By Counterforce Health Team in Nucala (mepolizumab) —

UnitedHealthcare's Coverage Criteria for Nucala (mepolizumab) in Texas: What Counts as "Medically Necessary"?

Answer Box: Getting Nucala Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Nucala (mepolizumab) with specific criteria: eosinophil count ≥150 cells/µL (or ≥300 cells/µL in past year) for severe asthma, documented failure of high-dose inhaled therapy, and specialist involvement. Fastest path: Submit PA through UnitedHealthcare Provider Portal with complete clinical documentation. First step today: Gather eosinophil labs, prior therapy records, and exacerbation history. Appeals must be electronic starting August 2025, with 72-hour expedited review available.

Table of Contents

Policy Overview

UnitedHealthcare covers Nucala (mepolizumab) across all plan types—HMO, PPO, and Medicare Advantage—but requires prior authorization through OptumRx for specialty drug management. The coverage criteria are consistent regardless of your specific UnitedHealthcare plan, though employer groups may have slight variations in step therapy requirements.

Plan Types and Applications:

  • Commercial plans: Follow UnitedHealthcare's standard medical necessity criteria
  • Medicare Advantage: Same criteria with additional CMS oversight
  • Medicaid managed care: Uses similar guidelines with state-specific modifications

You can find the most current policy documents on the UnitedHealthcare Provider Portal, which includes form PA-Med-Nec-Nucala with detailed coverage criteria.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all indications Complete PA form with clinical notes UHC PA Policy
Eosinophil Count ≥150 cells/µL recent OR ≥300 cells/µL past year Lab results within specified timeframe UHC Medical Necessity
Step Therapy High-dose ICS/LABA trial required Pharmacy records, failure documentation UHC Respiratory Policy
Specialist Care Pulmonologist/allergist involvement Specialist consultation notes UHC PA Requirements
Quantity Limits 30-day supply maximum Dosing aligned with FDA labeling OptumRx Guidelines

Indication Requirements

UnitedHealthcare covers Nucala for four FDA-approved indications, each with specific criteria:

Severe Eosinophilic Asthma (Ages 6+)

  • Eosinophil threshold: ≥150 cells/µL (most recent) OR ≥300 cells/µL (within past year)
  • Asthma severity: Documented severe persistent asthma despite optimized therapy
  • Age requirement: 6 years or older

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

  • Clinical criteria: Confirmed EGPA diagnosis with asthma history
  • Current therapy: On glucocorticoids ± immunosuppressive therapy
  • Disease activity: Evidence of ongoing symptoms requiring treatment

Hypereosinophilic Syndrome (HES)

  • Eosinophil threshold: ≥1,000 cells/µL documented within past 12 months
  • Duration: HES diagnosis for ≥6 months with symptoms >6 months
  • Age requirement: 12 years or older
  • Current therapy: On corticosteroids ± immunosuppressants

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

  • Prior therapy: Failed corticosteroids and surgery (or not surgical candidate)
  • Diagnosis: Documented CRSwNP requiring add-on maintenance therapy
Note: Off-label use requires additional documentation and may face higher scrutiny during review.

Step Therapy & Exceptions

UnitedHealthcare requires documented failure, intolerance, or contraindication to preferred therapies before approving Nucala.

Required Prior Therapies

  1. High-dose inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA)
  2. Adequate trial duration: Typically 3-6 months at maximally tolerated doses
  3. Alternative biologics: May require trials of preferred agents (varies by plan)

Medical Exception Pathways

  • Contraindication: Document specific medical reasons why preferred therapy cannot be used
  • Intolerance: Provide records of adverse effects from required prior therapies
  • Clinical urgency: Expedited review available for time-sensitive situations

Documenting Therapy Failure

Include specific details about:

  • Medication names, doses, and duration of trials
  • Objective measures of inadequate response (exacerbation frequency, symptom scores)
  • Reasons for discontinuation (side effects, lack of efficacy)

Required Diagnostics

Laboratory Requirements

  • Eosinophil count: Absolute count from complete blood count with differential
  • Timing: Most recent within 12 months; historical values may be considered
  • Multiple values: Pattern of elevated eosinophils strengthens the case

Supporting Clinical Data

  • Pulmonary function tests: Document airway obstruction and reversibility
  • Fractional exhaled nitric oxide (FeNO): If available, supports eosinophilic phenotype
  • Allergy testing: Total IgE and specific IgE results (when relevant)
  • Imaging: Chest X-ray or CT showing asthma-related changes
Tip: Submit the most recent labs first, then include historical values to show consistency of eosinophilic phenotype.

Quantity Limits & Site of Care

Dosing and Quantity Limits

  • Standard dosing: Every 4 weeks (28-30 day supply)
  • Severe asthma: 100mg (adults/adolescents), 40mg (ages 6-11)
  • EGPA/HES: 300mg (three 100mg injections)
  • CRSwNP: 100mg

Site of Care Requirements

UnitedHealthcare may require specific administration settings:

  • Initial doses: Often require medical supervision
  • Home administration: Requires prior approval and patient/caregiver training documentation
  • Specialty pharmacy: OptumRx specialty network for dispensing

Renewal Requirements

  • Annual reauthorization: Documentation of positive clinical response required
  • Response measures: Reduced exacerbations, decreased oral steroid use, improved symptoms
  • No combination therapy: Cannot be used with other anti-IL-5 biologics

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

When submitting a prior authorization, include these key elements:

Clinical History

  • Specific asthma phenotype (eosinophilic) with supporting lab values
  • Detailed exacerbation history (frequency, severity, hospitalizations)
  • Current symptoms despite optimized therapy

Prior Treatment Documentation

  • Complete medication history with doses, durations, and outcomes
  • Specific reasons for therapy failures or intolerances
  • Adherence assessment and optimization efforts

Supporting Evidence

  • Reference to FDA labeling for approved indications
  • Cite relevant guidelines (GINA, NAEPP)
  • Include peer-reviewed literature for complex cases

Treatment Plan

  • Proposed dosing schedule aligned with FDA recommendations
  • Monitoring plan for efficacy and safety
  • Expected clinical outcomes and measurement criteria

Appeals Process in Texas

UnitedHealthcare Internal Appeals

Starting August 1, 2025, all appeals must be submitted electronically through the UnitedHealthcare Provider Portal.

Standard Appeals Timeline

  • Submission deadline: 180 days from denial
  • Decision timeline: 30 days for pre-service, 60 days post-service
  • Required documents: Denial letter, clinical notes, supporting literature

Expedited Appeals

  • Decision timeline: 72 hours from submission
  • Eligibility: When delay could seriously jeopardize health
  • Submission: Same portal with urgency clearly indicated

Texas External Review Process

If UnitedHealthcare denies your internal appeal, Texas law provides independent external review.

External Review Rights

  • Timeline: Request within 4 months of final internal denial
  • Cost: Paid by the insurance company
  • Decision timeframe: 20 days standard, 5 days for urgent cases
  • Binding decision: Insurer must comply if overturned

Texas Department of Insurance Resources

Important: ERISA self-funded employer plans follow federal appeal rules, not Texas state requirements.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Eosinophil count too low Submit historical labs showing ≥300 cells/µL in past year Multiple CBC with differential results
Inadequate prior therapy Document specific trials with doses, durations, outcomes Pharmacy records, clinical notes
Not severe enough Provide exacerbation history, hospitalizations, oral steroid use Hospital records, prescription history
Missing specialist involvement Obtain consultation from pulmonologist/allergist Specialist evaluation and recommendations
Step therapy not completed Document failure/intolerance of preferred biologics Treatment records, adverse event documentation

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform identifies the specific denial basis and drafts point-by-point responses aligned with UnitedHealthcare's own coverage criteria, incorporating the right clinical evidence and regulatory requirements for Texas appeals.

Cost Savings Options

Manufacturer Support Programs

  • GSK For You: Patient assistance program for eligible patients
  • Copay assistance: Up to $10,000 annual support for commercially insured patients
  • Eligibility: Income and insurance requirements apply

Foundation Grants

  • Patient Advocate Foundation: Co-Pay Relief Program
  • HealthWell Foundation: Respiratory disease fund
  • Good Days: Chronic disease assistance

State and Federal Programs

  • Texas Medicaid: For eligible low-income patients
  • Medicare Part D: Coverage with prior authorization
  • 340B programs: Reduced pricing at qualifying healthcare facilities

FAQ

How long does UnitedHealthcare prior authorization take in Texas? Standard PA decisions are made within 10 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Nucala is non-formulary on my plan? Non-formulary drugs can still be covered with prior authorization and medical necessity documentation. You may face higher cost-sharing.

Can I request an expedited appeal if my initial PA is denied? Yes, if the delay in treatment could seriously jeopardize your health. Mark your appeal as "urgent" and provide clinical justification.

Does step therapy apply if I've tried biologics outside of Texas? Yes, UnitedHealthcare will consider prior therapy trials from any location if properly documented in your medical records.

What happens if I switch UnitedHealthcare plans during treatment? You'll need a new prior authorization for the new plan, but your treatment history will support the request.

How often do I need reauthorization for Nucala? Typically annually, with documentation of positive clinical response required for renewal.

Can my doctor do a peer-to-peer review if denied? Yes, providers can request a clinical discussion with UnitedHealthcare's medical director to discuss complex cases.

What if I disagree with the external review decision in Texas? External review decisions are binding. Further options may include legal consultation for cases involving plan violations.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies may vary by specific plan and employer group. Always consult your healthcare provider and insurance plan documents for the most current requirements. For personalized assistance with UnitedHealthcare denials and appeals, consider working with specialized advocacy services like Counterforce Health, which helps patients navigate complex prior authorization and appeals processes.

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