Real-World Evidence in Action: Assessing Drug-Drug Interactions to Drive Value-Based Decisions
Author(s)
Nadia Quignot, PhD1, Erika Braithwaite, PhD2, Isabelle Ragueneau-Majlessi, MD, MS3.
1Senior Director, Certara France, Paris, France, 2Certara LP – Sucursal em Portugal, Funchal, Portugal, 3Certara USA, Seattle, WA, USA.
1Senior Director, Certara France, Paris, France, 2Certara LP – Sucursal em Portugal, Funchal, Portugal, 3Certara USA, Seattle, WA, USA.
OBJECTIVES: Drug-drug interactions (DDIs) - in which one medication alters the effect of another - can lead to adverse drug events, reduced efficacy and increased healthcare costs. However, because most evidence for DDIs is derived from early-phase studies and case reports, their complexity and prevalence in diverse, real-world populations are often not well characterized. Real-world evidence (RWE) can better quantify the true impact of DDIs, offering actionable insights for clinicians and decision-makers. This study explores how RWE can support formulary choices, clinical decision tool design, and value-based contracting to enhance patient safety and resource optimization.
METHODS: We conducted a targeted review of case studies and real-world use cases where RWE has been applied to assess DDIs for value-based healthcare. Methodological approaches for selected use cases were critically analyzed, focusing on how RWE is integrated into decision-making frameworks, such as risk-scoring tools and population-level predictive models. Each case was evaluated for its impact on clinical or economic outcomes, including payer strategies and formulary management.
RESULTS: Although various tools and frameworks are emerging, there is no standardized approach for applying RWE in DDI risk prediction or formulary decision-making. Case examples showed that integrating RWE can help payers identify high-risk patient populations, restrict high-risk drug combinations, and implement effective clinical decision support tools. Moreover, RWE can support regulatory and guideline updates, contributing to evidence-based recommendations that reflect real-world practice.
CONCLUSIONS: Given the global rise in polypharmacy which heightens the risk of DDIs, this review underscores the urgent need for RWE to guide safer, more informed medication use. Using RWE to assess DDIs can bridge the gap between clinical trials and everyday practice, enhancing prescribing safety, reducing avoidable costs, and enabling more precise, patient-centered care. Future efforts should aim to harmonize RWE methods and strengthen collaboration across stakeholders to better leverage real-world data for safer, more effective healthcare.
METHODS: We conducted a targeted review of case studies and real-world use cases where RWE has been applied to assess DDIs for value-based healthcare. Methodological approaches for selected use cases were critically analyzed, focusing on how RWE is integrated into decision-making frameworks, such as risk-scoring tools and population-level predictive models. Each case was evaluated for its impact on clinical or economic outcomes, including payer strategies and formulary management.
RESULTS: Although various tools and frameworks are emerging, there is no standardized approach for applying RWE in DDI risk prediction or formulary decision-making. Case examples showed that integrating RWE can help payers identify high-risk patient populations, restrict high-risk drug combinations, and implement effective clinical decision support tools. Moreover, RWE can support regulatory and guideline updates, contributing to evidence-based recommendations that reflect real-world practice.
CONCLUSIONS: Given the global rise in polypharmacy which heightens the risk of DDIs, this review underscores the urgent need for RWE to guide safer, more informed medication use. Using RWE to assess DDIs can bridge the gap between clinical trials and everyday practice, enhancing prescribing safety, reducing avoidable costs, and enabling more precise, patient-centered care. Future efforts should aim to harmonize RWE methods and strengthen collaboration across stakeholders to better leverage real-world data for safer, more effective healthcare.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD153
Topic
Real World Data & Information Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Personalized & Precision Medicine