Neighborhood Health Plan RI Nucala Coverage Update

Coverage and Medical Necessity Criteria

Initial Approval — Universal Criteria and Severe Asthma

Covered when ALL of the following are met:

Universal criteria: Must not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., Dupixent, Fasenra, Xolair, Tezspire).

Reference to prohibited concurrent biologics

Age: Patient is at least 6 years of age.

Severe asthma age requirement

Severity: Patient must have severe disease as defined by the policy (severity components may include frequent symptoms, nighttime awakenings, high SABA use, major activity limitation, FEV1 reduction, or frequent/intense exacerbations).

Severity components referenced in policy

Specialist involvement: Nucala is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist.

Provider specialty requirement

Eosinophilic phenotype: Blood eosinophils ≥300 cells/µL within the previous 12 months OR ≥150 cells/µL within 6 weeks of dosing OR patient is dependent on systemic corticosteroids.

Indicates eosinophilic phenotype

Maintenance therapy: Patient is adherent to optimized maintenance therapy: medium- to high-dose inhaled corticosteroids AND an additional controller medication (e.g., LABA, LAMA, leukotriene modifier), unless contraindicated or not tolerated.

Optimized background therapy required

Not for acute use: Will not be used for treatment of acute bronchospasm or status asthmaticus.

Clinical usage restriction

Exacerbation history: Patient has inadequate asthma control with two or more exacerbations in the previous year requiring additional medical treatment (e.g., systemic corticosteroids for ≥3 days, ED/urgent care visits, or hospitalizations) despite maintenance therapy.

Exacerbation requirement

Baseline assessment: Baseline measurement of at least one of the following for assessment of clinical status: systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, or FEV1.

Baseline measures to assess clinical status

Initial Approval — EGPA

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age.

EGPA age requirement

Specialist involvement: Nucala is prescribed by, or in consultation with, a pulmonologist, rheumatologist, or allergist/immunologist.

Provider specialty requirement

Diagnosis: Patient has a confirmed diagnosis of EGPA (Eosinophilic Granulomatosis with Polyangiitis).

EGPA diagnostic criteria referenced

Eosinophils: Blood eosinophils ≥150 cells/µL within 6 weeks of dosing.

EGPA eosinophil threshold

Initial Approval — Hypereosinophilic Syndrome (HES)

Covered when ALL of the following are met:

Age: Patient is at least 12 years of age.

HES age requirement

Duration: Patient has been diagnosed with HES for at least 6 months prior to starting treatment.

Chronicity requirement

Exclude secondary causes: Patient does NOT have non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic infection, HIV, non-hematologic malignancy) and does NOT have FIP1L1-PDGFRα kinase–positive HES.

Exclusion of secondary or kinase-positive HES

Flare history: History of two or more HES flares within the previous 12 months requiring escalation in therapy (e.g., documented clinical worsening or increased eosinophil counts necessitating treatment change).

Initial Approval — CRSwNP

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age.

CRSwNP age requirement

Disease duration: Patient has bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks.

Symptom duration requirement

Intranasal corticosteroid failure: Patient has failed at least 8 weeks of intranasal corticosteroid therapy.

Prerequisite medical therapy

Biologic treatment indicators: Patient has at least three (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 of systemic corticosteroids per year or >3 months of low-dose corticosteroids; significant impairment in quality of life; significant loss of smell; comorbid asthma.

Initial and continuation therapy criteria

Covered when ALL of the following are met:

Indication: Medication is prescribed for an indicated diagnosis such as severe eosinophilic asthma, EGPA, HES, or CRSwNP listed in the Covered Diagnosis Codes appendix.

See Covered Diagnosis Codes appendix

Dose appropriateness: Prescribed dose matches the indication: 100 mg SC every 4 weeks for adults/adolescents (≥12 years) with severe eosinophilic asthma and CRSwNP; 40 mg SC every 4 weeks for pediatric patients 6–11 years (single-dose vial only); 300 mg SC every 4 weeks for EGPA and HES administered as three separate 100 mg injections (administer injections at least 2 inches apart).

Dose and administration details

Clinical response for CRSwNP: For continuation in CRSwNP, there must be documented disease response compared to baseline by improvement in signs/symptoms, imaging, or validated scoring tools OR improvement in at least one response criterion (reduced polyp size, reduced systemic corticosteroid need, improved quality of life, improved sense of smell, or reduction of comorbidity impact).

Response assessment examples include NPS, NC score, SNOT-22

Exclusions: Concurrent use with other biologic monoclonal antibody therapies is not permitted. Specifically, mepolizumab must not be used in combination with other anti-IgE, anti-IL-4, anti-IL-5, or IgG2 lambda monoclonal antibody agents (for example, Dupixent, Fasenra, Xolair, Tezspire). In addition, indication-specific anatomic and disease exclusions apply for CRSwNP (see below) and HES excludes secondary non‑hematologic causes and FIP1L1‑PDGFRα kinase‑positive disease.

CRSwNP-specific anatomic and disease exclusions include: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril, disease lacking signs of type 2 inflammation, cystic fibrosis, and mucoceles. For HES, patients with non‑hematologic secondary HES (e.g., drug hypersensitivity, parasitic infection, HIV, non‑hematologic malignancy) or FIP1L1‑PDGFRα kinase‑positive HES are excluded from coverage.

No additional unspecified exclusions are listed beyond the concurrent biologic use prohibition and the indication‑specific anatomic, secondary‑cause, and kinase‑positive exclusions described elsewhere in this policy.

Combination therapy with other biologics is explicitly prohibited: mepolizumab must not be used in combination with other anti‑IgE, anti‑IL‑4, anti‑IL‑5, or IgG2 lambda monoclonal antibody agents and such concurrent use may trigger denial of coverage.

Continuation criteria for CRSwNP require documented improvement compared to baseline. Continued therapy without documented improvement in signs, symptoms, imaging, or validated disease activity scores (for example NPS, NC score, SNOT‑22) may be considered not medically necessary and could result in non‑coverage.

Billing, Codes, and Clinical Thresholds

Quantity limits / NDC / Billable unitsNDC

NDC - 100 mg/mL single dose vial	3 vials every 28 days
NDC - 100 mg/mL single dose prefilled autoinjector or syringe	3 autoinjectors or syringes every 28 days
NDC - 40 mg/0.4 mL single-dose prefilled syringe	1 syringe every 28 days
Billable unit - Severe Asthma	100 billable units every 28 days
Billable unit - EGPA	300 billable units every 28 days
Billable unit - HES	300 billable units every 28 days
Billable unit - CRSwNP	100 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 ICD-10 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

Severe asthma eosinophil thresholdBlood eosinophils ≥ 300 cells/µL within the previous 12 months OR ≥ 150 cells/µL within 6 weeks of dosing; alternatively, systemic corticosteroid dependence qualifies

Age requirementPatient is at least 6 years of age

Documentation requiredBaseline measurement of clinical status (e.g., systemic corticosteroid use, inhaled corticosteroid use, hospitalizations/ER visits, or FEV1)

EGPA eosinophil threshold

EGPA eosinophil thresholdBlood eosinophils ≥ 150 cells/µL within 6 weeks of dosing

Age requirement

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization and quantity limits

Coverage is provided for an initial authorization period of six months. Authorizations may be renewed for up to 12 months based on documentation of continued clinical benefit. Quantity limits apply per NDC as listed below; requests exceeding these limits require justification and will be reviewed for medical necessity.

Initial authorization: 6 months; Renewal: up to 12 months
Quantity limits are enforced per NDC (see dosage and NDC list)

Billing Rule

Prior authorization and billing

Billing must follow HCPCS and NDC guidance. Use HCPCS code J2182 (Injection, mepolizumab, 1 mg) with the appropriate number of units billed (1 unit = 1 mg). When applicable, include the NDC on the claim to reflect the specific product dispensed (vial, prefilled syringe, or autoinjector).

Background and Indications

Background: Mepolizumab (Nucala) is an anti‑IL‑5 monoclonal antibody indicated for multiple eosinophilic disorders including severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP). Its mechanism targets interleukin‑5 to reduce eosinophil activity and counts. Indication‑specific eligibility requirements and exclusions are applied (for example, age limits, eosinophil thresholds, requirement to rule out alternative causes, and prohibition on concurrent use with other specified biologics).

Key Definitions and Disease Criteria

EGPA — definition and diagnostic components

Core EGPA definitionHistory or presence of asthma plus blood eosinophil level >10% or absolute eosinophil count >1000 cells/mm3

Required additional featuresTwo or more of: histopathologic eosinophilic vasculitis/perivascular eosinophilic infiltration/granulomatous inflammation, neuropathy, pulmonary infiltrates, sinonasal abnormalities, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity

Specialist involvementPrescribed by or in consultation with a pulmonologist, rheumatologist, or allergist/immunologist

Severe asthma components — severity features

Key severity componentsSymptoms throughout the day, frequent nighttime awakenings, SABA use several times per day, and extreme limitation of normal activities

Objective severity indicators

OpenPayer

Nucala (mepolizumab) subcutaneous therapy — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing, Codes, and Clinical Thresholds

Prior Authorization, Documentation, and Denial Risks

Background and Indications

Key Definitions and Disease Criteria