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

Getting Zanzalintinib (XL092) Covered by Cigna in Texas: Complete Coding, Appeals, and Prior Authorization Guide

Answer Box: Getting Zanzalintinib (XL092) Covered by Cigna in Texas

Zanzalintinib (XL092) is investigational and typically denied by Cigna, but coverage is possible through prior authorization and appeals. Start with your oncologist submitting a detailed PA request using ICD-10 codes specific to your cancer type and HCPCS code J3490. If denied, you have 180 days to file an internal appeal, then can request external review through Texas's Independent Review Organization (IRO) system. Success requires comprehensive documentation of medical necessity, failed prior treatments, and clinical trial or compassionate use justification.

Table of Contents

  1. Understanding Zanzalintinib Coverage Basics
  2. ICD-10 Coding for Medical Necessity
  3. HCPCS and Billing Requirements
  4. Prior Authorization Process
  5. Appeals Playbook for Texas
  6. Common Denial Reasons & Solutions
  7. When to Escalate
  8. Cost Assistance Options
  9. FAQ

Understanding Zanzalintinib Coverage Basics

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor (TKI) developed by Exelixis. Currently in Phase 1/2/3 clinical trials through the STELLAR program, it has no FDA approval for any indication as of 2025.

Coverage Reality Check:

  • Cigna and Express Scripts classify investigational drugs as non-standard benefits
  • Routine coverage is typically excluded from formularies
  • Prior authorization is required for any consideration
  • Success rates are low but not impossible with proper documentation
Note: The STELLAR-303 trial did not meet its primary overall survival endpoint, which may impact coverage decisions. However, individual patient circumstances and compelling clinical need can still justify approval.

ICD-10 Coding for Medical Necessity

Proper ICD-10 coding is critical for supporting your case. Use the most specific cancer diagnosis code available:

Primary Cancer Codes for XL092 Documentation

Cancer Type ICD-10 Code Example
Renal Cell Carcinoma C64.1, C64.2, C64.9 C64.9 (kidney, unspecified)
Non-Small Cell Lung C34.10–C34.90 C34.11 (upper lobe, right)
Hepatocellular Carcinoma C22.0 Primary liver cancer
Colorectal C18.9, C19, C20 C18.9 (colon, unspecified)
Pancreatic C25.xx C25.9 (pancreas, unspecified)

Supporting Codes

  • Z51.11 – Encounter for antineoplastic chemotherapy
  • Z85.xx – Personal history of malignant neoplasm (for recurrence)
  • C78.xx – Secondary malignant neoplasm (for metastases)

Documentation Requirements:

  • Include pathology reports confirming diagnosis
  • Stage and grade information
  • Molecular markers or genetic testing results
  • Prior treatment history with specific agents and outcomes

HCPCS and Billing Requirements

Since Zanzalintinib lacks FDA approval, standard drug codes don't exist:

Billing Codes

  • Primary HCPCS: J3490 ("Unclassified drugs")
  • Alternative: J9999 ("Not otherwise classified, antineoplastic drugs")
  • Hospital outpatient: C9399 ("Unclassified drugs and biologics")

Required Documentation for Claims

  • Drug name: Zanzalintinib (XL092)
  • Strength and dosage
  • Clinical trial number or expanded access program ID
  • Manufacturer lot numbers
  • "Investigational agent" notation

Units and Dosing: Document exact dosing protocol, frequency, and duration. Include weight-based calculations if applicable and any dose modifications based on toxicity or response.

Prior Authorization Process

Step-by-Step PA Submission

  1. Gather Required Documents
    • Complete medical records
    • Pathology and imaging reports
    • Prior treatment documentation
    • Clinical trial enrollment or expanded access approval
  2. Complete PA Form
    • Use Cigna's standard prior authorization form
    • Submit via provider portal or fax (verify current contact)
    • Include detailed medical necessity letter
  3. Medical Necessity Letter Components
    • Patient's specific diagnosis and staging
    • All prior therapies tried and outcomes
    • Why approved alternatives are inappropriate
    • Clinical rationale for investigational use
    • Supporting literature or trial data

Timeline Expectations

  • Standard review: 72 hours after complete submission
  • Expedited review: 24 hours if health would be jeopardized by delay
  • Missing information: Cigna may request additional documentation
Tip: Mark requests as expedited if you're currently on treatment or if delay would compromise your health. Your oncologist must justify the urgency.

Appeals Playbook for Texas

Internal Appeals Process

Timeline: 180 days from denial to file internal appeal

Required Steps:

  1. Submit written appeal to Cigna
  2. Include all supporting documentation
  3. Request peer-to-peer review if available
  4. Track submission and follow up

Decision Timeline:

  • Pre-service: 30 days
  • Post-service: 60 days
  • Urgent: 72 hours

External Review (IRO)

If internal appeal is denied, Texas law provides access to Independent Review Organization (IRO) review:

Eligibility:

  • Denial based on medical necessity
  • Treatment deemed experimental/investigational
  • Internal appeal completed or concurrent with expedited request

Timeline:

  • Standard: 20 days for IRO decision
  • Urgent: 5 days for emergency cases
  • Filing deadline: 4 months from final internal denial

How to Request:

  • Use IRO request form provided by Cigna
  • Submit to Texas Department of Insurance
  • No cost to patient (insurer pays IRO fees)
Important: IRO decisions are binding on the insurer. If approved, Cigna must provide coverage.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Investigational/Experimental" Provide FDA expanded access approval, clinical trial documentation, and compelling medical necessity
"Not medically necessary" Document failed standard therapies, contraindications to alternatives, and clinical guidelines supporting use
"Not covered benefit" Request formulary exception with detailed clinical justification
"Insufficient documentation" Submit complete medical records, pathology reports, and treatment history

Strengthening Your Case

Clinical Evidence to Include:

  • Peer-reviewed studies on XL092 mechanism of action
  • Phase I/II trial results showing activity in your cancer type
  • NCCN guidelines or other professional society recommendations
  • Molecular profiling supporting targeted therapy rationale

Prior Treatment Documentation:

  • Specific agents tried with dates and duration
  • Reason for discontinuation (progression, toxicity, intolerance)
  • Imaging or lab results showing treatment failure
  • Any contraindications to standard therapies

When to Escalate

Texas Department of Insurance

If you encounter procedural violations or unreasonable delays:

Contact Information:

  • Consumer hotline: 1-800-252-3439
  • Website: tdi.texas.gov
  • File complaints online for appeals process violations

Office of Public Insurance Counsel (OPIC)

For additional consumer assistance:

  • Help line: 1-877-611-6742
  • Provides guidance on appeals processes
  • Can assist with understanding your rights

IRO Information Line

For questions about external review:

  • Phone: 1-866-554-4926
  • Guidance on IRO process and requirements

Cost Assistance Options

While pursuing coverage, explore financial assistance:

Manufacturer Support

  • Contact Exelixis patient support programs
  • Expanded access programs may cover drug costs
  • Clinical trial participation typically includes drug at no cost

Foundation Assistance

  • National organizations may provide grants for investigational drugs
  • Cancer-specific foundations often have emergency assistance programs
  • Verify eligibility requirements and application deadlines
From our advocates: We've seen cases where patients successfully obtained coverage for investigational drugs by combining strong clinical documentation with persistence through the appeals process. One key factor was having the oncologist actively participate in peer-to-peer reviews and provide detailed explanations of why standard therapies weren't appropriate. While outcomes vary, thorough preparation and following proper procedures significantly improve approval chances.

FAQ

How long does Cigna prior authorization take in Texas? Standard PA decisions are made within 72 hours of complete submission. Expedited requests are decided within 24 hours if medical urgency is documented.

What if Zanzalintinib is not on Cigna's formulary? Request a formulary exception with detailed medical necessity documentation. Your oncologist must explain why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delay would jeopardize your health or if you're currently receiving treatment. Both internal appeals and external IRO reviews can be expedited.

Does step therapy apply to investigational drugs? Typically no, but Cigna may require documentation that standard therapies have been tried and failed before considering investigational options.

What happens if the IRO approves coverage? The decision is binding on Cigna. They must provide coverage according to the IRO's determination.

How much does the appeals process cost? Internal appeals are free. External IRO review is also free to patients—the insurer pays the IRO fees.

Can I get help with the appeals process? Yes, contact the Texas Department of Insurance consumer hotline (1-800-252-3439) or OPIC (1-877-611-6742) for assistance.

What if I'm in a clinical trial? Trial participation typically covers drug costs, but insurance may still be billed for administration and monitoring. Coordinate with your trial team and insurance.

About Coverage Appeals: Navigating insurance coverage for investigational drugs requires expertise in both clinical documentation and appeals procedures. 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.

The platform helps patients and clinicians gather the right evidence—from FDA labeling to peer-reviewed studies—and weaves them into appeals that meet procedural requirements while tracking deadlines and required documentation. For complex cases like investigational drug coverage, having expert guidance through the appeals process can significantly improve your chances of success.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, specific plan terms, and current policies. Always consult with your healthcare provider and insurance plan for personalized guidance. For the most current forms, deadlines, and procedures, verify directly with Cigna and the Texas Department of Insurance.

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