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Insights
We offer personalized insights and strategy, and spotlight data in a compelling way to shape policy, communicate value, secure reimbursement, and drive patient access.
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FDA’s 2026 Draft Guidance on Payer Communications
FDA’s 2026 draft guidance updates the framework for manufacturer communications with payors, formulary committees, and similar entities. The revised guidance clarifies expectations for drugs and devices, health care economic information, unapproved product communications, and follow-up when previously shared information becomes materially outdated.
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AI in Market Access: The Real Opportunity Is Better Payer Alignment
AI in market access can help biopharma teams apply payer intelligence earlier and more consistently across evidence, pricing, launch, and access strategy.
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The U.S. Biopharmaceutical Innovation Ecosystem at Risk: The 20-Year Threat to U.S. Innovation and Cures
A 20-year analysis of how research funding instability, FDA capacity challenges, and pricing policy pressures may affect future medicines, patient access, and U.S. biotech innovation.
Market Access Briefs
A Blend of Core Concepts and Breaking Headlines
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Pharmacy Benefit Manager (PBM) Reform
PBM Overview Pharmacy Benefit Managers (PBMs) work with health insurers, large employers and other payers to manage prescription drug benefits. The initial role of PBMs was to negotiate reimbursement rates with drug manufacturers, manage prescription drug claims, and reimburse pharmacies for dispensed medications. Since its inception, the role of the PBMs have evolved over time…
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Types and Uses of Cost-Effectiveness Models
Cost-Effectiveness Models: A Strategic Tool for Pricing and Market Access In today’s market, clinical efficacy alone is rarely enough to differentiate a product. Payers, health systems, and policy bodies want to know: Is the price justified by the value delivered? Cost-effectiveness modeling provides a structured way to answer that question by connecting clinical outcomes to…
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What Is a Patient Support Services Model?
Introduction to Patient Support Services Models A patient support services model is a data-driven tool or framework that helps forecast and analyze the various aspects of manufacturer-sponsored patient support programs. Patient support services models simulate real-world scenarios. They predict how changes in patient needs, insurance policies, program rules, and regulations impact patient support program enrollment, utilization, costs,…