Stephanie Spence, PharmD, CSP, Senior Director, Access Experience Team
In oncology, neurology, and immunology, innovators are introducing first-in-class therapies to patients who have had few, or no, options. These breakthroughs represent hope for individuals living with rare and complex conditions. But when a health plan’s current drug spend for a condition is near zero, the introduction of a high-cost, novel therapy requires a different kind of value narrative — one that goes beyond being clinically cutting-edge and demonstrates tangible impact on spend, quality, and utilization.
Across Precision AQ’s core therapeutic areas — oncology, neurology, and immunology — new product launches increasingly feature novel mechanisms of action and target small, heterogeneous patient populations. While this combination drives clinical excitement, it also invites heightened scrutiny from payers. Manufacturers who can translate clinical innovation into operational and financial language will secure cleaner, faster coverage decisions aligned with launch timelines, potentially mitigating ambiguous “new-to-market” blocks that delay access.
To meet payers’ proof-of-concept expectations, manufacturers must move beyond endpoints and craft a narrative that is both persuasive and operationally actionable. Begin by highlighting value drivers such as cost offsets, adherence improvements, and alignment with established decision frameworks. Then, strengthen the case with detailed budget impact projections, clearly defined inclusion criteria, and practical patient identification tools, ranging from traditional demographic and diagnostic approaches to advanced AI-powered solutions. Combined, these elements create a strategy that resonates with payers and accelerates coverage decisions.
Payers prioritize coverage when they see credible offsets — particularly within drug spend or high-cost services that influence total cost of care. Two critical approaches stand out:
FDA approval and guideline alignment matter, but they are not enough. Approvals can be questioned due to study design, and guideline updates often lag behind product launches. Payers still ask: “How does this impact our budget and quality metrics?” Connect your clinical guidance to quality measures that plans prioritize, such as STARS or HEDIS, rather than focusing solely on clinical endpoints. And remember, transparency builds trust: share pricing early in the conversation to establish credibility.
Forecasting is critical. Provide clear projections by line of business and spotlight precision: who qualifies, who does not, and why. Specify expected patient demographics and prevalence across commercial, Medicare Advantage, and Medicaid populations to help payers anticipate budget impact and design utilization controls.
Avoid vague inclusion criteria and soft endpoints. These can lead to restrictive prior authorization requirements and inconsistent approvals. During evidence planning, consider how study design might broaden diagnostic criteria unintentionally. Engage strategic partners to identify effective ways to distinguish your target population from near-neighbor conditions. Incorporate annotated labs, biomarkers, imaging, and timing requirements. Provide stepwise confirmation guidance along with EMR-friendly documentation checklists so front-line staff can capture the exact data payers need to facilitate access.
Quality of life (QoL) improvements matter deeply to providers and patients, but many payers do not prioritize QoL in pharmacy budget decisions unless they impact financial outcomes. Position QoL as a driver of trend and total cost-of-care metrics. Clearly demonstrate how QoL improvements reduce healthcare resource utilization and enhance productivity, creating measurable value that plans can leverage in employer group engagement.
Ready to rethink your market access strategy? Book a call with our team to build a value narrative that resonates with payers and accelerates coverage for your innovative therapy.