Neighborhood Health Plan RI Nucala Coverage Update

Coverage Criteria for Mepolizumab (Nucala)

Initial therapy — Severe Asthma

Covered when ALL of the following universal and severe asthma-specific criteria are met

Universal criteria: Must not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents;

See examples: Dupixent, Fasenra, Nucala, Xolair, Tezspire

Patient age and prescriber: Patient is at least 6 years of age; Nucala is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist;

Disease phenotype: Asthma with eosinophilic phenotype defined as blood eosinophils ≥ 300 cells/µL within previous 12 months or ≥ 150 cells/µL within 6 weeks of dosing OR patient is dependent on systemic corticosteroids;blood eosinophils ≥300 cells/µL within 12 months OR ≥150 cells/µL within 6 weeks OR systemic corticosteroid-dependent

Background therapy adherence: Patient is adherent to medium- to high-dose inhaled corticosteroids AND an additional controller medication (e.g., long-acting beta agonist, long-acting muscarinic antagonist, leukotriene modifier), unless contraindicated or not tolerated;

Exacerbation history: Inadequate asthma control with two or more exacerbations in the previous year requiring additional medical treatment (e.g., oral corticosteroids for ≥3 days, ED/urgent care visits, or hospitalizations) despite maintenance therapy;>=2 exacerbations/year

Baseline measurement of at least one measure (systemic corticosteroid use, inhaled corticosteroid use, hospitalizations/ER/unscheduled visits, or FEV1) required

Acute use exclusion: Will not be used for treatment of acute bronchospasm or status asthmaticus;

Initial therapy — EGPA

Covered when ALL of the following EGPA criteria are met

Age and prescriber: Patient is at least 18 years of age; Nucala is prescribed by, or in consultation with, a pulmonologist, rheumatologist, or allergist/immunologist;

Diagnosis: Confirmed diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA/Churg-Strauss Syndrome);

EGPA diagnostic features described in policy definitions

Eosinophil and steroid stability: Blood eosinophils ≥150 cells/µL within 6 weeks of dosing; 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);blood eosinophils ≥150 cells/µL within 6 weeks; stable oral corticosteroids ≥4 weeks

Physician must assess baseline disease severity using an objective tool (e.g., BVAS)

Initial therapy — HES

Covered when ALL of the following HES criteria are met

Age and disease duration: Patient is at least 12 years of age and has been diagnosed with HES for at least 6 months prior to starting treatment;

Exclusion of secondary causes: Does NOT have non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic infection, HIV, non-hematologic malignancy) or FIP1L1-PDGFRα kinase–positive HES;

Flare history and eosinophils: History of ≥2 HES flares in the prior 12 months AND blood eosinophils ≥1000 cells/µL within 4 weeks of dosing;>=2 flares; eosinophils ≥1000 cells/µL within 4 weeks

Must be used in combination with stable doses of at least one other HES therapy (e.g., oral corticosteroids, immunosuppressive agents, cytotoxic therapy)

Initial therapy — CRSwNP

Covered when ALL of the following CRSwNP criteria are met

Age: Patient is at least 18 years of age;

Disease characteristics: Bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks and failure of at least 8 weeks of intranasal corticosteroid therapy;>=8 weeks

Biologic treatment indicators: Patient has at least 3 of the following indicators for biologic treatment: evidence of type 2 inflammation (e.g., tissue eosinophils ≥10/hpf, blood eosinophils ≥150 cells/µL, or total IgE ≥100 IU/mL); >2 courses systemic corticosteroids per year or >3 months low-dose corticosteroids; significant quality-of-life impairment; significant loss of smell; comorbid asthma;at least 3 indicators

Renewal criteria

Renewal criteria — coverage continues when ALL relevant criteria are met

Continued eligibility: Patient continues to meet the universal and indication-specific relevant criteria and has absence of unacceptable toxicity from the drug (examples include parasitic/helminth infection, herpes zoster, severe hypersensitivity reactions);

Severe asthma response: Improvement in asthma symptoms or exacerbations evidenced by decrease in systemic corticosteroid use, two-fold or greater decrease in inhaled corticosteroid use for ≥3 days, fewer hospitalizations/ER/unscheduled visits, OR improvement in FEV1 from baseline;

EGPA response: Remission (BVAS=0 and prednisone/prednisolone ≤7.5 mg/day), decreased maintenance systemic corticosteroid dose, improved BVAS, improved asthma symptoms/exacerbations, or longer remission/decreased relapse rate;

HES response: Decrease in HES flares from baseline (HES flare defined as worsening signs/symptoms or increasing eosinophils on ≥2 occasions resulting in need to increase corticosteroids or add/increase cytotoxic or immunosuppressive therapy);

Medically necessary indications and response criteria

Covered when disease-specific response criteria or indications consistent with FDA labeling and clinical literature are met

Indications covered: Severe eosinophilic asthma; Eosinophilic Granulomatosis with Polyangiitis (EGPA/Churg-Strauss); Hypereosinophilic Syndrome (HES); Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Indications and response definitions as specified in policy

EGPA response criteria: Disease response evidenced by one or more: remission (BVAS=0 and prednisone ≤7.5 mg/day), decrease in maintenance systemic corticosteroid dose, improvement in BVAS vs baseline, improvement in asthma symptoms/exacerbations, or improved remission duration/decreased relapse rate.

From policy EGPA section

HES response criteria: Disease response evidenced by decrease in HES flares from baseline; HES flare defined as worsening signs/symptoms or increased eosinophils on ≥2 occasions resulting in need to increase oral corticosteroids or add/increase cytotoxic or immunosuppressive therapy.

From policy HES section

Use of Nucala (mepolizumab) in combination with other monoclonal biologic agents is not permitted. Combination therapy with anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (examples include Dupixent, Fasenra, Xolair, Tezspire) is excluded and requests that propose concurrent use should be denied.

For CRSwNP (chronic rhinosinusitis with nasal polyps), coverage is limited to patients who meet the CRSwNP criteria and do not have excluded conditions. Exclusions specific to CRSwNP include antrochoanal polyps, nasal septal deviation occluding a nostril, lack of type 2 inflammation, cystic fibrosis, and mucoceles. Other causes of nasal obstruction must be ruled out and therapy is intended to be used with intranasal corticosteroids unless contraindicated.

Where applicable, Medicare program requirements take precedence. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) must be followed for Medicare members; links to the CMS coverage database are provided in Appendix materials for reference.

The plan retains discretion to consider additional indications on an individual basis. In the absence of an applicable NCD/LCD/LCA for INTEGRITY (Medicare-Medicaid Plan) members, Neighborhood will apply the policy criteria but will give individual consideration to requests based on submitted clinical information.

Nucala is not appropriate for acute management of airway emergencies. It must not be used for treatment of acute bronchospasm or status asthmaticus; requests for use in these settings are non‑covered.

Coverage is intended to align with FDA-approved labeling and the relevant clinical literature. The policy criteria were adopted to ensure use for medically accepted indications and to promote cost-effective options where appropriate. Uses outside FDA labeling or accepted clinical evidence are generally not covered unless specifically allowed by plan discretion or applicable Medicare coverage determinations.

Coding, Dosing, and Diagnostic Criteria

Quantity limits and billing unitsNDC | mixed

NDC (100 mg/mL vial)	100 mg/mL single dose vial for injection: 3 vials every 28 days
NDC (100 mg/mL autoinjector/syringe)	100 mg/mL single dose prefilled autoinjector or syringe for injection: 3 autoinjectors or syringes every 28 days
NDC (40 mg/0.4 mL prefilled syringe)	40 mg/0.4 mL single-dose prefilled syringe for injection: 1 syringe every 28 days
Billable units (severe asthma/CRSwNP)	100 billable units every 28 days
Billable units (EGPA/HES)	300 billable units every 28 days

HCPCS CodeHCPCS

J2182

Injection, mepolizumab, 1 mg

NDCNDC

00173-0881-xx	100 mg/mL single dose vial
00173-0892-xx	100 mg/mL single dose prefilled autoinjector or syringe (cartons of 1)

Covered Diagnosis CodesICD-10Covered

D72.1	Eosinophilia
J45.50	Severe persistent asthma, uncomplicated
J45.51	Severe persistent asthma with (acute) exacerbation
J45.52	Severe persistent asthma with status asthmaticus
J82.81	Eosinophilic pneumonia, NOS
J82.82	Acute eosinophilic pneumonia
J82.83	Eosinophilic asthma
J82.89	Other pulmonary eosinophilia, not elsewhere classified
M30.1	Polyarteritis with lung involvement [Churg-Strauss]

Severe asthma eosinophil threshold

ThresholdBlood eosinophils ≥ 300 cells/µL within the previous 12 months OR ≥ 150 cells/µL within 6 weeks of dosing (or systemic corticosteroid dependence)

Age requirementPatient is at least 6 years of age

Prescriber requirementPrescribed by or in consultation with a pulmonologist or allergist/immunologist

EGPA eosinophil threshold

ThresholdBlood eosinophils ≥ 150 cells/µL within 6 weeks of dosing

Age requirement

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Initial approvals are for six months and are eligible for 12-month renewal. Claims should be billed using HCPCS code J2182 (Injection, mepolizumab, 1 mg; 1 billable unit = 1 mg).

Prior authorization required; initial approval = 6 months; eligible for 12-month renewal
Billing / coding: HCPCS J2182 (1 mg per unit)

Step Therapy

Step Therapy Exemption / Intent

MMP members who received this medication within the past 365 days are exempt from step therapy requirements. The step therapy criteria are intended to ensure use consistent with FDA labeling and to encourage use of cost-effective options when appropriate.

Members with documented receipt of the medication within the past 365 days are exempt from step therapy
Step therapy intent: align use with FDA labeling and promote cost-effective alternatives when appropriate

Background on Mepolizumab (Nucala)

Mepolizumab (Nucala) is a monoclonal antibody that targets interleukin-5 (anti‑IL‑5) and is indicated for eosinophilic-driven disorders. The agent is used in adults and pediatric patients for conditions characterized by elevated eosinophils, including severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP).

Clinical trials and evidence reviews supporting Nucala demonstrate reductions in exacerbations and improvements in disease-specific outcomes for eosinophilic phenotypes when used according to labeled dosing and patient selection criteria. The plan’s criteria reflect those labeled indications and the published clinical literature while including safeguards (for example, exclusions for combination biologic therapy and requirement for objective baseline assessments) to ensure appropriate patient selection and monitoring.

Definitions and Clinical Terms

EGPA (Eosinophilic Granulomatosis with Polyangiitis)

DefinitionEGPA defined by history or presence of asthma plus blood eosinophil level >10% or absolute eosinophil count >1000 cells/mm3 and two or more specific criteria (e.g., eosinophilic vasculitis, neuropathy, pulmonary infiltrates, sinonasal abnormalities, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity)

Diagnostic componentsHistopathologic evidence of eosinophilic vasculitis or eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; sinonasal abnormalities; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positivity

Prescriber and agePolicy requires patient be at least 18 years of age and prescribed by or in consultation with a pulmonologist, rheumatologist, or allergist/immunologist

Severe asthma (components)

Clinical featuresFrequent symptoms throughout the day; nighttime awakenings (often nightly); frequent SABA use several times per day; marked limitation of normal activities

OpenPayer

Nucala (mepolizumab) subcutaneous therapy — Coverage Criteria

Coverage Criteria for Mepolizumab (Nucala)

Coding, Dosing, and Diagnostic Criteria

Provider Requirements, Authorization, and Documentation

Background on Mepolizumab (Nucala)

Definitions and Clinical Terms