Beyond Relapses: BTK Inhibitor Coverage Strategies for PIRA in MS

EP: 1.Understanding PIRA and Its Clinical Significance in MS

EP: 2.Measuring What Matters: Evidence and End Points That Define Disability in MS

EP: 3.Closing the Gaps: Therapeutic Performance and the Promise of Innovation

EP: 4.Digging Deeper: Mechanisms of Progression and the Case for a Dual Therapeutic Approach

EP: 5.Aligning Evidence With Access: Disability Outcomes, Data, and Payer Decision-Making

EP: 6.Bridging the Gaps: BTK Inhibitors and the Future of MS Care

EP: 7.Redefining Value: What Payers Want From Comprehensive MS Treatments

EP: 8.Short-Term Wins vs Long-Term Gains: Rethinking MS Treatment Value

EP: 9.Evaluating the Future of MS Therapies: Balancing Early Data With Delayed Outcomes

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EP: 10.Beyond Relapses: BTK Inhibitor Coverage Strategies for PIRA in MS

EP: 11.The Value of Functional Outcomes and Elevating Patient Voices in MS Assessments

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Current Bruton tyrosine kinase (BTK) inhibitor trials specifically target patients with progression independent of relapse activity (PIRA), requiring participants to be relapse-free for 1 to 2 years before enrollment. This trial design effectively identifies patients in the progressive phase of multiple sclerosis (MS) who would most benefit from treatments targeting neurodegeneration rather than inflammation. The promising results, particularly with tolebrutinib in nonrelapsing secondary progressive MS, demonstrate the potential for BTK inhibitors to address this historically underserved patient population.

The transition from clinical trials to real-world practice presents challenges in identifying the optimal timing for BTK inhibitor initiation. Unlike oncology, where specific biomarkers guide treatment decisions, MS lacks clear indicators for when patients transition from relapsing to progressive disease phases. This uncertainty requires clinicians to make nuanced decisions about when to switch from relapse-focused therapies to progression-focused treatments, highlighting the need for better diagnostic tools and clinical guidelines.

Given the limited therapeutic options for progressive MS and the urgent need to prevent further disability accumulation, payers should develop coverage strategies that prioritize patient access while collecting real-world outcomes data. The strategy should focus on covering BTK inhibitors for clearly progressive patients while designing studies to validate their effectiveness using practical disability measures. This approach recognizes that progressive MS represents an area of significant unmet medical need where delayed treatment access could result in irreversible disability progression.