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    Enspryng™

    Drug - Enspryng™ (satralizumab injection) [Genentech Inc.]

    March 2021

    Therapeutic area - Cytokine and CAM Antagonists

    Initial approval criteria

    • Patient is ≥ 18 years AND
    • Patient has a confirmed diagnosis based on the following:
      • Patient was found to be seropositive for aquaporin-4 (AQP4) IgG antibodies AND
      • Patient has ≥ 1 core clinical characteristic (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions, symptomatic cerebral syndrome with NMOSD-typical brain lesions) AND
      • Alternative diagnoses have been excluded (e.g., multiple sclerosis, sarcoidosis, cancer, chronic infection) AND
    • Patient has a history of ≥ 1 relapses that required rescue therapy within the prior year or ≥ 2 relapses that required rescue therapy within the prior 2 years AND
    • Patient has an Expanded Disability Status Score (EDSS) of ≤ 6.5 (e.g., requires 2 walking aids [pair of canes, crutches, etc.] to walk about 20 m without resting) AND
    • Patient is at risk of having a disabling relapse of NMOSD for which oral agents (e.g., corticosteroids and immunosuppressants such as azathioprine and mycophenolate) alone are inadequate and biologic therapy is necessary AND
    • Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment and confirmed negative for active HBV AND
    • Patient has NOT received any live or live-attenuated vaccinations in the 4-weeks prior to or non-live vaccinations in the 2-weeks prior to, the start of therapy AND
    • Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment AND
    • Patient does NOT have an active infection, including clinically important localized infections AND
    • Satralizumab will NOT be administered concurrently with live vaccines AND
    • Patient is NOT on concomitant therapy with, and does NOT have hypersensitivity to, other interleukin-6 (IL-6) receptor antagonists (e.g., tocilizimab, sarilumab) AND
    • Patient has NOT previously received, and will NOT concomitantly receive therapy with, other drugs which can result in prolonged additive immunosuppression (e.g., alemtuzumab, cladribine, with corticosteroids and/or immunosuppressants such as azathioprine or mycophenolate are allowed] OR other immunosuppressant procedures (e.g., total lymphoid irradiation, bone marrow transplant) AND
    • Patient has NOT received therapy within the prior 6 months with any of the following:
      • Anti-BLyS monoclonal antibody (e.g., belimumab) OR
      • Therapies for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide, or dimethyl fumarate) AND
    • Patient will NOT concomitantly receive therapy with any of the following:
      • Complement-inhibitors (e.g., eculizumab, ravulizumab) OR
      • Anti-CD20-directed antibody (e.g., rituximab) OR
      • Anti-CD19-directed antibody (e.g., inebilizumab) AND
    • If Enspryng is prescribed for patient self-administration, prescriber attests that proper training in subcutaneous injection technique has been provided to the patient or the patient’s caregiver
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Disease response as indicated by stabilization/improvement in any of the following: neurologic symptoms as evidenced by a decrease in acute relapses, stability, or improvement in EDSS, reduced hospitalizations, reduction/discontinuation in plasma exchange treatments, and/or reduction/discontinuation of corticosteroids without relapse AND
    • Absence of unacceptable toxicity from the drug (e.g., severe hypersensitivity reactions, serious infections, severe hepatotoxicity, severe neutropenia)
    • Renewal approval is for 12 months

    Quantity limits

    Loading Doses: 1 mL prefilled syringe (120 mg) on days 1, 15, and 29 (total of 3 syringes)

    Maintenance Doses: 1 mL prefilled syringe (120 mg) every 28 days

    Billing for Enspryng

    • If Enspryng is prescribed for patient self-administration, it must be billed as a pharmacy claim
    • If Enspryng is administered by the provider, it must be billed as a medical claim

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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