UnitedHealthcare Nucala Prior Auth Policy Update

Coverage Criteria for Nucala (mepolizumab)

Initial Authorization (established users)

Covered when ALL of the following are met for each applicable indication:

Established therapy and response: Patient has been established on therapy with Nucala under an active UnitedHealthcare medical benefit authorization for the relevant indication

Supported for EGPA, severe asthma, HES in respective sections

Clinical response: Documentation of positive clinical response to Nucala therapy

Required for initial authorization

No concurrent biologic therapy: Patient is not receiving Nucala in combination with any of the following for treatment of the same indication: anti-interleukin-5 therapies (reslizumab, benralizumab), anti-interleukin-4 therapy (dupilumab), anti-IgE therapy (omalizumab), or thymic stromal lymphopoietin (TSLP) inhibitor therapy (tezepelumab)

Prohibits concurrent use for same indication

Initial Authorization (severe asthma)

Covered when ALL of the following are met for severe asthma:

Diagnosis of severe asthma

Requires eosinophilic phenotype as stated in separate node

Maintenance therapy: Nucala will be used in combination with maintenance controller therapy (examples: Advair/AirDuo [fluticasone/salmeterol], Breo Ellipta [fluticasone furoate/vilanterol], Symbicort [budesonide/formoterol], Trelegy [fluticasone furoate/umeclidinium/vilanterol])

Combination therapy required

Phenotype: Asthma is an eosinophilic phenotype

Eosinophilic phenotype required

No concurrent biologic therapy: Patient is not receiving Nucala in combination with any of the following for treatment of the same indication: anti-interleukin-5 (reslizumab, benralizumab), anti-interleukin-4 (dupilumab), anti-IgE (omalizumab), or TSLP inhibitor (tezepelumab)

Initial Authorization (HES)

Covered when ALL of the following are met for hypereosinophilic syndrome (HES):

Established therapy OR new diagnosis: Either patient has been established on therapy with Nucala under an active UnitedHealthcare medical benefit authorization for HES, OR diagnosis of HES ≥ 6 months ago

Either path acceptable as written

No secondary cause: There is no identifiable non-hematologic secondary cause of the patient's HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy)

Required for HES coverage

Prohibits concurrent biologic therapy

Reauthorization

Reauthorization will be approved when ALL of the following are met:

Positive clinical response: Documentation of positive clinical response to Nucala therapy

Required for reauthorization

Maintenance therapy for asthma: For severe asthma, Nucala is used in combination with maintenance controller therapy (examples listed in policy)

Applies to severe asthma reauthorization

No concurrent biologic therapy: Patient is not receiving Nucala in combination with any of the following for treatment of the same indication: anti-interleukin-5 therapies, anti-interleukin-4 therapy, anti-IgE therapy, or TSLP inhibitor therapy

Applies to reauthorization

HES Initial Authorization

Covered when ALL of the following are met

HES initial: Diagnosis of HES within 6 months; no identifiable non-hematologic secondary cause (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy); patient is not receiving Nucala in combination with anti-interleukin-5, anti-interleukin-4, anti-IgE, or TSLP inhibitor therapy for the same indication.

HES Reauthorization

Covered when ALL of the following are met

HES reauth: Documentation of positive clinical response to Nucala therapy; patient is not receiving Nucala in combination with listed biologics for the same indication.

Authorization for 12 months.

CRSwNP Initial Authorization

Initial authorization will be approved based on ONE of the following:

Established on therapy: Patient established on Nucala under an active UnitedHealthcare medical benefit authorization for CRSwNP with documentation of positive clinical response; will continue as add-on maintenance therapy; not receiving prohibited concomitant biologics.

New start CRSwNP: Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) and will be used as add-on maintenance therapy; patient is not receiving Nucala in combination with prohibited biologics.

CRSwNP Reauthorization

Reauthorization

CRSwNP reauth: Documentation of positive clinical response to Nucala therapy; patient will continue as add-on maintenance therapy; not receiving prohibited concomitant biologics.

Authorization will be issued for 12 months.

COPD Initial Authorization

Initial authorization will be approved based on ONE of the following:

Established on therapy COPD: Patient established on therapy with Nucala under an active UnitedHealthcare medical benefit authorization for COPD with documentation of positive clinical response; will continue as add-on maintenance therapy; patient is not receiving prohibited concomitant biologics.

New start COPD: Diagnosis of COPD with eosinophilic phenotype; Nucala used in combination with maintenance COPD inhaled therapy (examples: Advair/AirDuo [fluticasone/salmeterol], Bevespi Aerosphere [glycopyrrolate/formoterol], Breo Ellipta [fluticasone furoate/vilanterol], Symbicort [budesonide/formoterol], Trelegy Ellipta [fluticasone furoate/umeclidinium/vilanterol]); patient is not receiving prohibited concomitant biologics.

COPD Reauthorization

Reauthorization

COPD reauth: Documentation of positive clinical response to Nucala; continued use in combination with specified maintenance inhaled COPD therapy; patient is not receiving prohibited concomitant biologics.

Authorization will be issued for 12 months.

Limitations of use: Nucala (mepolizumab) is not indicated for relief of acute bronchospasm or status asthmaticus. This limitation applies across all covered indications and must be considered when evaluating requests for short‑term or emergency respiratory management; Nucala is an add‑on maintenance biologic rather than an acute rescue therapy.

Concomitant use of Nucala with other biologic therapies for the same indication is prohibited. Specifically, requests will be denied if the patient is receiving Nucala in combination with any of the following agents for treatment of the same condition: anti‑interleukin‑5 therapies (e.g., Cinqair [reslizumab], Fasenra [benralizumab]), anti‑interleukin‑4 therapy (e.g., Dupixent [dupilumab]), anti‑IgE therapy (e.g., Xolair [omalizumab]), or thymic stromal lymphopoietin (TSLP) inhibitor therapy (e.g., Tezspire [tezepelumab]).

Coverage determinations for Nucala may be subject to broader UnitedHealthcare program rules. Medical necessity policies and supply limitations can govern approvals, and UnitedHealthcare may use automated approval or re‑approval processes based on prior claim/medication history, diagnosis codes (ICD‑10), and claim logic. Providers should be aware that programmatic utilization management may affect the adjudication pathway and that site‑of‑care or medical benefit rules (for example, single‑dose vial billing) may also apply.

Coding and Diagnosis References

References to ICD-10 and claim logicmixed

No codes listed

HES diagnosis timing — diagnosis within 6 months

HES diagnosis timingDiagnosis of hypereosinophilic syndrome (HES) within the past 6 months is required for the 'new diagnosis' initial authorization path

Alternative established-therapy pathInitial authorization may instead be granted if the patient has been established on Nucala under an active UnitedHealthcare medical benefit authorization for HES

No secondary cause requirement (related)—cite in HES criteriaHES coverage requires no identifiable non-hematologic secondary cause (e.g., drug hypersensitivity, parasitic infection, HIV, non-hematologic malignancy)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Requirement — Evidence of Prior UnitedHealthcare Authorization

Prior authorization required. For initial requests, the provider must document that the patient was previously established on Nucala under an active UnitedHealthcare medical benefit authorization for the same indication (e.g., severe asthma, EGPA, HES, CRSwNP, COPD) when applicable. Failure to provide evidence of a prior active UnitedHealthcare medical benefit authorization for an existing course of Nucala therapy may lead to denial or affect coverage.

Applicable indications include severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), and COPD when specified.

Documentation Required

Initial Authorization Requirements

Initial authorization will only be approved when all indication-specific criteria and documentation requirements are met. At minimum, providers must: 1) confirm the patient meets the clinical diagnosis criteria for the requested indication; 2) show the patient was established on Nucala under an active UnitedHealthcare medical benefit authorization when that pathway is required; and 3) provide documentation of a positive clinical response to Nucala where specified. For severe asthma, documentation must also show Nucala is being used with maintenance controller therapy (examples below).

Background

Background: Mepolizumab (Nucala) is an anti–interleukin‑5 monoclonal antibody indicated as add‑on maintenance therapy for eosinophilic conditions. Indications include severe eosinophilic asthma (patients age 6 years and older), chronic rhinosinusitis with nasal polyps (CRSwNP) and other adult eosinophilic disorders, eosinophilic granulomatosis with polyangiitis (EGPA), chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype (adults), and hypereosinophilic syndrome (HES) in select patients (age 12 years and older where applicable). Nucala is supplied in prefilled autoinjector and prefilled syringe formulations; the single‑dose vial formulation is typically billed under the medical benefit—see the UnitedHealthcare Medical Benefit Drug Policy for respiratory interleukins for site‑of‑care and coding guidance.

Definitions and Limitations of Use

Limitation of use — not for relief of acute bronchospasm or status asthmaticus

Limitation of useNucala is not for relief of acute bronchospasm or status asthmaticus

Intended useIndicated as add-on maintenance therapy for chronic eosinophilic conditions; not for acute symptom relief

Provider action implicationDo not prescribe Nucala for immediate relief of acute bronchospasm or status asthmaticus; use acute rescue therapies instead

HES timing — Hypereosinophilic syndrome (HES) diagnosed within the past 6 months

HES timing requirementDiagnosis of HES within the past 6 months satisfies the 'new diagnosis' initial authorization pathway for HES

Related HES requirementAlternatively, established-on-therapy under an active UnitedHealthcare medical benefit authorization is acceptable instead of a recent diagnosis

Initial Therapy Criteria by Indication

Initial therapy

Initial therapy requirements vary by indication; common elements include established prior authorization or documented diagnosis, positive clinical response (if established), and prohibition on concurrent biologic therapies for the same indication.

Established authorization path: Patient established on Nucala under an active UnitedHealthcare medical benefit authorization for the indicated condition and documentation of positive clinical response

EGPA, severe asthma, HES sections reference this path

New diagnosis path (HES): Diagnosis of HES ≥ 6 months ago and no identifiable non-hematologic secondary cause

HES-specific requirement

Severe asthma path: Diagnosis of severe asthma with eosinophilic phenotype and use with maintenance controller therapy

Severe asthma-specific requirement

Continuation and Reauthorization Criteria

Continuation therapy

Reauthorization / continuation requirements

Positive clinical response: Documentation of positive clinical response to Nucala therapy is required for continuation

Reauthorization interval is 12 months

Continuation Therapy

Continuation (patients established on therapy)

Established therapy continuation: Patient established on Nucala under an active UnitedHealthcare medical benefit authorization may continue therapy with documentation of positive clinical response and as add-on maintenance therapy; not receiving prohibited concomitant biologics.

Step Therapy and Concomitant Medication Requirements

Required combination therapy (examples)
Combination inhaled corticosteroid (ICS) + long-acting beta2-agonist (LABA) — examples: Advair / AirDuo (fluticasone/salmeterol)
Breo Ellipta (fluticasone furoate/ vilanterol) — ICS/LABA example
Symbicort (budesonide/formoterol) — ICS/LABA example
Trelegy (fluticasone furoate/umeclidinium/vilanterol) — triple inhaler containing ICS/LABA component
General: Nucala must be used in combination with maintenance controller therapy (e.g., ICS/LABA, ICS, LABA)

Programmatic approval / utilization management
UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.
Use of automated approval and re-approval processes varies by program and/or therapeutic class; Medical Necessity or supply limitations may apply.

Site of Care and Billing Notes

Billing Rule

Infusion center / billing: single‑dose vial medical benefit and billing guidance

Single‑dose vial formulations are typically covered under the medical benefit; for site‑of‑care coding and billing (including infusion center use), refer to the UnitedHealthcare Medical Benefit Drug Policy: “Respiratory Interleukins (Cinqair, Fasenra and Nucala).”

Single‑dose vial is typically covered under the medical benefit
Refer to Medical Benefit Drug Policy for site coding and billing guidance

Revision History

2025-10-01effective_dateLatest

Policy effective date set to 2025-10-01 and annual review performed (added new COPD indication and updated concomitant use statements).

2025-07-01last_review

Annual review completed; added new indication and criteria for chronic obstructive pulmonary disease (COPD) and updated statements on concomitant biologic use across indications including Tezspire.

2024-07

OpenPayer

Nucala (mepolizumab) prior authorization for autoinjector and prefilled syringe

Coverage Criteria for Nucala (mepolizumab)

Coding and Diagnosis References

Provider Actions and Documentation Requirements

Background

Definitions and Limitations of Use

Initial Therapy Criteria by Indication

Continuation and Reauthorization Criteria

Step Therapy and Concomitant Medication Requirements

Site of Care and Billing Notes

Revision History