CurrentAvMedPolicy Pub. 100-2

Nucala (mepolizumab) subcutaneous for severe eosinophilic asthma prior authorization

Defines prior authorization and step-edit requirements for medical (J2182) use of Nucala (mepolizumab) SQ for members with severe eosinophilic asthma; applies to providers submitting requests to AvMed.

Policy Summary

PayerAvMed

PolicyNucala (mepolizumab) subcutaneous for severe eosinophilic asthma prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit a complete prior authorization form with prescriber signature and required clinical documentation (labs, spirometry, and pharmacy claims) to support each checked criterion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization period

12 monthsReauthorization period

>=6Minimum member age for coverage

>=150Eosinophil threshold

FEV1<80%Spirometry criterion

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inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial Authorization Criteria

Specialist involvement: Prescribed by or in consultation with an allergist, immunologist, or pulmonologist
Age: Member is 6 years of age or older>=6 years
Prior pharmacy approval: Has the member been approved for Nucala previously through the Health Plan pharmacy department?
Yes/No response required
Severe eosinophilic phenotype: Baseline (pre‑treatment) peripheral blood eosinophil level >= 150 cells/microliter>=150 cells/microliter
Submit labs collected within the past 12 months
Prior controller therapy
- High‑dose ICS plus additional controller: High‑dose inhaled corticosteroid (eg, >500 mcg fluticasone propionate equivalent/day) AND an additional asthma controller (eg, leukotriene receptor antagonist, LABA, theophylline)90 days
- Maximized ICS/LABA: One maximally dosed combination ICS/LABA product (eg, Advair, Dulera, Symbicort)90 days
Clinical severity
- Exacerbations: One or more exacerbations requiring additional medical treatment (eg, oral corticosteroids, ED/urgent care visits or hospitalizations) within the past 12 months
- Prior intubation: Any prior intubation for an asthma exacerbation
- Spirometry: Baseline FEV1 < 80% predicted normal ( < 90% for members 6–17 years) submitted within year of requestFEV1 <80% (<90% for 6–17)
  Submit spirometry within past 12 months

Eosinophil failure definition: Provider must submit member blood eosinophil count after a trial and failure of at least 90 consecutive days of therapy with high‑dose ICS AND LABA; failure is defined here as a blood count > 150 cells/microliter

Submit date and value of eosinophil count (labs within past 12 months)

inv-03: Concomitant biologics

Biologic combination exclusion: Use of concomitant therapy with Cinqair, Dupixent, Fasenra, Tezspire, and Xolair is considered experimental and investigational and will not be permitted; if an active authorization exists for any of these agents, subsequent requests for Nucala will not be approved.

The Health Plan considers concurrent use of Nucala (mepolizumab) with the following biologics to be experimental and investigational: Cinqair, Dupixent, Fasenra, Tezspire, and Xolair. Safety and efficacy of these combinations have not been established and such combinations will not be permitted.

If a member has an active authorization for any of the alternate biologics listed above (Cinqair, Dupixent, Fasenra, Tezspire, or Xolair), any subsequent request for Nucala will not be approved. Providers should not submit requests for Nucala when one of these authorizations is currently on file.

Coding, Age, and Clinical Thresholds

Medical J-codeHCPCS

J2182

Injection, mepolizumab, 1 mg (Nucala)

Baseline peripheral blood eosinophil count — threshold value

Baseline peripheral blood eosinophil count>= 150 cells/microliter (pre-treatment)

Documentation timeframeSubmit eosinophil lab collected within the past 12 months

Failure definition for controller therapyFailure after at least 90 consecutive days of high-dose ICS + LABA if eosinophils remain >150 cells/microliter

Age — minimum member age for coverage

Minimum member age for coverage>= 6 years

Age documentationMember age must be indicated on request form or chart notes

Age groups referenced for dosingDosing categories: 6–11 years (pediatric) and >=12 years (adolescent/adult)

Spirometry threshold — FEV1 criterion (including pediatric adjustment)

Spirometry (FEV1) threshold for adultsFEV1 < 80% predicted normal

Pediatric adjustment (ages 6–17)FEV1 < 90% predicted normal for members 6–17 years old

Timing for test submissionFEV1 must be submitted within 1 year of request

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid) on the request form and include accurate contact information. Fax completed requests to 1-877-535-1391. No additional phone calls will be necessary if all information (including phone and fax numbers) on the form is correct. Authorization can be delayed if the information provided is incomplete, incorrect, or illegible.

Drug: Nucala® SQ (mepolizumab) (J2182) (Medical)
Fax: 1-877-535-1391
Prescriber signature required (stamps not valid)

Documentation Required

Required Supporting Documentation

All supporting documentation listed below must be provided with the request. If documentation (lab results, diagnostics, chart notes) is missing, illegible, or incomplete, the request may be denied or delayed. Trials will be verified using pharmacy claims and/or submitted chart notes.

Baseline (pre-treatment) peripheral blood eosinophil level ≥ 150 cells/µL — submit labs collected within the past 12 months and date of test
Documented trial and inadequate response or intolerance to at least 90 consecutive days of high‑dose inhaled corticosteroid (ICS) plus an additional controller (e.g., leukotriene receptor antagonist, LABA, theophylline) or a maximally dosed combination ICS/LABA — submit pharmacy claims or chart notes verifying 90‑day compliance within the past year
For initial requests: baseline FEV1 % predicted (<80% for adults; <90% for ages 6–17) — submit test date and results within the year of request
For initial requests: documentation of one or more exacerbations in past 12 months requiring oral corticosteroids, ED/urgent care visit, or hospitalization, or any prior intubation for asthma exacerbation — submit chart notes or encounter records
Reauthorization: evidence of sustained positive clinical response to Nucala (e.g., increase in percent predicted FEV1 from baseline, reduced inhaled or oral corticosteroid use, reduced asthma symptoms) — submit objective measures and clinical notes
Provider specialty documentation when applicable (prescribed by or in consultation with an allergist, immunologist, or pulmonologist)

Denial Risk

Provider Action — Complete and Accurate Submission Required

Incomplete, incorrect, or missing documentation may delay processing or result in denial. Ensure all requested labs, dates, trial documentation (including pharmacy paid claims), and clinical notes are attached. Concomitant therapy with Cinqair®, Dupixent®, Fasenra®, Tezspire® and Xolair® is considered experimental/investigational; requests for Nucala will not be approved if an active authorization for any of these agents exists.

Verify pharmacy paid claims for required controller therapy trials (90 consecutive days) and include copies if available
Attach baseline eosinophil count with date and any follow-up eosinophil counts
Attach baseline and follow-up FEV1 measurements with dates
Attach documentation of exacerbations, hospitalizations, ED visits, or intubation as applicable
Specify administration site: physician's office or specialty pharmacy

Definitions and Recommended Dosing

Severe eosinophilic phenotype — definition used in this policy (baseline eosinophil threshold)

Severe eosinophilic phenotype definitionBaseline peripheral blood eosinophil level >= 150 cells/microliter prior to treatment

Lab timingEosinophil level should be from labs collected within the past 12 months

Clinical contextUsed to identify candidates for Nucala (mepolizumab) for severe eosinophilic asthma

Recommended dosing — pediatric and adult dosing regimens (syringe/vial options)

Pediatric dosing (6–11 years)40 mg subcutaneous every 4 weeks (prefilled syringe); may be administered by caregiver after training

Adult and adolescent dosing (>=12 years)100 mg subcutaneous every 4 weeks — available as lyophilized powder in single‑dose vial or solution in prefilled syringe/auto‑injector

Route and frequencySubcutaneous (SQ) injection every 4 weeks for all approved age groups

OpenPayer

Nucala (mepolizumab) subcutaneous for severe eosinophilic asthma prior authorization

Coverage Criteria for Nucala (mepolizumab) SQ

Coding, Age, and Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Background

Definitions and Recommended Dosing