Blue Cross Blue Shield - Iowa Nucala Coverage & Prior Auth

Coverage Criteria for Nucala (mepolizumab)

Initial Therapy - Asthma

Authorization of 6 months may be granted for treatment of severe asthma with an eosinophilic phenotype when ALL of the following are met

Asthma initial: A. Member is 6 years of age or older; B. Member meets either: (i) baseline blood eosinophil count ≥150 cells/µL; OR (ii) systemic corticosteroid dependence; C. Member has uncontrolled asthma demonstrated by at least one within the past year: (i) ≥2 exacerbations requiring oral or injectable corticosteroids; (ii) ≥1 exacerbation resulting in hospitalization or emergency medical care; (iii) poor symptom control (frequent symptoms or reliever use, activity limitation, night waking due to asthma); D. Inadequate control despite current treatment with BOTH: (i) medium-to-high dose inhaled corticosteroid; AND (ii) an additional controller at maximally tolerated doses (e.g., long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline); E. Member will continue maintenance asthma treatments (e.g., inhaled corticosteroid and additional controller) in combination with Nucala; F. Member will not use Nucala concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Tezspire, Xolair).see nodes

Authorization duration: 6 months

Continuation Therapy - Asthma

Authorization of 12 months may be granted for continuation when ALL of the following are met

Asthma continuation: 1. Nucala is being prescribed by or in consultation with an allergist/immunologist or pulmonologist; 2. Member is 6 years of age or older; 3. Asthma control has improved on Nucala as demonstrated by at least one: (a) reduction in frequency and/or severity of symptoms and exacerbations; (b) reduction in daily maintenance oral corticosteroid dose; 4. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Nucala; 5. Member will not use Nucala concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Tezspire, Xolair).none

Authorization duration: 12 months

Initial Therapy - EGPA

Authorization of 12 months may be granted for EGPA when ALL of the following are met

EGPA initial: 1. Member is 18 years of age or older; 2. History or presence of eosinophil count >1000 cells/µL or blood eosinophils >10%; 3. Member is currently taking oral corticosteroids unless contraindicated or not tolerated; 4. Member has at least two EGPA disease characteristics from the following: (a) biopsy with eosinophilic vasculitis/perivascular eosinophilic infiltration/eosinophil-rich granulomatous inflammation; (b) neuropathy (mono or poly); (c) non-fixed pulmonary infiltrates; (d) sino-nasal abnormality; (e) cardiomyopathy; (f) glomerulonephritis; (g) alveolar hemorrhage; (h) palpable purpura; (i) ANCA positive (MPO or PR3); 5. Member has had at least one relapse within 2 years prior to starting Nucala or has refractory disease.none

Authorization duration: 12 months

Continuation Therapy - EGPA

Authorization of 12 months may be granted for continuation when ALL of the following are met

EGPA continuation: 1. Member is 18 years of age or older; 2. Member has beneficial response to Nucala as demonstrated by any of: (a) reduction in frequency of relapses; (b) reduction in daily oral corticosteroid dose; (c) no active vasculitis.none

Authorization duration: 12 months

Initial Therapy - HES

Authorization of 12 months may be granted for HES when ALL of the following are met

HES initial: 1. Member is 12 years of age or older; 2. Member does not have HES secondary to a non-hematologic cause and is not FIP1L1-PDGFRA kinase-positive; 3. History or presence of blood eosinophil count ≥1000 cells/µL; 4. Member will not use Nucala as monotherapy; 5. Member has been on a stable dose of HES therapy (e.g., oral corticosteroid, immunosuppressive, and/or cytotoxic therapy); 6. Duration of HES ≥6 months; 7. Member has experienced ≥2 HES flares within the past 12 months.none

Authorization duration: 12 months

Continuation Therapy - HES

Authorization of 12 months may be granted for continuation when ALL of the following are met

HES continuation: 1. Member is 12 years of age or older; 2. Member has experienced a reduction in HES flares since starting Nucala; 3. Member will not use Nucala as monotherapy.none

Authorization duration: 12 months

Initial Therapy - CRSwNP

Authorization of 6 months may be granted for CRSwNP when ALL of the following are met

CRSwNP initial: 1. Member is 18 years of age or older with bilateral nasal polyposis and chronic sinusitis symptoms despite intranasal corticosteroid treatment for ≥2 months unless contraindicated; 2. CRSwNP despite either prior sino-nasal surgery OR prior systemic corticosteroids within the last 2 years that were ineffective or contraindicated; 3. Objective evidence of polyps shown by at least one: (a) bilateral nasal endoscopy/anterior rhinoscopy/CT showing polyps reaching below the lower border of the middle turbinate in each nostril; (b) Meltzer Clinical Score ≥2 in both nostrils; (c) total endoscopic nasal polyp score (NPS) ≥5 with ≥2 per nostril; 4. Symptoms include nasal blockage/congestion/obstruction plus one additional symptom (rhinorrhea, reduced/loss of smell, facial pain/pressure); 5. Member will continue daily intranasal corticosteroid while treated with Nucala unless contraindicated; 6. Member will not use Nucala concomitantly with other biologics indicated for CRSwNP (e.g., Dupixent, Xolair, Tezspire).none

Authorization duration: 6 months

Continuation Therapy - CRSwNP

Authorization of 12 months may be granted for continuation when ALL the following are met

CRSwNP continuation: 1. Member is 18 years of age or older; 2. Member has achieved or maintained a positive clinical response to Nucala evidenced by improvement in signs/symptoms of CRSwNP or reduction in corticosteroid use; 3. Member will continue daily intranasal corticosteroid while being treated with Nucala unless contraindicated; 4. Member will not use Nucala concomitantly with other biologics indicated for CRSwNP (e.g., Dupixent, Xolair, Tezspire).none

Authorization duration: 12 months

Initial Therapy - COPD

Authorization of 6 months may be granted for COPD when ALL of the following are met

COPD initial: 1. Member is 18 years of age or older; 2. Inadequately controlled COPD demonstrated by at least one within the past year: (a) ≥2 moderate exacerbations requiring systemic corticosteroid and/or antibiotic; (b) ≥1 severe exacerbation resulting in hospitalization or ED visit; 3. Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC < 0.7; 4. Classic signs/symptoms of COPD (e.g., dyspnea, wheezing, chest tightness, cough); 5. Baseline blood eosinophil count ≥300 cells/µL; 6. COPD remains uncontrolled after ≥3 months of maximally tolerated background controller therapy (LAMA-LABA and inhaled glucocorticoid unless contraindicated); 7. Member will continue background controller therapy in combination with Nucala; 8. Member will not exceed the maximum FDA-approved dose for this indication.none

Authorization duration: 6 months

Continuation Therapy - COPD

Authorization of 12 months may be granted for continuation when ALL of the following are met

COPD continuation: 1. Member is 18 years of age or older; 2. Member has achieved and maintained improved COPD control with Nucala as evidenced by at least one: (a) reduction in frequency and/or severity of exacerbations; (b) improvement in lung function (FEV1); 3. Member will continue to use maintenance COPD treatments (LAMA-LABA and inhaled glucocorticoid unless contraindicated) in combination with Nucala; 4. Member will not exceed the maximum FDA-approved dose for this indication.none

Authorization duration: 12 months

COPD continuation criteria

Authorization of 12 months may be granted for continuation of treatment of COPD in members 18 years of age or older when ALL of the following are met:

COPD continuation criteria: 1. Member has achieved and maintained improved COPD control with Nucala therapy as evidenced by at least one of: (a) a reduction in frequency and/or severity of exacerbations; OR (b) an improvement in lung function (FEV1); 2. Member will continue to use maintenance COPD treatments (LAMA-LABA and inhaled glucocorticoid, unless contraindicated) in combination with Nucala; 3. Member will not exceed the maximum FDA-approved dose for this indication.age >= 18 years

Authorization up to 12 months

Coverage for hypereosinophilic syndrome (HES) explicitly excludes cases that are secondary to a non‑hematologic cause and excludes FIP1L1‑PDGFRA kinase‑positive HES. These exclusions align with the HES initial therapy requirements which require the member to be ≥12 years and to have primary HES meeting the specified eosinophil and treatment history criteria; members with the listed secondary causes or the FIP1L1‑PDGFRA mutation are not eligible for Nucala under this policy.

For all labeled indications, the member may not receive Nucala concomitantly with any other biologic drug or targeted synthetic drug for the same indication. Concomitant use with another agent targeting the same disease indication will trigger denial of coverage.

The policy prohibits concurrent administration of Nucala with other biologic or targeted synthetic therapies for the same condition. Providers must ensure Nucala is not prescribed or administered together with another biologic/targeted synthetic agent for that indication to avoid a denial.

Members who have been receiving Nucala as samples or through the manufacturer's patient assistance program must still meet the policy's initial approval criteria to continue therapy under the plan. Documentation that satisfies the initial authorization requirements must be submitted for continuation.

If a member does not meet the coverage criteria specified in this policy for the requested indication, Nucala is considered not medically necessary. Requests that lack the required clinical evidence, diagnostic thresholds, or required prior therapy/maintenance treatments will be denied as not medically necessary.

Nucala is considered not medically necessary for members who fail to meet the indication‑specific criteria (for example, COPD continuation criteria requiring documented maintained improved COPD control) or who use Nucala concomitantly with another biologic or targeted synthetic drug for the same indication. Failure to continue required maintenance COPD therapy or to demonstrate benefit will also result in a determination of not medically necessary.

Coding and Diagnostic Thresholds

Procedure/Billing CodesHCPCS

J2182

Injection, Mepolizumab, 1mg

Eosinophil thresholds by indication

Asthma (baseline)Baseline blood eosinophil count ≥150 cells/µL

Asthma (alternative)Systemic corticosteroid dependence

COPDBaseline blood eosinophil count ≥300 cells/µL

HESBlood eosinophil count ≥1000 cells/µL

EGPAHistory or presence of eosinophil count >1000 cells/µL or blood eosinophils >10%

CRSwNP endoscopic and scoring thresholds

Meltzer Clinical Score

Provider Actions, Documentation and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation requests must include indication‑specific clinical evidence and documentation of concurrent maintenance therapy where applicable. Providers should submit medical records/chart notes demonstrating baseline and ongoing clinical response, prior therapies tried, and confirmation that Nucala is being used with required background maintenance treatments.

Prior authorization durations: initial approvals generally 6 months (some indications 12 months); continuation approvals up to 12 months for COPD when criteria met.
Do not prescribe Nucala concomitantly with other biologics or targeted synthetic drugs for the same indication.

Documentation Required

Clinical Evidence and Documentation Requirements

For all indications, submit clinical evidence showing baseline disease severity and response to Nucala. For initial requests include pretreatment labs (e.g., blood eosinophil counts, FIP1L1‑PDGFRA testing where applicable), objective assessments (spirometry for COPD, endoscopy/CT or validated polyp scores for CRSwNP), and documentation of prior medications tried (drug, dose, frequency, duration). For continuation requests provide chart notes demonstrating clinical benefit (e.g., reduced exacerbation frequency/severity, improved FEV1, improved symptom control, reduced steroid dependence). If medication was obtained as samples or via patient assistance, include documentation that the member meets initial-therapy criteria.

Definitions and Indication Notes

FDA‑Approved indications for Nucala (mepolizumab)

Severe eosinophilic asthmaAdd-on maintenance treatment for patients aged 6 years and older with an eosinophilic phenotype

EGPATreatment of adult patients with eosinophilic granulomatosis with polyangiitis

HESTreatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (≥6 months) without identifiable non-hematologic secondary cause

CRSwNPAdd-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps

COPD with eosinophilic phenotypeAdd-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype

Limitation of use

Background

Mepolizumab (Nucala) is an anti‑IL‑5 monoclonal antibody indicated as add‑on maintenance therapy for eosinophilic phenotypes across multiple diseases, including severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), and eosinophilic chronic obstructive pulmonary disease (COPD). The policy aligns coverage with these FDA‑approved indications and requires evidence of eosinophilic disease activity plus indication‑specific prior therapy and monitoring where applicable.

OpenPayer

Nucala (mepolizumab) — Coverage and Prior Authorization Criteria

Coverage Criteria for Nucala (mepolizumab)

Coding and Diagnostic Thresholds

Provider Actions, Documentation and Authorization

Definitions and Indication Notes

Background