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

The Requirements Checklist to Get Zanzalintinib (XL092) Covered by UnitedHealthcare in Georgia: Appeals, Compassionate Use, and Clinical Trial Access

Answer Box: Getting Zanzalintinib (XL092) Covered by UnitedHealthcare in Georgia

Zanzalintinib (XL092) is an investigational cancer drug not FDA-approved, making UnitedHealthcare coverage unlikely outside clinical trials. Your fastest path: 1) Apply for Exelixis's Expanded Access Program (drug provided free), 2) Submit UnitedHealthcare prior authorization for routine care costs with medical necessity letter citing exhausted standard therapies, and 3) If denied, file internal appeal within 180 days, then Georgia external review within 60 days. Start today: Have your oncologist contact Exelixis Medical Affairs to discuss compassionate use eligibility while pursuing insurance coverage for monitoring costs.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria for Coverage
  4. Documentation Requirements
  5. Submission Process
  6. Compassionate Use Alternative
  7. Appeals Process in Georgia
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Options
  10. Printable Checklist

Who Should Use This Checklist

This guide helps Georgia patients and their healthcare teams navigate UnitedHealthcare coverage for Zanzalintinib (XL092), an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Currently in Phase I/II/III clinical trials (including the STELLAR program), XL092 has no FDA approvals as of 2025.

You should use this checklist if:

  • You have advanced cancer with limited treatment options
  • Your oncologist recommends XL092 based on clinical evidence
  • You're ineligible for or can't access clinical trials
  • Standard therapies have failed or are contraindicated

Expected outcome: UnitedHealthcare will likely deny coverage for the investigational drug itself, but may cover routine care costs if you demonstrate medical necessity. The primary pathway is Exelixis's Expanded Access Program, which provides the drug at no cost.

Member & Plan Basics

Verify Your Coverage

Before starting, confirm these details with UnitedHealthcare:

Essential Information to Gather:

  • Member ID and group number
  • Plan type (Commercial, Medicare Advantage, Medicaid)
  • Current deductible and out-of-pocket maximum
  • Specialty pharmacy benefits (typically through OptumRx)
  • Prior authorization requirements for specialty drugs

Check Your Plan Status:

  • Log into UnitedHealthcare member portal or call member services
  • Verify active coverage and benefits
  • Confirm your oncologist is in-network
  • Review any existing prior authorizations
Note: UnitedHealthcare requires prior authorization for most specialty cancer drugs through their Optum Specialty Guidance Program, effective September 1, 2025.

Clinical Criteria for Coverage

Medical Necessity Requirements

UnitedHealthcare considers investigational drugs "not reasonable and necessary," excluding them from standard coverage. However, you may build a case for coverage by demonstrating:

Primary Criteria:

  • Life-threatening cancer diagnosis with poor prognosis
  • Exhausted all FDA-approved standard therapies per NCCN guidelines
  • Failed or contraindicated to at least 2-3 lines of approved treatment
  • ECOG performance status 0-2
  • Adequate organ function for treatment

Clinical Documentation Needed:

  • Complete treatment history with dates and responses
  • Molecular testing results (if applicable)
  • Current staging and imaging
  • Laboratory values within 30 days
  • Oncologist assessment of prognosis without treatment

ICD-10 Coding Requirements

Ensure your diagnosis is properly coded:

  • Primary cancer diagnosis (specific ICD-10 code required)
  • Metastatic disease if applicable
  • Previous treatment complications or contraindications
  • Performance status documentation

Documentation Requirements

Medical Necessity Letter Components

Your oncologist should include these elements in the medical necessity letter:

Header Information:

  • Patient demographics and UnitedHealthcare member ID
  • Provider NPI and credentials
  • Drug name: Zanzalintinib (XL092)
  • Requested treatment duration and dosing

Clinical Justification:

  1. Diagnosis and staging with ICD-10 codes
  2. Treatment history including:
    • All prior therapies with dates
    • Reasons for discontinuation (progression, toxicity)
    • Response duration for each treatment
  3. Current clinical status and prognosis
  4. Rationale for XL092 including:
    • Mechanism of action relevant to patient's cancer
    • Published clinical trial data supporting use
    • Why approved alternatives are unsuitable

Required Attachments:

  • Complete medical records
  • Pathology reports
  • Recent imaging studies
  • Laboratory results
  • Prior treatment summaries
  • Relevant clinical guidelines (NCCN, ESMO)
Clinician Corner: Reference specific clinical trial data from the STELLAR program when available. Include peer-reviewed publications demonstrating XL092's activity in your patient's cancer type.

Submission Process

Prior Authorization Submission

Step 1: Gather Required Forms

  • Access UnitedHealthcare provider portal at uhcprovider.com
  • Download specialty drug prior authorization form
  • Verify current form version (forms update regularly)

Step 2: Submit Documentation

  • Online: UnitedHealthcare Provider Portal (preferred method)
  • Phone: 1-800-711-4555 (OptumRx Prior Authorization)
  • Fax: Use fax number provided on current PA form
  • Mail: Address specified on current form

Step 3: Track Your Request

  • Record confirmation number
  • Check status in 2-3 business days
  • Standard review: 15 business days
  • Expedited review: 72 hours (if urgent)

Common Submission Errors to Avoid:

  • Incomplete treatment history
  • Missing ICD-10 codes
  • Outdated form versions
  • Insufficient clinical documentation
  • Wrong submission pathway (medical vs. pharmacy benefit)

Compassionate Use Alternative

Exelixis Expanded Access Program

Since UnitedHealthcare coverage is unlikely, the Expanded Access Program offers the most viable pathway to access XL092.

Eligibility Criteria:

  • Life-threatening cancer without curative options
  • Exhausted standard therapies per NCCN guidelines
  • ECOG performance status 0-2
  • Adequate organ function
  • Ineligible for clinical trials

Application Process:

  1. Week 1: Oncologist contacts Exelixis Medical Affairs
  2. Week 2: Submit clinical documentation package
  3. Week 3: Complete FDA Form 3926 (single-patient IND)
  4. Week 4+: FDA review (typically 30 days)

What's Covered:

  • Drug provided free by Exelixis
  • Routine care costs may be covered by insurance with proper documentation
  • Monitoring and administration typically billable to insurance

Contact Information:

  • Exelixis Medical Affairs (physician must initiate contact)
  • Email: [email protected] for insurance questions

At Counterforce Health, we help patients and providers navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned with payer policies.

Appeals Process in Georgia

Internal Appeals Timeline

Filing Deadline: 180 days from denial notice Insurer Response Time:

  • Pre-service decisions: 30 days
  • Post-service decisions: 60 days
  • Urgent/expedited: 72 hours

Required Documentation:

  • Original denial letter
  • Additional clinical evidence
  • Updated medical necessity letter
  • Supporting literature/guidelines

Georgia External Review

If internal appeal is denied, you can request external review through the Georgia Department of Insurance.

Key Requirements:

  • Filing deadline: 60 days from internal appeal denial
  • Cost: Free to patient
  • Timeline: 30 business days (standard), 72 hours (expedited)
  • Decision: Binding on UnitedHealthcare

How to File:

  1. Visit Georgia DOI website for external review application
  2. Submit required documentation:
    • Internal appeal denial letter
    • Medical records
    • External review application
  3. Contact DOI Consumer Services: 1-800-656-2298

Expedited Review Available If:

  • Delay would jeopardize life or health
  • Waiting would significantly decrease likelihood of regaining maximum function
  • Opinion of attending physician supports urgency
From our advocates: We've seen cases where patients initially denied for investigational drugs succeeded on appeal by demonstrating that all standard therapies were exhausted and the investigational drug represented the only remaining option. The key is thorough documentation of the treatment journey and clear evidence that approved alternatives won't work.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Investigational/Experimental" Emphasize compassionate use pathway; appeal for routine care costs only FDA Expanded Access approval, clinical trial data
"Not Medically Necessary" Document exhausted alternatives, poor prognosis without treatment Complete treatment history, oncologist letter
"Not FDA Approved" Acknowledge status; request coverage for monitoring/administration Focus on covered services, not the drug itself
"Step Therapy Not Met" Document contraindications or failures of required first-line therapies Treatment records, toxicity documentation
"Plan Exclusion" Challenge through external review with medical necessity evidence Policy language review, clinical guidelines

Cost Assistance Options

Financial Support Programs

Exelixis Expanded Access:

  • Drug provided at no cost
  • Application through physician
  • Covers drug supply only

Routine Care Coverage:

  • Submit insurance claims for monitoring
  • Appeal denials with medical necessity documentation
  • Counterforce Health can help draft appeals for these ancillary costs

Additional Resources:

  • Patient Advocate Foundation: 1-800-532-5274
  • CancerCare Financial Assistance: 1-800-813-4673
  • Georgia cancer support organizations

Printable Checklist

Before You Start

  • Verify UnitedHealthcare coverage status
  • Confirm oncologist is in-network
  • Gather complete medical records
  • Document all prior treatments and outcomes
  • Check clinical trial eligibility first

Documentation Package

  • Medical necessity letter from oncologist
  • Complete treatment history
  • Current staging and imaging
  • Laboratory results (within 30 days)
  • Pathology reports
  • Relevant clinical guidelines

Submission Steps

  • Complete UnitedHealthcare PA form (current version)
  • Submit via provider portal or approved method
  • Record confirmation number and submission date
  • Set calendar reminder to check status in 3 days
  • Prepare appeal documentation in case of denial

Parallel Pathways

  • Oncologist contacts Exelixis Medical Affairs
  • Initiate Expanded Access application
  • Continue insurance appeals for routine care
  • Explore additional financial assistance

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals and coverage strategies, visit Counterforce Health.

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