Elivaldogene autotemcel
RX501.149
This policy covers elivaldogene autotemcel (Skysona), a one‑time ex vivo Lenti‑D lentiviral gene therapy that transduces a patient’s autologous hematopoietic stem cells with ABCD1 to treat early, active cerebral X‑linked adrenoleukodystrophy (CALD). Coverage is limited to HCSC Ohio members assigned male at birth aged 4–17 with elevated VLCFA, gadolinium‑enhancing MRI lesions, Loes score 0.5–9 and NFS ≤1, requires all specified clinical and laboratory criteria (no prior gene therapy or allogeneic HSCT, adequate hematologic/hepatic/renal/cardiac function, negative HIV/HBV/HCV), and is subject to member benefit plan terms and state‑specific requirements; repeat treatment is not covered.
"Coverage of any FDA‑approved drug prescribed for an off‑label use recognized as safe and effective in one or more standard medical reference compendia adopted by HHS."
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