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

How to Get Zanzalintinib (XL092) Covered by Aetna in Georgia: Complete Appeals Guide and Compassionate Use Options

Answer Box: Your Fastest Path to Coverage

Zanzalintinib (XL092) is investigational and typically not covered by Aetna outside clinical trials. However, you have two main pathways: 1) Apply for compassionate use through Exelixis while pursuing insurance appeals, or 2) Submit a formulary exception request with robust medical necessity documentation. In Georgia, if denied, you can request external review through the Georgia Department of Insurance within 60 days. Start today by having your oncologist contact Exelixis Medical Affairs for expanded access eligibility while simultaneously submitting prior authorization to Aetna.

Table of Contents

Coverage Basics

Is Zanzalintinib (XL092) Covered by Aetna?

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. As of 2025, it has no FDA approvals and is available only through clinical trials or expanded access programs. Aetna considers investigational drugs non-covered unless mandated by law or through successful formulary exception appeals.

Which Aetna Plans Apply?

All Aetna commercial plans, including those through CVS Health, follow the same investigational drug policies. Coverage decisions are made through CVS Caremark's specialty pharmacy division and require prior authorization for all investigational treatments.

Prior Authorization Process

Who Submits the Request?

Your oncologist or treating physician must submit the prior authorization request. Patients cannot submit PA requests directly. The process requires:

  1. Clinical documentation including diagnosis (ICD-10), staging, and treatment history
  2. Medical necessity letter explaining why Zanzalintinib is needed
  3. Evidence of failed standard therapies or contraindications to approved alternatives

How to Submit

Providers can submit through:

Tip: Submit requests at least two weeks in advance when possible, as investigational drug reviews often require additional clinical review time.

Timing and Deadlines

Standard Review Timeline

  • Standard PA decisions: 30-45 days for investigational drugs
  • Expedited review: 72 hours for urgent medical situations
  • Peer-to-peer review: Can be requested if initially denied

What Qualifies as Urgent?

For expedited review, your physician must document that a delay would:

  • Seriously jeopardize life or health
  • Jeopardize ability to regain maximum function
  • Subject you to severe pain that cannot be adequately managed

Medical Necessity Criteria

Aetna's Requirements for Investigational Drugs

Based on Aetna's clinical policy bulletins, investigational drug coverage requires:

Requirement Documentation Needed
Serious/life-threatening condition Pathology report, staging documents
Failed standard therapies Treatment history with dates, outcomes, intolerance
No suitable alternatives Literature review, contraindications
Clinical trial ineligibility Statement explaining why trials aren't viable
Compelling clinical rationale Peer-reviewed evidence supporting use

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include:

  • Patient's cancer type and stage with ICD-10 codes
  • Complete treatment history including all prior TKIs tried and reasons for discontinuation
  • Clinical rationale for Zanzalintinib based on molecular profile or resistance patterns
  • Literature citations supporting investigational use
  • Trial ineligibility statement documenting why available studies aren't options

Understanding Costs

Coverage vs. Cost-Sharing

Even if approved, investigational drugs may have:

  • Higher copayments (often specialty tier pricing)
  • Coinsurance ranging from 20-50% of drug cost
  • Prior authorization renewal requirements every 6-12 months

Financial Assistance Options

Since Zanzalintinib is investigational, traditional manufacturer copay cards don't apply. However:

  • Expanded access programs typically provide drug at no cost
  • Clinical trials cover drug costs
  • Foundation grants may help with associated medical expenses

Denials and Appeals Process

Common Denial Reasons and Solutions

Denial Reason How to Overturn
"Investigational/Experimental" Submit formulary exception with compelling clinical evidence
"Not medically necessary" Provide detailed treatment history and resistance documentation
"Clinical trial available" Document trial ineligibility or access barriers
"Lack of evidence" Include peer-reviewed studies and FDA breakthrough therapy data

Internal Appeals Process

  1. File within 60 days of denial notice
  2. Submit additional evidence not included in original request
  3. Request peer-to-peer review with medical director
  4. Include patient impact statement describing clinical urgency

Renewal Requirements

When to Re-authorize

Investigational drug approvals typically require renewal every:

  • 6 months for most oncology indications
  • 3 months for rapidly evolving clinical situations
  • Annually for stable, long-term use

What Documentation Changes?

Renewal requests must include:

  • Updated imaging and response assessments
  • Tolerance documentation (side effects, dose modifications)
  • Continued medical necessity justification
  • Any new clinical evidence supporting ongoing use

Specialty Pharmacy Considerations

CVS Caremark Specialty Requirements

CVS Caremark Specialty Pharmacy handles investigational drugs through:

  • Specialized pharmacists trained in investigational drug protocols
  • Enhanced safety monitoring and documentation
  • Direct coordination with prescribers for ongoing management

Patient Portal Access

Patients can use the CVS Specialty portal to:

  • Track authorization status
  • Communicate with clinical pharmacists
  • Monitor refill schedules and supply limits
  • Access educational materials about their treatment

Compassionate Use Pathway

Exelixis Expanded Access Program

While pursuing insurance coverage, patients can simultaneously apply for compassionate use:

Eligibility Requirements:

  • Serious or life-threatening cancer diagnosis
  • Failed or intolerant to standard approved therapies
  • Ineligible for available Zanzalintinib clinical trials
  • Able to provide informed consent

Application Process:

  1. Physician contacts Exelixis Medical Affairs
  2. Submit FDA single-patient IND (Form 3926)
  3. Obtain IRB approval and patient consent
  4. Await 30-day FDA review (unless objection)
  5. Receive drug directly from manufacturer
Note: Compassionate use applications typically take 30-60 days but provide drug at no cost during the process.

Georgia External Review Process

When Internal Appeals Fail

If Aetna denies your internal appeal, Georgia law provides external review through the Georgia Department of Insurance:

Key Requirements:

  • File within 60 days of final internal denial
  • Use official DOI form (contact [email protected])
  • Include all documentation from internal appeals
  • No cost to patients for external review

Timeline:

  • Standard review: 30 business days
  • Expedited review: 72 hours for urgent cases
  • Decision is binding on Aetna

How to Request External Review

  1. Obtain the form by emailing [email protected]
  2. Submit within deadline (60 days post-denial)
  3. Include physician urgency letter if requesting expedited review
  4. Wait for independent physician review and binding decision

Contact Information: Georgia Department of Insurance, Administrative Procedure Division
708 West Tower, Floyd Building
Two Martin Luther King, Jr. Drive
Atlanta, GA 30334

Troubleshooting Common Issues

Portal Access Problems

If you can't access the Aetna or CVS Specialty portals:

  • Clear browser cache and try different browsers
  • Contact member services using the number on your ID card
  • Have your member ID and personal information ready

Missing Documentation

Common missing documents include:

  • Complete treatment history with specific drug names and dates
  • Pathology reports with molecular markers
  • Clinical trial screening documentation
  • Prior authorization forms from previous insurers

Frequently Asked Questions

Q: How long does Aetna PA take for investigational drugs in Georgia? A: Standard reviews take 30-45 days, but expedited reviews for urgent cases are completed within 72 hours.

Q: What if Zanzalintinib is completely non-formulary? A: You can request a formulary exception with medical necessity documentation, even for investigational drugs.

Q: Can I request expedited appeal if my condition is worsening? A: Yes, if your physician documents that delay would jeopardize your health, both internal and external appeals can be expedited.

Q: Does step therapy apply to investigational drugs? A: While traditional step therapy doesn't apply, Aetna requires documentation of failed standard therapies before considering investigational options.

Q: What happens if external review is denied in Georgia? A: External review decisions are binding on insurers, but you may have legal recourse through Georgia courts if procedural errors occurred.

Q: Can I get Zanzalintinib through clinical trials instead? A: Check ClinicalTrials.gov for active studies, though trial availability doesn't guarantee insurance coverage of associated costs.

From our advocates: We've seen patients successfully obtain coverage for investigational TKIs by combining compassionate use applications with persistent insurance appeals. The key is maintaining parallel pathways—don't wait for insurance approval to start the expanded access process, as both can take months to resolve. Having the drug available through compassionate use also strengthens your insurance appeal by demonstrating ongoing medical necessity.

At Counterforce Health, we help patients and clinicians navigate complex insurance denials for specialty medications. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that address payer-specific requirements and increase approval rates for challenging cases like investigational drug requests.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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