Over the last 20 years, US healthcare has shifted to a value-based system, with payers and healthcare providers being challenged to provide the best care at the lowest cost. Traditionally, physicians have tried to keep costs down using clinical trials’ results and limited data sets, but the complexity of real-world patient care now requires more sophisticated data to improve decision-making. As a result, real-world evidence (RWE) is coming to the fore, building a strong link between payers and healthcare providers and offering better patient care outcomes matched with more cost control.
RWE draws on diverse data sources, such as patient-generated data, public health records, clinical research and electronic health records (EHRs) to support healthcare decisions across the entire sector and is utilized by health care professionals, life science researchers, payers, policy makers and regulators, among others. The widespread use of digital health technologies, including wearables and apps, is also rapidly increasing real-time data collection.
According to GlobalData’s State of the Biopharmaceutical Industry 2025 (Mid-Year Update) there has been a substantial increase in the use of RWE over the last few years, with growth projected to continue. Regulatory bodies such as the FDA, the UK’s MHRA, and EU’s EMA, are playing a key role in accelerating the push for RWE within the sector, and in a survey by GlobalData, RWE was rated as the fifth most impactful industry trend for the next 12 months[i]. As demand grows for truly representative, long-term, real-world data, RWE is becoming ever more important in healthcare decision-making.
Key challenges and improved patient outcomes
RWE studies can be an effective way to increase efficiencies in processes such as clinical planning, participant recruitment and trial design, reducing timelines required to conduct clinical trials. However, when it comes to utilizing such vast amounts of data, the healthcare industry struggles, due to fragmented, siloed systems, non-standardized collection methods, and unstructured formats like free text and images. This lack of integration can hamper data sharing and vital analysis, limiting its usefulness.
Transforming real-world evidence into usable data involves leveraging AI and machine learning to extract valuable information, including physician notes and patient charts from EHRs. Companies like Veradigm streamline this process by combining data-driven clinical insights with advanced analytic tools. Veradigm’s system aggregates data from multiple EHR sources, including over 152 million patient records, ensuring standardized, high-integrity datasets.
Such datasets are utilized by various stakeholders, including biopharma researchers, to gain clinical insights from diverse patient populations. Government agencies, such as the FDA, use real-world data to assess whether treatments are effective and safe, and to identify unmet medical needs. Commercial biopharma teams leverage RWE to inform their market strategies, demonstrating how therapies perform outside clinical trials.
Closing a key knowledge gap for payers
As value-based reimbursement ties payment to outcomes, payers need evidence that a therapy improves real-world results across diverse populations, not just efficacy in highly selected, closely monitored trial cohorts. RWE supports payers’ treatment, coverage, and care-strategy decisions by showing how therapies actually perform once they move beyond clinical trials and into everyday practice. RWE – generated from sources such as EHRs – shows real-world effectiveness across broader demographics, comorbidities, and adherence patterns, helping payers understand which patients benefit, under what conditions, and how reliably those benefits show up in routine care.
When it comes to safety monitoring, RWE can also help payers assess real-world risks and benefits of therapies through post-marketing and longitudinal observation that extends beyond the limited timeframe and narrow eligibility criteria of clinical trials. EHR-derived insights also enable ongoing tracking of outcomes and early detection of adverse event signals across large populations, including older or more clinically complex patients, often underrepresented in trials but common in payer-covered populations. This closes a key knowledge gap for payers – whether the therapy’s benefit-risk profile holds up in real-world use, across care settings, and over time. With this visibility, payers can make more confident decisions.
Cost/benefit analysis
RWE allows payers to compare the effectiveness of different clinical practices and treatment pathways in real-world care by linking treatment choices to downstream utilization, readmissions, chronic disease management performance, and patient experience. It also helps reduce care variability by highlighting what works consistently in practice and supporting approaches that direct higher-intensity interventions to patients that need them most.
When payers can verify outcomes and identify which patients are most likely to benefit, they can negotiate value-based contracts and refine formulary positioning to prioritize therapies that deliver demonstrable real-world value. The result is better informed coverage and reimbursement decisions that reduce ineffective spending, prevent avoidable adverse events and complications, and keep total costs down by steering utilization toward treatments and clinical practices that are proven to improve outcomes out in the real world.
Introducing the Veradigm Network
Positioned at the intersection of providers, payers, and life sciences, Veradigm delivers access to large-scale, longitudinal EHR-derived data and analytics that support value-based care goals of improving outcomes while controlling costs.
The Veradigm Network enables timely data sharing and communication, including EHR alerts and clinical insights directly within provider workflows, helping clinicians respond to patient-specific needs in real time. These alerts can highlight relevant considerations such as comorbidities, therapy monitoring needs, adherence risks, or missed follow-ups, making gaps in care easier to identify and close. By reducing care fragmentation and supporting more coordinated, data-driven interventions, the Veradigm Network helps align payer and provider decisions.
For more on how Veradigm can help with your real-world data, download the free paper below.
[i] GlobalData: The State of the Biopharmaceutical Industry, 2025 (Mid-Year Update) Edition; Survey: The Most Impactful Emerging Industry Trends.
