‍Betsy's Note: RWE is not one thing. Landscape and Product RWE have distinct purposes, distinct timelines, and need to be planned accordingly.

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EXECUTIVE SUMMARY

Real-world evidence falls into two categories. Landscape RWE describes the disease environment a product is entering. Product RWE captures how that product performs once it is in the market. Planning for both begins during clinical development.

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Landscape RWE

Landscape RWE is evidence about the disease, the patient population, and the current standard of care. It has nothing to do with the product itself.

It addresses questions such as:

• How are patients currently diagnosed and treated?
• Where do they fall out of the care pathway?
• What does this disease cost the healthcare system in hospitalizations, readmissions, and lost productivity?
• What unmet needs exist that current treatments do not address?

This work does not require regulatory approval. It can begin during Phase II and III, years before launch. Payers and HTA bodies evaluate new therapies against the existing standard of care, and a manufacturer that has characterized that baseline with its own data is better positioned in those conversations than one relying solely on published literature.

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Product RWE

Product RWE captures how a therapy performs in routine clinical practice, in patient populations broader than those enrolled in a pivotal trial, over time horizons a clinical study cannot reach.

It addresses questions such as:

• How does the therapy perform in patients who would not have qualified for the trial?
• What do outcomes look like at year two or three?
• What happens to hospitalizations and total cost of care?
• Are there subgroups that respond in ways the trial did not reveal?

Generating this evidence requires a product that is actively being prescribed. It cannot exist before launch. The data infrastructure needed to capture it, however - registries, data partnerships, outcome tracking systems - must be established before launch. Real-world data from the first months of commercialization cannot be recovered retroactively.

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How They Work Together

Landscape RWE establishes the disease burden, characterizes unmet need, and can set the evidentiary baseline payers will reference when evaluating a new therapy. Product RWE then demonstrates how the therapy performs against that baseline in the real world, and supports access through formulary renewals, HTA submissions, and outcomes-based contracts.

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Planning Checkpoint

Before launch, two things should be in place.

First, a complete landscape: current documentation of disease burden, treatment patterns, and care pathway gaps.

Second, product RWE infrastructure ready to run on day one: data partnerships signed, registry design finalized, outcome measurement systems operational before the first commercial prescription is written.

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Betsy J. Lahue is CEO of Alkemi, a life sciences consulting firm specializing in HEOR, Market Access, and Market Shaping.

Alkemi has contributed to launches representing tens of billions in global sales and partners with life sciences executives to build evidence, value and access strategies that translate clinical innovation into real-world adoption. To discuss your program, contact us at www.alkemihealth.com/contact