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

How to Get Zanzalintinib (XL092) Covered by Humana in Pennsylvania: Complete Appeals Guide for Investigational Cancer Drugs

Quick Answer: Getting Zanzalintinib (XL092) Covered by Humana in Pennsylvania

Zanzalintinib (XL092) is investigational and typically denied by Humana Medicare Advantage plans. Your fastest path: 1) Apply for Exelixis's compassionate use program (drug supplied free), 2) Submit Humana prior authorization with compassionate use approval letter, 3) If denied, file internal appeal within 60 days, then external review through Pennsylvania's new state program (53% success rate). Start today by contacting your oncologist to initiate the Exelixis compassionate use application.

Table of Contents

Understanding Zanzalintinib Coverage Challenges

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Currently in Phase 1/2/3 clinical trials through the STELLAR program, it has no FDA approval and faces near-universal insurance denials.

Key Coverage Facts:

  • Status: Investigational only—not FDA-approved
  • Availability: Clinical trials or Exelixis compassionate use program
  • Humana Position: Excluded from formulary; denials cite "investigational/experimental" status
  • Drug Cost: $0 through compassionate use (insurance may cover routine care costs only)
Note: Recent STELLAR-303 trial results showed the drug did not meet its overall survival endpoint, which may affect both compassionate use eligibility and appeal success rates.

Step-by-Step: Fastest Path to Approval

1. Apply for Compassionate Use (Patient + Oncologist)

Timeline: 2-4 weeks
Who: Your oncologist initiates
Action: Contact Exelixis Medical Affairs for application forms
Documents needed: Cancer diagnosis, treatment history, clinical rationale

2. Submit Humana Prior Authorization (Oncologist)

Timeline: 14 days for standard review
Where: Humana provider portal or fax 1-888-447-3430
Key documents: Compassionate use approval letter, detailed medical necessity letter, ICD-10 codes, treatment history

3. File Internal Appeal if Denied (Patient/Oncologist)

Timeline: Must file within 60 days of denial
Where: Humana member appeals
Include: Original PA request, additional clinical evidence, peer-reviewed literature

4. Request External Review (Patient)

Timeline: Within 4 months of final internal denial
Where: Pennsylvania Insurance Department
Success rate: 53% of appeals overturned in 2024

Humana Prior Authorization Requirements

Humana requires comprehensive documentation for investigational drug requests, even though approval is unlikely without compelling circumstances.

Required Documentation Checklist

Patient Information:

  • Full demographics and Humana member ID
  • Policy details and effective dates

Clinical Information:

  • Primary cancer diagnosis with ICD-10 codes
  • Disease stage and progression status
  • Complete treatment history with dates
  • Documentation of failed therapies or contraindications
  • Current performance status and prognosis

Drug-Specific Details:

  • Zanzalintinib (XL092) with investigational status noted
  • Proposed dosing and administration schedule
  • Expected treatment duration
  • Monitoring plan

Medical Necessity Justification:

  • Why all FDA-approved alternatives are unsuitable
  • Clinical rationale based on tumor characteristics
  • Reference to relevant clinical trial data
  • Compassionate use program approval letter
Clinician Corner: Your medical necessity letter should address why approved TKIs like cabozantinib or lenvatinib are insufficient for this patient's specific clinical situation. Include molecular profiling results if available and reference NCCN guidelines for the patient's cancer type.

Appeals Playbook for Pennsylvania

Internal Appeals Process

Level 1: Standard Reconsideration

  • Deadline: 60 days from denial notice
  • Timeline: 30 days for decision (expedited: 72 hours if urgent)
  • Submit to: Humana member services or provider portal
  • Include: New clinical evidence, peer-reviewed studies, specialist consultation notes

Level 2: Independent Review (if applicable)

  • When: After Level 1 denial
  • Timeline: 30 days for decision
  • Requirements: Same as Level 1 plus any additional evidence

Pennsylvania External Review Process

Pennsylvania's independent external review program, launched in 2024, offers significant advantages for investigational drug appeals.

Eligibility Requirements:

  • Must complete Humana's internal appeals first
  • Applies to medical necessity and investigational treatment denials
  • Available for most commercial and Medicare Advantage plans

Process Steps:

  1. Submit Request: Online at pa.gov/reviewmyclaim or call 1-877-881-6388
  2. Eligibility Review: PID determines eligibility within 5 business days
  3. IRO Assignment: Independent review organization assigned within 1 business day
  4. Additional Evidence: You have 15 days to submit supporting documents
  5. Final Decision: Standard review within 45 days (expedited: 72 hours)

Success Statistics: In 2024, Pennsylvania's external review program overturned 53% of appealed denials, with over 259 successful reversals by fall 2024.

Common Denial Reasons & Solutions

Denial Reason Humana's Position Your Response Strategy
"Investigational/Experimental" Not FDA-approved Include compassionate use approval, clinical trial data, lack of alternatives
"Not medically necessary" Approved drugs available Document failure/contraindications to all approved TKIs, tumor-specific factors
"Not covered benefit" Outside formulary Request formulary exception with medical necessity justification
"Insufficient documentation" Missing clinical details Resubmit with complete treatment history, staging, molecular profiling

Cost-Saving Options

Primary Option: Exelixis Compassionate Use

  • Cost: $0 for the drug itself
  • Coverage: Insurance may cover administration, monitoring, supportive care
  • Eligibility: Serious condition, no approved alternatives, not eligible for clinical trials

Secondary Resources:

  • Counterforce Health provides specialized support for complex prior authorizations and appeals, helping patients and clinicians navigate insurance denials with evidence-backed strategies
  • Patient advocacy organizations for your specific cancer type
  • Hospital financial assistance programs for related care costs

When to Escalate

Contact Pennsylvania Insurance Department if:

  • Humana fails to meet appeal deadlines
  • You need help with the external review process
  • You suspect improper denial practices

Resources:

From our advocates: We've seen several cases where patients initially focused only on getting the investigational drug covered, when the real breakthrough came from securing compassionate use access first. This approach removes the financial pressure and strengthens any insurance appeal by showing another medical authority has deemed the treatment appropriate.

FAQ

How long does Humana prior authorization take for investigational drugs? Standard review is 14 days, but investigational drugs often receive expedited denials within 24-48 hours due to formulary exclusions.

What if Zanzalintinib is completely non-formulary? You can request a formulary exception, but success is unlikely without compassionate use approval. Focus on the Exelixis program first.

Can I request an expedited appeal in Pennsylvania? Yes, if your condition is urgent or life-threatening. Both Humana and Pennsylvania's external review offer expedited timelines (72 hours).

Does Pennsylvania's external review apply to Medicare Advantage? Yes, Pennsylvania's program covers most insurance types, including Medicare Advantage plans like those offered by Humana.

What happens if I'm approved through external review? The decision is binding on Humana. They must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal.

How does billing work for investigational TKIs? Since Zanzalintinib lacks FDA approval, it doesn't have permanent HCPCS J-codes. Compassionate use programs typically handle all drug-related logistics directly.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical notes to create targeted, evidence-backed responses. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeal processes, particularly for specialty medications and investigational treatments.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice, legal advice, or a guarantee of coverage outcomes. Always consult with your healthcare provider about treatment decisions and verify current policies with your insurance plan. Coverage policies and procedures may change without notice.

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