Betsy's Note: Many companies wait until after launch to think about real-world evidence. By then, payers are already asking questions you can't answer. Physicians want data you don't have, and commissioning new studies means waiting 18 months while the launch clock ticks.

The Lifecycle Gap

Here's what typically happens:

• Clinical trials generate efficacy data in controlled populations.
• Marketing builds launch materials around those endpoints.
• Access teams prepare dossiers with trial-based economic models.

Then launch day arrives.

Payers ask: "How does this perform in our population?"

Physicians wonder: "What happens in the patients I actually see?"

Guidelines committees question: "Where's the long-term comparative data?"

Now you're scrambling because you didn't plan for these questions. You didn't set up data collection infrastructure, and you don't understand the landscape well enough to anticipate what evidence you would need.

So while your team figures out which databases to use and which protocols to write, competitors who planned ahead already have data flowing. You're 18 months behind where you should be.

Two Types of RWE Strategy

The confusion around RWE timing comes from conflating two distinct applications:

Landscape RWE (Pre-Launch):

Understanding the real-world environment your product will enter:

• Current disease burden
• Treatment patterns
• Care gaps
• Provider decision-making

This is available now and shapes trial design and launch strategy.

Product RWE (Post-Launch):

Understanding how your product performs:

• Utilization patterns
• Comparative effectiveness
• Long-term outcomes
• Economic impact

This requires your product to exist in the real world.

Many teams ignore landscape RWE until questions expose how little they know about the market they're entering.

Strategic Applications Across the Lifecycle

Here's the approach that works: Understand the landscape before launch, then track your product after it.

PRE-LAUNCH: Build the Foundation

1 - Map the:

• Current disease landscape
• Patient journey
• Care continuum breaks

2 - Identify:

• Real unmet needs
• Complications, delays, and disruptions that define daily life for patients and providers

Use this to shape trial endpoints and economic stories that will resonate with decision-makers at launch.

3 - Plan your product RWE infrastructure:

• Databases identified
• Protocols drafted
• Partnerships established

Data collection should start at launch, not six months later.

POST-LAUNCH: Defend and Expand

• Track utilization and comparative effectiveness.
• Update economic models with real-world data.
• Monitor for emerging opportunities, new responsive subgroups, under-recognized needs, potential new indications.
• Refresh value messages as market dynamics shift rather than defending outdated claims built purely on trial projections.

The Planning Problem

By the time many teams realize they need landscape intelligence, trial designs are locked. When teams recognize the need for product-level RWE, payers have already formed opinions based on incomplete information.

It's often not the team's fault.

Here's the problem:

Teams struggle to secure investment for preparation. They only get funding after a crisis emerges. RWE budgets arrive after payers push back, physicians express doubt, and the launch stumbles.

By then, you're paying premium rates to answer questions that proper planning would have anticipated.

The teams who break this cycle reframe the investment.

They position RWE as more than a single function's line item. They show how early RWE investment improves decisions across the organization:

• Medical Affairs gets landscape intelligence that informs trial endpoint selection.
• Commercial gets real-world unmet needs that shape positioning.
• Access gets infrastructure ready at launch to generate the comparative data payers will demand.

Framed this way, as strategic infrastructure that de-risks launch, the budget conversation changes.

This requires earlier cross-functional conversations where Medical, Commercial, and Access align on what evidence the market will expect versus what trials will easily provide. Teams must compare the cost of preparation against the cost of scrambling.

Decision Advantage

Real-world evidence becomes strategic when it informs decisions before they're made:

• Which endpoints to prioritize in trials.
• Which populations to study first.
• Which value messages will resonate with which stakeholders.
• Which access barriers to address proactively versus reactively.

The companies building this capability will defend premium pricing when biosimilars launch, expand into new indications faster, and maintain formulary position as markets tightens.

Everyone else will continue to commission RWE studies after problems emerge, wondering why their value story never lands.

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