Anticipating Barriers, Accelerating Adoption: How a Multi-Stakeholder Roundtable Helped De-Risk the Launch of Factor XI Inhibitors

Objectives

• Identify real-world barriers to adoption of Factor XI inhibitors

• Understand payer expectations around classification and coverage

• Explore messaging strategies for health system and provider engagement

• Clarify patient segments most likely to benefit

• Generate actionable next steps to support launch readiness

Key Insights & Outcomes

1. Cost Avoidance Must Be Quantified,Not Assumed
While bleeding reduction was seen as a meaningful clinical advance, health system stakeholders stressed that economic value is the primary driver of adoption. Data on reduced ED visits, adverse events, and postoperative complications must be translated into clear cost avoidance models to resonate with financial decision-makers.

2. Payer Classification Is a Strategic Hurdle
Given the IV or subcutaneous delivery of some Factor XI agents, payers raised early concerns about how the therapy would be classified—under medical or pharmacy benefit—and how that would impact utilization controls and site-of-care decisions. The group emphasized the importance of positioning Factor XI inhibitors as a distinct class, not as a next-generation direct oral anticoagulant (DOAC).

3. Safety Alone Won’t Drive Uptake Without Context
Although participants agreed that bleeding reductions were promising, they noted that DOACs already perform exceptionally well in preventing thrombosis. The real differentiator will be net clinical benefit in clearly defined patient populations, such as postsurgical patients or those with high bleeding risk where DOACs are less optimal or contraindicated

4. Implementation Science Will Be Critical
The discussion identified multiple needs to support system-wide integration, including:

• Standardized bleeding risk frameworks tailored to Factor XI inhibitors

• Clear eligibility criteria and treatment algorithms

• Targeted education for PCPs and frontline clinicians

• Patient-centered materials to support shared decision-making

5. Multistakeholder Engagement Surfaces Hidden RisksSeveral operational and reimbursement issues—such as infusion staffing, outpatient workflow adjustments, and budget silos—emerged that might not have been considered in internal planning. These insights provided critical inputs for commercial strategy refinement.