Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Inebilizumab (Uplizna) may be considered medically necessary when the following criteria are met:
- Individual 18 years of age or older; and
- Individual diagnosed with neuromyelitis optica spectrum disorder (NMOSD) as confirmed by ANY of 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; and
- Individual is anti-aquaporin-4 (AQP4) antibody positive; and
- Diagnosis of multiple sclerosis (MS) or other diagnoses have been ruled out; and
- Prescribed by or in consultation with a neurologist or other healthcare provider experienced in treating NMOSD; and
- Individual is not concomitantly being treated with disease modifying therapies for MS or NMOSD; and
- Initial authorization will be for six (6) months.
Reauthorization Criteria
Reauthorization of inebilizumab (Uplizna) may be considered medically necessary when the following criteria are met:
- Individual diagnosed with AQP4 antibody positive NMOSD; and
- Prescribed by or in consultation with a neurologist or other healthcare provider experienced in treating NMOSD; and
- Individual has demonstrated a positive clinical response from baseline as demonstrated by a documented reduction in the signs and symptoms of NMOSD and/or reduction in the number and/or severity of relapses; and
- Reauthorization will be for no longer than 12 months.
Inebilizumab (Uplizna) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
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