A therapeutic product’s commercial success depends on more than just clinical performance; it requires alignment between evidence generation, coding pathways, reimbursement policy, and clinical practice. When manufacturers make strategic decisions on these elements early and continuously revisit them, they can shape payers’ assessment of value, patient access, providers’ care delivery, and how products are adopted within treatment pathways and clinical guidelines. Gaps in coding or reimbursement strategy at any point in the product journey can delay access and erode long-term value.

Avalere Health’s in-house clinicians, certified coders, and reimbursement strategists partner with stakeholders throughout a product’s lifecycle to support patient access. We help manufacturers anticipate challenges, strengthen positioning, and navigate complex regulatory and reimbursement hurdles.

What We Do

From early evidence planning through commercialization, our subject matter experts (SMEs) identify optimal coding strategies, analyze the competitive landscape, and support clinical data and reimbursement strategy alignment.

Clinical Expertise: Our team of physicians, nurses, and pharmacists integrates real-world clinical experience with strategic analysis to inform product positioning across the lifecycle. Drawing on direct insights into how providers make treatment decisions, follow protocols, and manage patient care, we evaluate clinical evidence needs, identify data gaps, and shape clinical narratives aligned with payer expectations and provider practice. From early product development through post-launch, we ensure clinical strategy remains aligned with evolving access and adoption requirements.

Figure 1. Meet Avalere Health Advisory’s Clinical SME Team

EHRs: Electronic Health Records; FDA: Food and Drug Administration; RWD: Real-World Data; RWE: Real-World Evidence; SAP: Statistical Analysis Plan

Coding Expertise: Medical coding is the foundation of reimbursement. Our coding specialists support clients by identifying appropriate codes, developing comprehensive coding strategies, and navigating code application processes. We proactively identify coding gaps and develop tailored strategies based on client priorities, product attributes, the competitive landscape, and the policy environment. Ongoing monitoring of coding updates enables us to anticipate changes that may affect products, while our provision of clear provider billing guidance helps promote accurate and consistent claims submission.

Figure 2. Meet Avalere Health Advisory’s Coding SME Team

Let’s Connect

Our team brings decades of combined experience from payers, providers, medical associations, and regulatory bodies. Whether you are a startup bringing your first product to market or an established company launching a next-generation innovation, we have the expertise to guide you through the complexities of market access. Contact us today to discuss how we can support your market access goals.

To read more about what topics are on the minds of our subject matter experts in Advisory, please browse our Insights. To learn more about our team, please check out our bios here.