Moda Health mepolizumab Prior Auth Coverage

Coverage Criteria for subcutaneous mepolizumab (Nucala)

Initial Therapy

Covered when ALL of the following relevant universal and indication-specific criteria are met

Universal Criteria: Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., benralizumab, omalizumab, reslizumab, dupilumab, tezepelumab)

Combination use is excluded

Severe Asthma: Patient is at least 6 years of age; AND patient must have severe disease; AND patient must have asthma with an eosinophilic phenotype indicated by blood eosinophils ≥300 cells/µL within previous 12 months OR ≥150 cells/µL within 6 weeks of dosing; AND must be used as add-on maintenance in patients regularly receiving BOTH medium-to-high dose inhaled corticosteroids AND an additional controller medication; AND will not be used for treatment of acute bronchospasm or status asthmaticus; AND patient must have two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days; AND baseline measurement of at least one objective status measure (e.g., systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, or FEV1)age ≥6; eosinophils ≥300 cells/µL within 12 months OR ≥150 cells/µL within 6 weeks

Used as add-on maintenance therapy

Eosinophilic Granulomatosis with Polyangiitis (EGPA): Patient is at least 18 years of age; AND has a confirmed diagnosis of EGPA; AND patient must have blood eosinophils ≥150 cells/µL within 6 weeks of dosing; AND patient has been on stable doses of concomitant oral corticosteroid therapy for at least 4 weeks (e.g., prednisone or prednisolone 7.5 mg/day); AND physician has assessed baseline disease severity utilizing an objective tool (e.g., BVAS)age ≥18; eosinophils ≥150 cells/µL

Baseline objective assessment required

Hypereosinophilic Syndrome (HES): Patient is at least 12 years of age; AND patient has been diagnosed with HES for at least 6 months prior to starting treatment; AND patient does NOT have non-hematologic secondary HES or FIP1L1-PDGFRα–positive HES; AND patient has a history of ≥2 HES flares within the previous 12 months; AND patient must have blood eosinophils ≥1000 cells/µL within 4 weeks of dosing; AND used in combination with stable doses of at least one other HES therapy (e.g., oral corticosteroids, immunosuppressive agents, cytotoxic therapy)age ≥12; eosinophils ≥1000 cells/µL

Exclude secondary causes and FIP1L1-PDGFRα–positive HES

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Patient is at least 18 years of age; AND patient has bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks; AND patient has failed at least 8 weeks of intranasal corticosteroid therapy; AND other causes of nasal congestion/obstruction have been ruled out; AND physician has assessed baseline disease severity utilizing an objective tool; AND therapy will be used in combination with intranasal corticosteroids unless not able to tolerate or contraindicatedage ≥18; symptom duration ≥8 weeks

CRSwNP requires prior intranasal corticosteroid trial

Continuation/Renewal

Renewal approval requires ALL of the following

Universal Renewal: Patient continues to meet the universal and other indication-specific relevant criteria identified in Initial Therapy; AND absence of unacceptable toxicity from the drug (examples: parasitic helminth infection, herpes zoster, severe hypersensitivity reactions such as anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash)

Assess for unacceptable toxicity

Severe Asthma Response: Improvement in asthma symptoms or exacerbations as evidenced by decrease in one or more of the following: use of systemic corticosteroids, two-fold or greater decrease in inhaled corticosteroid use for at least 3 days, fewer hospitalizations, fewer ER visits, fewer unscheduled visits to healthcare provider; OR improvement from baseline in FEV1

At least one of these is required

EGPA Response: Disease response as indicated by improvement in signs and symptoms compared to baseline as evidenced by one or more of the following: remission (BVAS=0 and prednisone/prednisolone daily dose ≤7.5 mg), decrease in maintenance systemic corticosteroid dose, improvement in BVAS score, improvement in asthma symptoms or exacerbations, or improvement in duration of remission/decrease in relapse rate

Response criteria for HES and CRSwNP

Covered when evidence of disease response is documented as specified per indication

Indication response options: For HES: decrease in HES flares from baseline (HES flare defined as worsening of clinical signs and symptoms or increasing eosinophils on ≥2 occasions resulting in need to increase oral corticosteroids or increase/add cytotoxic or immunosuppressive HES therapy). For CRSwNP: improvement in signs/symptoms compared to baseline in nasal obstruction, CT sinus opacification, or disease activity scoring tool (e.g., NPS, NC, SNOT-22) OR improvement in at least one of: reduction in polyp size, reduction in need for systemic corticosteroids, improvement in quality of life, improvement in sense of smell, or reduction of impact of comorbidities.see indication-specific definitions

Preserve indication-specific language for documentation

The policy excludes concurrent use of mepolizumab with other specified biologic monoclonal antibodies. Combination use with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., benralizumab, omalizumab, reslizumab, dupilumab, tezepelumab) is not permitted. For Hypereosinophilic Syndrome (HES), the policy additionally excludes patients with non-hematologic secondary HES (for example, drug hypersensitivity, parasitic helminth infection, HIV infection, or non-hematologic malignancy) and excludes FIP1L1–PDGFRα kinase–positive HES; HES coverage requires prior diagnosis for ≥6 months and other HES-specific criteria as shown elsewhere in the policy.

Where applicable, Medicare guidance takes precedence. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) from CMS must be followed for outpatient Part B drugs. The plan may consider additional indications at its discretion consistent with its coverage policies.

Summary: mepolizumab must not be used in combination with other monoclonal antibodies targeting IgE, IL‑4, IL‑5, or IgG2 lambda. Concurrent therapy with agents such as benralizumab, omalizumab, reslizumab, dupilumab, or tezepelumab is excluded and may result in non‑coverage.

Coding, Quantity Limits, and Dosing

Covered HCPCS CodesHCPCSCovered

J2182

Injection, mepolizumab, 1 mg: 1 billable unit = 1 mg

NDCs (product-specific)NDC

00173-0881-xx	Nucala 100 mg/mL lyophilized powder single-dose vial
00173-0892-xx	Nucala 100 mg/mL single-dose prefilled autoinjector or syringe (cartons of 1)
00173-0904-xx	Nucala 40 mg/0.4 mL single-dose prefilled syringe (cartons of 1)

Covered ICD-10 CodesICD-10Covered

D72.110	Idiopathic hypereosinophilic syndrome [IHES]
D72.111	Lymphocytic Variant Hypereosinophilic Syndrome [LHES]
D72.119	Hypereosinophilic syndrome [HES], unspecified
J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J45.50	Severe persistent asthma, uncomplicated
J82.81	Eosinophilic pneumonia, NOS
J82.82	Acute eosinophilic pneumonia

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Blood eosinophil thresholds by indication

Severe Asthma (blood eosinophils)≥ 300 cells/µL within previous 12 months OR ≥ 150 cells/µL within 6 weeks of dosing

EGPA (blood eosinophils)≥ 150 cells/µL within 6 weeks of dosing

Hypereosinophilic Syndrome (HES) (blood eosinophils)≥ 1000 cells/µL within 4 weeks of dosing

Prior Authorization, Documentation, and Billing Actions Required

Prior Authorization

Prior Authorization Required — show indication-specific criteria and dosing

Prior authorization is required. Demonstrate that the member meets indication-specific criteria including age, diagnosis, baseline objective disease severity measures, and blood eosinophil counts where applicable.

Indication-specific dosing must be reflected on the prior authorization request; use HCPCS J2182 for billing (1 unit = 1 mg).
Document age and confirmed diagnosis, baseline objective disease severity measures (e.g., FEV1, BVAS, NPS, SNOT-22), and baseline blood eosinophil count within the timeframes specified by indication.

Billing Rule

PA and Billing — indication-specific dosing; bill with J2182

Use J2182 (injection, mepolizumab, 1 mg) for billing and ensure PA dosing aligns with the approved indication-specific dose (e.g., 40 mg q4w for ages 6–11; 100 mg q4w for ≥12 with severe eosinophilic asthma or CRSwNP; 300 mg q4w as three 100 mg injections for EGPA and HES).

Background

Mepolizumab is an anti‑IL‑5 monoclonal antibody indicated as add‑on maintenance therapy for eosinophil‑driven disorders. It is used across several indications including severe eosinophilic asthma, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP). The agent reduces eosinophil activity by targeting interleukin‑5 and dosing/age thresholds, as well as indication‑specific eosinophil counts, are required for coverage decisions.

Definitions and Clinical Terms

inv-22: Severe asthma (as used in policy) — definition and clinical features

Definition (policy)Asthma characterized by persistent symptoms, frequent SABA use, nighttime awakenings, very limited activities, frequent exacerbations requiring systemic corticosteroids, and reduced lung function (percent predicted FEV1 <60% may be present)

Required age for coveragePatient must be at least 6 years of age

Treatment contextUsed as add-on maintenance therapy in patients regularly receiving medium-to-high dose inhaled corticosteroids plus an additional controller medication

Clinical severity features (examples)Symptoms throughout the day; nighttime awakenings often 7x/week; SABA several times per day; extremely limited normal activities; FEV1 <60% predicted; frequent exacerbations requiring systemic corticosteroids

inv-23: EGPA (policy definition) — diagnostic criteria summary

OpenPayer

Mepolizumab (subcutaneous) coverage

Coverage Criteria for subcutaneous mepolizumab (Nucala)

Coding, Quantity Limits, and Dosing

Prior Authorization, Documentation, and Billing Actions Required

Background

Definitions and Clinical Terms