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

Do You Qualify for Zanzalintinib (XL092) Coverage by Humana in Ohio? Decision Tree & Appeal Guide

Answer Box: Your Path to Coverage

Zanzalintinib (XL092) is investigational and typically not covered by Humana Medicare Advantage outside clinical trials. However, you can pursue coverage through:

  1. Check clinical trial eligibility first—trials cover routine care costs
  2. Request formal coverage determination using Humana's Medicare Part D form within 72 hours
  3. If denied, file external review through Ohio Department of Insurance within 180 days

First step today: Call your oncologist to discuss trial options and contact Exelixis about expanded access programs.

Table of Contents

How to Use This Guide

This guide helps you navigate Humana's coverage process for Zanzalintinib (XL092), an investigational cancer drug currently in clinical trials. Since it's not FDA-approved, standard insurance coverage is extremely limited.

Important: Zanzalintinib is only available through:

  • Clinical trials (preferred option)
  • FDA Expanded Access programs
  • Compassionate use (rarely covered by insurance)

Most requests will be denied as "experimental," but this guide shows you the proper steps and appeal rights in Ohio.

Eligibility Triage: Do You Qualify?

Diagnosis Requirements

You likely qualify for consideration if:

  • ✅ Confirmed advanced/metastatic solid tumor (RCC, colorectal, hepatocellular carcinoma, prostate cancer)
  • ✅ Measurable disease per RECIST criteria
  • ✅ Performance status ECOG 0-2 or Karnofsky ≥70%
  • ✅ Adequate organ function (liver, kidney, bone marrow)

Prior Treatment History

Review your treatment timeline:

  • ✅ Failed or intolerant to standard therapies
  • ✅ Progressed after PD-1/PD-L1 inhibitors (for most indications)
  • ✅ Previous VEGFR-TKI therapy (for RCC patients)
  • ✅ No more than 1-2 prior systemic regimens (varies by indication)

Clinical Trial Eligibility

Check if you qualify for active trials:

Note: Clinical trials are the preferred path as they cover routine care costs and provide access to the latest protocols.

If "Likely Eligible" - Document Checklist

Required Documentation

Before submitting any coverage request, gather:

Medical Records:

  • Pathology report confirming cancer diagnosis with ICD-10 codes
  • Recent imaging showing disease progression (within 8 weeks)
  • Complete treatment history with dates, doses, and outcomes
  • Documentation of treatment failures or intolerances
  • Current performance status assessment

Insurance Information:

  • Humana member ID and policy details
  • Evidence of Coverage document
  • Previous denial letters (if applicable)

Submission Path

For Humana Medicare Advantage members:

  1. Complete Form ALL0419D - Request for Medicare Prescription Drug Coverage Determination
  2. Fax to: 877-486-2621
  3. Include physician supporting statement addressing:
    • Why all formulary alternatives are inappropriate
    • Specific contraindications or treatment failures
    • Risk of harm if treatment is delayed

Timeline: Humana must respond within 72 hours for standard requests, 24 hours for expedited.

If "Possibly Eligible" - Tests to Request

Additional Workup Needed

Performance Status Assessment:

  • Request formal ECOG or Karnofsky assessment from oncologist
  • Document functional limitations affecting daily activities

Biomarker Testing:

  • RAS mutation status (for colorectal cancer patients)
  • HIF-2α pathway markers (where applicable)
  • MSI/MSS status for colorectal indications

Organ Function Labs:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Liver function tests
  • Coagulation studies (PT/INR, aPTT)

Timeline to Re-apply

  • After completing workup: 2-4 weeks
  • If enrolled in trial: Coverage determination not needed
  • If expanded access approved: Submit coverage request with FDA authorization

If "Not Yet" - Alternative Options

FDA-Approved Alternatives

For RCC patients:

  • Cabozantinib (Cabometyx)
  • Lenvatinib + pembrolizumab
  • Axitinib + avelumab

For Colorectal Cancer:

  • Regorafenib (Stivarga)
  • Trifluridine/tipiracil (Lonsurf)
  • Fruquintinib (Fruzaqla)

Expanded Access Programs

Contact Exelixis directly:

  • Visit manufacturer's expanded access page (verify with the source linked below)
  • Physician must complete FDA Form 3926
  • IRB approval required before treatment

Eligibility for Expanded Access:

  • Life-threatening condition
  • No comparable alternatives
  • Reasonable expectation of benefit
  • Manufacturer agreement to provide drug

If Denied - Ohio Appeal Process

Level 1: Internal Appeal (Redetermination)

Deadline: 65 days from denial notice Timeline: 7 calendar days for Humana decision How to file: Use appeal form included with denial letter

Required elements:

  • Written request for redetermination
  • New medical evidence (if available)
  • Physician letter addressing denial reasons

Level 2: External Review (Ohio)

When it applies: After internal appeal denial Deadline: 180 days from final denial Process: File through your health plan, not directly with Ohio DOI

Ohio External Review Steps:

  1. Submit written request to Humana
  2. Humana forwards to Ohio Department of Insurance
  3. Independent Review Organization (IRO) assigned
  4. Timeline: 30 days standard, 72 hours expedited

Contact Ohio DOI: 1-800-686-1526 for questions about external review eligibility

Important: Medicare Advantage appeals follow federal rules, not Ohio's standard external review process. However, Ohio DOI can assist with complaints and guidance.

Level 3: Federal Appeals

Administrative Law Judge (ALJ): If amount in controversy exceeds $180 (2024 threshold) Medicare Appeals Council: Next level if ALJ denies Federal Court: Final option for amounts over $1,860

Coverage Decision Flowchart

Cancer Diagnosis Confirmed
           ↓
    Clinical Trial Available?
           ↓                    ↓
        YES                    NO
         ↓                     ↓
    Enroll in Trial    Check Expanded Access
         ↓                     ↓
    Routine Care          FDA Authorization?
     Covered                   ↓
                           YES    NO
                            ↓     ↓
                    Submit Coverage   Explore
                     Request        Alternatives
                         ↓
                    Likely Denied
                         ↓
                    File Appeal
                         ↓
                   External Review

Frequently Asked Questions

How long does Humana prior authorization take in Ohio? Standard requests: 72 hours. Expedited requests (when delay could harm health): 24 hours. Source: CMS regulations

What if Zanzalintinib is non-formulary? Request a formulary exception with physician supporting statement explaining why all covered alternatives are inappropriate. Success rate is very low for investigational drugs.

Can I request an expedited appeal? Yes, if delay would "seriously jeopardize your life, health, or ability to regain maximum function." Physician must provide written statement supporting urgency.

Does step therapy apply if I've failed treatments outside Ohio? Yes, document all prior treatments regardless of location. Out-of-state treatment failures count toward step therapy requirements.

What happens if I move from Ohio during an appeal? External review rights may change based on your new state's laws. Contact the new state's insurance department for guidance.

Are there financial assistance programs? Exelixis may provide drug free of charge through expanded access. Hospital administration and monitoring costs typically aren't covered by insurance.

How do I find clinical trials in Ohio? Search ClinicalTrials.gov by location. Major Ohio cancer centers include Cleveland Clinic, Ohio State, and University of Cincinnati.

What's the difference between Right to Try and Expanded Access? Expanded Access requires FDA and IRB approval but provides more safety oversight. Right to Try bypasses FDA review but offers less protection.

Resources & Next Steps

Immediate Actions

  1. Contact your oncologist to discuss clinical trial eligibility
  2. Review current Humana formulary for covered alternatives
  3. Gather complete treatment history including dates and outcomes

Key Contacts

Humana Member Services: 1-800-457-4708 Ohio Department of Insurance: 1-800-686-1526 FDA Project Facilitate (Oncology): For expanded access guidance

Official Resources

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate insurance denials by creating targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals that address specific payer requirements, increasing approval rates for complex cases like investigational drug coverage.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for specific guidance. For official Ohio insurance appeals information, contact the Ohio Department of Insurance at 1-800-686-1526.

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