Opinion
Video
Panelists discuss how payers can evaluate BTK inhibitors by considering specific MS phenotypes and FDA indications rather than applying traditional step therapy protocols that may delay optimal treatment.
Video content above is prompted by the following:
Multiple sclerosis (MS) presents unique challenges for payers due to its complex disease continuum spanning clinically isolated syndrome, relapsing-remitting MS, and progressive forms. The FDA’s specific approval language for Bruton tyrosine kinase (BTK) inhibitors will be crucial in determining formulary placement, as more targeted indications for progressive MS could justify separate coverage categories rather than traditional step therapy protocols. This specificity would provide payers with clearer guidance on appropriate patient populations and help avoid generic prior authorization approaches that may not suit MS’s heterogeneous nature.
Unlike oncology, the MS field lacks comprehensive clinical guidelines that clearly define the hierarchical placement of the 22-plus available disease-modifying therapies. This absence of standardized treatment algorithms creates significant challenges for payers seeking evidence-based formulary decisions. The neurology community’s inability to reach consensus on treatment hierarchies forces payers to develop their own coverage criteria, often resulting in suboptimal patient outcomes when rigid step therapy protocols delay access to appropriate treatments.
Given MS’s diverse phenotypes and the critical importance of early intervention, payers must adopt more nuanced coverage strategies that move beyond traditional fail-first approaches. The progressive nature of MS means that delaying treatment while patients fail through older therapies can irreversibly worsen disability outcomes. Payers should collaborate with national societies like the American Academy of Neurology to develop coverage criteria that recognize MS’s unique characteristics and prioritize preventing long-term disability over short-term cost containment.
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