CurrentUnitedHealthcarePolicy N/A

Nucala (mepolizumab) prior authorization for eosinophilic conditions

This document is a UnitedHealthcare prior authorization (PA) request form governing coverage requirements for Nucala (mepolizumab) for indications including severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps. It affects prescribing providers requesting PA for beneficiaries.

Policy Summary

PayerUnitedHealthcare

PolicyNucala (mepolizumab) prior authorization for eosinophilic conditions

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the indication-specific PA form and attach medical records documenting age, diagnosis, eosinophil counts, prior controller therapy, and clinical response for initial or re-authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indications listed on the form

6/12/18minimum age thresholds

>=150eosinophil threshold (screening)

>=300eosinophil threshold (12 months)

Coverage Criteria for Nucala (mepolizumab)

Policy Summary

PayerUnitedHealthcare

PolicyNucala (mepolizumab) prior authorization for eosinophilic conditions

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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Initial Therapy

Severe eosinophilic asthma — Initial authorization covered when ALL of the following are met

Severe asthma initial criteria: 1) Beneficiary is 6 years of age or older; 2) Diagnosis of severe eosinophilic asthma; 3) Pre-treatment eosinophil count >=150 cells/mcL at screening within the past 6 weeks OR >=300 cells/mcL within 12 months OR sputum eosinophils >3% (provide value and date); 4) Inadequate control after a minimum of 3 months of high-dose inhaled corticosteroid in combination with a long-acting beta-agonist; 5) Two or more asthma exacerbations requiring systemic/oral corticosteroids or hospitalization in the past 12 months (document dates and treatments); 6) Prebronchodilator FEV1 below 80% in adults or below 90% in adolescents (provide value); 7) Nucala is being used as add-on maintenance treatment (not for acute bronchospasm or status asthmaticus); 8) Nucala is not being used concurrently as dual therapy with other monoclonal antibody treatments.

Form requires listing measured eosinophil and FEV1 values and attaching supporting documentation (medical records).

Continuation Therapy

Severe asthma — Re-authorization covered when ALL of the following are met

Severe asthma re-authorization: 1) Complete PA form questions 1–11; 2) Attach medical records documenting the beneficiary's current asthma status and response to Nucala (including exacerbation history and FEV1 where available); 3) Demonstrated continued clinical benefit evidenced by reduction in asthma exacerbations from baseline supported by medical records.

Prescriber signature and supporting documentation must be included with the request.

EGPA

EGPA — Initial authorization covered when ALL of the following are met

EGPA initial criteria: 1) Beneficiary is 18 years of age or older; 2) Confirmed diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

Re-authorization requires documentation of clinical improvement since initiating Nucala (attach medical records).

HES

Hypereosinophilic Syndrome (HES) — Initial authorization covered when ALL of the following are met

HES initial criteria: 1) Beneficiary is 12 years of age or older; 2) Diagnosis of Hypereosinophilic Syndrome (HES) with no identifiable non-hematologic secondary cause.

Re-authorization requires documentation of clinical improvement since initiating Nucala (attach medical records).

Nasal Polyps

Chronic rhinosinusitis with nasal polyps — Initial authorization covered when ALL of the following are met

Nasal polyps initial criteria: 1) Beneficiary is 18 years of age or older; 2) Diagnosis of chronic rhinosinusitis with nasal polyps; 3) Documented trial and failure of monotherapy with intranasal corticosteroids; 4) Beneficiary will continue intranasal steroids concomitantly with Nucala.

Attach medical records; re-authorization requires documented clinical improvement since starting Nucala.

This policy covers Nucala (mepolizumab) as add-on maintenance therapy for listed eosinophil-driven conditions. It is not intended for relief of acute bronchospasm or treatment of status asthmaticus; the PA form explicitly asks whether Nucala is being used for those acute indications and such use is outside the maintenance therapy purpose of this authorization. The form also queries and discourages concurrent use as dual therapy with other monoclonal antibodies.

Common deficiencies that delay or jeopardize approval include missing objective eosinophil data, absent documentation of prior controller therapy failure, and incomplete clinical records for re‑authorization. Specifically, requests often lack the required pre-treatment eosinophil count (or sputum eosinophil result) and do not list the numeric value or timing, fail to document a minimum of 3 months of high‑dose inhaled corticosteroid plus long‑acting beta‑agonist prior to initiation, or omit attached medical records showing response to therapy for continuation requests. For nasal polyps, missing documentation that the patient tried and failed monotherapy with intranasal steroids or confirmation that intranasal steroids will be continued with Nucala are frequent omissions.

Key Clinical Thresholds and Coding Values

Pre-treatment blood eosinophil count — severe eosinophilic asthma

Blood eosinophil threshold (screening within 6 weeks)>= 150 cells/mcL

Blood eosinophil threshold (within 12 months)>= 300 cells/mcL

Timing requirement for screening value150 cells/mcL must be measured within 6 weeks prior to the request

Alternate timing for higher threshold300 cells/mcL may be documented within the 12 months prior to use

Sputum eosinophil percentage

Sputum eosinophil threshold> 3%

Use as alternate criterionSputum >3% can be used instead of blood eosinophil thresholds for severe eosinophilic asthma

DocumentationForm asks to list eosinophil count when selecting this criterion

Age thresholds by indication

Severe eosinophilic asthma>= 6 years of age

Hypereosinophilic Syndrome (HES)>= 12 years of age

Eosinophilic Granulomatosis with Polyangiitis (EGPA)>= 18 years of age

Chronic rhinosinusitis with nasal polyps>= 18 years of age

FEV1 prebronchodilator

Prebronchodilator FEV1 — adultsBelow 80%

Prebronchodilator FEV1 — adolescentsBelow 90%

Form requirementQuestion 6 requests listing of the FEV1 value when selecting this criterion

Pre-treatment eosinophil thresholds (definitions) — severe eosinophilic asthma

Primary blood eosinophil definition for severe asthma>= 150 cells/mcL at screening within 6 weeks

Alternate blood eosinophil definition>= 300 cells/mcL within 12 months prior to use

Sputum eosinophil alternativeSputum eosinophils >3% qualifies as an alternate pre-treatment criterion

Documentation instructionForm asks provider to list the eosinophil count and date when selecting threshold criteria

Provider Actions, Documentation, and Denial Risks

Prior Authorization

PA Form Completion Required

Complete the PA form for the listed indications and attach supporting records. The form must confirm beneficiary age, diagnosis/indication, and include prescriber signature and beneficiary identifiers.

Complete indication-specific questionnaire items on the PA form (Severe eosinophilic asthma, EGPA, HES, Nasal polyps).
Include beneficiary identifiers: last name, first name, beneficiary ID, DOB, gender.
Include prescriber name, NPI, prescriber signature, date, and requester contact information (phone, fax).
Specify drug name, strength, quantity per 30 days, and requested length of therapy; check initial vs continuation and desired days (30/60/90/120/180/365 as applicable).

Documentation Required

Severe Eosinophilic Asthma — Documentation & Reauthorization

For severe eosinophilic asthma, document objective eosinophil testing and prior controller therapy failure, and attach clinical notes showing benefit for re-authorization.

Age requirement: beneficiary must be 6 years of age or older for severe asthma indication.
Document diagnosis of severe eosinophilic asthma on the PA form and in attached medical records.
Eosinophil thresholds: pre-treatment serum eosinophil count ≥150 cells/mcL within 6 weeks prior to request OR ≥300 cells/mcL within 12 months prior to use OR sputum eosinophils >3%. Record the date and value.
Prior controller therapy: evidence of inadequate control after ≥3 months of high‑dose inhaled corticosteroid plus a long-acting beta-agonist (document dates and therapies tried).
Exacerbation history: documentation of ≥2 asthma exacerbations requiring systemic/oral corticosteroids or hospitalization in the past 12 months (list dates and treatments).
Lung function: pre-bronchodilator FEV1 below 80% in adults (or below 90% in adolescents) should be recorded with value and date.
Nucala must be used as add‑on maintenance therapy (not for acute relief, not in combination with other biologics).
Re-authorization: attach medical records showing continued clinical benefit (reduced exacerbations) compared to baseline and objective/clinical response since starting therapy.

Step Therapy

Nasal Polyps — Step Therapy & Concomitant Intranasal Steroids

For chronic rhinosinusitis with nasal polyps, the policy requires documented failure of intranasal steroid monotherapy and ongoing use of intranasal steroids with Nucala.

Age requirement: beneficiary must be ≥18 years for the nasal polyps indication.
Confirm diagnosis: chronic rhinosinusitis with nasal polyps documented on the PA form and in records.
Step requirement: documented trial and failure of intranasal steroid monotherapy prior to initiating Nucala; include agent, dose, duration, and reason for failure.
Concomitant therapy: beneficiary must continue intranasal steroids while receiving Nucala—document plan to continue and the intranasal steroid prescribed.
Re-authorization: attach records showing clinical improvement since beginning Nucala.

Denial Risk

Potential Triggers for Denial

Common causes for denial — ensure all required labs, age criteria, prior therapy trials, and documentation of benefit are present before submission.

Missing or out-of-range eosinophil counts (failure to meet ≥150 cells/mcL within 6 weeks OR ≥300 cells/mcL within 12 months, or missing sputum >3%).
Age not meeting indication-specific minimums (severe asthma <6 years, nasal polyps <18 years, EGPA/HES below required ages).
Lack of documented trial/failure of required prior controller therapy (e.g., ≥3 months high-dose ICS + LABA for severe asthma; intranasal steroid trial for nasal polyps).
Insufficient evidence of exacerbation history or objective measures (no documentation of ≥2 exacerbations or hospitalizations in past 12 months when required).
No prescriber signature, missing beneficiary identifiers, or incomplete PA form fields (drug name, strength, quantity, length of therapy).
Requesting Nucala for acute relief, dual biologic therapy, or unapproved indications without supporting documentation.
Failure to attach medical records demonstrating clinical benefit for re-authorization requests.

OpenPayer

Nucala (mepolizumab) prior authorization for eosinophilic conditions

Coverage Criteria for Nucala (mepolizumab)

Key Clinical Thresholds and Coding Values

Provider Actions, Documentation, and Denial Risks

Background

Definitions and Thresholds