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

Getting Zanzalintinib (XL092) Covered by UnitedHealthcare in Michigan: Clinical Trials, Compassionate Use, and Appeals Guide 2025

Answer Box: Your Path to Zanzalintinib Access

Zanzalintinib (XL092) is an investigational drug not yet FDA-approved. UnitedHealthcare typically denies coverage outside clinical trials. Your fastest path: 1) Search active trials at ClinicalTrials.gov for "XL092" or contact your oncologist about STELLAR program studies, 2) If trial-ineligible, pursue Exelixis compassionate use via your doctor (requires FDA Form 3926), 3) File UnitedHealthcare prior authorization with trial enrollment or compassionate use approval. Michigan residents have strong appeal rights through DIFS external review (127 days to file after final denial, 60-day decision timeline).

Table of Contents

  1. Understanding Zanzalintinib Coverage Challenges
  2. Clinical Trial Access: The Primary Route
  3. Compassionate Use Programs
  4. UnitedHealthcare Prior Authorization Process
  5. Appeals Playbook for Michigan Residents
  6. Timeline and Documentation Requirements
  7. Financial Support and Bridge Options
  8. When to Escalate: Michigan DIFS External Review
  9. FAQ: Common Questions

Understanding Zanzalintinib Coverage Challenges

Zanzalintinib (XL092) by Exelixis is an investigational oral multi-targeted tyrosine kinase inhibitor currently in clinical trials. It has no FDA approval as of 2025, which creates significant coverage barriers with all insurers, including UnitedHealthcare.

UnitedHealthcare's standard position on investigational drugs is clear: coverage is typically limited to approved clinical trials or exceptional compassionate use cases. The STELLAR-303 trial did not meet its overall survival endpoint, further limiting coverage arguments outside of active research protocols.

Note: Unlike approved drugs where you can appeal based on medical necessity, investigational drugs require demonstrating either trial enrollment or extraordinary circumstances warranting compassionate use.

Coverage at a Glance

Requirement What it Means Where to Find It Source
FDA Status Investigational only FDA Orange Book FDA
UHC Coverage Clinical trials/compassionate use only UHC Medical Policy UHC Provider Portal
PA Required Yes, with trial/compassionate use documentation Member services or provider portal OptumRx Guidelines
Appeal Deadline 180 days internal, 127 days external (Michigan) Denial letter Michigan DIFS

Clinical Trial Access: The Primary Route

Clinical trials remain the most reliable path to accessing Zanzalintinib. UnitedHealthcare generally covers routine care costs for patients enrolled in qualified clinical trials, making this your strongest coverage strategy.

Active Trial Options

Search ClinicalTrials.gov for "XL092" or "zanzalintinib" to find current studies. Key active trials include:

  • EXACT trial: Phase II for metastatic clear cell renal cell carcinoma patients who progressed after adjuvant pembrolizumab
  • XL092-311: Zanzalintinib vs. everolimus in metastatic neuroendocrine tumors
  • NEO-COMBAT XL: Combination with cemiplimab in anaplastic thyroid cancer

Eligibility Requirements

Most trials require:

  • ECOG performance status 0-2
  • Measurable disease per RECIST 1.1 criteria
  • Progression on or intolerance to standard therapies
  • Adequate organ function (labs within 14 days)
  • No contraindications to study drugs
Clinician Corner: When referring patients to trials, prepare a comprehensive treatment history including all prior therapies, response duration, and reasons for discontinuation. Trial coordinators need this information for rapid screening.

Steps to Enroll

  1. Week 1: Your oncologist searches active trials and contacts study coordinators
  2. Week 2: Screening visit with labs, imaging, and eligibility assessment
  3. Week 3: Consent process and enrollment if eligible
  4. Week 4: Treatment initiation with routine care coverage through UnitedHealthcare

Compassionate Use Programs

If you're ineligible for clinical trials, Exelixis offers compassionate use access through their expanded access program.

Eligibility Criteria

  • Life-threatening or seriously debilitating cancer
  • No comparable approved treatment options available
  • Failed or unable to tolerate standard therapies
  • ECOG performance status 0-2
  • Potential benefit outweighs risks
  • Ineligible for suitable clinical trials

Required Documentation

Your oncologist must submit:

  • FDA Form 3926 (single-patient IND application)
  • Comprehensive medical history and treatment timeline
  • Recent imaging and laboratory results
  • IRB acknowledgment or waiver
  • Risk-benefit assessment letter

Process Timeline

  • Week 1: Oncologist contacts Exelixis Medical Affairs to discuss case
  • Week 2: Complete FDA Form 3926 and supporting documentation
  • Week 3: FDA and IRB review (can be expedited for urgent cases)
  • Week 4: Drug shipment and treatment initiation if approved
Important: Exelixis typically provides the investigational drug at no cost, but routine care costs (visits, labs, imaging) remain the patient's responsibility.

UnitedHealthcare Prior Authorization Process

Even with trial enrollment or compassionate use approval, you'll likely need UnitedHealthcare prior authorization for associated costs.

Required Documentation

Submit through the UHC Provider Portal or member services:

  • Clinical trial enrollment confirmation or compassionate use approval letter
  • Prescriber letter of medical necessity
  • Complete treatment history with prior therapy failures
  • Current staging and performance status
  • ICD-10 diagnosis codes
  • Estimated treatment duration and monitoring plan

Medical Necessity Letter Checklist

Your oncologist should include:

  • Primary diagnosis with ICD-10 codes and staging
  • Treatment history: All prior therapies, response duration, reasons for discontinuation
  • Clinical rationale: Why standard options are exhausted or contraindicated
  • Trial/compassionate use status: Enrollment confirmation or approval documentation
  • Monitoring plan: How treatment response and toxicity will be assessed

Processing Timeline

  • Standard review: 5-15 business days via OptumRx
  • Expedited review: 24-72 hours for urgent cases
  • PreCheck automation: Not available for investigational drugs

Counterforce Health specializes in helping patients navigate complex prior authorization requirements for investigational drugs. Their platform can analyze denial letters and draft evidence-backed appeals aligned to UnitedHealthcare's specific policies.

Appeals Playbook for Michigan Residents

Michigan residents have robust appeal rights under the Patient's Right to Independent Review Act (PRIRA) when UnitedHealthcare denies coverage.

Internal Appeals (Required First Step)

Timeline: File within 180 days of initial denial

Process:

  1. Submit appeal through UHC member portal or by mail/fax
  2. Include denial letter and new supporting evidence
  3. Request peer-to-peer review with oncology medical director
  4. Decision typically within 15-30 days

Key Documents:

  • Original denial letter
  • Updated medical necessity letter
  • Trial enrollment or compassionate use documentation
  • Published literature supporting off-label use (if applicable)

External Review Through Michigan DIFS

If UnitedHealthcare upholds the denial, Michigan's Department of Insurance and Financial Services (DIFS) provides independent external review.

Timeline: File within 127 days of final internal denial

Process:

  1. Complete FIS 0018 form online or by mail
  2. Include all denial letters, medical records, and physician statements
  3. DIFS assigns Independent Review Organization (IRO)
  4. Standard decision: 60 days maximum
  5. Expedited decision: 72 hours with physician urgency letter

Required Documents:

  • Completed FIS 0018 external review form
  • Copy of final internal denial letter
  • Medical records and treatment history
  • Treating Provider Certification for experimental/investigational denials
  • Physician letter for expedited review (if applicable)
From Our Advocates: We've seen Michigan DIFS overturn UnitedHealthcare denials for investigational drugs when patients provided strong evidence of trial enrollment and exhausted standard options. The key is demonstrating that the investigational drug represents the only viable treatment path, not just a preference over approved alternatives.

Timeline and Documentation Requirements

Critical Deadlines

Stage Timeline Key Actions
Initial PA Submission Before treatment start Submit via UHC provider portal with trial/compassionate use docs
Internal Appeal Filing Within 180 days of denial Include new evidence addressing denial reasons
DIFS External Filing Within 127 days of final internal denial Complete FIS 0018 form with comprehensive documentation
Expedited External Review 72-hour decision Requires physician urgency letter

Documentation Checklist

Before Starting:

  • Insurance card and member ID
  • Complete treatment history documentation
  • Current staging and imaging reports
  • Laboratory results (within 30 days)
  • Trial screening or compassionate use application

For Appeals:

  • All denial letters and EOBs
  • Updated medical necessity letter
  • Trial enrollment confirmation or compassionate use approval
  • Peer-reviewed literature (if available)
  • Physician urgency letter (for expedited review)

Financial Support and Bridge Options

Exelixis Support Programs

While Zanzalintinib isn't commercially available, Exelixis provides support through:

  • Free drug supply for approved compassionate use cases
  • Clinical trial cost coverage for investigational drug and some monitoring
  • Patient navigation services through trial coordinators

Bridge Coverage During Appeals

If you're between insurance plans or facing coverage gaps:

  1. Continue trial participation: Most trials provide drug regardless of insurance status
  2. Hospital charity care: For monitoring visits and labs during appeals
  3. State programs: Michigan Medicaid expansion may cover routine care
  4. Foundation grants: Limited options for investigational drugs, but may help with supportive care costs

Independent Patient Assistance

  • CancerCare: Financial assistance for treatment-related costs
  • Patient Advocate Foundation: Case management and financial aid
  • American Cancer Society: Transportation and lodging support for trial participation

When to Escalate: Michigan DIFS External Review

Contact Michigan DIFS when:

  • UnitedHealthcare denies coverage despite trial enrollment
  • Internal appeals are denied without adequate review
  • Delays jeopardize your ability to continue treatment
  • You need expedited review for urgent medical situations

Michigan DIFS Contact Information:

Tip: DIFS staff can help you complete forms and understand the process. Don't hesitate to call with questions about your specific situation.

The platform offered by Counterforce Health can be particularly valuable during the external review process, as they specialize in crafting evidence-backed appeals that address specific payer policies and regulatory requirements.

FAQ: Common Questions

Q: How long does UnitedHealthcare prior authorization take for investigational drugs? A: Standard processing is 5-15 business days, but investigational drugs often require manual review extending to 30 days. Request expedited review if treatment delays pose clinical risks.

Q: Can I get Zanzalintinib covered if I'm not eligible for clinical trials? A: Coverage is extremely limited outside trials. Compassionate use through Exelixis may provide drug access, but routine care costs remain your responsibility unless covered through appeals.

Q: What if UnitedHealthcare says the drug is "experimental" and won't cover any related costs? A: File an internal appeal with evidence that routine monitoring is standard of care regardless of the specific drug used. Michigan DIFS external review has overturned similar denials when proper documentation is provided.

Q: Does step therapy apply to investigational drugs? A: Traditional step therapy doesn't apply since there's no approved indication. However, UnitedHealthcare may require documentation that you've exhausted all approved therapies for your specific cancer type.

Q: Can I request an expedited appeal in Michigan? A: Yes, for both internal UnitedHealthcare appeals and DIFS external review. You'll need a physician letter stating that delays would jeopardize your health or treatment outcome.

Q: What happens if my trial closes while I'm on treatment? A: Contact Exelixis immediately about compassionate use continuation. Most sponsors provide transition pathways for patients benefiting from investigational drugs when trials close.

Q: Are there alternatives if Zanzalintinib isn't accessible? A: Your oncologist can discuss approved TKIs like cabozantinib or lenvatinib depending on your cancer type. NCCN guidelines provide treatment pathways for most indications where Zanzalintinib is being studied.

Q: How much does Zanzalintinib cost if I have to pay out-of-pocket? A: There's no commercial price since it's investigational. Clinical trials and compassionate use programs typically provide the drug at no cost, but routine care expenses vary by insurance coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and requirements may change; verify current information with official sources.

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