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

Getting Zanzalintinib (XL092) [investigational] Covered by Humana in New York: Clinical Trial Access and Compassionate Use Pathways

Answer Box: Your Fastest Path to Zanzalintinib (XL092) Access

Zanzalintinib is investigational—Humana won't cover it as a standard drug. Your three pathways: 1) Clinical trials (search ClinicalTrials.gov for "XL092" or "zanzalintinib"), 2) Exelixis Expanded Access Program (free drug, insurance covers routine care), or 3) New York external appeal if denied compassionate use coverage.

Start today: Have your oncologist contact Exelixis Medical Affairs for expanded access eligibility while simultaneously checking trial options. If Humana denies routine care coverage, you have 4 months to file a New York external appeal with strong physician attestation.

Table of Contents

  1. Understanding Zanzalintinib Coverage Reality
  2. Clinical Trial Access: Your First Option
  3. Exelixis Expanded Access Program
  4. When Humana Says No: Coverage Scenarios
  5. New York External Appeal Strategy
  6. Medical Necessity Documentation
  7. Timeline and Deadlines Tracker
  8. Scripts and Templates
  9. Frequently Asked Questions

Understanding Zanzalintinib Coverage Reality

Zanzalintinib (XL092) is an investigational multi-target TKI from Exelixis with no FDA approvals as of 2025. This creates a coverage challenge: Humana Medicare Advantage plans generally exclude investigational treatments under standard Medicare rules.

Coverage at a Glance

Requirement Status What This Means Source
FDA Approval None Not a covered Part D drug Humana EOC 2026
Prior Authorization N/A Categorically excluded Humana PA List
Step Therapy N/A No pathway to coverage Medicare rules
External Appeal Available For routine care costs NY DFS

The reality: You're not seeking drug coverage—you're seeking access to the drug itself through manufacturer programs, then potentially seeking coverage for associated medical care.

Clinical Trial Access: Your First Option

Clinical trials remain the most straightforward path to zanzalintinib access, with study drug provided at no cost.

  1. Search ClinicalTrials.gov for "zanzalintinib" or "XL092"
  2. Filter by location: Select New York or nearby states
  3. Review inclusion criteria: Age, cancer type, prior treatments, performance status
  4. Contact study coordinator: Listed phone number for each active trial
Tip: Zanzalintinib is being studied in multiple tumor types through Exelixis' STELLAR program. Even if you don't match one trial's criteria, others may be opening.

Why Trials Work Best

  • No insurance battles: Study drug is sponsor-provided
  • Comprehensive care: All study-related costs typically covered
  • Access to expertise: Leading cancer centers with trial experience
  • Regulatory pathway: FDA-supervised safety monitoring

Exelixis Expanded Access Program

When clinical trials aren't an option, Exelixis offers a compassionate use program for XL092 through single-patient Expanded Access INDs.

Eligibility Criteria

Based on typical Exelixis expanded access requirements:

  • Life-threatening cancer with no curative options
  • Standard therapies exhausted or contraindicated
  • ECOG performance status 0-2
  • Adequate organ function (recent labs required)
  • Not eligible for clinical trials
  • Potential benefit outweighs risks per treating oncologist

Application Process Timeline

Week 1: Initial Contact

  • Your oncologist contacts Exelixis Medical Affairs
  • Provides diagnosis, staging, treatment history, current status
  • Exelixis confirms drug availability and case eligibility

Week 2: Documentation Package Submit to Exelixis:

  • Complete treatment history with dates and outcomes
  • Pathology and molecular testing reports
  • Recent imaging and staging documentation
  • ECOG status and laboratory results (within 30 days)
  • Oncologist's prognosis and risk-benefit assessment

Week 3: FDA Single-Patient IND

  • Oncologist files FDA Form 3926
  • Includes treatment plan, rationale, informed consent
  • IRB review required (can be expedited for urgent cases)

Week 4+: Approvals and Drug Shipment

  • FDA typically responds within 30 days (faster for oncology)
  • IRB approval for protocol and consent
  • Exelixis ships drug to treating center pharmacy

When Humana Says No: Coverage Scenarios

Even with expanded access approval, Humana may deny coverage for routine care costs associated with zanzalintinib treatment. Here's what to expect:

Common Denial Reasons

  1. "Experimental/Investigational": Drug lacks FDA approval
  2. "Not Medically Necessary": No established standard of care
  3. "Not a Covered Benefit": Outside Part D drug definition

What Humana Should Cover

Under expanded access, you're not asking Humana to pay for the drug—Exelixis provides it free. You're requesting coverage for:

  • Laboratory monitoring (CBC, comprehensive metabolic panel)
  • Imaging studies (CT scans, MRIs for response assessment)
  • Clinic visits for drug administration and monitoring
  • Management of side effects
  • Hospitalization for treatment-related complications

Documentation Strategy

When requesting coverage for routine care:

  • Attach expanded access approval letters (FDA and Exelixis)
  • Clarify scope: "Coverage requested only for monitoring and supportive care"
  • Emphasize medical necessity: Standard monitoring per oncology protocols
  • Reference precedent: Similar expanded access cases covered by plan
From our advocates: We've seen success when families clearly separated the "free investigational drug" from "standard medical care that would be needed for any cancer treatment." Plans are more likely to approve routine monitoring when they understand they're not paying for the experimental agent itself.

New York External Appeal Strategy

New York offers robust external appeal rights through the Department of Financial Services, including coverage for experimental treatments when standard options are exhausted.

External Appeal Eligibility

You can appeal Humana's denial if it involves:

  • Medical necessity of routine care during expanded access
  • Experimental/investigational treatment coverage (with physician attestation)
  • Out-of-network services when in-network options unavailable

Filing Requirements

Timeline: Must file within 4 months of Humana's final internal appeal decision

Required Documents:

  • External Appeal Application
  • Physician Attestation Form (experimental/investigational)
  • All denial letters and internal appeal decisions
  • Medical records supporting necessity
  • Treatment history and failure documentation

Physician Attestation Requirements

The certifying physician must be:

  • Licensed in New York (or treating the patient)
  • Board-certified or board-eligible in relevant specialty
  • Qualified to treat the specific condition

Attestation must document:

  • Standard services have been ineffective or inappropriate
  • No more beneficial standard service covered by plan
  • Investigational treatment is medically appropriate

Decision Timeline

  • Standard appeal: 30 days
  • Expedited appeal: 72 hours (if delay threatens health)
  • Non-formulary drug appeal: 24 hours (expedited)

Appeals are binding on Humana if overturned.

Medical Necessity Documentation

Strong documentation is crucial whether pursuing expanded access or appealing coverage denials.

Clinician Corner: Medical Necessity Letter Checklist

Patient Information

  • Diagnosis with ICD-10 codes
  • Cancer stage and molecular markers
  • Performance status (ECOG/Karnofsky)
  • Prognosis without treatment

Treatment History

  • Prior therapies with dates, doses, duration
  • Best response achieved (CR, PR, SD, PD)
  • Reason for discontinuation (progression, toxicity)
  • Current disease status with imaging dates

Clinical Rationale

  • Why zanzalintinib is appropriate for this patient
  • Mechanism of action relevant to tumor biology
  • Expected benefits based on preclinical/clinical data
  • Risk-benefit assessment and monitoring plan

Guideline Support

  • Reference to NCCN guidelines for tumor type
  • Clinical trial data supporting mechanism
  • FDA guidance on expanded access criteria
  • Peer-reviewed literature on multi-target TKIs

Timeline and Deadlines Tracker

Expanded Access Timeline

  • Week 1: Exelixis contact and initial review
  • Week 2: Documentation submission
  • Week 3: FDA Form 3926 filing
  • Week 4+: Approvals and drug access

Appeal Deadlines (New York)

  • Internal appeal: Per Humana policy (typically 60 days from denial)
  • External appeal: 4 months from final internal appeal decision
  • Expedited external: File immediately for urgent cases

Coverage Determination

  • Standard: 72 hours after prescriber statement received
  • Expedited: 24 hours if health threatened
Note: Keep detailed records of all submission dates, phone calls, and correspondence. New York's external appeal database shows that well-documented cases with clear timelines have higher success rates.

Scripts and Templates

Patient Script: Calling Humana

"I'm calling about coverage for routine medical care while my oncologist pursues expanded access to an investigational drug called zanzalintinib through Exelixis. The drug itself will be provided free by the manufacturer, but I need coverage for standard cancer monitoring—lab work, scans, and clinic visits. Can you help me understand the prior authorization process for the medical care portion?"

Oncologist Script: Exelixis Contact

"I have a patient with [cancer type, stage] who has progressed on [prior therapies]. Based on the tumor biology and mechanism of action, zanzalintinib may be appropriate. I'd like to discuss eligibility for your expanded access program. The patient has [ECOG status], adequate organ function, and is not eligible for current clinical trials due to [specific reason]."

Email Template: Requesting Clinical Notes

Subject: Medical Records Request for Insurance Appeal - [Patient Name]

"I need complete medical records for an insurance appeal, including:

  • All oncology visit notes from [date range]
  • Pathology reports and molecular testing
  • Imaging reports with radiologist interpretations
  • Laboratory results from recent visits
  • Treatment summaries with dates and responses

Please include documentation of prior therapy failures and current disease status. This is for a New York external appeal with a 4-month deadline."

Counterforce Health: Streamlining Your Appeal Process

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex cases like investigational drug access. The platform analyzes denial letters, identifies specific denial criteria, and drafts point-by-point rebuttals using the right clinical evidence—FDA guidance, peer-reviewed studies, and recognized guidelines—while ensuring all procedural requirements are met for New York external appeals.

For zanzalintinib cases, Counterforce Health can help coordinate the expanded access application with insurance coverage requests, ensuring that routine care costs are properly documented and appealed when denied. The system tracks New York's specific deadlines and procedural requirements while providing clinicians with time-saving templates and patients with clear next steps.

Frequently Asked Questions

Q: How long does the Exelixis expanded access process typically take? A: Generally 3-4 weeks from initial contact to drug shipment, assuming complete documentation and FDA/IRB approval. Urgent cases may be expedited.

Q: What if I live in New York but my oncologist is out of state? A: Out-of-state physicians can file FDA expanded access applications. For New York external appeals, the physician attestation can come from any qualified specialist treating the patient.

Q: Does Humana cover any investigational cancer drugs? A: Humana's Medicare Advantage plans exclude investigational treatments under standard Medicare rules. Coverage typically requires FDA approval for at least one indication.

Q: Can I appeal directly to New York without going through Humana's internal process? A: No. You must complete Humana's internal appeal process first. The 4-month external appeal clock starts from their final internal decision.

Q: What's the success rate for New York external appeals on investigational drugs? A: Success rates vary by case specifics. Use the DFS External Appeals Database to search similar cases and see outcomes with detailed medical justifications.

Q: Are there financial assistance programs for routine care costs? A: Yes. Check with CancerCare, Patient Advocate Foundation, and hospital financial counselors for assistance with monitoring and supportive care costs.

Q: What if zanzalintinib receives FDA approval during my treatment? A: FDA approval would change coverage landscape significantly. Work with your oncologist to transition from expanded access to commercial coverage, potentially requiring new prior authorization.

Q: Can I request expedited review for all processes? A: Expedited review is available when delay would seriously jeopardize health. Document rapid disease progression, declining performance status, or urgent clinical need.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and current policies. Always consult with your healthcare team and insurance representatives for personalized guidance. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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