Neighborhood Health Plan Nucala Coverage & Prior Auth

Medical Necessity and Coverage Criteria

Severe Asthma

Covered when ALL of the following are met for Severe Asthma:

Severe Asthma criteria: Member is at least 6 years of age; AND Member must have severe disease; AND Nucala is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist; AND Member has 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 member is dependent on systemic corticosteroids; AND Member is adherent to current treatment with both of the following at optimized doses: medium-to-high dose inhaled corticosteroids AND an additional controller medication (e.g., LABA, LAMA, leukotriene modifier) unless contraindicated or not tolerated; AND Will not be used for treatment of acute bronchospasm or status asthmaticus; AND Member 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); AND 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.age >=6; eosinophils >=300/150

See chunk 12 for full list

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Covered when ALL of the following are met for EGPA:

EGPA criteria: Member is at least 18 years of age; AND Nucala is prescribed by, or in consultation with, a pulmonologist, rheumatologist, or allergist/immunologist; AND Member has a confirmed diagnosis of EGPA (Churg-Strauss); AND Member must have blood eosinophils >= 150 cells/µL within 6 weeks of dosing; AND Member has been on stable doses of concomitant oral corticosteroid therapy for at least 4 weeks (e.g., prednisone ~7.5 mg/day); AND Physician has assessed baseline disease severity using an objective tool (e.g., BVAS, history of asthma/exacerbations, duration of remission, rate of relapses).age >=18; eosinophils >=150

See chunk 13

Hypereosinophilic Syndrome (HES)

Covered when ALL of the following are met for Hypereosinophilic Syndrome (HES):

HES criteria: Member is at least 12 years of age; AND Member has been diagnosed with HES for at least 6 months prior to starting treatment; AND Member does NOT have non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic infection, HIV, non-hematologic malignancy) or FIP1L1-PDGFRα kinase–positive HES; AND Member has a history of 2 or more HES flares within the previous 12 months requiring escalation of therapy; AND Member must have blood eosinophils >= 1000 cells/µL within 4 weeks of dosing; AND Therapy is 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

See chunk 14

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Covered when ALL of the following are met for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP):

CRSwNP criteria: Member is at least 18 years of age; AND Member has bilateral symptomatic sino-nasal polyposis with symptoms lasting at least 8 weeks; AND Member has failed at least 8 weeks of intranasal corticosteroid therapy; AND Member has at least three 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 unless contraindicated, significant impairment in quality of life, significant loss of smell, or comorbid asthma; AND Member does not have antrochoanal polyps, nasal septal deviation occluding at least one nostril, disease lacking type 2 inflammation, cystic fibrosis, or mucoceles; AND Other causes of nasal obstruction have been ruled out; AND Physician has assessed baseline disease severity with an objective tool; AND Therapy will be used in combination with intranasal corticosteroids unless contraindicated or not tolerated.age >=18

See chunk 15

COPD with eosinophilic phenotype

Covered when ALL of the following are met for COPD with eosinophilic phenotype:

COPD criteria: Member is at least 18 years of age; AND Diagnosis is confirmed by spirometry showing post-bronchodilator FEV1/FVC < 0.7; AND Member demonstrates classic signs/symptoms of COPD (e.g., dyspnea, chronic cough, sputum production, activity limitation); AND Absolute blood eosinophil count >=150 cells/µL prior to initiating therapy; AND Member has inadequately controlled COPD defined as either >=2 moderate exacerbations treated with systemic glucocorticoids/antibiotics OR >=1 severe exacerbation requiring hospitalization/ED visit in the prior year; AND Member is currently receiving maintenance inhaled triple therapy (ICS+LAMA+LABA) OR receiving LAMA+LABA with a contraindication to ICS; AND Member will continue maintenance COPD treatments in combination with the requested medication.age >=18; eosinophils >=150; FEV1/FVC <0.7

See chunks 16-17

Indication-specific coverage criteria

Covered when ALL of the following are met for the indicated condition:

Universal criteria: Member continues to meet the universal and indication-specific relevant criteria identified in section III and has no unacceptable toxicity from the drug.

Examples of unacceptable toxicity include parasitic (helminth) infection, herpes zoster, severe hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash).

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

See chunk 21

EGPA response criteria: Improvement in signs/symptoms compared to baseline as evidenced by remission (BVAS=0 and prednisone <=7.5 mg/day), decreased maintenance corticosteroid dose, improved BVAS, improved asthma symptoms/exacerbations, or longer remission/decreased relapse rate.

BVAS referenced (chunk 22)

Do not use mepolizumab in combination with other monoclonal antibody biologics that target related pathways. Specifically, combination therapy with anti-IgE, anti-IL-4, anti-IL-5, or IgG2 lambda monoclonal antibody agents (for example, Dupixent, Fasenra, Xolair, Tezspire, or another Nucala regimen) is not permitted. Hypereosinophilic syndrome (HES) secondary causes must be excluded prior to approval — members with non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy) or FIP1L1–PDGFRα kinase–positive HES are specifically excluded. For CRSwNP requests, excluded diagnoses/conditions include antrochoanal polyps, a nasal septal deviation that occludes a nostril, disease lacking type 2 inflammation, cystic fibrosis, and mucoceles; other non-biologic causes of nasal obstruction should be ruled out.

For Medicare beneficiaries, these plan coverage criteria apply only in the absence of an applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). Neighborhood Health Plan of Rhode Island will consider each request individually and may cover additional indications at the plan's discretion when supported by submitted clinical information.

Mepolizumab is not indicated for treatment of acute bronchospasm or status asthmaticus and must not be used for those presentations. Requests for use exclusively for acute bronchospasm or status asthmaticus should be considered not medically necessary.

Therapy will not be supported if the member does not meet both the universal and the applicable indication-specific criteria or if the member has evidence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include parasitic (helminth) infection, herpes zoster infection, and severe hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, or rash). For Medicare members, plan criteria are superseded where an applicable NCD/LCD exists; the plan will review and give individual consideration to requests based on prescriber-submitted information.

Product Codes, Dosing, and Clinical Thresholds

Product presentations and unit dosingNDCCovered

00173-0881-xx	100 mg/mL single dose vial for injection (Nucala)
00173-0892-xx	100 mg/mL single dose prefilled autoinjector or syringe for injection (Nucala)
(additional) 100 mg/mL single dose prefilled autoinjector or syringe (cartons of 1)	NDC series 00173-0892-xx

Quantity limits / Unit Dosing (NDC unit)mixedCovered

100 mg/mL single dose vial	3 vials every 28 days (single-dose vial must be prepared/administered by healthcare professional)
100 mg/mL single dose prefilled autoinjector or syringe	3 autoinjectors or syringes every 28 days (may be self-administered)
40 mg/0.4 mL single-dose prefilled syringe	1 syringe every 28 days

Covered HCPCS CodesHCPCSCovered

J2182

Injection, mepolizumab, 1 mg (1 billable unit = 1 mg)

Covered NDCsNDCCovered

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]

Authorization length

Authorization lengthInitial: 6 months; Renewal: up to 12 months

Blood eosinophil thresholds

Blood eosinophil thresholdsSevere asthma: ≥300 cells/µL within previous 12 months OR ≥150 cells/µL within 6 weeks of dosing; CRSwNP: ≥150 cells/µL (as indicator of type 2 inflammation); HES: ≥1000 cells/µL within 4 weeks of dosing; EGPA: >10% or >1000 cells/mm3

Specific clinical thresholds

EGPA eosinophil threshold>10% or >1000 cells/mm3

Severe asthma lung function thresholdFEV1 <60% predicted (component of severity assessment)

Prior Authorization, Documentation, and Operational Expectations

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are provided for 6 months; renewals may be eligible for 12 months. Quantity limits and dosing must be followed per the policy's quantity limit table.

Initial approval: 6 months
Renewal approval: up to 12 months
See quantity limits (e.g., 100 mg/mL vial: 3 vials/28 days; 100 mg/mL autoinjector/syringe: 3/28 days; 40 mg/0.4 mL prefilled syringe: 1/28 days

Documentation Required

Prior Authorization and Renewal Documentation

Documentation that the member meets both universal criteria and the indication-specific criteria must be submitted with the prior authorization request. Renewal requests must also document continued meeting of universal and indication-specific criteria and absence of unacceptable toxicity.

Clinical Background and Indication Overview

Mepolizumab (Nucala) is a humanized monoclonal antibody that targets interleukin‑5 (IL‑5), resulting in reduction of eosinophil activity and counts. It is indicated for treatment of multiple eosinophil‑driven conditions, including severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and certain eosinophilic phenotypes of COPD. Neighborhood Health Plan of Rhode Island adopted these coverage criteria to align use with FDA labeling and relevant clinical evidence and to ensure safe, appropriate, and cost‑effective prescribing.

Key Clinical Definitions and Terms

inv-28: EGPA — Definition

Core definitionEGPA is defined by history or presence of asthma plus blood eosinophils >10% or absolute eosinophil count >1000 cells/mm3

Supportive clinical features (need ≥2)Histopathologic eosinophilic vasculitis or eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; sinonasal abnormalities; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positivity

Typical prescriber specialtiesPrescribed by or in consultation with pulmonologist, rheumatologist, or allergist/immunologist (per coverage criteria)

inv-29: EGPA — Additional definition

Alternate/concise definitionEosinophilic Granulomatosis with Polyangiitis (EGPA): asthma plus blood eosinophils >10% or >1000 cells/mm3 and two or more characteristic clinical criteria (e.g., neuropathy, pulmonary infiltrates, sinonasal disease, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity)

OpenPayer

Mepolizumab (Nucala) subcutaneous therapy — Coverage Criteria

Medical Necessity and Coverage Criteria

Product Codes, Dosing, and Clinical Thresholds

Prior Authorization, Documentation, and Operational Expectations

Clinical Background and Indication Overview

Key Clinical Definitions and Terms