DraftUnitedHealthcarePolicy N/A

Prior Authorization Form and Coverage Criteria for Nucala (mepolizumab)

Prior authorization request form for Nucala (mepolizumab) covering severe eosinophilic asthma, EGPA, HES, and chronic rhinosinusitis with nasal polyps; for prescribers submitting PA to the payer.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization Form and Coverage Criteria for Nucala (mepolizumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach medical records documenting diagnosis, baseline eosinophil counts, prior therapies and duration, exacerbation history, and evidence of clinical benefit for re-authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4indication sections

>=150eosinophil threshold

3 mominimum ICS+LABA trial

2+required exacerbations

Coverage Criteria for Nucala (mepolizumab)

Initial Therapy — Severe Eosinophilic Asthma

Severe Asthma Initial Authorization — Covered when ALL of the following are met

Severe Asthma initial criteria: 1) Diagnosis of severe eosinophilic asthma; 2) Pre-treatment serum eosinophil count >=150 cells/µL at screening (within the past 6 weeks) OR >=300 cells/µL within 12 months (or sputum eosinophils); 3) Inadequate control after a minimum of 3 months of high‑dose inhaled corticosteroid in combination with a long‑acting beta‑agonist; 4) Two or more asthma exacerbations requiring systemic corticosteroids or hospitalization in the past 12 months; 5) Prebronchodilator FEV1 below 80% in adults (90% in adolescents) as applicable; 6) Nucala is being requested as add‑on maintenance therapy (not for relief of acute bronchospasm or status asthmaticus).see individual nodes

Attach medical documentation (e.g., eosinophil values, FEV1, exacerbation history, prior therapy duration) to the PA request form

Continuation Therapy — Severe Eosinophilic Asthma

Severe Asthma Re-authorization — Covered when ALL of the following are met

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization Form and Coverage Criteria for Nucala (mepolizumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Severe Asthma re-authorization criteria: 1) Documentation of continued clinical benefit from Nucala evidenced by reductions in asthma exacerbations from baseline; 2) Medical records documenting the beneficiary's current asthma status and response to Nucala treatment must be attached to the PA request form.clinical improvement vs baseline

Attach medical documentation (see form questions 1-11)

Initial Therapy — EGPA

EGPA Initial Authorization — Covered when ALL of the following are met

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

Attach medical documentation confirming diagnosis (see form questions 12-13)

Continuation Therapy — EGPA

EGPA Re-authorization — Covered when

EGPA re-authorization criteria: 1) Documentation of ongoing clinical benefit since initiation of Nucala; 2) Attach medical records as requested on the form (re‑authorization questions 12–14).clinical benefit documentation

Attach medical documentation

Initial Therapy — HES

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.age >=12

Attach medical documentation confirming diagnosis (see form questions 15–16)

Continuation Therapy — HES

HES Re-authorization — Covered when

HES re-authorization criteria: 1) Documentation that the beneficiary has shown clinical improvement since beginning Nucala, supported by medical records.clinical improvement

Attach medical documentation (see form questions 15–17)

Initial Therapy — Chronic Rhinosinusitis with Nasal Polyps

Nasal Polyps Initial Authorization — Covered when ALL of the following are met

Nasal polyps initial criteria: 1) Diagnosis of chronic rhinosinusitis with nasal polyps; 2) Beneficiary tried and failed monotherapy with nasal steroids; 3) Beneficiary will continue intranasal steroids concomitantly with Nucala.failure of nasal steroid monotherapy

Document prior therapy and plan to continue intranasal steroids on the PA form (see questions 19–21)

Continuation Therapy — Nasal Polyps

Nasal Polyps Re-authorization — Covered when

Nasal polyps re-authorization criteria: 1) Documentation that the beneficiary has shown clinical improvement since beginning Nucala, supported by medical records.clinical improvement

Attach medical documentation (see form questions 18–22)

The PA form explicitly asks whether Nucala is being used for the relief of acute bronchospasm or status asthmaticus. This is not an indicated use for maintenance authorization and must be answered on the form; requests indicating use for acute bronchospasm or status asthmaticus are outside the maintenance-treatment intent of this policy and will be queried accordingly.

Requests that do not include the required diagnostic criteria, baseline measurements, prior therapy trials, or evidence of benefit on re-authorization will be considered not medically necessary. Specifically, the form requires documentation of diagnosis (e.g., severe eosinophilic asthma or chronic rhinosinusitis with nasal polyps), pre-treatment eosinophil counts or equivalent, confirmation of prior therapy trials (such as ≥3 months of high‑dose inhaled corticosteroid plus a long‑acting beta‑agonist for severe asthma, or failed nasal steroid monotherapy for nasal polyps), and for continuation requests, medical records demonstrating continued clinical benefit (for example, reductions in exacerbations or documented clinical improvement). Absence of these items may lead to denial.

Key Clinical Thresholds and Coding Parameters

Pre-treatment serum eosinophil count

Threshold>= 150 cells/µL at screening (within past 6 weeks) OR >= 300 cells/µL within 12 months (or sputum eosinophils)

ContextRequired as part of Severe Asthma initial authorization questions on the PA form

DocumentationList measured value and attach medical records showing date and result

Minimum prior inhaled therapy duration

Requirement>= 3 months of high‑dose inhaled corticosteroid plus long‑acting beta‑agonist (LABA)

Applies toSevere eosinophilic asthma initial authorization after inadequate control

DocumentationPA form asks whether beneficiary had inadequate control after this minimum trial; attach records

Required exacerbations

Required historyTwo or more asthma exacerbations requiring systemic (oral) corticosteroids or hospitalization in the past 12 months

PurposeUsed to establish severity and eligibility on the PA form

DocumentationForm requests listing of exacerbations and supporting medical records

Prebronchodilator FEV1 threshold

Adult thresholdPrebronchodilator FEV1 below 80% (adults)

Adolescent thresholdPrebronchodilator FEV1 below 90% (adolescents)

DocumentationPA form asks to list FEV1 value; attach spirometry to support eligibility

Forms, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Form Completion

Prior authorization requires completion of the benefit-specific PA form. The form must include beneficiary demographics, prescriber information, drug name/strength/quantity, indication-specific questions (see Severe Asthma, EGPA, HES, Nasal Polyps sections), and requested initial or continuation length of therapy. Attach the completed PA form to the request.

Include drug name, strength, quantity per 30 days, and requested length of therapy (initial and continuation options).
Signatures and date of prescriber are required on the form.
Attach the completed PA form to the electronic or faxed prior authorization submission.

Step Therapy

Step Therapy for Nasal Polyps

For nasal polyps, the PA form requires documentation of prior topical intranasal steroid therapy failure and confirmation that intranasal steroids will be continued concomitantly with biologic therapy. Requests without evidence of these step-therapy elements may be denied.

Must document trial and failure of monotherapy with intranasal steroids before approval.
Document whether intranasal steroids will be continued with Nucala.
Re-authorization must include evidence of clinical improvement since initiation.

Documentation Required

Required Documentation

Attach medical records that support the diagnosis and clinical criteria for the requested indication. Incomplete documentation is a common cause for denial.

Diagnosis confirmation (clinic notes, specialist consultation).
Baseline objective measures as applicable (e.g., pre-treatment serum eosinophil counts, sputum eosinophils, pre-bronchodilator FEV1 values).
Documentation of prior therapies and duration (e.g., inhaled corticosteroid + LABA for ≥3 months, intranasal steroid trials, systemic corticosteroid courses).
History of exacerbations, hospitalizations, or systemic steroid bursts (dates and details).
For re-authorization: documentation of clinical benefit since starting therapy (reduced exacerbations, improved symptoms or objective measures).

Denial Risk

Denial Triggers for Severe Asthma

Denials for Severe Asthma are triggered when required laboratory or clinical evidence of eosinophilic severe asthma or adequate prior therapy is missing, or when there is no documentation of benefit on re-authorization.

Missing pre-treatment serum eosinophil count (e.g., ≥150 cells/µL within 6 weeks prior or ≥300 cells/µL within 12 months) or equivalent sputum eosinophil data.
No evidence of inadequate control after a minimum of 3 months of high-dose inhaled corticosteroid plus a long-acting beta-agonist.
Absence of documentation of ≥2 asthma exacerbations requiring systemic corticosteroids or hospitalization in the past 12 months.
Missing pre-bronchodilator FEV1 values showing airflow limitation when required (adult <80%, adolescent <90%) where applicable.
For re-authorization: lack of documentation demonstrating continued clinical benefit (e.g., reduced exacerbations) since initiation.

Denial Risk

Denial Triggers for Other Indications

Denials for other indications occur when age criteria, diagnosis confirmation, or required prior therapy documentation are absent.

EGPA: Missing confirmation of diagnosis or if patient is under 18 years of age.
HES: Missing confirmation of diagnosis or if patient is under 12 years of age, or presence of an identifiable non-hematologic secondary cause.
Chronic rhinosinusitis with nasal polyps: Lack of documentation confirming diagnosis, failure of intranasal steroid monotherapy, or absence of plan to continue intranasal steroids with biologic therapy.
General: Absence of attached medical records that document prior treatments, objective measures, or clinical course as required for the indication.

Background

Nucala (mepolizumab) is indicated for eosinophil‑driven conditions included on this PA: severe eosinophilic asthma, EGPA, HES, and chronic rhinosinusitis with nasal polyps. The form captures key baseline and eligibility data needed to assess appropriateness, including pre‑treatment eosinophil thresholds (for severe asthma: ≥150 cells/µL at screening or ≥300 cells/µL within 12 months or sputum eosinophils), prior treatment history (for severe asthma: inadequate control after ≥3 months of high‑dose inhaled corticosteroid plus LABA; for nasal polyps: failed monotherapy with nasal steroids), and required documentation of clinical benefit for re‑authorization (for example, reductions in exacerbations or other evidence of improvement). These items must be provided as part of the PA request to determine coverage under the policy.

Definitions and Age Criteria

Severe eosinophilic asthma

DefinitionSevere eosinophilic asthma: asthma with elevated eosinophil counts (>=150 cells/µL at screening or >=300 cells/µL within 12 months)

Additional criteriaInadequate control after >=3 months of high‑dose inhaled corticosteroid plus LABA

Exacerbation historyTwo or more exacerbations requiring systemic corticosteroids or hospitalization in past 12 months

Usage noteNucala must be used as add‑on maintenance, not for acute bronchospasm/status asthmaticus

EGPA

DefinitionEosinophilic granulomatosis with polyangiitis (EGPA): confirmed diagnosis required

Age requirementPatient must be 18 years of age or older for EGPA indication

DocumentationPA form requests confirmation of diagnosis and attachment of medical records

HES

DefinitionHypereosinophilic syndrome (HES): diagnosis required with no identifiable non‑hematologic secondary cause

Age requirementBeneficiary must be 12 years of age or older for HES indication

DocumentationPA form requests attachment of medical records and asks whether clinical improvement has been shown for re‑authorization