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

Getting Zanzalintinib (XL092) Covered by Cigna in California: Clinical Trial Access, Compassionate Use, and Appeals Guide

Answer Box: How to Get Zanzalintinib (XL092) Coverage

Zanzalintinib (XL092) is investigational and not FDA-approved, making direct Cigna coverage extremely rare. Your fastest path to access:

  1. Check clinical trial eligibility on ClinicalTrials.gov (search "XL092" or "zanzalintinib")
  2. If no suitable trial, request Exelixis compassionate use/expanded access through your oncologist
  3. For routine care costs, submit prior authorization with compassionate use approval letter

California advantage: If denied as "investigational," you can file a free Independent Medical Review (IMR) through DMHC with relatively high overturn rates (around 50% for some plans). Start with your oncologist contacting Exelixis medical affairs today.

Table of Contents

Understanding XL092 Coverage Challenges

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. It's currently in multiple Phase 1/2/3 studies as part of the STELLAR program but has no FDA approvals as of 2025.

Why Cigna Typically Denies Coverage

Primary denial reasons:

  • Not FDA-approved: Cigna formularies only list FDA-approved medications
  • Experimental/investigational classification: Standard exclusion in most commercial plans
  • No established medical necessity criteria: Lacks coverage policies for investigational agents
Note: Even with Express Scripts managing Cigna's pharmacy benefits, investigational drugs rarely receive prior authorization approval outside clinical trials or compassionate use programs.

Coverage Possibilities

Limited scenarios where coverage may be considered:

  1. Clinical trial routine care: Standard-of-care services during trial participation
  2. Compassionate use approval: With Exelixis expanded access program documentation
  3. Formulary exception: Rare, requires extraordinary medical necessity evidence

Clinical Trial Access (Preferred Route)

Active XL092 Studies

Current trials include:

  • Metastatic clear cell renal cell carcinoma studies
  • Combination trials with immunotherapy (durvalumab + tremelimumab)
  • Phase II leiomyosarcoma trials

Search process:

  1. Visit ClinicalTrials.gov
  2. Search "XL092" or "zanzalintinib"
  3. Filter by location (California) and recruitment status
  4. Review eligibility criteria with your oncologist

Insurance Coverage for Trial Participation

What Cigna typically covers in trials:

  • Routine office visits and consultations
  • Standard-of-care imaging and laboratory tests
  • Management of side effects
  • Emergency care related to trial participation

What's excluded:

  • The investigational drug itself (provided by Exelixis)
  • Research-only procedures
  • Non-standard monitoring beyond routine care
Tip: Confirm trial coverage details with Cigna before enrollment. Request written confirmation of what services will be covered.

Compassionate Use/Expanded Access Program

Exelixis Expanded Access Criteria

General eligibility requirements:

  • Life-threatening or seriously debilitating cancer
  • No comparable approved treatment options available
  • Documented failure or intolerance of standard therapies
  • Ineligible for appropriate clinical trials
  • ECOG performance status 0-2
  • Potential benefit outweighs risks

Application Process

Step 1: Oncologist Assessment Your treating oncologist must:

  • Contact Exelixis medical affairs team
  • Confirm expanded access availability for your indication
  • Obtain compassionate use protocol and forms

Step 2: Documentation Requirements

  • Complete diagnosis and staging with ICD-10 codes
  • Comprehensive prior treatment history
  • Current performance status and recent imaging
  • Risk-benefit analysis and treatment rationale

Step 3: Regulatory Submission

  • Physician files FDA Form 3926 (single-patient IND)
  • IRB approval or acknowledgment
  • Exelixis sponsor support confirmation

Timeline for Compassionate Use

  • Standard requests: 2-4 weeks for review and approval
  • Emergency/urgent cases: Can be processed within days when medically justified
  • Ongoing treatment: Requires periodic renewals with updated clinical data

Cigna Prior Authorization Process

When to Submit PA for XL092

Scenarios requiring prior authorization:

  1. Routine care costs during compassionate use
  2. Administration and monitoring services
  3. Management of drug-related side effects

Required Documentation

Clinical Information Packet:

  • Letter of medical necessity from oncologist
  • Diagnosis with ICD-10 codes
  • Complete treatment history with dates and outcomes
  • Current ECOG performance status
  • Recent imaging and laboratory results
  • Exelixis compassionate use approval letter

Evidence Supporting Medical Necessity:

  • Published phase II/III trial data
  • Relevant NCCN or other guideline references
  • Mechanism of action rationale for your tumor type
  • Documentation of failed standard therapies

Submission Process

For Commercial Cigna Plans:

  1. Call Cigna prior authorization line (number on member ID card)
  2. Complete "Prescription Drug Authorization and Exception Request" form
  3. Fax completed packet to Cigna medical review department

Timeline:

  • Standard review: 15 business days
  • Expedited review: 24-72 hours for urgent cases
  • Decision notification: Within 72 hours of determination
Important: Clearly mark requests as "urgent" when treatment delays could compromise outcomes.

Appeals Playbook for California

Internal Appeals Process

First-Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Review time: 30 days for standard appeals
  • Expedited: 72 hours for urgent medical situations

Required Appeal Documentation:

  • Copy of original denial letter
  • Updated letter of medical necessity
  • Additional clinical evidence or literature
  • Peer-reviewed studies supporting XL092 use

Peer-to-Peer Review

Requesting physician consultation:

  • Available for complex oncology cases
  • Allows direct discussion between your oncologist and Cigna medical director
  • Can be requested during initial PA or appeal process

Preparation for peer-to-peer:

  • Have complete treatment timeline ready
  • Prepare specific questions about denial rationale
  • Document key discussion points and outcomes

External Review Options

If internal appeals are exhausted, California offers robust external review rights through the Department of Managed Health Care (DMHC) or Department of Insurance (CDI).

California Independent Medical Review (IMR)

When IMR Applies to XL092

Qualifying scenarios:

  • Denial based on "experimental/investigational" classification
  • Medical necessity disputes
  • Coverage determination disagreements

DMHC IMR Process

Eligibility Requirements:

  • DMHC-regulated health plan (most HMOs and many PPOs)
  • Written denial citing experimental/investigational status
  • Treating physician certification of medical necessity

Required Documentation:

  • DMHC IMR application form
  • Copy of Cigna's written denial
  • Physician Certification for Experimental/Investigational Denials (DMHC/IMR 110)
  • Supporting medical records and literature

IMR Success Rates

Recent California data shows promising overturn rates:

  • Anthem Blue Cross experimental/investigational denials: 49.1% overturned in 2023
  • Additional 6.4% reversed by plan before final decision
  • Many investigational cancer drug denials are successfully appealed with strong evidence

IMR Timeline

Standard IMR:

  • Application review: 7 days for DMHC acknowledgment
  • Decision timeline: 30 days from complete documentation
  • Implementation: Plan must comply with binding decision

Expedited IMR:

  • For cases where delay would seriously jeopardize health
  • Decision time: Typically within days of complete submission
  • Requires physician certification of urgency
Key Advantage: IMR is free for California residents and decisions are binding on insurance companies.

Cost and Patient Assistance

Exelixis Support Programs

Compassionate use typically includes:

  • Free investigational drug supply
  • Some clinical monitoring support
  • Patient navigation assistance

What patients may still pay:

  • Routine care costs (office visits, standard labs)
  • Travel expenses for specialized centers
  • Non-covered supportive medications

Financial Assistance Resources

Manufacturer programs:

  • Contact Exelixis patient access team
  • May cover some routine care costs during compassionate use

Foundation grants:

  • Cancer-specific foundations often assist with travel and care costs
  • Applications typically require financial documentation

State programs:

  • California has various cancer support programs
  • Contact California Department of Health Services for current options

Timeline and Documentation Tracker

Pre-Application Checklist

Before starting any coverage request:

  • Insurance card and member ID
  • Complete treatment history with dates
  • Recent imaging reports and lab results
  • Oncologist contact information
  • Prior authorization denial letters (if any)

30-Day Action Plan

Week 1:

  • Research clinical trial options
  • Schedule oncologist appointment to discuss XL092

Week 2:

  • Initiate Exelixis compassionate use inquiry
  • Gather required clinical documentation

Week 3:

  • Submit FDA expanded access application (if approved by Exelixis)
  • Prepare Cigna prior authorization packet

Week 4:

  • Submit Cigna PA request
  • Monitor for decision and prepare appeals if needed

Documentation Renewal Schedule

For ongoing treatment:

  • Every 3 months: Updated performance status and imaging
  • Every 6 months: Comprehensive treatment review
  • Annually: Full compassionate use program renewal

FAQ

How long does Cigna prior authorization take for investigational drugs in California? Standard review takes 15 business days, but expedited review for urgent cases can be completed in 24-72 hours. Always request expedited review when treatment delays could compromise outcomes.

What if XL092 is completely non-formulary on my Cigna plan? You can request a formulary exception, but approval is rare for investigational drugs. Focus on documenting compassionate use approval and emphasizing coverage for routine care costs rather than the drug itself.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California IMR offer expedited pathways when delays would seriously jeopardize health or maximum function. Your physician must certify the urgency.

Does step therapy apply to investigational drugs? Step therapy typically doesn't apply since investigational drugs aren't on formularies. However, you'll need to document failure or contraindications to all approved alternatives in your indication.

What's the difference between DMHC and CDI for appeals? DMHC regulates most HMOs and managed care plans, while CDI regulates some PPO and indemnity plans. Both offer Independent Medical Review, but processes differ slightly. Check your ID card or plan documents to determine which regulates your plan.

How much does California IMR cost? California IMR is completely free for patients. The health plan pays all costs associated with the independent review process.

What happens if I win an IMR decision? The decision is binding on Cigna. They must authorize and cover the requested services as outlined in the IMR determination, typically within 3 business days.

Can I get help filing appeals in California? Yes, the DMHC Help Center (888-466-2219) provides free assistance. Additionally, organizations like Health Consumer Alliance and legal aid groups can help with complex cases.

Getting Expert Help

When navigating complex investigational drug coverage, having experienced support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed rebuttals. Their platform identifies the specific denial basis and drafts point-by-point responses aligned to each plan's own rules, pulling the right clinical evidence and weaving it into appeals that meet procedural requirements while tracking deadlines.

For patients facing investigational drug denials, Counterforce Health can help identify the strongest medical necessity arguments and ensure all required documentation is properly submitted to maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with your plan and relevant regulatory agencies.

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