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

How to Get Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in Illinois: Complete Appeals Guide for Investigational Cancer Drugs

Answer Box: Getting Zanzalintinib (XL092) Covered in Illinois

Zanzalintinib (XL092) is investigational and typically excluded from Blue Cross Blue Shield of Illinois coverage. Your fastest path: 1) Apply for Exelixis expanded access program (free drug, 30-60 days), 2) Submit prior authorization with robust medical necessity documentation, and 3) If denied, file internal appeal within 180 days, then external review with Illinois Department of Insurance within 4 months. Start today by having your oncologist contact Exelixis Medical Affairs while simultaneously gathering documentation for insurance submission.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all investigational drugs BCBSIL Provider Portal BCBSIL PA Requirements
Formulary Status Not covered (investigational/experimental) BCBSIL Drug Lists BCBSIL Policy
Medical Necessity Life-threatening condition, no alternatives Provider documentation required BCBSIL PA Summary
Appeal Deadline 180 days from denial Internal appeal first Illinois Insurance Code
External Review 4 months after final denial Illinois DOI Portal Illinois Health Carrier External Review Act

Step-by-Step: Fastest Path to Approval

1. Contact Exelixis Medical Affairs (Day 1)

Who: Your oncologist
Action: Call Exelixis Medical Affairs to initiate expanded access application
Timeline: 30-60 days for approval
Source: Exelixis Medical Affairs

2. Gather Clinical Documentation (Days 1-7)

Who: Patient and clinic staff
Documents needed:

  • Complete treatment history with dates and outcomes
  • Pathology reports and molecular testing
  • Performance status documentation
  • Laboratory results and imaging Timeline: 1 week to compile

3. Submit Prior Authorization to BCBSIL (Day 7)

Who: Healthcare provider
Method: BCBSIL Provider Portal
Timeline: 5-15 business days for decision
Required: Medical necessity letter, clinical documentation, ICD-10 codes

4. Monitor Decision (Days 12-22)

Expected outcome: Likely denial due to investigational status
If approved: Begin treatment coordination
If denied: Proceed to step 5

5. File Internal Appeal (Within 180 days)

Who: Patient or authorized representative
Contact: 1-877-860-2837
Timeline: 15 business days for standard appeal decision
Source: BCBSIL Appeal Process

6. Request External Review (Within 4 months of final denial)

Who: Patient
Contact: Illinois DOI External Review or 877-850-4740
Timeline: 45 days for standard review, 72 hours for expedited
Cost: Free to consumer

7. Pursue Compassionate Use Simultaneously

Parallel track: Don't wait for insurance—apply for expanded access while appeals proceed
Benefit: Free drug supply during process

Patient Profile: Who Qualifies

Ideal candidates for Zanzalintinib coverage appeals:

  • Advanced solid tumor diagnosis (renal cell carcinoma, hepatocellular carcinoma, leiomyosarcoma)
  • Failed or intolerant to standard FDA-approved therapies
  • Good performance status (ECOG 0-2)
  • Life expectancy sufficient to benefit from treatment
  • No access to appropriate clinical trials

Clinical trial eligibility should be explored first through ClinicalTrials.gov or the STELLAR program.

Pre-Authorization Preparation

Medical Necessity Letter Checklist

Your oncologist's letter must address:

✅ Specific diagnosis with ICD-10 codes and staging
✅ Treatment history with dates, duration, and reason for discontinuation
✅ Clinical rationale for zanzalintinib based on mechanism of action
✅ Lack of alternatives - why FDA-approved options aren't suitable
✅ Supporting literature from peer-reviewed sources
✅ Monitoring plan for safety and efficacy

Clinician Corner: Reference the STELLAR clinical trial data and emphasize the multi-target kinase inhibitor mechanism when other TKIs have failed. Include molecular markers if relevant to patient's tumor profile.

Required Documentation

  • Pathology report with molecular testing results
  • Treatment timeline showing prior therapies and outcomes
  • Performance status assessment (ECOG or Karnofsky)
  • Laboratory values (CBC, CMP, liver function)
  • Imaging studies demonstrating disease progression
  • Contraindications to standard therapies if applicable

Submission Process

BCBSIL Prior Authorization Portal

  1. Access: Log into BCBSIL Provider Portal
  2. Select: Prior Authorization Request
  3. Enter: Patient demographics and insurance information
  4. Upload: All supporting documentation as PDFs
  5. Submit: Ensure confirmation number is received

Alternative Submission Methods

  • Fax: Check current fax number in provider portal (numbers change frequently)
  • Phone: 1-877-860-2837 for urgent cases
  • Mail: Address provided in denial letter or member services

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Investigational/Experimental" Emphasize compassionate use criteria FDA expanded access approval, life-threatening diagnosis
"Not medically necessary" Demonstrate failure of alternatives Detailed treatment history with outcomes
"Not FDA approved" Reference expanded access pathway Clinical trial ineligibility documentation
"Insufficient documentation" Provide complete clinical picture All requested records and assessments

Appeals Playbook for Illinois

Internal Appeal Process

Timeline: File within 180 days of denial
Contact: 1-877-860-2837 (TTY/TDD: 711)
Fax: 1-866-643-7069
Decision timeline: 15 business days (24 hours for expedited)

Required elements:

  • Copy of original denial letter
  • Additional clinical documentation
  • Updated medical necessity letter
  • Peer-reviewed literature supporting use

External Review Process

When to use: After internal appeal denial
Deadline: 4 months (120 days) from final adverse determination
Contact: Illinois DOI or 877-850-4740
Cost: Free to consumer
Decision: Binding on insurance company

Expedited external review available if delay would seriously jeopardize health - decision within 72 hours.

From our advocates: We've seen success with external reviews when families provided comprehensive documentation showing the patient exhausted all FDA-approved options and met expanded access criteria. The independent physician reviewers often understand the clinical rationale better than insurance medical directors. While outcomes aren't guaranteed, thorough preparation significantly improves chances.

Compassionate Use Alternative

While pursuing insurance coverage, simultaneously apply for Exelixis expanded access program:

Application Process

  1. Physician contacts Exelixis Medical Affairs
  2. Submit medical records and treatment history
  3. Complete FDA Single-Patient IND (Form 3926)
  4. Obtain IRB approval and patient consent
  5. Receive drug supply at no cost

Timeline

  • Standard: 30-60 days
  • Urgent: Expedited review possible
  • Cost: Free drug; insurance may cover monitoring

Counterforce Health can help coordinate the expanded access application while simultaneously preparing your insurance appeals with targeted, evidence-backed documentation that addresses specific payer criteria.

When to Escalate

Illinois Department of Insurance Resources

Office of Consumer Health Insurance (OCHI)
Phone: 877-527-9431
Services: Appeal assistance, consumer rights education, complaint filing

Illinois Attorney General Health Care Bureau
Helpline: 1-877-305-5145
Services: Informal intervention with insurers, complex case assistance

Filing a DOI Complaint

File anytime during the process if you believe BCBSIL violated Illinois insurance laws:

  • Online complaint form
  • Include all correspondence and documentation
  • DOI investigates and can impose penalties up to $50,000

FAQ

How long does BCBSIL prior authorization take in Illinois?
Standard PA decisions: 5-15 business days. Expedited reviews (for urgent cases): within 72 hours. Source: BCBSIL PA Requirements

What if Zanzalintinib is not on BCBSIL's formulary?
Investigational drugs are typically excluded from formularies. Request a formulary exception with medical necessity documentation and evidence of clinical trial ineligibility.

Can I request an expedited appeal in Illinois?
Yes, for urgent medical situations. BCBSIL must respond within 24 hours for expedited appeals. External reviews can also be expedited with 72-hour decisions.

Does step therapy apply to investigational drugs?
BCBSIL typically requires failure of FDA-approved alternatives before considering investigational therapies. Document all prior treatments with specific reasons for discontinuation.

What happens if external review approves coverage?
The decision is binding. BCBSIL must provide coverage according to the external reviewer's determination. Failure to comply can result in state penalties.

How much does Zanzalintinib cost without insurance?
No established U.S. list price exists since it's investigational. Expanded access provides the drug free; clinical trials cover drug costs.

Can I appeal if I live in Illinois but have BCBS from another state?
Illinois external review laws apply to all plans covering Illinois residents. Contact the Illinois DOI for assistance regardless of which Blue Cross plan you have.

What if my oncologist won't help with appeals?
Seek a second opinion from another oncologist familiar with investigational therapies. Counterforce Health can also help prepare appeals documentation to support your case.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance company. Coverage decisions depend on individual medical circumstances and specific plan benefits. For personalized assistance with appeals and prior authorization, consider consulting with patient advocacy services or legal professionals specializing in healthcare coverage.

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