Nusinersen (Spinraza)

Covered: Nusinersen (Spinraza) is approved only for pediatric and adult patients with genetically confirmed SMA type I or II (homozygous deletion/mutation or compound heterozygous mutation of SMN1 on 5q); no off‑label uses or other SMA types are covered. Key requirements: initial authorization needs baseline motor milestone documentation, re‑authorization requires documented clinical response (improvement/maintenance/achievement of motor milestones), patient must meet FDA‑approved indication and safety criteria, and approvals are limited to 12 months.

"Re-authorization requires documented response to therapy (policy: 'For a re-authorization request, an individual is responding to Spinraza therapy."

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