Coverage is provided in the following conditions:
Universal Criteria
ï‚· Must not be used in combination with another anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody (e.g., benralizumab, omalizumab, reslizumab, dupilumab, etc.); AND
Severe Asthma
ï‚· Patient is at least 6 years of age; AND
ï‚· Patient must have severe* disease; AND
ï‚· Patient must have asthma with an eosinophilic phenotype defined as blood eosinophils ≥300 cells/µL within previous 12 months or ≥150 cells/µL within 6 weeks of dosing OR the patient is dependent on systemic corticosteroids; AND
ï‚· Must be used for add-on maintenance treatment in patients regularly receiving BOTH of the following:
o Medium to high-dose inhaled corticosteroids; AND
o An additional controller medication (e.g., long-acting beta agonist, leukotriene modifiers, etc.); AND
ï‚· Will not be used for treatment of acute bronchospasm or status asthmaticus; AND
ï‚· Patient must have two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to the regular maintenance therapy defined above); AND
ï‚· Baseline measurement of at least one of the following for assessment of clinical status:
o Use of systemic corticosteroids
o Use of inhaled corticosteroids
o Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition
o Forced expiratory volume in 1 second (FEV1)
Eosinophilic Granulomatosis with Polyangiitis (EGPA)/Churg-Strauss Syndrome
ï‚· Patient is at least 18 years of age; AND
ï‚· Patient has a confirmed diagnosis of EGPA§ (aka Churg-Strauss Syndrome); AND
ï‚· Patient must have blood eosinophils ≥150 cells/µL within 6 weeks of dosing; AND
ï‚· Patient has been on stable doses of concomitant oral corticosteroid therapy for at least 4 weeks (i.e., prednisone or prednisolone at a dose of 7.5 mg/day); AND
ï‚· Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., Birmingham Vasculitis Activity Score [BVAS], history of asthma symptoms and/or exacerbations, duration of remission, or rate of relapses, etc.)
Hypereosinophilic Syndrome (HES)
ï‚· Patient is at least 12 years of age; AND
ï‚· Patient has been diagnosed with HES for at least 6 months prior to starting treatment; AND
ï‚· Patient does NOT have non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy) or FIP1L1- PDGFRα kinase-positive HES; AND
ï‚· Patient has a history of 2 or more HES flares within the previous 12 months (e.g., documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy); AND
ï‚· Patient must have blood eosinophils ≥1000 cells/µL within 4 weeks of dosing; AND
ï‚· Used in combination with stable doses of at least one other HES therapy (e.g., oral corticosteroids, immunosuppressive agents, cytotoxic therapy, etc.)
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
ï‚· Patient is at least 18 years of age; AND
ï‚· Patient has bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks; AND
ï‚· Patient has failed on at least 8 weeks of intranasal corticosteroid therapy; AND
ï‚· Patient has at least four (4) of the following indicators for biologic treatment [Note: Patients with a history of sino-nasal surgery are only required to have at least three (3) of the indicators]:
o Patient has evidence of type 2 inflammation (i.e., biological biomarkers indicating immune dysregulation and epithelial barrier dysfunction)
o Patient has required two or more short courses of systemic corticosteroids within the previous year o Disease significantly impairs the patient’s quality of life o Patient has experienced significant loss of smell o Patient has a comorbid diagnosis of asthma; AND
ï‚· Patient does not have any of the following:
o Antrochoanal polyps o Nasal septal deviation that would occlude at least one nostril
o Disease with lack of signs of type 2 inflammation o Cystic fibrosis o Mucoceles; AND
ï‚· Other causes of nasal congestion/obstruction have been ruled out (e.g., acute sinusitis, nasal infection or upper respiratory infection, rhinitis medicamentosa, tumors, infections, granulomatosis, etc.); AND
ï‚· Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
ï‚· Therapy will be used in combination with intranasal corticosteroids unless not able to tolerate or is contraindicated
