CER Daily Newsfeed

Reflections from the ISPOR RWE Summit 2025: Laura Pizzi on the Future of Real-World Evidence

(10/15, The Evidence Base) reports “...[Laura Pizzi, ISPOR Chief Science Officer:] The main tools we need to leverage RWE already exist. These include data-quality checklists, protocol templates (e.g., the HARPER template), and protocol registries for pre-specification of study plans such as the RWE protocol registry hosted by ISPOR, which is free and publicly available. Regarding AI, there’s still a lack of tools guiding its use, at least for producing decision-grade analyses that meet regulator or HTA standards. Best practices on how to validate AI output are needed, with ongoing work in this area to compare AI output using different LLM platforms or with human checks at certain points in the research process.” Full

Pharma’s Real-World Data Dilemma: Strategic Asset or Wasted Resource?

(10/13, Ilan Behm and Ted Search, Biopharma Dive) comments “...In the end, the true value of real-world data lies not in its sheer volume but in how effectively it is transformed into actionable evidence. By setting clear objectives, prioritizing strategy over data abundance, and layering analytics with clinical expertise, pharma companies can unlock the full potential of RWD to accelerate development, improve market access, and deliver better outcomes for patients. Those who take a thoughtful, strategy-first approach will not only avoid costly inefficiencies, but also gain a competitive edge in an increasingly data-driven healthcare landscape.” Full

From QALYs to Equal Value Life Years: Is Anyone Making the Shift?

(10/15, Antony P. Martin and Peter J. Neumann, Center for the Evaluation of Value and Risk in Health) comments “...We conducted a PubMed search as of October 6, 2025 to evaluate the question. We used the search terms ‘evLY’ and ‘QALY,’ restricting the search to studies focused on United States populations and settings. Our search found only 60 results referencing evLY since 2020, compared to over 3,568 results for QALYs or about 1.7% of the total. A separate preliminary search of published US-based cost-effectiveness analyses yielded only three results between 2020-2023, compared to 1,332 cost/QALY studies in the same period...Is the evLY destined to remain in the shadow of the QALY? Time will tell. But for now and seemingly into at least the near future, QALYs seem destined to remain the dominant summary measure used globally for assessing preferences in cost-effectiveness analyses.” Full