In an Uncertain Policy Environment, Pharma Needs Timely Real-World Data More Than Ever

In today’s volatile healthcare landscape, Medicaid cuts, Inflation Reduction Act provisions, and shifting CDC recommendations are reshaping who gets access to which therapies and when. As a result, pharma companies are scrambling to understand how policy changes affect patient access, treatment utilization, and patient outcomes. But is staying abreast of these constant changes even possible? And if so, how?

The answer—in a nutshell—is timely access to real-world data (RWD), which doesn’t just inform policy responses, it empowers life sciences organizations to track, anticipate, and shape patient outcomes in real time. Here’s how:

RWD illuminates how policy shifts affect patient behavior

Government policy is among the most powerful drivers of treatment access in the US. For instance, when the CDC recommends a new vaccine and Medicare or Medicaid picks up the tab, patient adoption can spike. But the reverse is also true: If coverage is withdrawn, patients stop using those treatments, potentially jeopardizing their health. Without timely data, pharma companies can’t see these shifts until long after the consequences have happened.

Take, for example, the evolving story around adult RSV vaccinations. In our study, titled “Hospitalization Risk Among U.S. Adults Receiving Respiratory Syncytial Virus Vaccines,” our team found that patients vaccinated in 2024 had more pre-existing respiratory conditions compared to those in 2023. Findings like these help pharma teams adjust strategies, refine targeting, and ensure the right patients are getting the right care when it matters most.

Another powerful example of the value of RWD comes from our second study, “Impact of Medicaid Enrollment Provisions on Postpartum Coverage and Resource Use in Three US States,” which was presented at ISPOR 2025, the annual conference for the International Society for Pharmacoeconomics and Outcomes Research. In it, we examined postpartum Medicaid coverage across Georgia, Florida, and South Carolina—three states that did not expand Medicaid under the Affordable Care Act.

Historically, pregnancy-related Medicaid coverage lasted only 60 days postpartum, leaving mothers vulnerable during a critical window: nearly half of maternal deaths occur in the first year after childbirth, according to the CDC.

The study assessed the impact of two federal provisions that extended postpartum Medicaid coverage in these states. We found that 96% of mothers in the dataset retained coverage for at least six months—a strong indication that policy was working as intended. Yet, the data also revealed something more nuanced: Although coverage increased, newly covered patients had fewer preventive office visits. This raised urgent follow-up questions: Were these patients healthier, or were barriers like transportation or health literacy preventing patients from seeking care?

Our study shows the need not just for comprehensive data, but also for timely data. Mortality, hospitalization, and preventable complications don’t wait for year-old data to be analyzed. In this case, the ability to assess coverage, utilization, and health outcomes in near-real-time could give health systems and pharma alike the ability to intervene faster and more effectively, potentially resulting in better outcomes for these patients.

RWD provides a strategic advantage

For pharma companies, the stakes are high. Policy changes—whether driven by congress, CMS, or state legislatures—can open or close doors to access in an instant. Companies need to understand not just how many patients were affected, but how those changes influenced treatment patterns, adherence, and clinical outcomes. This is where timely RWD is so valuable.

In the context of the Inflation Reduction Act, for example, RWD can help identify patients who can no longer afford medications like those for atrial fibrillation. Many negotiations around pricing and access require evidence beyond the clinical trial, particularly because the treatments that are targeted the most are those that have been on the market for years. The only way to compare a treatment against new competitors that were not originally in your clinical trial is to use RWD. Real-world data expands findings beyond the clinical trial setting, therefore helping pharma companies with pricing and access negotiations.

By surfacing these insights quickly, pharma companies could support policy advocacy, adjust access strategies, and engage healthcare providers with real-time evidence of patient need.

RWD offers a more complete—and timely—view of the patient journey

What makes today’s RWD especially powerful is its breadth. Traditional claims and lab data, while valuable, often miss the nuances captured in clinical notes or physician observations—especially in rare diseases or niche subpopulations. That’s why combining structured data with unstructured electronic medical record data is so critical.

Consider a rare condition without a defined ICD-10 code. Historically, these patients would be invisible to claims-based studies. But with unstructured data, pharma teams can identify key terms, symptoms, or treatment notes that signal the presence of the disease—opening doors for targeted research, patient support, and treatment development.

Moreover, even common diseases like diabetes are now viewed through a more segmented lens. Instead of studying "all patients with diabetes," pharma companies are using RWD to explore how specific subpopulations—defined by comorbidities, social determinants, or genetic factors—respond to specific therapies. The result is more personalized, precise evidence that supports better care and smarter commercialization strategies.

Timely RWD is no longer a luxury—it’s a necessity

Ultimately, every condition is a rare condition when viewed through the lens of an individual patient. In the wake of shifting government coverage policies, pharma companies can no longer rely on outdated or incomplete data to make access and treatment decisions.

As government policies continue to evolve, the companies best equipped to respond won’t be those with the most data—they’ll be the ones with the right data, at the right time, with the tools to act on it. That’s the future of RWD. And in an uncertain policy environment, it’s pharma’s most important advantage.

Mike Munsell, PhD, Director, RWD HEOR at Panalgo, a Norstella company