Coverage is subject to the specific terms of the member’s benefit plan.
The use of inebilizumab-cdon (Uplizna) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is, or in consult with, a neurologist; and
- The individual must have a diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD); and
- The individual has positive serologic test for anti-AQP4 antibodies; and
- The individual has a history of ≥ 1 relapses that required rescue therapy within the past 12 months; and
- The individual has an Expanded Disability Status Score (EDSS) of ≤ 6.5; and
- The individual must have one of the core clinical characteristics from the following:
- Optic neuritis; or
- Acute myelitis; or
- Area postrema syndrome: episode of otherwise unexplained hiccups or nausea and vomiting; or
- Acute brainstem syndrome; or
- Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; or
- Symptomatic cerebral syndrome with NMOSD-typical brain lesions.
Initial Authorization: 6 months
Continuation of therapy with inebilizumab-cdon (Uplizna) may be considered medically necessary when the following is met:
- The individual must have experienced stabilization, slowing of disease progression, or improvement of the condition since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including:
- Reduction in relapse rate
- Reduction in symptoms (such as pain, fatigue, motor function).
Continuation Authorization: 12 months
Inebilizumab (Uplizna) for any other indication is considered not medically necessary.