Fasenra (benralizumab) — Medical Mutual

Initial criteria

• Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, etc.); AND
• Will NOT be used for treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome, etc.) or relief of acute bronchospasm or status asthmaticus; AND
• Severe Asthma:
• • Patient age ≥ 6 years; AND
• • Severe disease; AND
• • Asthma with an eosinophilic phenotype indicated by blood eosinophils ≥150 cells/µL OR dependent on systemic corticosteroids; AND
• • Used as add-on maintenance treatment in patients regularly receiving BOTH medium/high-dose inhaled corticosteroids AND an additional controller medication (e.g., LABA, LAMA, leukotriene modifiers, etc.); AND
• • ≥2 exacerbations in previous year requiring oral corticosteroids ≥ 3 days (in addition to maintenance therapy); AND
• • Baseline measurement of at least one of: systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits due to condition, or FEV1; AND
• EGPA/Churg-Strauss Syndrome:
• • Patient age ≥ 18 years; AND
• • Confirmed diagnosis of EGPA; AND
• • Relapsing or refractory disease; AND
• • Prior treatment with oral corticosteroids with or without immunosuppressive therapy; AND
• • Stable oral corticosteroid dose for ≥ 4 weeks prior to starting Fasenra; AND
• • Physician assessed baseline disease severity with objective measure (e.g., BVAS, history of asthma symptoms, duration of remission, rate of relapses, etc.); AND
• EGPA defined as: history/presence of asthma, eosinophils >10% or >1000 cells/mm3, and ≥2 of neuropathy, pulmonary infiltrates, sinonasal abnormalities, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity, or histopathologic evidence.

Reauthorization criteria

• Patient continues to meet universal and indication-specific criteria; AND
• No unacceptable toxicity (e.g., parasitic infection, severe hypersensitivity reactions); AND
• Severe Asthma: Improvement in asthma symptoms/exacerbations as evidenced by decrease in one or more of: systemic corticosteroid use, ≥ two-fold reduction in inhaled corticosteroid use × at least 3 days, hospitalizations, ER visits, unscheduled visits, or improvement in FEV1 compared to baseline; OR
• EGPA: Disease response with improvement in signs/symptoms compared to baseline as evidenced by one or more of: remission (BVAS=0 plus prednisolone/prednisone ≤ 7.5 mg/day), decreased relapse frequency, decreased daily corticosteroid dose, or improvement on disease activity tool (VDI, BVAS, FVC, FEV1, ACQ-6, etc.)

Approval duration

initial 6 months, renewal 12 months