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

Work With Your Doctor to Get Zanzalintinib (XL092) Covered by Aetna in New York: Provider Partnership Guide

Answer Box: Your Partnership Path to Coverage

Zanzalintinib (XL092) requires close collaboration with your oncologist since it's investigational and only available through Exelixis's compassionate use program or clinical trials. In New York, your fastest path involves: (1) Your doctor submitting FDA Form 3926 for expanded access, (2) crafting a comprehensive medical necessity letter citing failed standard therapies, and (3) leveraging New York's strong external appeal rights if initially denied. Start today by scheduling a focused visit to document your treatment history and discuss compassionate use eligibility with your oncology team.

Table of Contents

  1. Set Your Goal: What Approval Requires
  2. Visit Preparation: Building Your Case
  3. Evidence Kit Assembly
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Support
  6. After-Visit Documentation
  7. Respectful Persistence Strategy
  8. Appeals Playbook for Aetna in New York
  9. FAQ

Set Your Goal: What Approval Requires

Getting Zanzalintinib (XL092) covered by Aetna CVS Health in New York requires understanding that this isn't a typical prior authorization—it's an investigational drug approval process that demands exceptional documentation.

Your partnership with your oncologist centers on two parallel tracks:

  1. Compassionate Use Access: Your doctor must apply to Exelixis for expanded access via FDA Form 3926, demonstrating you're ineligible for clinical trials but have exhausted standard options.
  2. Insurance Coverage: Even with compassionate use approval, Aetna must separately approve coverage, typically requiring proof that standard therapies have failed and this represents your best remaining option.
Note: Unlike approved drugs where prior authorization focuses on formulary placement, investigational drugs require proving medical necessity under "experimental/investigational" policies that vary by plan.

Coverage at a Glance: Aetna Requirements

Requirement What It Means Where to Find It
Prior Authorization Required for all investigational oncology drugs Aetna Clinical Policy Bulletins
Medical Necessity Must prove standard options exhausted Provider letter with treatment history
FDA Status Compassionate use or trial enrollment FDA Form 3926 or trial documentation
Appeals Timeline 180 days internal, 4 months external NY DFS External Appeals

Visit Preparation: Building Your Case

Come to your appointment prepared to document why Zanzalintinib represents your best option. Your oncologist needs specific details to build a compelling case.

Prepare Your Treatment Timeline:

  • List every cancer treatment you've tried, with start/stop dates
  • Document why each treatment was discontinued (progression, intolerance, contraindication)
  • Note any dose reductions or treatment delays
  • Include supportive care medications that failed

Symptom and Functional Impact Documentation:

  • Current symptoms affecting daily activities
  • ECOG performance status changes over time
  • Quality of life impacts from disease progression
  • Any urgent medical needs requiring expedited review

Bring These Documents:

  • Complete pathology reports with molecular testing results
  • Recent imaging showing disease progression
  • Laboratory results demonstrating organ function
  • Prior treatment records from other oncologists
  • Insurance denial letters if you've already attempted coverage
Tip: Request copies of all clinic notes from your visit—you'll need these for appeals documentation.

Evidence Kit Assembly

Your oncologist will need comprehensive evidence to support both the compassionate use application and insurance coverage request. Help them gather:

Clinical Evidence:

  • Biomarker testing confirming your cancer type matches Zanzalintinib's targets
  • Imaging demonstrating measurable disease progression
  • Documentation of ECOG performance status 0-2 (required for compassionate use)
  • Proof of adequate organ function for treatment safety

Treatment History Documentation:

  • Detailed records of all prior therapies with specific reasons for failure
  • Evidence of contraindications to standard alternatives
  • Documentation of treatment-related toxicities requiring discontinuation

Literature Support:

  • Phase I/II trial data showing Zanzalintinib efficacy in your cancer type
  • NCCN guidelines confirming standard options are exhausted
  • Peer-reviewed studies supporting the drug's mechanism of action

Counterforce Health specializes in assembling exactly this type of evidence package, helping patients and providers identify the strongest clinical and literature support for investigational drug appeals.

Medical Necessity Letter Structure

Your oncologist's medical necessity letter serves as the foundation for both compassionate use and insurance approval. Here's the essential structure:

Header and Patient Information:

  • Provider letterhead with full credentials
  • Patient demographics, insurance ID, and diagnosis with ICD-10 codes
  • Clear statement: "Requesting coverage for Zanzalintinib (XL092) for [specific diagnosis]"

Clinical Rationale Section:

  1. Diagnosis and Staging: Include primary diagnosis, date of diagnosis, current staging, and molecular characteristics
  2. Prior Treatment History: Chronological list of all therapies tried, duration, response, and reason for discontinuation
  3. Current Clinical Status: Recent labs, imaging, performance status, and disease progression evidence
  4. Treatment Justification: Why Zanzalintinib is medically necessary given exhausted standard options

Supporting Evidence:

  • Citations to clinical trial data showing efficacy
  • References to FDA guidance on compassionate use
  • NCCN guideline excerpts showing standard options are exhausted
  • Peer-reviewed literature supporting the treatment approach

Monitoring and Safety Plan:

  • Proposed dosing regimen and administration schedule
  • Laboratory monitoring plan for toxicity management
  • Response assessment timeline with imaging intervals
Clinician Corner: Include specific language like "no reasonable alternative exists" and "potential benefit outweighs risks"—these phrases align with both FDA compassionate use criteria and insurance medical necessity standards.

Peer-to-Peer Support

When Aetna requests a peer-to-peer review, your oncologist will speak directly with an Aetna medical director. You can support this process:

Prepare a One-Page Case Summary:

  • Patient age, diagnosis, stage, and key molecular markers
  • Timeline of prior treatments with specific failure reasons
  • Current clinical status and urgency of treatment need
  • Key literature citations supporting Zanzalintinib use

Offer Scheduling Flexibility:

  • Provide your oncologist's available time windows
  • Emphasize any urgent clinical factors requiring expedited review
  • Suggest having the peer-to-peer within 48 hours of request

Key Talking Points for Your Doctor:

  • Emphasize that standard therapies per NCCN guidelines have been exhausted
  • Reference specific clinical trial data showing efficacy in similar patients
  • Highlight the investigational nature requiring compassionate use approval
  • Stress that delay in treatment could result in irreversible disease progression

After-Visit Documentation

Immediately after your appointment, ensure proper documentation for your appeal file:

Request These Documents:

  • Complete visit notes with treatment plan
  • Updated problem list with current staging
  • Laboratory and imaging orders for baseline assessment
  • Prescription for Zanzalintinib with specific dosing

Portal Messaging Strategy:

  • Thank your provider for their time and comprehensive assessment
  • Confirm next steps for compassionate use application submission
  • Request estimated timeline for FDA Form 3926 completion
  • Ask for copies of all documentation for your personal records

Save Everything:

  • Print or download all portal communications
  • Keep copies of insurance correspondence
  • Maintain a chronological file of all treatment-related documents
  • Document all phone calls with dates, times, and outcomes

Respectful Persistence Strategy

Balancing advocacy with maintaining positive provider relationships requires strategic communication:

Weekly Update Cadence:

  • Monday: Check portal for any new results or communications
  • Wednesday: Brief message if awaiting critical documentation
  • Friday: Summary message if multiple issues need coordination

Escalation Approach:

  1. Week 1-2: Direct communication with your oncologist via portal
  2. Week 3: Contact nurse coordinator or clinical coordinator
  3. Week 4+: Request appointment to discuss barriers and alternative approaches

Professional Communication Templates:

For routine follow-up: "Hi Dr. [Name], hoping for a quick update on the Zanzalintinib compassionate use application. Please let me know if you need any additional information from me to move this forward."

For urgent situations: "Dr. [Name], I'm concerned about the timeline for getting Zanzalintinib approved given my recent scan results. Could we schedule a brief call to discuss next steps and any barriers you're encountering?"

Appeals Playbook for Aetna in New York

New York offers some of the strongest patient appeal rights in the nation. Here's your step-by-step process:

Internal Appeal (Level 1):

  • Timeline: File within 180 days of denial
  • Process: Submit via Aetna member portal or written request
  • Decision: 30 days standard, 72 hours expedited
  • Required: Medical necessity letter, clinical documentation, literature support

Expedited Internal Appeal:

  • When to Use: Urgent medical need where delay could cause harm
  • Timeline: 72 hours for decision
  • Documentation: Physician attestation of urgency required

External Appeal (Level 2):

  • Timeline: Within 4 months of final internal denial
  • Process: NY DFS External Appeal Application
  • Cost: $25 maximum (waived if approved or financial hardship)
  • Decision: 30 days standard, 72 hours expedited
  • Success Rate: Approximately 58% for cancer-related appeals

Required Documentation for Appeals:

  • Complete denial letter from Aetna
  • All medical records supporting treatment need
  • Physician attestation that standard treatments are ineffective
  • Peer-reviewed literature supporting investigational use
  • Evidence of compassionate use approval from Exelixis
New York Advantage: The DFS External Appeals Database allows you to search prior decisions for similar investigational drug cases, providing precedent citations for your appeal.

When Treatment is Needed Now

If your condition requires immediate treatment, platforms like Counterforce Health can rapidly assemble comprehensive appeal packages with the clinical evidence and literature citations needed to support expedited reviews—often turning around documentation within 24-48 hours when working with your oncology team.

FAQ

How long does Aetna prior authorization take for investigational drugs? Standard prior authorization decisions take 30-45 days, but investigational drugs often require additional clinical review. Request expedited review (72 hours) if your oncologist can document urgent medical need.

What if Zanzalintinib isn't on Aetna's formulary? Investigational drugs typically aren't on formularies. You'll need to request a formulary exception based on medical necessity and lack of covered alternatives.

Can I appeal if I've failed treatments outside New York? Yes. New York appeals accept treatment history from any location. Ensure your oncologist documents all prior therapies with specific failure reasons.

Does Aetna require step therapy for investigational drugs? Step therapy requirements vary by plan, but investigational drugs typically bypass standard step therapy if you can demonstrate failure of or contraindications to all approved alternatives.

What happens if my external appeal is approved? Aetna must cover the treatment and refund your $25 appeal fee. The decision is binding and cannot be overturned by the insurance company.

How do I find similar cases in the NY appeals database? Search the DFS database using terms like "investigational drug," "experimental treatment," or your specific cancer type to find precedent decisions.

Can I get help with the compassionate use application? Yes. Contact Exelixis directly through their medical information department, or work with patient advocacy organizations that specialize in expanded access applications.

What if my oncologist is hesitant to pursue compassionate use? Request a second opinion or ask for referral to an oncologist experienced with investigational drug access. Some cancer centers have dedicated expanded access coordinators.

From Our Advocates: We've seen patients successfully obtain coverage for investigational TKIs by emphasizing the "no reasonable alternative" standard in their appeals. One patient's case was strengthened by including a detailed timeline showing progression through every NCCN-recommended therapy, plus molecular testing results that specifically supported the investigational drug's mechanism. The key was demonstrating that standard care had truly been exhausted, not just that the investigational option seemed promising.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan benefits, and medical necessity determinations. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official appeals guidance in New York, contact the Department of Financial Services at 1-800-400-8882.

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