By Counterforce Health Team in Zanzalintinib (XL092) [investigational] —

How to Get Zanzalintinib (XL092) Covered by UnitedHealthcare in Texas: Appeals, Compassionate Use, and Alternative Pathways

Answer Box: Getting Zanzalintinib (XL092) Covered in Texas

Zanzalintinib (XL092) is investigational and typically denied by UnitedHealthcare outside clinical trials. Your fastest path: 1) Submit prior authorization with comprehensive medical necessity documentation through the UnitedHealthcare provider portal, 2) Request peer-to-peer review if denied, 3) File internal appeal within 180 days, then pursue Texas Independent Review Organization (IRO) external review if needed. Alternative: Apply for Exelixis compassionate use program while navigating insurance appeals.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up Timeline and Expectations
  6. If You're Asked for More Information
  7. If Your Request is Denied
  8. Texas External Review Process
  9. Alternative Access Pathways
  10. Quick Reference Checklist

What This Guide Covers

This guide helps patients and healthcare providers navigate UnitedHealthcare's coverage process for Zanzalintinib (XL092), an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Currently in clinical trials through the STELLAR program, this drug has no FDA approvals as of 2025.

Who this helps:

  • Patients prescribed Zanzalintinib by their oncologist
  • Healthcare providers submitting prior authorization requests
  • Caregivers advocating for coverage approval

Realistic expectations: UnitedHealthcare typically denies investigational drugs outside clinical trials. However, with proper documentation and persistence through the appeals process, some patients may secure coverage through compassionate use exceptions or external review.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and providers navigate complex prior authorization requirements by identifying denial reasons and crafting point-by-point rebuttals aligned to each plan's specific policies.

Before You Start: Verify Your Coverage

Check Your Plan Type

Different UnitedHealthcare plans follow different rules:

Plan Type Prior Auth Process Appeals Process
Commercial (employer) UnitedHealthcare internal Texas IRO available
Medicare Advantage UnitedHealthcare + Medicare rules Medicare appeals process
Medicaid managed care State Medicaid rules Texas fair hearing
ERISA self-funded Employer plan rules Federal ERISA appeals

Confirm Network Status

Verify your oncologist is in-network through the UnitedHealthcare provider directory. Out-of-network providers may face additional barriers for investigational drug approvals.

Understand Specialty Pharmacy Requirements

UnitedHealthcare requires investigational drugs to be dispensed through approved specialty pharmacies when coverage is granted. Your provider cannot dispense directly without specific authorization.

Gather Required Documentation

Essential Clinical Information

Diagnosis Documentation:

  • Complete pathology report with ICD-10 codes
  • Molecular/biomarker testing results
  • Staging information and imaging reports

Treatment History:

  • Detailed record of all prior therapies tried
  • Dates, dosages, and duration of each treatment
  • Documentation of treatment failures, progression, or intolerances
  • Contraindications to standard therapies

Medical Necessity Support:

  • Comprehensive physician letter explaining why Zanzalintinib is needed
  • Clinical trial data or compassionate use protocol information
  • Literature supporting off-label or investigational use
  • Treatment goals and expected outcomes

Required Forms and Contacts

Prior Authorization Submission:

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Complete the PA Form
    • Patient demographics and insurance information
    • Prescriber details and NPI number
    • Drug information: Zanzalintinib (XL092), dosage, frequency
    • Primary diagnosis with ICD-10 code
  2. Attach Supporting Documentation
    • Medical necessity letter from oncologist
    • Complete treatment history
    • Relevant clinical trial information
    • FDA expanded access documentation (if applicable)
  3. Submit Through Preferred Channel
Tip: Submit electronically when possible for faster processing and automatic tracking.

Follow-Up Timeline and Expectations

Standard Processing Times

UnitedHealthcare must respond within 30 days for pre-service requests under Texas law. However, investigational drug requests often require additional review time.

Typical Timeline:

  • Initial review: 5-10 business days
  • Medical director review: 10-15 business days
  • Final determination: Up to 30 days

When to Follow Up

  • Day 7: Call to confirm receipt and check status
  • Day 15: Request status update if no response
  • Day 25: Escalate if approaching deadline

Status Check Script: "I'm calling about prior authorization request [reference number] for Zanzalintinib XL092 for [patient name]. Can you provide a status update and expected decision date?"

If You're Asked for More Information

UnitedHealthcare may request additional documentation, particularly for investigational drugs. Common requests include:

Medical Necessity Clarification

  • More detailed explanation of why standard therapies are inappropriate
  • Additional clinical evidence supporting investigational use
  • Specific treatment goals and success metrics

Clinical Trial Information

  • Enrollment status in relevant clinical trials
  • Explanation of why trial participation isn't possible
  • FDA expanded access program documentation
Note: Respond to information requests within the specified timeframe (usually 14 days) to avoid automatic denial.

If Your Request is Denied

Understanding Denial Reasons

Common denial codes for investigational drugs:

  • "Experimental/Investigational" - Drug lacks FDA approval
  • "Not Medically Necessary" - Insufficient clinical justification
  • "Alternative Available" - Standard therapies not exhausted

Peer-to-Peer Review

Request a peer-to-peer conversation between your oncologist and UnitedHealthcare's medical director within 48 hours of denial. This allows direct discussion of clinical rationale and may result in approval without formal appeal.

Peer-to-Peer Request Script: "I'm requesting a peer-to-peer review for the denied prior authorization [reference number]. The treating oncologist is available [provide availability] to discuss the medical necessity."

Internal Appeal Process

If peer-to-peer doesn't resolve the denial:

  1. File within 180 days of denial notice
  2. Submit through UnitedHealthcare appeals portal
  3. Include all original documentation plus additional supporting evidence
  4. Expect response within 30 days for pre-service appeals

Texas External Review Process

Texas law provides strong external review rights for investigational drug denials.

IRO Eligibility Requirements

You can request Independent Review Organization (IRO) review if:

  • All internal UnitedHealthcare appeals are completed
  • Denial is based on medical necessity or investigational status
  • You have a Texas-regulated health plan (not ERISA self-funded)

IRO Timeline and Process

Step Timeline Action Required
Request IRO Within 4 months of final denial Submit form provided by UnitedHealthcare
IRO Assignment 1 business day Texas Department of Insurance assigns reviewer
Review Decision 20 days (5 for urgent) IRO issues binding decision
Implementation Immediate UnitedHealthcare must comply if overturned

IRO Contact Information:

Important: IRO decisions are binding on UnitedHealthcare. If the external reviewer approves coverage, the insurer must provide the drug.

Alternative Access Pathways

Exelixis Compassionate Use Program

While pursuing insurance coverage, consider applying for manufacturer compassionate use:

  • Eligibility: Serious/life-threatening condition with no satisfactory alternatives
  • Requirements: FDA expanded access approval, physician supervision
  • Cost: Typically provided at no charge during application process
  • Timeline: 30-60 days for approval (varies by case complexity)

Contact Exelixis medical affairs for application materials and eligibility criteria.

Clinical Trial Enrollment

Check ClinicalTrials.gov for active Zanzalintinib studies. Trial participation provides drug access at no cost while contributing to research.

From our advocates: We've seen patients successfully combine multiple strategies - submitting insurance appeals while applying for compassionate use creates backup options. One Texas patient received approval through IRO external review after UnitedHealthcare initially denied coverage for an investigational TKI, emphasizing the importance of persistence through all available channels.

Quick Reference Checklist

Before Submitting PA:

  • Verify in-network oncologist
  • Confirm plan type and appeals rights
  • Gather complete medical records
  • Document all prior therapy failures
  • Prepare medical necessity letter

Submission Package:

  • Completed OptumRx PA form
  • Medical necessity letter
  • Pathology/molecular testing reports
  • Treatment history documentation
  • Clinical trial or expanded access info

If Denied:

  • Request peer-to-peer within 48 hours
  • File internal appeal within 180 days
  • Apply for compassionate use program
  • Prepare for Texas IRO if needed

Key Contacts:

  • OptumRx PA: 1-800-711-4555
  • PA Fax: 1-844-403-1027
  • Texas IRO: 1-866-554-4926
  • TDI Consumer Help: 1-800-252-3439

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Texas? Standard timeline is up to 30 days, but investigational drugs often require additional medical director review, potentially extending to 45-60 days.

What if Zanzalintinib is completely non-formulary? Non-formulary status doesn't prevent coverage if medical necessity is established. Focus on documenting why FDA-approved alternatives are inappropriate.

Can I request expedited review? Yes, if delay would jeopardize your health. Submit urgent PA requests with physician certification of medical urgency.

Does step therapy apply to investigational drugs? UnitedHealthcare typically requires exhaustion of FDA-approved alternatives before considering investigational agents, even in compassionate use cases.

What happens if my employer plan is self-funded? Self-funded ERISA plans follow federal appeals rules, not Texas IRO process. Check your summary plan description for specific procedures.

How much does external IRO review cost? Texas IRO review is free to patients - UnitedHealthcare pays the review fee as required by state law.

Can I appeal while applying for compassionate use? Yes, pursue both pathways simultaneously. Insurance approval provides long-term coverage while compassionate use offers interim access.

What documentation strengthens investigational drug appeals? Focus on clinical trial data, peer-reviewed literature, medical society guidelines, and detailed explanation of why standard therapies are inadequate.

Getting help with complex appeals: Counterforce Health helps patients and providers turn insurance denials into successful appeals by identifying specific denial reasons and crafting evidence-backed responses aligned to each insurer's policies and procedures.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. For additional help with Texas insurance issues, contact the Texas Department of Insurance at 1-800-252-3439.

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