The RWE Communication Gap That's Costing Manufacturers Formulary Access

Payers say they want real-world evidence to inform formulary positioning, set utilization management criteria, and underwrite the outcomes-based contracts that tie reimbursement to what a therapy actually delivers outside the clinic. Health care professionals want it to target the right therapies to the right patients without cycling through trial and error. Used well, it is a powerful commercial tool manufacturers have for improving access, commercial success, and patient benefit. The problem, and the fix, is in how that evidence gets communicated.

Only 18% of payers surveyed through AMCP's Research Institute reported actually using real-world evidence in their formulary and coverage decision-making. But 80% said they wanted to.¹

That gap, documented in a study published in the Journal of Managed Care & Specialty Pharmacy, is a consequential disconnect in market access and product lifecycle management. Manufacturers who close it can move from approval to access faster and build the payer relationships needed to sustain it. Manufacturers who don't are generating data that payers want but can't act on.

"Pharmaceutical manufacturers are producing a lot of RWE, and the payers are interested in it, but there's been this disconnect in the communication between the two," said Cate Lockhart, PharmD, PhD, chief science officer at AMCP, in a recent interview with Pharmaceutical Commerce.

It isn't a science problem. It is a communication problem, and one that carries direct consequences for how manufacturers engage with the payers, providers, and patients who depend on that evidence to make better decisions.

Why Aren’t Payers Using Evidence They Say They Want?

The barriers Lockhart's initiative identified are practical, structural, and persistent. According to the study, payers receive RWE from manufacturers but often lack the experience and shared framework to evaluate what they're looking at.

“The payers in particular don’t have a lot of experience in evaluating RWE or using it in their decisions,” Lockhart told Pharmaceutical Commerce. “They’re very skilled at understanding clinical trial data and doing those assessments, but they don’t have as much experience with other types of studies, like observational research or other kinds of RWE.”

The consequence shows up not in the quality of the evidence, but in how it lands.

“It’s not that the RWE that’s produced by the pharmaceutical manufacturers is poor quality. It’s usually quite the opposite,” she said. “But it’s more that the results and how they’re presented or communicated have not always been aligned with what the payers find most useful as part of their decision-making process.”

According to Lockhart, what the AMCP initiative found was a structural gap: existing standards addressed how to design or publish an RWE study, but none defined which types of RWE or endpoints manufacturers should be generating to support payer decision-making.

“There’s plenty of standards and guidelines and checklists and so forth out there describing RWE, but most of them are about how to design a good RWE study or how to report it for publication. But there was nothing really specific about what kind of RWE and what kind of endpoints payers are interested in.”

The AMCP payer survey found that the largest barrier to using RWE was payers' lack of understanding and experience interpreting and applying it, a finding that confirmed the need for standards to streamline how RWE could be incorporated into coverage and reimbursement decisions.¹

Why Does RWE Matter Across the Product Lifecycle?

For manufacturers, the nature of that barrier matters: a standards and experience gap is fixable in a way that fundamental skepticism of RWE would not be. A 2024 AMCP Foundation survey found that 54% of managed care professionals considered significant growth in value-based contracting over the next five years to be likely.² Contracts that tie reimbursement to real-world performance depend on one thing: credible post-market performance data.

Tommy Bramley, senior vice president of global consulting services at Cencora, has spent more than two decades at the intersection of evidence generation, market access, and patient outcomes. He has watched RWE evolve from a post-approval surveillance mechanism into an expected component of the evidence package that payers, providers, and regulators rely on from early development through long-term outcomes tracking.

“There’s a growing reliance on RWE and an expectation by payers and providers that there’ll be label expansion or additional data that will come to better inform the decision-making process,” Bramley told Pharmaceutical Commerce in a previous interview. “On the payer side, that would be the formulary positioning, the tiering, any type of utilization management. On the provider side, they truly want that data to better target the therapies to their patients, so what is going to work so they don’t have to go through a series of trial and error.”

Clinical trials establish what a therapy can do under controlled conditions. Real-world evidence fills in what happens when those conditions give way to the complexity of actual patient care. “Once you release it into the wild,” Bramley said, “it’s a much different story in terms of comorbidities of the patients and medication-taking behavior, and do you truly get that return on investment either in health or lower utilization of precious healthcare resources. It’s that translation bridge between what’s happening in the laboratory and what’s happening in the real world.”

In specialty pharma, those constraints run deeper.

“You have very high-cost products for typically smaller populations, and that’s where your traditional methods in phase three may not apply,” Bramley said. “It’s difficult to have a placebo control arm or find enough patients, and that’s where you start to construct your external control arms or your synthetic control arms.”

In the post-approval period, the evidence agenda shifts toward demonstrating outcomes for the patients actually receiving a therapy , and using that data to inform reimbursement strategy and payer relationships. “It’s thinking about outcomes-based contracts,” Bramley said. “It’s showing the difference that these therapies can make in patients’ lives. You can capture that through patient-reported outcomes or utilization measures to show this product really does lower the total cost of care.”

What Does the Solution Look Like?

AMCP’s response to the structural gap was to publish its RWE Standards in the Journal of Managed Care & Specialty Pharmacy , a framework built to operate from both ends of the communication problem. For manufacturers, it establishes a roadmap specifying which study types and endpoints carry weight at each stage of a product’s life cycle. For payers, it provides a 29-criteria checklist across six categories, giving formulary teams a structured basis for evaluating what arrives in front of them.

“A lot of the questions about strong or credible RWE is really just in the communication and the translation,” Lockhart said. “And so these RWE standards are really meant as being that kind of translation tool.” It also broadens what qualifies. “RWE is more than just post-marketing safety and effectiveness,” she said. “There’s a lot of varieties of RWE that can be relevant throughout the life cycle.”

Bramley argues that the manufacturers who will use this moment most effectively are those who build their evidence generation plan early , before launch, and ideally before the pivotal trial is fully designed. “An RWE plan can help you identify unmet needs that this therapy can fulfill. It can help you understand how a particular therapy may stand up against the standard of care and comparative effectiveness, and you can start to think through what are those endpoints that are important from a regulatory perspective, but also from an HTA or a payer perspective.” By the time a manufacturer is preparing to launch, that early groundwork shapes how quickly access can be established and how well the evidence maps to the questions payers are going to ask.

How Should Manufacturers Communicate Real-World Data?

A common evidence framework solves half the problem. The other half is presentation, and Lockhart is direct about what separates evidence that payers act on from evidence they set aside.

"One thing that we have learned and are trying to really kind of hammer home is that transparency is key. Transparency in reporting is key," she said. Payers have their own data; most sit on significant claims datasets, but may not be familiar with the strengths and limitations of the external sources manufacturers draw from, whether electronic health records, patient-reported outcomes, or real-world registries. "The strategy for communicating it is really about transparency so that a payer can understand the data provenance, the quality, any limitations that could influence their decisions."

A core question payers need answered is whether a study’s patient population reflects their own membership. “Payers are looking for real-world data that they can translate into something that applies to their own member population,” Lockhart said. Evidence that cannot answer that question , however rigorous, will not inform a formulary decision.

GLP-1s illustrate what becomes visible when RWE is communicated well, and what stays hidden when it isn't. Real-world data has confirmed that weight loss with semaglutide and tirzepatide can fall short of clinical trial benchmarks, a finding a 2025 study in Diabetes, Obesity and Metabolism quantified directly, reflecting lower real-world dosing and adherence.³ But the same evidence base has surfaced signals the trials were not designed to detect. “There’s also some interesting benefits that are arising in other areas — cardiovascular benefits, fracture risk benefits that are emerging from this RWE,” Lockhart said. Both findings are relevant to payers managing coverage decisions for millions of members. Neither is accessible without well-communicated, transparent data.

What Is the Payoff for Manufacturers Who Invest in Evidence Generation Early and Communicate It Well?

For manufacturers who align their evidence strategy to payer needs from the outset, not as an afterthought to the regulatory package, the downstream benefits are compounding: earlier formulary access, more favorable tiering, and the foundation for outcomes-based contracts that require credible real-world performance data to function.

Bramley points to early evidence planning as the multiplier that makes all of it possible. “What we encourage for pharma is to have those evidence generation plans in place early so you can support your launch and have a faster launch in terms of maximizing that benefit across the globe for patients who are going to do very well on that particular therapy,” he said.

“It’s a very, very powerful tool in terms of optimizing the access and maximizing the patient benefit,” Bramley said.

Payers have indicated what they need. What remains is for manufacturers to build evidence strategies that are designed from the start to be used, not just produced.

References

1. Lockhart CM, et al. AMCP real-world evidence standards: Overcoming barriers to using real-world evidence in US payer decision-making. J Manag Care Spec Pharm. 2025;31(12):1230–1236. https://www.jmcp.org/doi/10.18553/jmcp.2025.25108

2. Kenney JT, Gleason PP. Emerging trends in pharmaceutical payment models: Perspectives on the 2024 AMCP Foundation Survey. J Manag Care Spec Pharm. 2025;31(2-a Suppl):S20–S24. https://pmc.ncbi.nlm.nih.gov/articles/PMC11785357/

3. Thomsen M, et al. Real-world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP-1RA-based weight-loss therapies. Diabetes Obes Metab. 2025. https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16364