Payer Research: A Strategic Driver of ROI Across the Lifecycle
From early development to post-launch, payer-informed research anticipates barriers, supports decisions, and protects—and grows—ROI.
Meeting FDA requirements is table stakes. The challenge is generating the right evidence for payer decision-making—durability, meaningful comparators, and total cost-of-care impact. Early, transparent engagement helps ensure studies address both clinical and economic needs and bridge the gap between approval and reimbursement.
That theme ran through Magnolia Market Access’ September 25 webinar, How to Get the Biggest ROI on Research? Applying Market Access Insights Throughout the Product Lifecycle. Payer leaders Dr. Maria Lopes, Chief Medical Officer at a national PBM, and Mr. Mike Margevicius, Pharmacy Director at a large national health plan, joined our payer market research team to discuss how manufacturers can shape research, so it resonates with coverage and reimbursement decisions. Their discussion surfaced practical steps manufacturers can act on. Best practices emphasized the right methodology (qual + quant), the right stakeholders, the right timing, and the right evidence.
Timing is Everything
Payer input should not be a one-and-done step. Early conversations help shape comparators and endpoints; in Phase 3 and pre-launch, payer feedback pressure-tests value messages, likely utilization management (UM), and contracting scenarios; post-launch, you track reactions and adjust as new data, competitors, and policies land. Treat timing as an iterative process across the lifecycle—early development, Phase 2–3, pre-launch, launch, and post-launch.
Plans also have a realistic planning horizon. As Mr. Margeviciusput it, “Phase 3 or late Phase 3 is probably the right range.” Health plans lean in when a product is inside the next 6–18 months and likely to move spend. Earlier touchpoints are useful for direction, but they won’t replace that near-term focus. Plans revisit as data, competitors, and policies evolve—engagement shouldn’t be a one-time event.
A practical tip as you approach Prescription Drug User Fee Act (PDUFA) timing: ground the conversation in the size of the plan’s problem. Dr. Lopes noted best-practice decks that pull ICD-10 codes to estimate exposure and per-member-per-month (PMPM) impact—helping a plan see why this matters now. A mixed-methods approach (ad boards/interviews and surveys/discrete-choice) produces more decision-grade payer insight than a single method alone.
Endpoints that Matter to Coverage
Here’s the crux of the gap: regulatory endpoints open the door, but payers look for outcomes that reflect real-world value and total cost of care—reductions in hospitalizations, ER visits, and readmissions; durability of effect; and a clear tie to unmet need and standard of care.
From the health-plan seat, Mr. Margevicius was direct on endpoint choice: “I don’t want to see an endpoint for a test that doesn’t mean anything in actual practice.” Surrogates can play a role, but if they aren’t validated or connected to outcomes and resource use, they won’t carry weight with a P&T audience.
“There’s this gap and tension between what the FDA allows or wants you to do, and what a payer expects.”
— Dr. Maria Lopes, Chief Medical Officer at a national PBM
On patient-reported outcomes (PROs), the panel drew a line between generic “patients like it” measures and validated instruments that correlate with utilization (e.g., asthma control scales tied to exacerbations and hospitalizations). The latter are far more persuasive.
Payers respond to robust designs, validated endpoints, head-to-head data, long-term safety/durability, and post-marketing evidence; they challenge unvalidated surrogates, short follow-up, small/open-label studies, inconsistent findings, and economic evidence gaps.
Durability, Comparisons, and Cost Offsets
Short trials can create uncertainty—especially for high-cost therapies. Dr. Lopes called out gene therapies as a prime example: plans need confidence that the effect is durable and that expected offsets are real, not assumed. Mr. Margevicius made a similar point on chronic conditions: 26-week data rarely answers a years-long question.
Comparative context also matters. Head-to-head is the gold standard; when that’s not feasible, realistic comparators and transparent cross-trial reads help reduce guesswork.
“We’re presented with a 26-week trial… we need to know how this therapy performs longer term.”
— Mike Margevicius, Pharmacy Director at a large national health plan
Unsurprisingly, real-world and longer-term evidence can move access. The panel highlighted how classes like PCSK9 inhibitors and SGLT2 inhibitors advanced once cardiovascular outcomes were demonstrated. They also noted how GLP-1s and curative hepatitis C therapies reshaped standards as outcomes translated into measurable utilization and cost impacts. And when evidence is still emerging, plans often consult KOLs to pressure-test what is meaningful in practice.
What to Do Next: Practical Steps for Manufacturers
- Engage early—and again at milestones. Use Phase 2/early Phase 3 input to shape endpoints and comparators; revisit in late Phase 3/pre-launch to stress-test pricing, UM, and the P&T story; monitor post-launch to keep pace with perceptions, policies, and competitors.
- Prioritize decision-grade endpoints. Focus on outcomes that connect to clinical relevance and economics—hospitalizations, readmissions, durable effect—and be explicit about how they tie to total cost of care. If you use PROs, pick validated tools linked to resource use.
- Plan for durability and comparisons. Build follow-up long enough to answer, “does it last?” and, where possible, include head-to-head or credible comparator evidence. If you can not, be transparent about limits and how you addressed them.
- Communicate novel data to payers with plan time constraints in mind. Send a concise email with a clear executive summary and links for deeper detail; highlight guideline changes and relevant pipeline/indication updates; reserve meetings for major updates (e.g., new indications or significant outcomes).
- Pressure-test access levers. Evaluate reactions to anticipated formulary placement, tiering, and UM; test willingness-to-pay and value messages; assess contracting preferences (e.g., rebates, outcomes-based); and identify RWE/PRO evidence gaps for the next wave.
The Bottom Line
Plan evidence generation with payers in mind and engage early—and iteratively. ROI on research is highest when payer insights are built in early and revisited often. Design for real-world decision criteria, check in at key milestones, and make it easy for busy teams to see what’s clinically meaningful, who benefits, and how that changes utilization and cost. The best evidence packages balance what regulators require with what payers value. Ultimately, strong research doesn’t just get products approved—it gets them covered, reimbursed, and into the hands of patients who need them.
Ready to make your research matter to payers?
Contact the experienced team at Magnolia Market Access to align endpoints and payer narratives across the product lifecycle—and translate your evidence into access.