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

How to Get Zanzalintinib (XL092) Covered by Aetna CVS Health in Michigan: Complete Appeals Guide

Answer Box: Getting Zanzalintinib (XL092) Covered in Michigan

Zanzalintinib (XL092) is an investigational drug not FDA-approved, so Aetna CVS Health typically denies coverage outside clinical trials. Your fastest path to coverage in Michigan: 1) Apply to Exelixis compassionate use program with your oncologist, 2) Submit Aetna prior authorization with compassionate use approval letter, and 3) If denied, file Michigan DIFS external review within 127 days. Start with your oncologist gathering complete treatment history and documenting why approved alternatives have failed or are unsuitable.

Table of Contents

  1. Understanding Zanzalintinib Coverage Reality
  2. Pre-Authorization Preparation
  3. Submitting Your Aetna Request
  4. When Aetna Says No: The Appeal Process
  5. Michigan DIFS External Review
  6. Common Denial Reasons & How to Fix Them
  7. Costs and Patient Support Options
  8. Frequently Asked Questions

Understanding Zanzalintinib Coverage Reality

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Since it's not FDA-approved, Aetna CVS Health excludes investigational drugs from standard coverage under their pharmacy clinical policy bulletins. However, coverage may be possible through compassionate use programs combined with medical necessity appeals.

Note: Recent clinical trial data showed the STELLAR-303 study did not meet its overall survival endpoint, which may impact coverage decisions. Always verify current trial status with your oncologist.

Coverage at a Glance

Requirement Status What This Means Source
FDA Approval No Not approved for any indication FDA Orange Book
Aetna Formulary Not Listed Requires prior authorization as investigational Aetna Drug Guide
Compassionate Use Available Through Exelixis program Exelixis Medical Affairs
Appeal Rights Yes 180 days internal, 127 days external in Michigan Michigan DIFS

Pre-Authorization Preparation

Before submitting any coverage request, gather comprehensive documentation. Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to each plan's own rules.

Essential Documentation Checklist

Medical Records:

  • Complete oncology treatment history with dates
  • Pathology reports confirming diagnosis
  • Recent imaging showing disease progression
  • Laboratory values and performance status
  • ICD-10 diagnosis codes

Prior Therapy Documentation:

  • All FDA-approved therapies tried and failed
  • Dates of treatment, duration, and response
  • Reasons for discontinuation (progression, toxicity, contraindications)
  • Supporting clinical notes from treating oncologist

Compassionate Use Application:

Clinician Corner: Medical Necessity Letter

Your oncologist's letter should address:

  1. Patient's specific diagnosis and stage
  2. Complete prior treatment history with outcomes
  3. Clinical rationale for Zanzalintinib based on mechanism of action
  4. Why approved alternatives are unsuitable (failed, contraindicated, or intolerable)
  5. Treatment goals and expected outcomes
  6. References to published literature supporting off-label use
  7. Compassionate use program approval status

Submitting Your Aetna Request

Step-by-Step Submission Process

Step 1: Verify Your Coverage

  • Log into Aetna member portal to confirm your plan details
  • Review your pharmacy benefits and prior authorization requirements
  • Note: Investigational drugs are processed through medical benefits, not pharmacy

Step 2: Complete Prior Authorization Forms

  • Use Aetna's standard prior authorization form for medical drugs
  • Submit through provider portal or fax to designated medical review department
  • Include all supporting documentation in single submission

Step 3: Submit Complete Package Your submission should include:

  • Completed prior authorization form
  • Medical necessity letter from oncologist
  • Complete medical records
  • Compassionate use program approval letter
  • Clinical trial ineligibility documentation
  • Published literature supporting use

Expected Timeline: Standard review takes 30-45 days. Request expedited review if medically urgent.

When Aetna Says No: The Appeal Process

Most initial requests for investigational drugs are denied. Don't give up—appeals have higher success rates when properly documented.

Aetna Internal Appeals Process

Level 1 Internal Appeal (180 days to file):

  • File within 180 days of denial notice
  • Submit new clinical evidence not in original request
  • Request peer-to-peer review with Aetna medical director
  • Include updated compassionate use documentation

Expedited Appeals (72 hours for urgent cases):

  • Available when delay would jeopardize health
  • Requires physician attestation of medical urgency
  • Same documentation requirements as standard appeal

Peer-to-Peer Review Script

When requesting a peer-to-peer call with Aetna's medical director:

"I'm calling to request a peer-to-peer review for [Patient Name], member ID [number], regarding coverage for Zanzalintinib XL092 through the Exelixis compassionate use program. The patient has [diagnosis] with disease progression on [list prior therapies]. Based on [specific clinical rationale and published data], this investigational therapy represents the most appropriate next treatment option. I have additional clinical documentation I'd like to discuss directly with your medical director."

Michigan DIFS External Review

If Aetna upholds their denial after internal appeals, Michigan residents have strong external review rights.

Michigan External Review Process

Filing Deadline: 127 days from final internal denial

Required Forms:

Review Timeline:

  • Standard Review: Decision within 56 days (up to 84 days if extended)
  • Expedited Review: 72 hours for urgent cases with physician attestation

How to File:

  • Online through DIFS portal
  • Phone: 877-999-6442
  • Mail/fax: Contact DIFS for current submission details
From our advocates: "We've seen Michigan DIFS external reviews succeed when the treating oncologist clearly documents why the investigational drug aligns with current standard of care, even if not FDA-approved. The key is showing the Independent Review Organization that denial conflicts with accepted medical practice for the patient's specific situation."

Independent Review Organization (IRO) Process

Michigan assigns qualified medical experts to review your case, examining:

  • Whether Aetna's denial criteria align with standard of care
  • Scientific evidence supporting the treatment
  • Patient-specific circumstances and medical necessity
  • Appropriate application of policy criteria

The IRO's decision is binding on Aetna.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Investigational/Experimental" Show compassionate use approval + medical necessity Exelixis program letter, clinical rationale
"Not FDA-approved" Document clinical trial ineligibility + no alternatives Trial screening records, prior therapy failures
"Not medically necessary" Provide evidence-based rationale Published literature, guidelines, case-specific need
"No coverage outside trials" Request formulary exception Medical necessity letter, compassionate use approval

Costs and Patient Support Options

Exelixis Support Programs

Compassionate Use Program:

  • Drug provided at no cost when approved
  • Application through treating oncologist
  • Covers drug cost but not administration/monitoring

Insurance Coverage Support

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for investigational drugs, providing templates and tracking deadlines to improve approval odds. Visit www.counterforcehealth.org for specialized support.

Additional Resources

  • Patient advocacy organizations for your specific cancer type
  • Hospital financial counselors for coverage navigation
  • Michigan Department of Health and Human Services for additional state programs

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Michigan? Standard review takes 30-45 days. Expedited review for urgent cases is completed within 72 hours.

What if Zanzalintinib isn't on Aetna's formulary? Investigational drugs typically aren't on formularies. Request coverage through medical benefits with compassionate use documentation.

Can I request an expedited appeal? Yes, if delay would jeopardize your health. Your physician must attest to medical urgency in writing.

What counts as medical necessity for investigational drugs? Evidence that approved treatments have failed, are contraindicated, or unsuitable, plus clinical rationale for the investigational therapy.

How successful are Michigan DIFS external reviews? Success rates vary, but comprehensive documentation and clear medical necessity significantly improve approval odds.

Does Aetna cover compassionate use drugs? Not automatically, but coverage is possible through prior authorization and appeals with proper documentation.

What if I can't afford the appeals process? Michigan provides free external review through DIFS. Many patient advocacy organizations also offer free support.

Can my doctor file appeals for me? Yes, with your written consent. Many appeals are more successful when filed by the treating physician.

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 case-specific guidance. Coverage policies and appeal processes may change; verify current requirements with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.