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

How to Get Zanzalintinib (XL092) Covered by Humana in Virginia: Appeals Guide for Investigational Cancer Treatment

Answer Box: Getting Zanzalintinib (XL092) Coverage from Humana in Virginia

Zanzalintinib (XL092) is investigational and typically denied by Humana as "not covered outside clinical trials." However, you have three main pathways: 1) Request a formulary exception with strong medical necessity documentation, 2) Apply for Exelixis' compassionate use program (drug provided at no cost), and 3) If denied, file an external review with Virginia's State Corporation Commission within 120 days. Start by having your oncologist submit a prior authorization request through Humana's provider portal within 72 hours, emphasizing failed standard therapies and clinical evidence supporting Zanzalintinib for your specific cancer type.

First step today: Call your oncologist to initiate both the Humana formulary exception request and contact Exelixis Medical Affairs for compassionate use eligibility.

Table of Contents

Understanding Zanzalintinib Coverage Challenges

Zanzalintinib (XL092) by Exelixis is an investigational multi-target tyrosine kinase inhibitor (TKI) currently in Phase 1/2/3 clinical trials through the STELLAR program. Since it lacks FDA approval, Humana typically denies coverage with reasons like "not covered outside clinical trials" or "experimental/investigational."

However, Humana's Medicare Advantage plans in Virginia do support formulary exceptions for medically necessary treatments when standard alternatives have failed. With Humana's relatively low prior authorization denial rate of approximately 3.5% in Medicare Advantage, many denials that do occur stem from documentation gaps rather than blanket policy restrictions.

Note: Virginia expanded Medicaid in 2019 and has achieved a historic low uninsured rate of 6.4% as of 2023, meaning more patients have coverage options for appealing denials.

Humana's Formulary Exception Process

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all investigational drugs Humana provider portal Humana PA Resources
Medical Necessity Must prove standard treatments inadequate Clinical documentation CMS Exception Guidelines
Supporting Statement Prescriber must explain medical rationale Provider submission Humana Exception Process
Decision Timeline 72 hours from complete submission Humana notification Humana Drug Guide

Step-by-Step: Fastest Path to Approval

  1. Oncologist initiates request (Day 1)
    • Submit formulary exception via Humana provider portal
    • Include ICD-10 codes, prior therapy failures, performance status
  2. Gather supporting documentation (Days 1-3)
    • Recent imaging showing disease progression
    • Lab results confirming adequate organ function
    • Treatment history with dates and outcomes
  3. Submit medical necessity letter (Day 3)
    • Reference Phase 2/3 Zanzalintinib data for your cancer type
    • Cite NCCN guidelines where applicable
    • Document contraindications to standard therapies
  4. Follow up within 72 hours (Day 6)
    • Call Humana at 800-555-2546 if no response
    • Request expedited review if clinically urgent
  5. Prepare for peer-to-peer (Day 7-10)
    • Humana may request physician-to-physician discussion
    • Have clinical rationale and literature ready

Medical Necessity Documentation

Clinician Corner: Essential Elements

Your oncologist's medical necessity letter should include:

Clinical History

  • Specific cancer diagnosis with staging (ICD-10 codes)
  • ECOG performance status 0-2 or Karnofsky ≥70%
  • Measurable disease per RECIST criteria

Prior Treatment Failures

  • Dates and duration of previous therapies
  • Specific reasons for discontinuation (progression, toxicity)
  • Documentation of inadequate response to standard-of-care options

Zanzalintinib Rationale

  • Reference to relevant clinical trial data (STELLAR program results)
  • Multi-target TKI mechanism addressing resistance pathways
  • Expected benefit based on molecular profile or tumor characteristics

Safety Monitoring Plan

  • Baseline and ongoing laboratory monitoring
  • Dose modification protocols
  • Management of anticipated side effects
From our advocates: We've seen strongest success when oncologists include specific trial data showing Zanzalintinib activity in the patient's exact cancer type, along with clear documentation that all FDA-approved options have been exhausted or are contraindicated. Generic "experimental treatment" requests typically fail.

Exelixis Compassionate Use Program

Since Zanzalintinib remains investigational, Exelixis provides the drug at no cost through their Expanded Access/Compassionate Use Program. This can serve as a backup while appealing Humana's denial.

Eligibility Requirements

Patient Criteria:

  • Serious or life-threatening advanced/metastatic solid tumor
  • Failed or intolerant to standard approved therapies
  • Ineligible for available Zanzalintinib clinical trials
  • ECOG performance status 0-2
  • Adequate organ function (liver, kidney, bone marrow)

Application Process:

  1. Oncologist contacts Exelixis Medical Affairs to confirm availability
  2. Submit FDA Form 3926 (single-patient IND application)
  3. Obtain IRB approval or acknowledgment from institution
  4. Patient informed consent for compassionate use
  5. Await FDA review (30 days unless objection)

Timeline: Typically 30-60 days from initial contact to drug access.

For more information on navigating insurance appeals for investigational cancer treatments, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

Virginia External Review Process

If Humana denies your formulary exception, Virginia's State Corporation Commission Bureau of Insurance provides an independent external review process.

Filing Requirements

Standard External Review

  • File within 120 days of Humana's final denial
  • Complete Form 216-A (External Review Request)
  • Include denial letter and medical records
  • Decision within 45 days

Expedited External Review

  • For urgent cases where delay jeopardizes health
  • Provider certifies urgency via Form 216-C
  • Decision within 72 hours for life-threatening cases
  • 6 business days for experimental treatment denials

How to File

Submit to Virginia SCC Bureau of Insurance:

  • Mail: P.O. Box 1157, Richmond, VA 23218
  • Email: [email protected]
  • Fax: (804) 371-9915
  • Phone: 1-877-310-6560 (information only)

Required Forms:

Appeals Timeline and Deadlines

Stage Timeline Action Required Contact
Initial PA Request 72 hours Oncologist submits via portal Humana Provider Portal
Internal Appeal 65 days from denial Patient/provider files appeal 800-555-2546
External Review (Standard) 120 days from final denial File Form 216-A with VA SCC (877) 310-6560
External Review (Expedited) Immediate for urgent cases Provider certifies urgency [email protected]
Tip: Virginia allows expedited external review for cancer treatment denials without exhausting internal appeals first—a special provision reflecting the state's commitment to timely cancer care.

Cost and Financial Assistance

Since Zanzalintinib is investigational, traditional copay cards don't exist. However, several options can help:

Primary Options:

  • Exelixis Compassionate Use: Drug provided at no cost
  • Clinical Trial Participation: Routine costs typically covered
  • Humana Specialty Pharmacy: CenterWell Specialty (800-486-2668) can assist with prior authorization

Additional Support:

  • Cancer Financial Assistance: Organizations like CancerCare, Patient Advocate Foundation
  • Virginia Poverty Law Center: Health assistance for appeals guidance
  • Humana Member Services: 800-555-2546 for coverage questions

For specialty drugs in Virginia, Humana requires filling at in-network specialty pharmacies like CenterWell, which can coordinate with your oncology team and assist with appeals documentation.

When to Escalate

Contact Virginia State Regulators:

  • Virginia SCC Bureau of Insurance: (877) 310-6560
  • Managed Care Ombudsman: Available through same number
  • File complaint: If Humana violates appeal timelines or procedures

Legal Resources:

  • Virginia Poverty Law Center: Health assistance program
  • Private attorneys: For suspected ERISA or bad faith violations

Counterforce Health can also help analyze your specific denial and craft appeals that address Humana's exact policy language and requirements, improving your chances of approval.

FAQ

How long does Humana prior authorization take in Virginia? Standard decisions within 72 hours of receiving complete documentation. Expedited reviews for urgent cases can be processed within 24 hours.

What if Zanzalintinib is completely non-formulary? You can request a formulary exception with strong medical necessity documentation. If denied, Virginia's external review process provides independent evaluation.

Can I request an expedited appeal for cancer treatment? Yes. Virginia allows expedited external review for cancer cases where delay could jeopardize health, with decisions within 72 hours.

Does Humana cover clinical trial costs? Routine patient care costs in qualifying clinical trials are typically covered under Medicare. Research-specific costs are covered by the trial sponsor.

What happens if external review upholds the denial? The decision is binding, but you retain rights to pursue legal action or explore other coverage options like employer appeals for self-funded plans.

How do I find Virginia-specific Humana policies? Contact Humana Member Services at 800-555-2546 or check your plan's Evidence of Coverage document for Virginia-specific procedures.

Can I appeal while applying for compassionate use? Yes. Pursue both pathways simultaneously since compassionate use provides the drug at no cost while appeals may establish future coverage.

What's the success rate for external reviews in Virginia? Specific statistics aren't publicly available, but independent medical reviewers evaluate each case based on clinical evidence and medical necessity standards.

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 plan for specific coverage decisions. Coverage policies and procedures may change; verify current requirements with your insurer and state regulators.

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