December 12, 2025

When RWE Actually Starts (Hint: Not at Launch)

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Betsy J. Lahue
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When RWE Actually Starts

(Hint: Not at Launch)

Everyone thinks they understand RWE.

But that's because our industry built the wrong mental model for it.

For years, RWE has been treated as a post-launch activity, something you collect once the treatment is on the market.

And that idea has quietly held teams back.

THE BAND-AID APPROACH

When your first real-world study starts after launch, you're reacting, not shaping decisions.

RWE becomes a band-aid: patching holes in the value story, explaining trial gaps, "fixing" objections that were predictable.

But smart teams don't use RWE that way.

They use it before launch to reveal burden, map care patterns, and define unmet need.

They use it during launch to understand early adoption and refine engagement.

They use it after launch to defend value, strengthen submissions, and spot new opportunities.

They treat RWE as a strategy, not a post-launch activity.

THE REAL PROBLEM

The outdated belief that RWE begins after approval.

The future belongs to companies who see RWE as a strategy decision-making advantage that starts early, compounds over time, and shapes the entire access trajectory.

If you want access to move faster, RWE has to start sooner.

10 WAYS TO USE RWE ACROSS THE PRODUCT LIFECYCLE

PRE-LAUNCH

1. Assess Disease Landscape

  • Understand clinical and economic burden
  • Account for the 2-year lag in published evidence
  • Use real-time data for population insights

2. Map Epidemiology & Patient Funnel Inputs

  • Identify incident and prevalent populations
  • Understand treatment patterns, leakage, unmet need

3. Uncover Unmet Patient Needs

  • Locate breakdowns in the symptoms → diagnosis → treatment pathway
  • Identify delays, complications, structural gaps

4. Identify Unmet Provider Needs

  • Know who manages patients and how they get there
  • Surface provider beliefs that drive or block adoption

5. Detect Care Linkage Gaps

  • Map patient barriers and care gaps
  • Integrate qualitative and quantitative insights

DURING & POST-LAUNCH

6. Track Utilization & Comparative Effectiveness

  • Monitor prescribing, adherence, real-world outcomes
  • Compare real-world performance vs. trial results

7. Strengthen Access Negotiations & Value Submissions

  • Tailor HTA and P&T submissions with fresh data
  • Update health economic models with current utilization and outcomes
  • Influence guidelines and policy discussions

8. Refresh Field Tools & Publications

  • Keep payer tools aligned with evolving evidence
  • Publish long-term outcomes and comparative data

9. Build an Early-Warning System

  • Spot emerging signals in subgroups and practice patterns
  • Explore new indications or unmet needs early

10. Guide Life Cycle & Asset Management

  • Refine positioning with longitudinal evidence
  • Inform Commercial teams on shifting opportunities

EARLY INVESTMENT VS. LATE REGRET

Many companies still wait until they have a problem to invest in RWE.

Smart teams invest before they need to.

Because by the time you're scrambling to patch evidence gaps post-launch, you've already lost months, maybe years, of market momentum.

RWE helps you understanding the world your product enters, the barriers it will face, and the opportunities it can create.

That insight compounds. But only if you start early.

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Want to rethink how you're using RWE?

Let's talk about building a strategy that starts sooner and shapes access faster.

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