By Counterforce Health Team in Tagrisso (osimertinib) —

How to Get Tagrisso (osimertinib) Covered by UnitedHealthcare in Texas: Prior Authorization Guide, Appeals Process, and Medical Necessity Requirements

Answer Box: Getting Tagrisso Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Tagrisso (osimertinib) based on documented EGFR-mutant NSCLC and FDA-approved indications. In Texas, you have 180 days to appeal denials internally, then 4 months for external review. Fastest path: Have your oncologist submit PA through the UHC Provider Portal with EGFR mutation report (del19, L858R, or T790M), pathology confirming NSCLC, and line of therapy documentation. Start today by calling UHC member services to confirm your plan's formulary status and PA requirements.

Table of Contents

UnitedHealthcare Policy Overview

UnitedHealthcare treats Tagrisso as a Tier 3 specialty drug requiring prior authorization across most commercial, Medicare Advantage, and Medicaid plans. The drug must be dispensed through Optum Specialty Pharmacy for most members.

Plan Types and Coverage

  • Commercial plans: Standard PA requirements with OptumRx formulary management
  • Medicare Advantage: Follow CMS guidelines plus UHC-specific criteria
  • ERISA self-funded employer plans: May have modified criteria; use federal external review process
  • Texas Medicaid: Managed through state Medicaid formulary with additional PA requirements
Note: Texas has not expanded Medicaid, so many residents rely on marketplace plans or employer coverage with varying formulary designs.

EGFR Testing and Indication Requirements

UnitedHealthcare's 2025 Tagrisso PA policy requires specific EGFR mutations documented by validated testing:

Required EGFR Mutations by Indication

Clinical Setting Required EGFR Mutation Additional Requirements
First-line metastatic NSCLC Exon 19 deletion or L858R Stage IV disease, oncologist prescriber
Post-EGFR TKI progression T790M Prior EGFR TKI failure documented
Adjuvant after resection Exon 19 deletion or L858R Stage IB-IIIB, prior/ineligible for platinum chemo
CNS metastases Any EGFR mutation Brain or leptomeningeal mets documented

Testing Documentation Requirements

Your EGFR mutation report must include:

  • Specific mutation type (not just "EGFR-positive")
  • Test methodology (PCR, NGS, or ctDNA)
  • CLIA-certified laboratory or FDA-approved test
  • Date of testing and specimen type (tissue or plasma)

Source: UHC Tagrisso PA Policy

Step Therapy and Medical Exceptions

UnitedHealthcare's current Tagrisso policy does not require step therapy for FDA-approved indications when used with appropriate EGFR mutations. However, some employer plans may add step therapy requirements.

When Step Therapy May Apply

  • Plan-specific modifications by large employers
  • State Medicaid programs with additional restrictions
  • Off-label use not covered by NCCN guidelines

Medical Exception Pathways

If step therapy is required, document:

  • Contraindications to alternative EGFR TKIs
  • Prior intolerance or failure (from any insurer)
  • CNS involvement requiring superior penetration
  • Cardiac comorbidities making alternatives riskier

Quantity Limits and Specialty Pharmacy

Standard Quantity Limits

  • 1 tablet per day regardless of strength (40mg or 80mg)
  • 30-day supply for initial fills
  • 90-day supply may be available after stable dosing

Optum Specialty Pharmacy Requirement

All Tagrisso prescriptions must go through Optum Specialty Pharmacy:

  1. Prescriber sends Rx directly to Optum Specialty
  2. Patient calls to set up account and shipping
  3. Clinical pharmacist provides counseling
  4. Monthly refills with adherence monitoring
Tip: Retail pharmacies will reject Tagrisso claims. Ensure your oncologist knows to route prescriptions to Optum Specialty from the start.

Required Diagnostics and Documentation

Clinical Documentation Checklist

For Initial PA Submission:

  • Pathology report confirming NSCLC
  • Staging documentation (CT chest/abdomen/pelvis, brain MRI)
  • EGFR mutation testing report
  • Performance status assessment
  • Prior treatment history (if applicable)
  • Oncologist's medical necessity letter

For PA Renewals (every 12 months):

  • Recent imaging showing stable/responding disease
  • Tolerability assessment
  • Confirmation of continued benefit
  • Updated performance status

Timing Requirements

  • EGFR testing: Must be current for the line of therapy
  • Staging scans: Within 30 days of PA submission preferred
  • Clinical notes: Recent visit documenting treatment plan

Evidence to Support Medical Necessity

Key Guidelines to Reference

  1. NCCN Guidelines: Tagrisso as Category 1 recommendation for EGFR-mutant NSCLC
  2. FDA Labeling: Approved indications and dosing
  3. ASCO Guidelines: Treatment recommendations for targeted therapy

Sample Medical Necessity Statement

"Patient has metastatic lung adenocarcinoma with confirmed EGFR exon 19 deletion by [test name] on [date]. Per NCCN Guidelines and FDA labeling, osimertinib is the preferred first-line therapy for this molecularly-defined subset, showing superior progression-free survival and CNS control compared to earlier-generation EGFR TKIs in the FLAURA trial."

Appeals Process in Texas

Internal Appeals Timeline

  • Commercial plans: 180 days from denial to file appeal
  • Standard review: 30 days for pre-service, 60 days for post-service
  • Expedited review: 72 hours for urgent cases

External Review Process

For fully insured plans:

  • File with Texas Department of Insurance (TDI)
  • 4 months from final internal denial
  • 20 days for standard review, 5 days for urgent
  • Contact: TDI Consumer Help at 1-800-252-3439

For ERISA self-funded plans:

  • Use federal external review through HHS/MAXIMUS
  • 4 months from final denial
  • 45 days standard, 72 hours expedited
  • More information at Healthcare.gov External Review

Required Appeal Documents

  • Original denial letter
  • Complete medical records
  • EGFR mutation report
  • Updated medical necessity letter
  • Relevant guideline excerpts
  • Prior authorization form (if resubmitting)

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Not medically necessary" Cite NCCN Category 1 recommendation Guidelines, FDA label, clinical trials
"Missing EGFR mutation" Resubmit with complete lab report Full pathology report with specific mutation
"Wrong line of therapy" Clarify treatment history and setting Prior treatment records, progression notes
"Experimental/investigational" Reference FDA approval FDA labeling, approval date, indication
"Step therapy required" Request medical exception Contraindication documentation, prior failures

Cost Assistance and Support Programs

Manufacturer Support

  • AstraZeneca Patient Assistance Program: Income-based free drug program
  • Tagrisso Copay Card: Up to $25,000/year for eligible commercial patients
  • Contact: 1-844-275-2360

Foundation Grants

  • CancerCare Co-Payment Assistance Foundation
  • Patient Advocate Foundation
  • Leukemia & Lymphoma Society

Texas-Specific Resources

  • Cancer Services Network of Texas: Local support programs
  • Texas Department of Health Services: State pharmaceutical assistance programs

FAQ

How long does UnitedHealthcare PA take in Texas? Standard PA decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Tagrisso is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Cite the lack of therapeutic alternatives for EGFR-mutant NSCLC.

Can I request an expedited appeal? Yes, if delay would jeopardize your health or ability to regain function. Document disease progression or urgent clinical need.

Does step therapy apply if I failed EGFR TKIs outside Texas? Prior treatment history from any location counts. Provide documentation of previous EGFR TKI use and failure/intolerance.

What's the cost after PA approval? Varies by plan. Texas has oral chemotherapy parity laws that may limit out-of-pocket costs for some plans. Contact member services for specific copay information.

How do I know if my plan is ERISA self-funded? Check your insurance card or Summary Plan Description. Self-funded plans typically say "ASO" or "administered by UnitedHealthcare" rather than "insured by."

When to Get Help

If you're struggling with denials or complex appeals, consider working with a healthcare coverage specialist. Counterforce Health helps patients, clinicians, and pharmacies turn insurance denials into successful appeals by creating evidence-backed, policy-aligned submissions that address the specific denial reasons and payer requirements.

From our advocates: We've seen Tagrisso appeals succeed when they directly address the EGFR mutation requirement with complete lab reports and clearly establish the line of therapy. The most common oversight is submitting a pathology report that mentions EGFR-positive results without specifying the exact mutation type (del19, L858R, T790M) that UHC's policy requires.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for plan-specific requirements. For questions about Texas insurance regulations, contact the Texas Department of Insurance at 1-800-252-3439.

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