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.
(3 Min Read)
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 teams winning at value and access take a different approach. They build RWE strategy into development, long before their product generates any real-world data.
The distinction matters: you can't study your product in the real world until it exists there, but you can understand the real-world landscape it will enter. That intelligence shapes everything from trial design to launch readiness.
Here's what typically happens:
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.
The confusion around RWE timing comes from conflating two distinct applications:
Landscape RWE (Pre-Launch):
Understanding the real-world environment your product will enter:
This is available now and shapes trial design and launch strategy.
Product RWE (Post-Launch):
Understanding how your product performs:
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.
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:
2 - Identify:
Use this to shape trial endpoints and economic stories that will resonate with decision-makers at launch.
3 - Plan your product RWE infrastructure:
Data collection should start at launch, not six months later.
POST-LAUNCH: Defend and Expand
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:
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.
Real-world evidence becomes strategic when it informs decisions before they're made:
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.
Need help building a robust RWE strategy prior to launch?
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Betsy J. Lahue is CEO of Alkemi, where she helps life sciences companies solve acute value & access challenges and address emerging competitive threats. Her insights on market access and commercialization have guided successful launches across therapeutic areas.
Alkemi - HEOR & Market Access Consulting For Pharmaceutical & Life Sciences Companies
Alkemi helps Pharmaceutical, Biotech, and Medtech leaders:
→ Prove value with clarity and speed
→ Build robust evidence
→ Improve patient access to breakthrough medical treatments