Real-world evidence (RWE) and health economics and outcomes research (HEOR) have become standard inputs into payer decisions, yet most Market Access field training still centers on the clinical dossier. Field Reimbursement Managers, Access Account Directors, and Regional Access Managers are often the only representatives of a life sciences company in the room with a Pharmacy and Therapeutics (P&T) Committee, a payer medical director, or a health system contracting team. When those professionals cannot connect clinical findings to real-world outcomes and economic value, it becomes harder to answer the questions that influence coverage and formulary decisions.
Clinical trial data shows how a therapy performs under controlled conditions. Payers and health systems also need to understand how it is likely to perform in the populations they manage and whether the expected outcomes justify the cost. RWE draws on registries, claims data, electronic health records, and patient-reported outcomes to describe how a therapy performs outside the trial setting. HEOR translates performance into economic measures that payer, clinical, and finance teams can use.
Knowing the label and pivotal trial endpoints is essential, but it does not fully prepare someone for an access conversation. Payer discussions require an additional command of real-world outcomes, economic evidence, and coverage considerations. Yet many field teams receive extensive clinical training without the same preparation in RWE, HEOR, and payer decision-making.
Field Reimbursement Managers (FRMs): FRMs work directly with provider offices to resolve prior authorization and coverage barriers.[1],[2] To help provider offices address these barriers, FRMs need to understand the payer’s criteria and know which approved evidence is relevant to the case.
Market Access Account Directors and National Account Managers: These roles sit across the table from Pharmacy and Therapeutics Committees, payer medical directors, and health system contracting teams. They need to present clinical and economic evidence in a format that payer decision-makers recognize and can evaluate, including the structure established by the AMCP Format for Formulary Submissions.[3],[4]
Regional and Strategic Access Managers: These teams translate national HEOR strategies for regional markets where plan types, populations, and formulary priorities can vary considerably.
Although these roles use evidence differently, each needs a stronger working knowledge of health economics than traditional launch training typically provides.
Research shows that RWE is playing a growing role in payer decisions. A recent ISPOR literature review found broad payer interest in RWE, although its use remains limited by inconsistent methods, delayed availability, and a lack of transparency in how some studies are conducted.[5] This makes it important for field teams to explain not only what the RWE shows, but also how the study was designed, where the data came from, and how relevant the findings are to the payer’s population.
Since its introduction in 2000, the AMCP Format for Formulary Submissions has provided a common framework for sharing clinical and economic evidence with healthcare decision-makers.[6] It specifies what clinical and economic evidence a submission should contain and how that evidence should be structured for a Pharmacy and Therapeutics Committee to act on it.[7] Without that familiarity, even a strong evidence package may be difficult to communicate in a way that supports the committee’s review process.
Reimbursement and payer policy environments shift constantly, and the organizations that keep field reimbursement training current see stronger performance from their FRM teams than those that treat training as a one-time launch event.[8] At the same time, RWE and HEOR are becoming part of earlier drug development and clinical trial design. As a result, field teams must be prepared to discuss evidence that emerges quickly and changes often.[9]
Good practices guidance from ISPOR and ISPE calls for greater rigor and stakeholder engagement in how RWE studies are conducted.[10] That same rigor needs to extend to how the resulting evidence is taught to the people carrying it into the field.
Training that closes this gap shares a few characteristics regardless of therapeutic area:
Build fluency, not just recall. Learners should practice connecting specific evidence to the questions payers are likely to ask.
Teach the format. Familiarity with the AMCP Format helps teams understand how payers review clinical and economic evidence.[11]
Practice realistic objections. Training should include questions and challenges based on the therapy’s actual evidence, not generic payer scenarios.
Create a consistent value story. National and regional teams should communicate the same core story while adapting the supporting evidence to each plan and population.
This level of fluency cannot be built through a single launch training session. It requires ongoing, role-specific learning based on the product’s evidence, the questions each team encounters, and changes in the payer environment.
ERS develops Market Access training around each product’s evidence, payer landscape, and field responsibilities. We help FRMs, Account Directors, and Regional Access Managers communicate clinical and economic value with greater clarity and confidence.
Contact ERS to discuss your team’s training needs.
Real-world evidence describes how a therapy performs outside a clinical trial, drawn from claims data, registries, electronic health records, and patient-reported outcomes. HEOR uses that evidence, alongside clinical trial data, to quantify economic value: cost per outcome, budget impact, and comparative value that a payer can act on. RWE shows how a therapy performs in practice, while HEOR evaluates the clinical and economic value of those outcomes.
FRMs are frequently the first field-facing role to encounter a payer’s coverage criteria in a live prior authorization or appeal.[12] Understanding the therapy’s RWE and economic value helps FRMs identify and explain the evidence relevant to a payer’s coverage requirements, within the boundaries of their role.
Payer organizations increasingly weigh RWE alongside randomized controlled trial data when evaluating a therapy for formulary placement, particularly when it demonstrates real-world safety, effectiveness, or cost outcomes.[13] Frameworks like the AMCP Format guide how that evidence should be structured for a Pharmacy and Therapeutics Committee to use in a coverage decision.[14]
Field roles fall back on clinical trial language in conversations that require economic and real-world context. Without this training, field teams may rely too heavily on clinical trial language when payers need economic and real-world context. Important evidence can then go unused, and teams may struggle to answer payer questions effectively.
[1]Centers for Medicare & Medicaid Services. Prior Authorization and Pre-Claim Review Initiatives. https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives
[2]American Medical Association. 2024 AMA Prior Authorization Physician Survey. https://www.ama-assn.org/system/files/prior-authorization-survey.pdf
[3]Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions, Version 5.0. 2024. https://www.amcp.org/sites/default/files/2024-04/AMCP-Format-5.0-JMCP-web_0.pdf
[4]Watkins JB, Sullivan SD, Sampsel E, Fullerton DS, Graff JS et al. Evolution of the AMCP Format for Formulary Submissions. JMCP. 2020;26(6):696-700. https://doi.org/10.18553/jmcp.2020.26.6.696
[5]M Malone DC, Brown M, Hurwitz JT, Peters L, Graff JS. Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies? Value Health. 2018;21(3):326-333. https://doi.org/10.1016/j.jval.2017.08.3013
[6]Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions, Version 5.0. 2024. https://www.amcp.org/sites/default/files/2024-04/AMCP-Format-5.0-JMCP-web_0.pdf
[7]Watkins JB, Sullivan SD, Sampsel E, Fullerton DS, Graff JS et al. Evolution of the AMCP Format for Formulary Submissions. JMCP. 2020;26(6):696-700. https://doi.org/10.18553/jmcp.2020.26.6.696
[8]Salas E, Tannenbaum SI, Kraiger K, Smith-Jentsch KA. The science of training and development in organizations. Psychological Science in the Public Interest. 2012;13(2):74-101. https://doi.org/10.1177/1529100612436661
[9]U.S. Food and Drug Administration. Framework for FDA's Real-World Evidence Program. December 2018. https://www.fda.gov/media/120060/download
[10]Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making. Value Health. 2017;20(8):1003-1008. https://doi.org/10.1016/j.jval.2017.08.3019
[11]Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions, Version 5.0. 2024. https://www.amcp.org/sites/default/files/2024-04/AMCP-Format-5.0-JMCP-web_0.pdf
[12]American Medical Association. 2024 AMA Prior Authorization Physician Survey. https://www.ama-assn.org/system/files/prior-authorization-survey.pdf
[13]M Malone DC, Brown M, Hurwitz JT, Peters L, Graff JS. Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies? Value Health. 2018;21(3):326-333. https://doi.org/10.1016/j.jval.2017.08.3013
[14]Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions, Version 5.0. 2024. https://www.amcp.org/sites/default/files/2024-04/AMCP-Format-5.0-JMCP-web_0.pdf
