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Inebilizumab-cdon (Uplizna™)
Commercial Utilization Management Policy
Version Date: October 2021

Restricted Product(s):

  • inebilizumab-cdon (Uplizna™) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

  • For treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

  1. The patient is 18 year of age or older; AND
  2. The patient has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD) [medical record documentation required]; AND
  3. The patient is anti-aquaporin-4 (AQP4) antibody seropositive [medical record documentation required]; AND
  4. The diagnosis has been confirmed by the presence of at least one of the following core clinical characteristics [medical record documentation required]:
    1. Optic neuritis; OR
    2. Acute myelitis; OR
    3. Area postrema syndrome: episode of otherwise unexplained hiccups or nausea and vomiting; OR
    4. Acute brainstem syndrome; OR
    5.  Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; OR
    6. Symptomatic cerebral syndrome with NMOSD-typical brain lesions; AND
  5. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent used in the treatment of NMOSD (e.g., eculizumab, satralizumab) [medical record documentation required]; AND
  6. The patient has tried and had an inadequate response to satralizumab (Enspryng™) [medical record documentation required]; OR
  7. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to satralizumab (Enspryng™) [medical record documentation required]; AND
  8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  9. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval:

  1. The patient was approved through Blue Cross NC initial criteria for approval; OR
  2. The patient would have met initial criteria for approval at the time they started therapy; AND
  3. For patients with a diagnosis of neuromyelitis optica spectrum disorder (NMOSD):
    1. The patient has demonstrated clinical benefit while using the requested agent (i.e., reduction of relapses or disease stabilization) [medical record documentation required]; AND
    2. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent used in the treatment of NMOSD (e.g., eculizumab, satralizumab) [medical record documentation required]; AND
  4. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  5. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 365 days (1 year)
FDA Label Reference
MedicationIndicationDosingHCPCSMaximum Units*
inebilizumab-cdon (Uplizna™)
intravenous (IV) infusion		NMOSD in patients ≥18 years old
  • IV:
    Initial: 300 mg followed by 300 mg 2 weeks later
  • Subsequent doses (starting 6 months from first infusion): 300 mg every 6 months
J1823600

*Maximum units allowed for duration of approval

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
    4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
    5. Requirement of a change in the requested restricted product formulation; AND
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References:

All information referenced is from FDA package insert unless otherwise noted below

  1. .Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-63.

Policy Implementation/Update Information:

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.
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