Criteria
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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
Inebilizumab (Uplizna) must be prescribed by, or in consult with, a neurologist;
and
-
The individual has positive serologic test for anti-AQP4 antibodies;
and
-
The individual has a history of greater than or equal to one (1) relapse that required rescue therapy within the past 12 months;
and
-
The individual has an Expanded Disability Status Score (EDSS) of less than or equal to 6.5;
and
-
The individual must have one (1) 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: Six (6) months
Reauthorization Criteria
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 inebilizumab-cdon (Uplizna), 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).
Inebilizumab (Uplizna) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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