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Medicare AdvantageCoverageHigh impact

Roctavian™ (valoctocogene roxaparvovec-rvox) (Revised)

Humana·KY, SC · Hematology, Internal Medicine, Pharmacy·Medicaid
Effective date
Feb 1, 2026
We identified it
Jun 25, 2026
Days to comply

Summary

CRITICAL: Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy for severe hemophilia A, was voluntarily withdrawn from the market in February 2026 for commercial reasons. This policy revision (April 22, 2026) reflects this market withdrawal. New treatment initiation is NO LONGER AVAILABLE, though previously treated patients will continue long-term follow-up. Billing teams must immediately STOP processing new prior authorization requests and deny any new treatment claims.

Action Required

Action needed
IMMEDIATELY (retroactive to February 2026): Billing team must cease all prior authorization requests for Roctavian (valoctocogene roxaparvovec-rvox). Update billing system and clinical decision support tools to flag and DENY any new treatment initiation claims for this drug. Notify all providers in hematology and internal medicine departments that Roctavian is no longer available for new patients. Verify any claims submitted between February 2026 and present for new treatment initiation and deny appropriately. For existing patients already treated with Roctavian, continue processing claims related to long-term follow-up and support only. Update internal policy documentation to reflect market withdrawal status. Document all actions taken for compliance audit purposes.