing in HEOR

(July/August 2025, Beth Fand Incollingo, ISPOR: Value & Outcomes Spotlight) reports “...[Mark McClellan, MD, PhD], who served as former commissioner of both the FDA and the Centers for Medicare & Medicaid Services (CMS), noted that ‘there’s a lot going on at CMS around advancing real-world data interoperability to support better patient-care decisions, such as protocols to slow the progression of diabetes or coronary artery disease.’ He added that the FDA can turn to RWE18 to resolve critical epidemiology questions, such as which subpopulations should be eligible to receive specific vaccines.” Full

Duke-Margolis 2025 RWE Policy Series: Integrating Research into Care and Advancing Payer-Focused Evidence Frameworks

(8/18, Katie McCool, The Evidence Base) reports “...On aligning RWE with timely coverage decisions, Jaksa called for stakeholders to ‘come together to figure out… what evidence gaps can we quickly knock out,’ while [AMCP’s Cate Lockhart] suggested creating alerts for payers when ‘there’s some new evidence… that might be useful for you.’ [CMMI’s Kate Davidson] pointed to leveraging patient-generated health data to ‘provide patients with… shared decision making with the providers’ and align incentives between patients and providers.” Full

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review: Industry Groups Call For Changes

(8/18, Lisa Takagi, Pink Sheet) reports “...While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.” Subscription Required