ModifiedCignaPolicy IP0422

Immunologicals - Nucala

Defines prior authorization, coverage criteria, dosing, and prescriber requirements for Nucala (mepolizumab) for asthma, COPD, CRSwNP, EGPA, and HES for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyImmunologicals - Nucala

Policy CodePolicy IP0422

Change TypeMaterial updates to indications, eosinophil thresholds, and approval durations

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation that the patient meets indication-specific criteria (including required prior therapy trials, eosinophil thresholds, and specialist prescribing/consultation).

SourceLink

POLICY UPDATE CHANGES

Chronic Obstructive Pulmonary Disease (COPD) criteria and indication were added to the policy.

Policy title updated from Mepolizumab to Immunologicals - Nucala and multiple indication-specific changes made (e.g., asthma diagnostic criteria, approval durations).

Eosinophil level requirements clarified for EGPA and asthma to require a measured level ≥ 150 cells/µL within specified recent time windows or prior to monoclonal antibody treatment.

Initial authorization durations changed for multiple indications (asthma from 12 to 6 months; EGPA initial duration set to 9 months; hypereosinophilic syndrome initial duration set to 8 months).

≥ 6 monthsInitial approval duration for many indications

100 mg q4wTypical adult dosing (≥12 years)

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Coverage Criteria for Nucala (mepolizumab)

Asthma

Approve for asthma when ONE of the following (A or B) is met:

A) Initial Therapy: Approve for 6 months if ALL of (i-v) are met

A.i Age: Patient is >= 6 years of age

A.ii Eosinophil: Patient has a blood eosinophil level >= 150 cells/µL within the previous 6 weeks OR had a blood eosinophil level >= 150 cells/µL prior to treatment with Nucala or another monoclonal antibody therapy that may alter blood eosinophil levels>=150 cells/µL

A.iii Controller therapy: Patient has received at least 3 consecutive months of combination therapy with BOTH: an inhaled medium- or high-dose corticosteroid AND at least one additional asthma controller or maintenance medication (use of a combination inhaler that contains both fulfills this requirement)>=3 months

A.iv Lung function or bronchodilator responsiveness: Either (a) FEV1 < 80% predicted AND FEV1/FVC < 0.80 OR (b) evidence of bronchodilator/exercise/bronchial challenge responsiveness (increase >12% and >200 mL in FEV1 or other positive challenge); children 6–11 years require only >12% increaseFEV1 criteria as specified

A.v Uncontrolled asthma: One of: (a) two or more asthma exacerbations requiring systemic corticosteroids in the previous year; OR (b) one or more exacerbations requiring hospitalization, ED, or urgent care in the previous year; OR (c) asthma worsens upon tapering systemic corticosteroids

B) Continuing therapy: Approve for 1 year if ALL: patient has already received at least 6 months of therapy with Nucala; AND continues therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, decreased symptoms, fewer hospital/ED/urgent care visits, decreased oral corticosteroid requirement)>=6 months

Chronic Obstructive Pulmonary Disease (COPD)

Approve for COPD when ONE of the following (A or B) is met:

A) Initial Therapy: Approve for 6 months if ALL of (i-v) are met

A.i Age: Patient is >= 18 years of age

A.ii Eosinophil: Patient has a blood eosinophil level >= 300 cells/µL within the previous 6 weeks OR had a blood eosinophil level >= 300 cells/µL prior to treatment with Nucala or another monoclonal antibody therapy that may alter blood eosinophil levels>=300 cells/µL

A.iii Background therapy: Either (a) at least 3 consecutive months of combination therapy with inhaled LABA + LAMA + ICS (single-entity or combination inhalers acceptable) OR (b) at least 3 consecutive months of LABA + LAMA with a prescriber-documented contraindication to ICS

Chronic Rhinosinusitis with Nasal Polyps (partial)

Approve for CRSwNP when ONE of the following (A or B) is met:

A) Initial Therapy: Approve for 6 months if ALL of (i-vi) are met

A.i Age: Patient is >= 18 years of age

A.ii Diagnosis evidence: Chronic rhinosinusitis with nasal polyps evidenced by direct examination, endoscopy, or sinus CT scan

A.iii Symptom duration: Patient has experienced two or more of the following symptoms for at least 6 months: nasal congestion, nasal obstruction, nasal discharge, and/or reduction or loss of smell>=6 months

Chronic Obstructive Pulmonary Disease (Initial)

Covered when ALL of the following are met for COPD initial therapy:

COPD Initial Therapy: Patient meets BOTH of the following: (1) patient has received at least 3 consecutive months of combination therapy with an inhaled LABA and an inhaled LAMA (single-entity or combination inhalers acceptable); AND (2) prescriber documents a contraindication to inhaled corticosteroid; AND patient meets ONE of: (a) two or more COPD exacerbations requiring systemic corticosteroid with/without antibiotic in the prior 12 months OR (b) one or more exacerbations requiring hospitalization in the prior 12 months (hospitalization includes admission or observation >24 hours).see node

Chronic Obstructive Pulmonary Disease (Continuation)

Covered when ALL of the following are met for COPD continuation (patient currently receiving Nucala):

COPD Continuation: Patient has already received at least 6 months of Nucala; AND continues combination inhaled LABA and LAMA therapy; AND has experienced a beneficial clinical response as defined by reduced COPD symptoms, reduced exacerbations, reduced COPD-related hospitalizations, reduced emergency department or urgent care visits, OR improved lung function parameters.6 months

Prescriber must be an allergist, immunologist, or pulmonologist or consult with one.

Chronic Rhinosinusitis with Nasal Polyps (Initial)

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

CRSwNP Initial: Patient is ≥ 18 years; AND has CRSwNP evidenced by direct examination, endoscopy, or CT; AND has had two or more symptoms (nasal congestion, nasal obstruction, nasal discharge, or reduced/loss of smell) for ≥ 6 months; AND meets BOTH: (a) received ≥ 4 weeks of intranasal corticosteroid therapy AND (b) will continue intranasal corticosteroid therapy with Nucala; AND meets ONE of: (a) at least one systemic corticosteroid course ≥5 days within previous 2 years OR (b) contraindication to systemic corticosteroids OR (c) prior surgery for nasal polyps; AND Nucala is prescribed by or in consultation with an allergist, immunologist, or ENT;6 months symptoms; 4 weeks intranasal steroid

Initial approval duration 6 months; dosing 100 mg SC q4w.

Chronic Rhinosinusitis with Nasal Polyps (Continuation)

Covered when ALL of the following are met for CRSwNP continuation (currently receiving Nucala):

CRSwNP Continuation: Patient has already received ≥ 6 months of Nucala; AND continues intranasal corticosteroid therapy; AND has responded to therapy as determined by the prescriber (examples: improved nasal congestion, reduced sinus opacification, decreased sino-nasal symptoms, reduced polyp size, improved sense of smell).6 months

Approve for 1 year if criteria met; dosing 100 mg SC q4w.

Eosinophilic Granulomatosis with Polyangiitis (EGPA) (Initial)

Covered when ALL of the following are met for EGPA (Initial):

EGPA Initial: Patient is ≥ 18 years; AND has active, non-severe disease; AND is currently receiving a systemic corticosteroid for a minimum of 4 weeks; AND patient meets ONE of: (1) blood eosinophil level ≥ 150 cells/µL within the previous 4 weeks OR (2) had a blood eosinophil level ≥ 150 cells/µL prior to treatment with Nucala or another monoclonal antibody therapy that may alter blood eosinophil levels; AND medication is prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist.eosinophil >=150 cells/µL within 4 weeks or prior to monoclonal therapy

Initial approval duration 9 months; dosing 300 mg SC q4w.

Eosinophilic Granulomatosis with Polyangiitis (Continuation)

Covered when ALL of the following are met for EGPA continuation (currently receiving Nucala):

EGPA Continuation: Patient has already received at least 9 months of Nucala; AND patient has responded to therapy as determined by the prescriber (examples: reduced relapse rate, corticosteroid dose reduction, reduced eosinophil levels).9 months

Approve for 1 year if criteria met; dosing 300 mg SC q4w.

Hypereosinophilic Syndrome (Initial)

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

HES Initial: Patient is ≥ 12 years; AND has HES for ≥ 6 months; AND has FIP1L1–PDGFRα–negative disease; AND does NOT have an identifiable non-hematologic secondary cause per prescriber; AND patient had a blood eosinophil level ≥ 1,000 cells/µL prior to treatment with any monoclonal antibody therapy that may alter blood eosinophil levels; AND patient has tried at least one other HES treatment for ≥ 4 weeks; AND Nucala is prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist.HES eosinophils >=1000 cells/µL prior to monoclonal therapy; disease >=6 months

Initial approval duration 8 months; dosing 300 mg SC q4w.

Hypereosinophilic Syndrome (Continuation)

Covered when ALL of the following are met for HES continuation (currently receiving Nucala):

HES Continuation: Patient has already received at least 8 months of Nucala; AND patient has responded to therapy as determined by the prescriber (examples: decreased number of flares, improved fatigue, reduced corticosteroid requirements, decreased eosinophil levels).8 months

Approve for 1 year if criteria met; dosing 300 mg SC q4w.

The pivotal hypereosinophilic syndrome (HES) trial excluded patients with FIP1L1–PDGFRα kinase–positive disease and non‑hematologic secondary causes of HES; all enrolled patients had a baseline blood eosinophil count ≥ 1,000 cells/µL and had been on stable HES therapy for ≥ 4 weeks prior to randomization.

Requests for Nucala for the following uses are not covered and are considered not medically necessary: atopic dermatitis; concurrent use of Nucala with another monoclonal antibody therapy; and eosinophilic gastrointestinal disorders including eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis.

Claims and services billed for conditions or diagnoses that are not covered under this Coverage Policy will be denied as not covered when submitted without covered diagnosis or procedure codes under the applicable policy.

Use of Nucala for any indication not listed among the FDA‑approved or policy‑supported indications is considered not medically necessary, including the explicit examples of atopic dermatitis and eosinophilic gastrointestinal disorders.

Coding and Lab Thresholds

Considered Medically Necessary when criteria metHCPCSCovered

J2182

Injection, mepolizumab, 1 mg

Blood eosinophil thresholds

Asthma eosinophil threshold≥ 150 cells/µL within the previous 6 weeks or ≥150 cells/µL prior to monoclonal antibody therapy

COPD eosinophil threshold≥ 300 cells/µL within the previous 6 weeks or ≥300 cells/µL prior to monoclonal antibody therapy

HES trial thresholdBaseline blood eosinophil count ≥ 1,000 cells/µL (study entry)

EGPA blood eosinophil level

EGPA eosinophil requirement≥ 150 cells/µL within the previous 4 weeks or ≥150 cells/µL prior to treatment with a monoclonal antibody that may alter eosinophil levels

Prescriber requirement for EGPANucala prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of Nucala through the prescription benefit. Initial approvals are typically issued for the durations specified in the FDA-Approved Indications (for example, 6 months for most initial therapies and 9 months for EGPA initial therapy). Continuing therapy approvals are typically granted for 1 year when continuation criteria are met. Because of the specialized skills required for evaluation, diagnosis, and monitoring, Nucala must be prescribed by or in consultation with an appropriate specialist as specified by indication.

Initial approvals: typically 6 months (EGPA initial = 9 months as specified); continuation approvals: typically 1 year when continuation criteria met
1 month = 30 days for authorization calculations
Nucala must be prescribed by or in consultation with an appropriate specialist (see indication-specific prescriber requirements below)

Documentation Required

Prior Authorization Documentation Requirements

Requests must include documentation that the patient meets the indication-specific criteria outlined in the policy (see FDA-Approved Indications). This includes, as applicable: confirmation of diagnosis by exam, endoscopy, or imaging for CRSwNP; documentation of eosinophil counts at the required thresholds and timing; documentation of prior therapy trials and durations; and evidence of clinical response for continuation requests.

Background and Indication Summary

Nucala (mepolizumab) is an anti–interleukin‑5 (anti–IL‑5) monoclonal antibody used as add‑on maintenance therapy in eosinophil‑driven disorders. Indications in this policy include severe eosinophilic asthma (approved for patients ≥ 6 years), chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES; patients ≥ 12 years with disease ≥ 6 months), and an eosinophilic phenotype of COPD (adults). Clinical trials supporting these indications generally enrolled patients with elevated blood eosinophil counts (examples used in trials include thresholds such as ≥ 150 cells/µL, ≥ 300 cells/µL, or ≥ 1,000 cells/µL depending on the indication) and assessed efficacy over weeks to months depending on the condition.

Clinical Definitions and Terms

Peripheral blood eosinophil thresholds in trials

Trial threshold ≥150 cells/µLAsthma trials required peripheral blood eosinophil count ≥ 150 cells/µL at screening

Trial threshold ≥300 cells/µLMATINEE COPD study required blood eosinophil ≥ 300 cells/µL at screening (and ≥150 cells/µL within prior 12 months)

HES study threshold ≥1,000 cells/µLHES study enrolled patients with baseline eosinophils ≥ 1,000 cells/µL

Non-severe EGPA (definition examples)

Definition of non-severe EGPAVasculitis without life- or organ-threatening manifestations (examples: rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis)

EGPA age criterionPatient is ≥ 18 years of age for EGPA initial therapy

Policy Summary

PayerCigna

PolicyImmunologicals - Nucala

Policy CodePolicy IP0422

Change TypeMaterial updates to indications, eosinophil thresholds, and approval durations

Effective Date

Next Review Date

SourceLink

On This Page

Diagnosis-specific documentation: e.g., CRSwNP evidenced by direct exam, endoscopy, or sinus CT
Required lab results: blood eosinophil levels with timing consistent with the indication (examples: ≥150 cells/µL within prior 6 weeks for asthma; ≥300 cells/µL within prior 6 weeks for COPD; ≥150 cells/µL within prior 4 weeks for EGPA; pre-treatment thresholds when prior mAb therapy may have altered counts)
Documentation of prior therapy trials and durations (see controller/prior trial requirements)
For continuation: documentation of prior duration of Nucala therapy (minimums vary by indication) and prescriber-assessed clinical benefit

Step Therapy

Controller Therapy Prerequisites

For asthma and COPD initial therapy requests, prior trials of specified inhaled controller therapies are required before approval. Use of single-entity inhalers or combination inhalers containing the required classes will satisfy the requirement.

Asthma: at least 3 consecutive months of combination therapy with BOTH: a medium- or high-dose inhaled corticosteroid (ICS) AND at least one additional controller (see policy for acceptable controllers)
COPD: at least 3 consecutive months of combination therapy with ALL of the following for COPD initial pathway: inhaled LABA, inhaled LAMA, and inhaled ICS; OR at least 3 months of inhaled LABA + inhaled LAMA when ICS is contraindicated per prescriber

Step Therapy

Required Prior Trials

Specific prior trials must be documented per indication before authorization will be approved. For CRSwNP, document at least 4 weeks of intranasal corticosteroid therapy and plan to continue intranasal corticosteroid with Nucala. For COPD, document prior LABA+LAMA+ICS combination therapy (or LABA+LAMA with documented contraindication to ICS). For EGPA and HES, document trials of other indicated systemic therapies where specified.

CRSwNP: ≥4 weeks intranasal corticosteroid trial prior to approval and continuation of intranasal corticosteroid during Nucala therapy
COPD: ≥3 consecutive months of inhaled LABA + LAMA + ICS combination OR ≥3 months LABA + LAMA plus documented contraindication to ICS
EGPA/HES: trial of systemic corticosteroid (EGPA: minimum 4 weeks) and at least one other HES treatment for ≥4 weeks as applicable (examples: systemic corticosteroids, hydroxyurea, cyclosporine, imatinib, or pegylated-interferon)

Prior Authorization

Prescriber and Specialist Consultation Requirement

Prescriber requirements vary by indication. Nucala must be prescribed by or in consultation with specialists appropriate to the condition being treated. Prior authorization requests should confirm the specialty involvement.

Asthma: prescribed by or in consultation with a physician experienced in managing severe asthma (examples: allergist, immunologist, pulmonologist)
COPD: prescribed by or in consultation with an allergist, immunologist, or pulmonologist
CRSwNP: prescribed by or in consultation with an allergist, immunologist, or otolaryngologist (ENT)
EGPA and HES: prescribed by or in consultation with an allergist, immunologist, pulmonologist, or rheumatologist

Documentation Required

Required Clinical Documentation and Claims Note

Prescribers must supply clinical documentation attesting to indication-specific requirements, prior therapy durations, eosinophil lab results with dates, and clinical response when requesting continuation. Claims submitted without covered diagnosis or required supporting documentation will be denied as not covered.

Include dates and values for blood eosinophil counts meeting the policy thresholds and timing
Document prior medication names, durations (e.g., ≥3 months), and rationale if contraindications prevent standard trials
For continuation requests: document total duration of prior Nucala therapy meets the minimum for continuation (e.g., ≥6 months for most indications, ≥8 months for HES) and objective/subjective evidence of clinical benefit
Claims without covered diagnosis/procedure codes or lacking required documentation will be denied