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

How to Get Zanzalintinib (XL092) Covered by Cigna in Illinois: Coding, Appeals, and Investigational Drug Access

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

Zanzalintinib (XL092) is an investigational drug that Cigna typically doesn't cover outside clinical trials. However, Illinois patients have strong appeal rights. Your fastest path: 1) Submit a formulary exception request with detailed medical necessity documentation, 2) If denied, file an internal appeal within 180 days, 3) Request external review through Illinois Department of Insurance within 4 months of final denial. Use ICD-10 codes specific to your cancer type and HCPCS code J3490 for billing. Start by having your doctor contact Cigna at 1-800-244-6224 for prior authorization.

Table of Contents

Understanding Zanzalintinib Coverage Challenges

Zanzalintinib (XL092) presents unique coverage challenges because it's still investigational. Developed by Exelixis as a next-generation multi-targeted tyrosine kinase inhibitor (TKI), it's currently in phase 1/2/3 studies through the STELLAR program but has no FDA approval as of 2025.

Coverage at a Glance

Requirement What it means Where to find it Source
PA Required? Yes, formulary exception needed Cigna provider portal Cigna PA Requirements
Formulary Status Not covered (investigational) Cigna formulary documents Cigna National Formulary
Step Therapy N/A (not on formulary) Provider documentation Express Scripts PA
Appeals Deadline 180 days internal, 4 months external Illinois DOI Illinois External Review

Cigna, like most insurers, excludes investigational drugs from standard coverage. However, Illinois law provides robust appeal rights that can sometimes overcome initial denials when strong medical evidence supports the request.

ICD-10 Coding for Cancer Treatment

Accurate ICD-10 coding is crucial for any coverage request. Since zanzalintinib targets multiple pathways, your specific cancer diagnosis determines the appropriate codes.

Primary Cancer Codes for TKI Treatment

For solid tumors where zanzalintinib might be considered:

  • C78.xx - Secondary malignant neoplasm (specify site)
  • C34.xx - Malignant neoplasm of bronchus and lung
  • C25.xx - Malignant neoplasm of pancreas
  • C22.xx - Malignant neoplasm of liver

For hematologic malignancies:

  • C91.10 - Chronic lymphocytic leukemia, not having achieved remission
  • C92.1 - Chronic myeloid leukemia, not otherwise specified
Documentation Tip: Always include the most specific code available. For example, use C34.10 (upper lobe, unspecified side) rather than the general C34.9 if location is known.

Supporting Codes

Include relevant history and treatment codes:

  • Z51.11 - Encounter for antineoplastic chemotherapy
  • Z87.891 - Personal history of nicotine dependence (if applicable for lung cancer)
  • Z85.xx - Personal history of malignant neoplasm (for recurrence cases)

Product Coding: HCPCS and Billing Requirements

Since zanzalintinib lacks FDA approval, it has no permanent HCPCS J-code or NDC number. This creates billing complexity but doesn't prevent coverage requests.

HCPCS Codes for Investigational Drugs

Use these unclassified drug codes:

  • J3490 - "Unclassified drugs" (most common for oral agents)
  • J9999 - "Not otherwise classified, antineoplastic drugs"
  • C9399 - Unclassified drugs and biologics (hospital outpatient only)

Billing Documentation Requirements

When using unclassified codes, include in Box 19 or remarks:

  • Drug name: "Zanzalintinib (XL092)"
  • Strength and dosage
  • Clinical trial number (if applicable)
  • ICD-10 code Z00.6 for clinical research participation
Important: Verify billing requirements with Cigna's provider services, as investigational drug policies can vary by plan type.

Clean Request Anatomy: Building Your PA

A well-structured prior authorization request significantly improves approval chances. Here's what Cigna reviewers expect to see:

Essential Components

  1. Patient Information
    • Complete demographics and Cigna ID
    • Diagnosis with ICD-10 codes
    • Current performance status
  2. Clinical Justification
    • Detailed treatment history
    • Prior therapy failures or contraindications
    • Why standard alternatives aren't appropriate
    • Expected clinical benefit
  3. Supporting Evidence
    • Relevant clinical trial data
    • FDA expanded access documentation (if applicable)
    • Physician attestation of medical necessity

Sample Request Structure

Patient: [Name], DOB [Date], Cigna ID [Number]
Diagnosis: Metastatic renal cell carcinoma (C64.9, C78.01)

Request: Coverage for zanzalintinib (XL092) 20mg daily

Medical Necessity:
- Failed cabozantinib (progression after 8 months)
- Intolerant to lenvatinib (grade 3 diarrhea, dose reduction ineffective)
- No other approved TKI options appropriate
- Enrolled in compassionate use protocol [number]

Supporting Documentation:
- Progress notes showing treatment failures
- Imaging confirming progression
- Lab values supporting safety for new therapy

Common Coding Pitfalls to Avoid

Several coding mistakes can delay or derail coverage requests:

Unit Conversion Errors

  • Verify dosing units (mg vs mcg)
  • Calculate total daily dose correctly
  • Account for different formulations

Mismatched Codes

  • Don't use specific J-codes for similar but different drugs
  • Ensure ICD-10 codes match the actual diagnosis
  • Verify HCPCS codes align with administration route

Missing Documentation

  • Always include drug name in unclassified code submissions
  • Provide clear rationale for investigational use
  • Include all required supporting documents

Cigna's Formulary Exception Process

For investigational drugs like zanzalintinib, you'll need a formulary exception rather than standard prior authorization.

Step-by-Step Process

  1. Initial Contact (Day 1)
    • Physician calls Cigna provider services: 1-800-244-6224
    • Request formulary exception for investigational drug
    • Obtain case reference number
  2. Documentation Submission (Days 2-3)
  3. Review Period (Days 4-7)
    • Standard review: 72 hours after complete submission
    • Expedited review: 24 hours if urgent medical need
    • Cigna may request additional information
  4. Decision Notification
    • Approval: Authorization sent to pharmacy/provider
    • Denial: Written explanation with appeal rights
From our advocates: We've seen formulary exceptions succeed when physicians provide detailed documentation of why every approved alternative has failed or is contraindicated. The key is demonstrating that the investigational drug is the only remaining option with potential benefit.

Appeals Playbook for Illinois Patients

Illinois provides strong appeal rights that can overcome initial denials. The process has specific timelines and requirements.

Internal Appeals (First Level)

  • Timeline: File within 180 days of denial
  • Decision deadline: 15 business days for pre-service requests
  • Expedited option: 24 hours if delay risks health
  • How to file: Written request to Cigna appeals department

External Review (Independent)

If internal appeals fail, Illinois law guarantees independent review:

  • Eligibility: After completing internal appeals
  • Timeline: Must file within 4 months of final denial
  • Process: Illinois Department of Insurance coordinates review
  • Cost: Free to patients (insurer pays)
  • Decision: Binding on insurance company

Required Forms for External Review

  1. External Review Request Form
  2. Experimental/Investigational Drug Certification (physician completes)
  3. Copy of final denial letter
  4. Insurance ID card copy

Contact Information

  • Illinois Department of Insurance: (877) 527-9431
  • External Review Coordinator: Use forms on IDOI website
  • Illinois Attorney General Health Care Helpline: (877) 305-5145

When to Escalate Beyond Insurance

Sometimes insurance appeals aren't enough. Illinois residents have additional options:

State Regulator Complaint File with Illinois Department of Insurance if:

  • Cigna violates appeal timelines
  • Required forms aren't provided
  • Decision appears to violate state law

Attorney General Intervention The Illinois AG's Health Care Bureau can:

  • Investigate unfair claim practices
  • Facilitate resolution discussions
  • Pursue enforcement action if needed

Federal Options For employer plans subject to ERISA:

  • Department of Labor complaint
  • Federal court lawsuit (after exhausting appeals)

Manufacturer Programs Exelixis may offer:

  • Expanded access programs
  • Compassionate use protocols
  • Patient assistance for approved indications

Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed requests that align with payer policies. Their platform can help identify the specific denial reasons and develop targeted responses that address Cigna's requirements while leveraging Illinois appeal rights.

FAQ: Zanzalintinib Coverage Questions

How long does Cigna prior authorization take in Illinois? Standard PA decisions come within 72 hours of complete submission. Expedited requests (when delay risks health) get 24-hour turnaround. Missing documentation can extend timelines.

What if zanzalintinib isn't on Cigna's formulary? It's not—investigational drugs rarely are. You'll need a formulary exception with strong medical necessity documentation. Focus on why approved alternatives have failed or are inappropriate.

Can I request an expedited appeal in Illinois? Yes, if delay would seriously jeopardize your health. Your physician must certify the urgency. Expedited internal appeals get 24-hour decisions; external reviews can be completed in 72 hours.

Does step therapy apply to investigational drugs? Typically no, since they're not on formulary. However, Cigna will expect documentation that you've tried and failed appropriate approved therapies before considering experimental options.

What counts as medical necessity for zanzalintinib? Cigna looks for: documented failure of approved alternatives, contraindications to standard therapy, compelling clinical rationale, and evidence the investigational drug offers meaningful benefit potential.

How much does external review cost in Illinois? Nothing for patients. Illinois law requires insurers to pay all external review costs, including the independent physician reviewer's fees.

Verification Steps: Cross-Checking with Cigna Resources

Before submitting any request:

  1. Confirm current formulary status via Cigna drug lookup tool
  2. Verify PA requirements through provider portal
  3. Check for policy updates that might affect investigational drug coverage
  4. Review Illinois-specific plan documents for any state-mandated benefits

Quick Audit Checklist

Before submission, verify:

  • Correct ICD-10 codes for diagnosis
  • Appropriate HCPCS code (J3490 for zanzalintinib)
  • Complete drug name and strength in billing
  • All prior therapies documented with outcomes
  • Medical necessity clearly articulated
  • Supporting literature attached
  • Forms completed and signed
  • Submission method confirmed (portal vs fax)

Sources & Further Reading

Disclaimer: This information is for educational purposes only and doesn't constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan terms. Always consult your healthcare provider about treatment options and contact Counterforce Health or qualified professionals for coverage assistance. For official Illinois insurance information, visit the Illinois Department of Insurance website.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.