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

Getting Zanzalintinib (XL092) Covered by Humana in Illinois: Clinical Trial Access and Compassionate Use Appeals

Quick Answer: Zanzalintinib (XL092) is an investigational cancer drug not yet FDA-approved, so Humana typically won't cover it outside clinical trials. Your fastest path: 1) Ask your oncologist to check active trials at ClinicalTrials.gov, 2) If trial-ineligible, request compassionate use through Exelixis, 3) Submit Humana formulary exception with supporting docs within 72 hours. Illinois residents have strong appeal rights including external review within 30 days of denial.

Table of Contents

When Clinical Trial Access Makes Sense

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor from Exelixis currently in Phase II/III trials. Since it lacks FDA approval, Humana won't typically cover it outside of clinical trials or compassionate use programs.

Current Active Trials (2026):

  • Metastatic leiomyosarcoma (NCT06571734)
  • Metastatic castration-resistant prostate cancer post-177Lu-PSMA-617
  • Clear cell renal cell carcinoma (EXACT trial)
  • Neuroendocrine tumors (XL092-311)
  • Anaplastic thyroid cancer (NEO-COMBAT XL)

Trial Eligibility Criteria:

  • Age ≥18 years
  • ECOG performance status 0-2
  • Measurable disease per RECIST v1.1
  • Adequate organ function (LVEF >50%, QTcF ≤480 ms)
  • ≥2 prior systemic therapies (≤2 prior TKIs)
  • No recent kinase inhibitors (<14 days) or radiation (<4 weeks)
Tip: Contact your oncologist immediately to search ClinicalTrials.gov for "XL092" or "zanzalintinib" to find the most current trials accepting patients.

Available Alternatives on Humana's Formulary

If Zanzalintinib isn't accessible, Humana covers several FDA-approved multi-target TKIs that may be appropriate based on your cancer type:

Recently Approved TKIs (2024-2025)

Drug Name Indication Humana Tier Prior Authorization
Cabozantinib HCC, RCC, NETs, thyroid cancer Tier 4 Specialty Required
Zongertinib (Hernexeos) NSCLC with HER2 TKD mutations Tier 4 Specialty Required
Sevabertinib (Hyrnuo) NSCLC with HER2 TKD mutations Tier 4 Specialty Required
Taletrectinib (Ibtrozi) ROS1-positive NSCLC Tier 4 Specialty Required
Repotrectinib (AUGTYRO) NTRK fusion-positive tumors Tier 4 Specialty Required

Established Multi-Target TKIs

  • Sorafenib (Nexavar): First-line for HCC, RCC
  • Regorafenib (Stivarga): Second-line HCC post-sorafenib
  • Lenvatinib (Lenvima): Thyroid cancer, HCC combination therapy
  • Selpercatinib (Retevmo): RET fusion-positive cancers

All require prior authorization through Humana's specialty pharmacy with decisions typically within 72 hours.

Pros and Cons of Each Approach

Clinical Trial Enrollment

Pros:

  • Drug provided at no cost
  • Close monitoring and expert care
  • Access to cutting-edge therapy
  • Potential to help advance cancer research

Cons:

  • Strict eligibility criteria (only 10.1% of HCC patients meet criteria for similar TKIs)
  • May require travel to specialized centers
  • Randomization risk (may receive placebo)
  • Time-consuming screening process

Compassionate Use/Expanded Access

Pros:

  • Direct access to investigational drug
  • No placebo risk
  • Physician controls dosing and monitoring

Cons:

  • Requires extensive documentation
  • FDA approval needed (Form 3926)
  • Insurance unlikely to cover costs
  • Limited to life-threatening conditions

Formulary Alternatives

Pros:

  • FDA-approved with established safety profiles
  • Covered by Humana (after PA approval)
  • Readily available through specialty pharmacies
  • Established dosing and monitoring guidelines

Cons:

  • May not target same pathways as Zanzalintinib
  • Potential for different side effect profiles
  • Step therapy requirements may delay access

Exception Strategy for Zanzalintinib

If clinical trials aren't available and you need Zanzalintinib urgently, request a formulary exception from Humana.

Required Documentation Checklist

✅ Humana's "Request for Medicare Prescription Drug Coverage Determination" form
✅ Prescriber's supporting statement including:

  • All treated diagnoses with ICD-10 codes
  • Complete history of prior therapies (dates, results, reasons for discontinuation)
  • Current medication regimen
  • Safety assessment and contraindication review
  • Medical necessity justification

✅ Clinical evidence supporting Zanzalintinib:

  • Relevant clinical trial data
  • Compassionate use program approval (if applicable)
  • Literature supporting efficacy in your specific cancer type

Submission Process

  1. Complete forms with your oncologist's office
  2. Submit via Humana provider portal or fax to 877-486-2621
  3. Request expedited review if 72-hour delay could cause serious harm
  4. Follow up within 24-48 hours to confirm receipt
Important: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements.

Switching Logistics and Coordination

If Starting an Alternative TKI First

Week 1-2: Prior Authorization

  • Oncologist submits PA request with medical necessity letter
  • Include staging scans, lab results, and prior therapy documentation
  • Specify planned dosing, monitoring schedule, and treatment goals

Week 3-4: Approval and Initiation

  • Humana specialty pharmacy contacts patient for delivery coordination
  • Schedule baseline labs and imaging per FDA labeling
  • Review drug interactions and side effect management

Transitioning to Zanzalintinib Later

Document everything during alternative therapy:

  • Response assessments (imaging, tumor markers)
  • Toxicities and dose modifications
  • Reasons for discontinuation or treatment failure
  • Quality of life impacts

This documentation strengthens future appeals for Zanzalintinib access.

Re-trying for Zanzalintinib Later

When to Resubmit

  • Progressive disease on current therapy with imaging evidence
  • Intolerable toxicities requiring dose reductions or delays
  • New clinical trial data supporting Zanzalintinib efficacy
  • FDA approval or breakthrough therapy designation

Strengthening Your Case

Keep detailed records of:

  • Treatment response timeline with dates
  • Hospitalizations or complications from current therapy
  • Functional status changes (ECOG performance status)
  • Patient-reported outcomes and quality of life measures

Counterforce Health's platform can help identify the strongest evidence points and align them with Humana's specific coverage criteria for investigational drugs.

Illinois-Specific Appeal Rights

Illinois provides robust patient protections for insurance denials, with timelines that are stricter than many states.

Appeal Timeline

Level Deadline to File Decision Timeline
Internal Appeal 65 days from denial 15 business days (24 hours if expedited)
External Review 30 days from final denial 5 business days
Expedited External Same as above 24-72 hours

External Review Process

Illinois' Health Carrier External Review Act guarantees independent physician review of denials. The reviewer must be board-certified in your condition with no conflicts of interest.

Key Contacts:

  • Illinois Department of Insurance Consumer Hotline: 877-527-9431
  • Illinois Attorney General Health Care Helpline: 1-877-305-5145
Note: Illinois' 30-day external review deadline is shorter than the 4-month window in many states, so act promptly after internal appeal denials.

Required Documentation for External Review

  • Copy of final adverse determination from Humana
  • Completed external review application
  • Medical records supporting medical necessity
  • Any additional clinical evidence

Frequently Asked Questions

How long does Humana prior authorization take for investigational drugs?
Standard decisions within 72 hours; expedited decisions within 24 hours if delay could endanger health. Submit requests via Humana's provider portal.

What if Zanzalintinib isn't on Humana's formulary at all?
Request a formulary exception with medical necessity documentation. Humana must provide coverage for medically necessary treatments even if non-formulary.

Can I get expedited appeals in Illinois?
Yes, both internal appeals (24 hours) and external reviews (24-72 hours) can be expedited if delays could seriously jeopardize your health.

Does Humana cover clinical trial costs?
Medicare Advantage plans must cover routine patient care costs in qualifying clinical trials, but the investigational drug itself is typically provided by the sponsor.

What happens if my external review is approved?
Humana must provide coverage as determined by the independent reviewer. The decision is binding on the insurance company.

Are there patient assistance programs for investigational drugs?
Exelixis may provide Zanzalintinib through compassionate use programs for eligible patients. Contact your oncologist to initiate the application process.

How do I file a complaint against Humana in Illinois?
Contact the Illinois Department of Insurance at 877-527-9431 or file online complaints through their consumer portal.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan details, and medical necessity. Always consult with your healthcare provider and insurance plan directly for personalized guidance.

For comprehensive support with insurance appeals and prior authorizations, Counterforce Health helps patients and clinicians turn denials into targeted, evidence-backed appeals that align with payer-specific requirements.

Sources & Further Reading

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