Enspryng (satralizumab-mwge) — Medical Mutual

Initial criteria

• Patient age ≥ 18 years; AND
• Patient has been evaluated and screened for hepatitis B virus (HBV) prior to initiating treatment and confirmed negative for active HBV; AND
• Patient has been evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Live or live-attenuated vaccinations will not be administered within the 4 weeks prior to start of therapy and will not be administered concurrently while on treatment; AND
• Patient is not on concomitant therapy with, and does not have hypersensitivity to, other interleukin-6 (IL-6) receptor antagonists (e.g., tocilizumab, 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, cyclophosphamide, mitoxantrone) [Note: corticosteroids and/or immunosuppressants such as azathioprine or mycophenolate are allowed]; AND
• Patient has not previously received, and will not concomitantly receive, other immunosuppressant procedures (total body irradiation, bone marrow transplant); AND
• Patient has not received therapy within the prior 6 months with anti-BLyS monoclonal antibody (e.g., belimumab); AND
• Patient has not received therapy within the prior 6 months with therapies for prevention of multiple sclerosis relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate); AND
• Patient will not concomitantly receive therapy with complement-inhibitors (e.g., eculizumab, ravulizumab); AND
• Patient will not concomitantly receive therapy with anti-CD20-directed antibody (e.g., rituximab); AND
• Patient will not concomitantly receive therapy with anti-CD19-directed antibody (e.g., inebilizumab); AND
• Patient has a confirmed diagnosis of NMOSD with: seropositive aquaporin-4 (AQP4) IgG antibodies; AND at least one core clinical characteristic; AND alternative diagnoses excluded; AND
• Patient has a history of ≥ 1 relapse requiring rescue therapy within prior year OR ≥ 2 relapses requiring rescue therapy within prior 2 years; AND
• Patient has Expanded Disability Status Score (EDSS) ≤ 6.5; AND
• Patient is at risk of a disabling relapse of NMOSD for which oral agents (corticosteroids, immunosuppressants such as azathioprine, mycophenolate) alone are inadequate and biologic therapy is necessary

Reauthorization criteria

• Patient continues to meet universal and indication-specific relevant criteria (excluding prerequisite therapy); AND
• Absence of unacceptable toxicity from the drug (examples: severe hypersensitivity reactions, serious infections, elevated liver enzymes, severe neutropenia); AND
• Disease response as indicated by stabilization or improvement in one or more of the following: decrease in acute relapses, improved stability, improvement in EDSS, reduced hospitalizations, reduction/discontinuation in plasma exchange treatments, or reduction/discontinuation of corticosteroids without relapse

Approval duration

6 months initial, 12 months renewal