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

How to Get Zanzalintinib (XL092) Covered by Cigna in Georgia: Clinical Trial Access, Compassionate Use, and Appeals Guide

Answer Box: Getting Zanzalintinib (XL092) Approved by Cigna in Georgia

Zanzalintinib (XL092) is investigational and not on Cigna formularies, but you have three paths: (1) Clinical trial enrollment where Cigna covers routine care costs while Exelixis provides the drug, (2) Compassionate use through Exelixis Medical Affairs with prior authorization for associated services, or (3) Appeals process including Georgia's external review. Start by searching ClinicalTrials.gov for active XL092 studies, then contact your oncologist to explore compassionate use if no suitable trial exists.

Table of Contents

When Clinical Trials or Compassionate Use Make Sense

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor from Exelixis with no FDA approvals as of 2025. Cigna's formulary policies exclude experimental drugs, making direct coverage extremely rare outside of clinical trials or compassionate use programs.

Clinical trials are typically the preferred path because:

  • The investigational drug is provided free by the sponsor
  • Cigna's Clinical Trials Administrative Policy covers routine patient care costs for qualified individuals in approved trials
  • No complex prior authorization needed for the drug itself

Compassionate use becomes relevant when:

  • No suitable clinical trial is available or accessible
  • Patient meets Exelixis's expanded access criteria
  • Standard treatments have failed or are contraindicated
Note: Georgia residents have additional protection through the state's external review process, which can overturn denials for investigational treatments when supported by appropriate medical evidence.

Typical Coverage Alternatives on Cigna Formulary

While XL092 remains investigational, several FDA-approved multi-target TKIs are typically covered by Cigna and may be required as step therapy:

VEGFR/Multi-Target TKIs (Common Alternatives)

Drug Typical Indications Formulary Status Prior Authorization
Cabozantinib (Cabometyx) RCC, HCC, DTC Usually Tier 4-5 Required
Lenvatinib (Lenvima) DTC, HCC, endometrial, RCC Usually Tier 4-5 Required
Sorafenib (Nexavar) HCC, RCC, DTC Usually Tier 4-5 Required
Sunitinib (Sutent) RCC, pNET, GIST Usually Tier 4-5 Required
Regorafenib (Stivarga) mCRC, GIST, HCC Usually Tier 4-5 Required

Sources: Cigna National Preferred Formulary

Documentation Requirements for Alternatives

Cigna's prior authorization process typically requires:

  • FDA-labeled indication or guideline-supported off-label use
  • Complete diagnosis with ICD-10 codes
  • Prior therapy history with dates and outcomes
  • Prescribing by appropriate specialist

Pros and Cons: Trial vs. Compassionate Use vs. Appeals

Clinical Trial Enrollment

Pros:

  • Drug provided free by Exelixis
  • Routine care costs covered under Cigna's clinical trial policy
  • Access to cutting-edge treatment protocols
  • Close monitoring and support

Cons:

  • Strict eligibility criteria
  • May require travel to trial sites
  • Randomization risk in controlled trials
  • Limited availability of open studies

Compassionate Use/Expanded Access

Pros:

  • Access outside of trial constraints
  • Individualized dosing possible
  • Available for patients ineligible for trials

Cons:

  • Complex FDA approval process (Form 3926)
  • Requires IRB oversight
  • Cigna may still deny coverage for associated costs
  • Limited availability from manufacturer

Appeals Process

Pros:

  • Georgia's external review provides independent medical evaluation
  • Binding decision on insurer if overturned
  • No cost to consumer for external review

Cons:

  • Lengthy process (potentially 4-6 months total)
  • Requires exhaustive documentation
  • Success not guaranteed
  • May delay treatment initiation

Exception Strategy: When and How to Request Coverage

Step 1: Exhaust Standard Alternatives

Before requesting XL092 coverage, document trials of approved alternatives:

  • Which multi-target TKIs were tried (cabozantinib, lenvatinib, sorafenib, etc.)
  • Duration of treatment and best response achieved
  • Reasons for discontinuation (progression, toxicity, contraindications)
  • Why remaining approved options are inappropriate

Step 2: Establish Medical Necessity

Work with your oncologist to prepare a comprehensive letter addressing:

  • Diagnosis and staging with ICD-10 codes
  • Performance status and prognostic factors
  • Prior treatment history with specific agents, dates, and outcomes
  • Mechanism-based rationale for XL092's multi-target approach
  • Published evidence supporting XL092 in your tumor type
  • Risk-benefit assessment compared to available alternatives

Step 3: Submit Prior Authorization

Use Cigna's electronic PA system:

  • CoverMyMeds portal at covermymeds.com
  • SureScripts integration through EHR
  • Phone submission: 1-800-882-4462

Include supporting documentation:

  • Compassionate use approval letter from Exelixis (if applicable)
  • Peer-reviewed literature on XL092
  • Relevant treatment guidelines
  • Complete medical records
Tip: For investigational drugs, specify whether you're requesting coverage for the drug itself or just routine care costs associated with its use.

Appeals Process in Georgia

Internal Appeal with Cigna

If initially denied, you have 180 days from the denial date to file an internal appeal. Submit:

  • Written appeal letter explaining why coverage should be approved
  • Additional medical evidence or expert opinions
  • Request for peer-to-peer review between your oncologist and Cigna medical director

External Review in Georgia

After final internal denial, Georgia residents can request external review within 120 days. The process involves:

Timeline:

  • Day 1: Submit external review request to Georgia Insurance Commissioner
  • Day 1-5: Commissioner screens eligibility and notifies Cigna
  • Day 6: Independent Review Organization (IRO) assigned
  • Day 26-45: IRO decision issued (20 days for investigational cases)

Required Documents:

Contact Information:

Important: External review decisions are binding on Cigna. If the IRO determines XL092 is medically necessary, Cigna must provide coverage.

Re-trying for XL092: Documentation During Alternative Treatments

If you must try approved alternatives first, document everything for future XL092 appeals:

Treatment Response Documentation

  • Imaging results with RECIST measurements
  • Tumor markers and biomarker changes
  • Quality of life assessments
  • Performance status changes over time

Toxicity and Tolerability Records

  • Grade and frequency of adverse events
  • Dose modifications required
  • Treatment interruptions and reasons
  • Supportive care measures needed

Resistance Development

  • Molecular profiling at progression (if available)
  • Mechanism of resistance if identified
  • Cross-resistance patterns to related agents

This documentation strengthens future appeals by demonstrating that approved alternatives were given adequate trials but proved insufficient.

FAQ: Common Questions About XL092 Coverage

Q: How long does Cigna prior authorization take in Georgia? A: Standard PA decisions are issued within 5 business days. Expedited requests for urgent situations receive decisions within 24-72 hours.

Q: What if XL092 is denied as experimental/investigational? A: You can appeal through Cigna's internal process, then request external review through Georgia's Insurance Commissioner. Include physician certification that standard treatments are inadequate.

Q: Can I get expedited review if my condition is rapidly progressing? A: Yes. Georgia allows expedited external review when delay would seriously jeopardize life, health, or ability to regain maximum function.

Q: Does Cigna cover routine care costs during compassionate use? A: Potentially, under their clinical trials administrative policy, but requires prior authorization for associated services.

Q: How do I find XL092 clinical trials? A: Search ClinicalTrials.gov using terms "XL092" or "zanzalintinib." Contact listed study coordinators to discuss eligibility.

Q: What's the success rate for external reviews in Georgia? A: Georgia doesn't publish insurer-specific overturn rates, but national data suggests meaningful success rates (20-50%) when appeals include strong medical evidence.

Q: Can I request a peer-to-peer review? A: Yes. Ask your oncologist to request a peer-to-peer discussion with Cigna's medical director to explain your case directly.

Q: What if I have an ERISA employer plan? A: ERISA plans may follow federal external review standards rather than Georgia's process. Check your Summary Plan Description for specific appeal procedures.

Counterforce Health helps patients and clinicians navigate complex insurance denials by transforming them into targeted, evidence-based appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's requirements. We pull the right medical evidence—from FDA labeling to peer-reviewed studies and specialty guidelines—and weave it into appeals that meet procedural requirements while tracking deadlines and required documentation.

For additional support navigating your XL092 coverage appeal, visit www.counterforcehealth.org to learn how our platform can help strengthen your case with payer-specific evidence and documentation.

From our advocates: We've seen cases where patients initially denied investigational drug coverage succeeded on appeal by demonstrating that multiple approved alternatives had failed or caused intolerable toxicity. The key was comprehensive documentation of each prior treatment trial and a clear mechanistic rationale for why the investigational agent offered a different approach. While outcomes vary, thorough preparation significantly improves appeal success rates.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Always consult with your healthcare provider about treatment decisions and consider consulting with a qualified attorney for complex insurance disputes. Coverage policies and procedures may change; verify current requirements with your specific plan and state regulators.

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