Moving the Needle: Value and Use of Real-World Evidence in Oncology Clinical Pathways Decision-Making
Author(s)
Phoenix J. Riley, PharmD, MSc1, Caitlyn SOLEM, PhD, MS2, Sumati Rao, PhD, MS2, Susan Hogue, PharmD, RPh, MPH1.
1AESARA Inc., Chapel Hill, NC, USA, 2GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC, USA.
1AESARA Inc., Chapel Hill, NC, USA, 2GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC, USA.
OBJECTIVES: Oncology presents unique challenges with limited time frames to demonstrate therapeutic value. This research investigates the role of real-world evidence (RWE) in complementing traditional randomized controlled trials (RCTs) to inform clinical decision support (CDS) and payer strategies, ultimately driving more patient-centric care and value-based decision-making.
METHODS: An advisory board of eight US oncology clinical-decision makers was conducted to understand RWE utilization in oncology pathways. A formal gap analysis assessing actionable data needs, stakeholder confidence in RWE, and dissemination strategies to inform pathways and CDS was presented to participants. Emphasis was placed on RWE role in validating clinical trial findings, addressing critical patient-centric outcomes, and optimizing pathways.
RESULTS: Advisors (3 medical directors, 4 pharmacy directors, 1 consultant) agreed RWE has significant potential to reshape oncology decision-making when it directly informs actionable outcomes, validates treatment effectiveness beyond clinical trials, and considers patient experiences and financial impacts. Challenges persist, including inconsistent interpretations of RWE potential, non-standardized research prioritization, and a lack of practical application frameworks. To overcome these hurdles, advisors identified promising opportunities through strategic partnerships (i.e., pharmaceutical companies and health plans). While all agreed these collaborations can strengthen evidence generation, enhance quality measure understanding, and create more robust data collection, most agreed these measures were not currently implemented. This integrated approach suggests RWE faces implementation hurdles; coordinated efforts among stakeholders could substantially enhance its practical utility in healthcare decision-making.
CONCLUSIONS: There is a critical need for more nuanced, collaborative approaches to RWE in oncology. By prioritizing actionable, patient-centered outcomes, fostering strategic partnerships, and addressing implementation challenges, RWE can significantly enhance the quality of CDS. This underscores a call to action for oncology stakeholders: leveraging RWE is an opportunity and an imperative to optimize treatment pathways, improve payer alignment, deliver superior patient outcomes, and enhance patient care in the evolving oncology landscape.
METHODS: An advisory board of eight US oncology clinical-decision makers was conducted to understand RWE utilization in oncology pathways. A formal gap analysis assessing actionable data needs, stakeholder confidence in RWE, and dissemination strategies to inform pathways and CDS was presented to participants. Emphasis was placed on RWE role in validating clinical trial findings, addressing critical patient-centric outcomes, and optimizing pathways.
RESULTS: Advisors (3 medical directors, 4 pharmacy directors, 1 consultant) agreed RWE has significant potential to reshape oncology decision-making when it directly informs actionable outcomes, validates treatment effectiveness beyond clinical trials, and considers patient experiences and financial impacts. Challenges persist, including inconsistent interpretations of RWE potential, non-standardized research prioritization, and a lack of practical application frameworks. To overcome these hurdles, advisors identified promising opportunities through strategic partnerships (i.e., pharmaceutical companies and health plans). While all agreed these collaborations can strengthen evidence generation, enhance quality measure understanding, and create more robust data collection, most agreed these measures were not currently implemented. This integrated approach suggests RWE faces implementation hurdles; coordinated efforts among stakeholders could substantially enhance its practical utility in healthcare decision-making.
CONCLUSIONS: There is a critical need for more nuanced, collaborative approaches to RWE in oncology. By prioritizing actionable, patient-centered outcomes, fostering strategic partnerships, and addressing implementation challenges, RWE can significantly enhance the quality of CDS. This underscores a call to action for oncology stakeholders: leveraging RWE is an opportunity and an imperative to optimize treatment pathways, improve payer alignment, deliver superior patient outcomes, and enhance patient care in the evolving oncology landscape.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR24
Topic
Health Policy & Regulatory
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Reimbursement & Access Policy
Disease
SDC: Oncology