ModifiedmhnPolicy CP.PHAR.200

Mepolizumab (Nucala) prior authorization and coverage criteria

Defines medical necessity criteria, required documentation, dosing limits, prescriber specialties, and approval durations for Nucala (mepolizumab) for multiple eosinophilic indications for Centene-affiliated health plans (commercial and Medicaid). Affects prescribing providers and medical reviewers.

Policy Summary

Payermhn

PolicyMepolizumab (Nucala) prior authorization and coverage criteria

Policy CodePolicy CP.PHAR.200

Change TypeAdded COPD indicationrevised COPD eosinophil thresholdupdated approval durations

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results) demonstrating the member meets indication-specific criteria and eosinophil thresholds for prior authorization.

SourceLink

POLICY UPDATE CHANGES

RT4: added criteria for new FDA approved indication of COPD.

For COPD, revised blood eosinophil count requirement from '≥ 300 cells/µL' to '≥ 150 cells/µL at time of request or ≥ 300 cells/µL in the past 12 months'.

For all indications, initial approval duration for Medicaid revised from 6 to 12 months and for Commercial to include 'or to the member's renewal date, whichever is longer'.

HCPCS code J2182 listed as Injection, mepolizumab, 1 mg for coding reference.

6Indications with specific criteria

Age 6+Minimum age (severe asthma)

100 mg

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Common adult dose q4w

12 moMedicaid initial approval

6 moCommercial initial approval

≥150/µLCOPD eosinophil threshold

Coverage Criteria and Indications

Chronic Rhinosinusitis with Nasal Polyps — Continued therapy criteria

D. Chronic Rhinosinusitis with Nasal Polyps (must meet all) :

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Chronic Obstructive Pulmonary Disease — Continued therapy criteria

E. Chronic Obstructive Pulmonary Disease (must meet all) :

ALL of the following

one_of
- a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
Member is responding positively to therapy;
Nucala is not prescribed concurrently with Cinqair, Dupixent, Fasenra, Xolair, or Tezspire;
If request is for a dose increase, new dose does not exceed 100 mg every 4 weeks.

Coding, Dosing, and Thresholds

Coding — none listed in this chunkmixed

N/A	No discrete CPT/HCPCS/ICD codes listed in this part of the document.

HCPCS codes referencedHCPCS

J2182

Injection, mepolizumab, 1 mg

Referenced HCPCS CodesHCPCS

J2182

Injection, mepolizumab, 1 mg

Eosinophil count thresholds — per indication

Severe asthma thresholdAbsolute blood eosinophil count ≥150 cells/mcL within the past 3 months

HES thresholdBlood eosinophil count ≥1,000 cells/mcL within the past 3 months

COPD threshold (current)Blood eosinophil count ≥150 cells/µL at time of request

COPD threshold (historical)Blood eosinophil count ≥300 cells/µL within the past 12 months

Dose limits — age-specific and EGPA/HES note

Age 6–11 dosing limit40 mg subcutaneous every 4 weeks

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for mepolizumab (HCPCS J2182). Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Requests lacking adequate documentation may be denied. Inclusion of codes in this policy is informational only and does not guarantee coverage; coding errors or outdated coding guidance may result in claim denials.

Prior authorization required for mepolizumab (J2182).
Submit clinical documentation: office notes, recent blood eosinophil counts, exacerbation history, controller therapy trials, and specialty consults as applicable.
Requests lacking documentation that member meets all approval criteria may be denied.
Coding inclusion is informational — providers should verify coding guidance prior to claim submission.

Documentation Required

COPD — Required Clinical Documentation

Background and Clinical Context

Mepolizumab is an interleukin‑5 (IL‑5) antagonist monoclonal antibody approved as add‑on maintenance therapy for eosinophilic phenotypes, including severe asthma (age ≥6 years), CRSwNP, COPD with an eosinophilic phenotype, EGPA, and HES. It is intended for maintenance treatment of these eosinophilic conditions rather than for acute management.

Definitions and Abbreviations

Mepolizumab (Nucala) — drug definition

Drug classInterleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa)

Proprietary nameNucala (mepolizumab)

Indication summaryUsed as add-on maintenance therapy for multiple eosinophilic conditions per FDA labeling

Eosinophilic phenotype — clinical definition

DefinitionClinical phenotype documented by elevated blood eosinophil counts meeting specified thresholds per indication (e.g., severe asthma ≥150 cells/mcL recent; COPD ≥150 cells/µL current or ≥300 cells/µL historical)

ApplicationDetermines eligibility for mepolizumab across asthma, COPD, CRSwNP, EGPA, and HES indications

Policy Summary

Payermhn

PolicyMepolizumab (Nucala) prior authorization and coverage criteria

Policy CodePolicy CP.PHAR.200

Change TypeAdded COPD indicationrevised COPD eosinophil thresholdupdated approval durations

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results) demonstrating the member meets indication-specific criteria and eosinophil thresholds for prior authorization.

SourceLink

On This Page

Age ≥12 / Adults dosing limit100 mg subcutaneous every 4 weeks

EGPA/HES dose noteEGPA and HES may require higher dosing; see indication-specific dosing (300 mg SC every 4 weeks) — dose increases must not exceed indication limits

Dose limits — indication maximums

HES maximum doseDose does not exceed 300 mg every 4 weeks

CRSwNP maximum doseDose does not exceed 100 mg every 4 weeks

COPD maximum doseDose does not exceed 100 mg every 4 weeks

Age-based dosing threshold

Pediatric (6–11 years)40 mg SC every 4 weeks

Adolescents and adults (≥12 years)100 mg SC every 4 weeks

Administration routeSubcutaneous (SC) injection every 4 weeks per dosing table

EGPA/HES dosing

EGPA dosing regimen300 mg SC every 4 weeks

HES dosing regimen300 mg SC every 4 weeks (dose limit/maximum 300 mg q4w)

Dose increase constraintIf request is for a dose increase for EGPA/HES, new dose must not exceed 300 mg every 4 weeks

COPD eosinophil threshold

COPD current eosinophil criterion (point-of-request)≥150 cells/µL at time of request

COPD historical eosinophil criterionOR ≥300 cells/µL documented within the past 12 months

Documentation requirementProvider must submit lab documentation supporting eosinophil value per criteria

For COPD indication requests, documentation must support the eosinophilic phenotype: blood eosinophil count ≥ 150 cells/µL at the time of request or ≥ 300 cells/µL in the past 12 months. Provider must document history of exacerbations (≥ 2 moderate or ≥ 1 severe in past 12 months) and that the member has failed appropriate inhaled therapy (see step therapy details). If the request is for continuation/renewal, include evidence the member is responding to therapy.

Eosinophil threshold for COPD: ≥ 150 cells/µL at time of request OR ≥ 300 cells/µL in past 12 months.
Document ≥ 2 moderate or ≥ 1 severe COPD exacerbations in past 12 months.
Include prior therapy documentation per COPD step therapy (see next callout).

Step Therapy

COPD Step Therapy Requirement

Prior to approval for COPD, member must have failed at least one of the following (unless contraindicated): failure of triple inhaled therapy (LABA + LAMA + ICS) at maximally indicated doses for ≥ 3 months. If ICS is contraindicated, failure of dual therapy (LABA + LAMA) for ≥ 3 months is required. Provider must attest the member is concomitantly receiving the appropriate maintenance inhaled therapy.

Failure of triple inhaled therapy (LABA + LAMA + ICS) for ≥ 3 months is required prior to mepolizumab approval for COPD.
If ICS contraindicated, failure of dual therapy (LABA + LAMA) for ≥ 3 months is required.
Provider attestation of current concomitant maintenance inhaled therapy is required.

Step Therapy

Intranasal Corticosteroid Adherence (CRSwNP)

For chronic rhinosinusitis with nasal polyps (CRSwNP) continuation or initiation requests, provider must document adherence to intranasal corticosteroid therapy (unless contraindicated) prior to approval or continuation of Nucala. Evidence of clinical benefit (e.g., reduced polyp size, reduced systemic steroid use, improved smell or quality of life) should be provided for renewals.

Demonstrated adherence to at least two intranasal corticosteroids (one must be Xhance™) for ≥ 4 weeks each prior to initial approval unless contraindicated.
Nucala must be prescribed concurrently with an intranasal corticosteroid unless contraindicated.
For continuation, provide objective/clinical evidence of response to therapy.

Step Therapy

Step Therapy Considerations — Severe Asthma

For severe asthma candidates, providers should document prior use of medium- to high-dose ICS plus an additional controller (e.g., LABA) with persistent exacerbations despite adherence. Adherence measures (such as PDC) and exacerbation history (≥ 2 exacerbations in past 12 months requiring systemic corticosteroids, ER visit, or hospitalization) must be submitted. Specialty prescriber requirement applies.

Severe asthma: document medium- to high-dose ICS plus additional controller and persistent exacerbations despite adherence.
Provide exacerbation history: ≥ 2 exacerbations in past 12 months (systemic corticosteroids increase, ER visit, or hospitalization).
Prescribed by or in consultation with pulmonologist, immunologist, or allergist; age and dosing limits apply.

Denial Risk

Diagnoses/Indications Not Authorized

Requests for diagnoses or indications not covered by this policy (non–FDA approved indications not addressed here) are not authorized unless supported by the plan's off‑label use policies or sufficient clinical evidence. Acute bronchospasm and status asthmaticus are explicitly not authorized.

Non‑FDA approved indications not addressed in this policy require supporting documentation per off‑label use policies (CP.CPA.09 commercial; CP.PMN.53 Medicaid).
Acute bronchospasm and status asthmaticus are not authorized indications.

DocumentationEosinophil counts must be supported by lab results submitted with prior authorization request

HES — abbreviation and definition

AbbreviationHES = Hypereosinophilic syndrome

DefinitionA disorder of persistent eosinophilia; policy references HES criteria including exclusion of non-hematologic secondary causes and FIP1L1PDGFRα negativity

Age considerationTreatment criteria in policy apply to patients aged ≥12 years for HES

CRSwNP — abbreviation and definition

AbbreviationCRSwNP = Chronic rhinosinusitis with nasal polyps

DefinitionChronic rhinosinusitis characterized by bilateral nasal polyps and signs/symptoms ≥12 weeks; adult indication (≥18 years) per policy

Therapy contextPolicy requires prior intranasal corticosteroid therapy unless contraindicated

COPD — abbreviation and definition

AbbreviationCOPD = Chronic obstructive pulmonary disease

DefinitionAirflow limitation diagnosis (eg, postbronchodilator FEV1/FVC <0.7 or FEV1 20–80% predicted) with eosinophilic phenotype per policy criteria

Age requirementPolicy applies to adults aged ≥18 years for COPD indication

Severe asthma (pivotal trials) — definition and trial-aligned thresholds

Trial-defined severe asthmaTwo or more exacerbations despite regular use of high-dose inhaled corticosteroids plus an additional controller; clinically significant exacerbation includes doubling maintenance oral glucocorticoids for ≥3 days, hospital admission, or ED visit

Guideline alignmentGINA recommends Nucala as adjunct for patients ≥6 years with exacerbations or poor control on high-dose ICS/LABA and eosinophilic biomarkers

Clinical componentsRequires concurrent ICS plus LABA or LTRA and prescriber specialty (pulmonologist, immunologist, or allergist)

PDC (Proportion of Days Covered) — adherence measure

DefinitionPDC (Proportion of Days Covered) = sum of days covered divided by number of days in timeframe; PDC ≥0.8 equals ~144 days covered out of the last 180 days

Use in policyPDC ≥0.8 used as evidence of adherence to controller therapy for continued therapy assessments

Calculation examplePDC 0.8 ≈ 144/180 days (~5 months out of 6 months)

HES flare — definition

Definition of flareWorsening of HES-related clinical symptoms or increase in blood eosinophils requiring escalation in therapy, or increase in maintenance oral corticosteroid dose by ≥10 mg for 5 days, or addition/escalation of cytotoxic/immunosuppressive therapy

Clinical examplesMay include worsening skin lesions, nasal congestion, polyposis, dysphagia, fatigue, pruritus or pain

Policy useHistory of ≥2 flares in past 12 months used to define uncontrolled HES for initial approval

EGPA remission threshold

Remission thresholdStable prednisone dose ≤7.5 mg/day is considered remission per EULAR and pivotal trial definitions

ContextUsed in EGPA management and trial definitions referenced in policy appendix

Implication for therapyFailure to taper below this threshold may prompt consideration of additional immunosuppressant therapy per guidance

EGPA — expanded definition and prior clarifications

Expanded definitionEGPA = Eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss) — policy aligns diagnostic and eosinophilia criteria with pivotal trials and ACR classification guidance

Eosinophilia requirementPolicy revised EGPA eosinophilia requirement to eosinophils >1 x10^9/L and/or >10% leukocytes in alignment with pivotal study design and guidelines

Treatment contextEGPA initial and continued therapy criteria require specialist prescriber and dosing not to exceed 300 mg every 4 weeks