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-cdon (Uplizna) may be considered medically necessary for an initial seven (7) months for the treatment of an individual 18 years of age or older with Neuromyelitis Optica Spectrum Disorder (NMOSD) when the following criteria are met:
- Individual is anti-aquaporin-4 (AQP4) antibody positive; and
- Individual exhibits ONE of the following core clinical characteristics of NMOSD:
- Optic neuritis; or
- Acute myelitis; or
- Area postrema syndrome (episode of otherwise unexplained hiccups or nausea and vomiting); or
- Acute brain stem 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 has had at least 1 discrete clinical attack of CNS symptoms; and
- Alternative diagnoses (e.g., multiple sclerosis, ischemic optic neuropathy) have been ruled out; and
- Individual has been screened for hepatitis B viral (HBV) infection and ALL of the following:
- ONE of the following:
- Individual is negative for both HBsAg and anti-HBV; or
- Individual is negative for HBsAg and positive for HBcAb AND the prescriber has consulted with a gastroenterologist or a hepatologist before initiating and during treatment; or
- Individual is a carrier of HBV (i.e., positive results for HBsAg) AND the prescriber has consulted with a gastroenterologist or a hepatologist before initiating and during treatment; and
- Individual does not have active HBV infection (i.e., positive results for HBsAg and anti-HBV); and
- If the screening for HBV was positive for prior HBV infection, the prescriber will monitor the individual for HBV flare-up or reactivation during and after treatment; and
- Individual has had testing for quantitative serum immunoglobulins and ONE of the following:
- Individual has normal serum immunoglobulin levels; or
- Individual has low serum immunoglobulin levels AND the prescriber has consulted with an immunologist before initiating treatment; and
- Individual has been evaluated for active tuberculosis infection and tested for latent tuberculosis infection AND does not have active or untreated tuberculosis.