Valoctocogene Roxaparvovec-rvox

This policy covers valoctocogene roxaparvovec‑rvox (Roctavian), a single‑dose AAV5‑mediated, liver‑directed gene therapy delivering a B‑domain–deleted hFVIII transgene to produce factor VIII for treatment of severe congenital hemophilia A. Coverage is limited to adults ≥18 years assigned male at birth with severe hemophilia A (FVIII ≤1 IU/dL) who have received ≥1 year of prophylactic FVIII, have no detectable FVIII inhibitors, test negative for anti‑AAV5 antibodies by the FDA‑approved AAV5 DetectCDx assay, and remain subject to member benefit plan exclusions and other policy criteria.

"Coverage of FDA-approved drugs when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."

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