Natalizumab (Tysabri)

Tysabri (natalizumab) is covered only for FDA‑approved relapsing forms of multiple sclerosis and moderately‑to‑severe Crohn’s disease in adults ≥18, and is excluded for primary progressive MS, immunocompromised patients, and any concomitant use with other DMTs or immunosuppressants. Approval requires specialist prescribing/consult (neurologist for MS, gastroenterologist for CD), documentation of prior therapy failure or highly‑active disease (MS: ≥1 DMT failure or defined aggressive‑MS criteria; CD: elevated CRP plus ≥2 prior biologic failures ≥2 months each), dosing 300 mg IV every 4 weeks, and time‑limited authorizations (MS: 1 year; CD initial: 3 months, reauth: 1 year) with documentation of response for CD reauthorizations.

"FDA‑approved indication: Crohn's disease (CD)"

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