How Payers Are Scrutinizing Endpoints and What Evidence Resonates Most in 2025
For decades, pharmaceutical market access conversations revolved around price. Could a manufacturer justify a premium? Would contracting or rebates secure preferred placement? In 2025, pricing is only one part of the story.
Payers are looking beyond price tags. They want confidence that a therapy’s value story holds up under scrutiny. That means endpoints, comparators, and evidence packages must align tightly with real-world expectations, or risk triggering skepticism that slows or blocks access.
Why Pricing Alone No Longer Wins
Pricing has always been a sensitive lever in negotiations. But as policy pressure mounts (think IRA and MFN), payer tolerance for price variance is thinner than ever. A premium price must be backed by credible, compelling evidence that demonstrates both clinical relevance and economic impact.
Payers are now asking:
- Do these endpoints reflect real-world patient outcomes, or just trial convenience?
- Is the comparator chosen realistic, or designed to overstate benefit?
- Does the data package address not only efficacy, but durability, adherence, and total cost of care?
Without clear answers, even well-priced therapies may hit coverage roadblocks.
The Shift Toward Value Story Validation
Value story validation is emerging as the critical checkpoint before access decisions are made. It’s no longer enough to build an internal narrative. Manufacturers must test their assumptions with payers directly, and adjust based on the feedback.
Key shifts we’re seeing in 2025:
- Endpoint scrutiny: Traditional measures are no longer taken at face value.
- PFS (Progression-Free Survival): A drug might show longer PFS, but if it doesn’t translate into overall survival, quality of life gains, or reduced healthcare utilization, payers may not view it as meaningful enough to justify a premium price.
- HbA1c (blood sugar control): A therapy might lower HbA1c, but if it doesn’t reduce complications, hospitalizations, or improve adherence, payers may question whether the clinical benefit is worth the cost.
- Comparator choice under the microscope: Using a weak comparator to “win” in trials is a red flag; payers want evidence against realistic market standards.
- Real-world relevance: Payers expect RWE or claims-linked data to complement trial results, showing how therapies perform outside controlled environments.
- Economic clarity: Evidence must support not only cost-effectiveness but budget impact, demonstrating why a therapy deserves space on the formulary.
What High-Performing Teams Do Differently
The most forward-thinking access teams are already embedding value story validation into their strategy. They:
- Engage payers early and often to test whether evidence priorities match payer expectations.
- Use iterative advisory models instead of one-off boards, so feedback evolves as policy and competitor landscapes shift.
- Integrate RWE and claims data to fill gaps between trial results and payer expectations.
- Build flexibility into their evidence plans, knowing that what payers want today may change tomorrow.
By validating in real time, these teams avoid costly late-stage surprises that can derail access, like misaligned endpoints or unconvincing comparators.
The Bottom Line
In 2025, price still matters. But payers are telling us that evidence matters more. Manufacturers who validate their value story to ensure endpoints, comparators, and evidence resonate with payer expectations are the ones best positioned to secure access.
The future of market access isn’t about generating more data. It’s about generating the right data, testing assumptions continuously, and proving value beyond the price tag.