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

How to Get Zanzalintinib (XL092) Covered by Aetna CVS Health in Virginia: Appeals, Forms & Timelines

Answer Box: Getting Zanzalintinib (XL092) Covered by Aetna CVS Health in Virginia

Zanzalintinib (XL092) is investigational and typically denied by Aetna CVS Health unless part of a clinical trial or compassionate use program. Your fastest path: 1) Have your doctor request a formulary exception with detailed medical necessity documentation, 2) If denied, file an internal appeal within 180 days, 3) Use Virginia's expedited external review (72 hours for urgent cases) through the State Corporation Commission Bureau of Insurance. Start today by downloading Aetna's formulary exception form and gathering prior treatment records.

Table of Contents

Plan Types & Coverage Implications

Your Aetna CVS Health plan type affects how Zanzalintinib (XL092) requests are handled:

Commercial Plans (HMO/PPO/EPO): Investigational drugs like Zanzalintinib require prior authorization and are typically excluded unless clear medical necessity is demonstrated. PPO plans may offer slightly more flexibility for out-of-network specialists involved in clinical trials.

Medicare Advantage: Follows Medicare Part B/D guidelines. Investigational drugs are generally not covered unless part of a qualifying clinical trial under Medicare's coverage with evidence development policy.

Medicaid Managed Care: Virginia Medicaid follows strict formulary guidelines. Investigational agents require prior authorization and are rarely approved outside of clinical trial settings.

Note: Self-funded employer plans may have different policies. Check your Summary Plan Description for investigational drug coverage.

Formulary Status & Tier Placement

Current Status: Zanzalintinib (XL092) is not on Aetna's formulary as of 2025. It's classified as investigational/experimental, meaning:

  • No standard tier placement
  • Requires formulary exception request
  • Subject to medical necessity review
  • May require peer-to-peer clinical discussion

Alternative Agents: Aetna typically covers FDA-approved alternatives like:

  • Cabozantinib (Cometriq, Cabometyx)
  • Lenvatinib (Lenvima)
  • Other targeted therapies per NCCN guidelines

Check current formulary status at CVS Caremark formulary lookup.

Prior Authorization Requirements

Zanzalintinib requires prior authorization through Aetna's medical benefit (not pharmacy benefit) due to its investigational status.

Required Documentation

Clinical Information:

  • Complete diagnosis with ICD-10 codes
  • Prior treatment history and outcomes
  • Documentation of treatment failures/intolerances
  • Current performance status
  • Laboratory values and staging information

Regulatory Documentation:

  • FDA Expanded Access (compassionate use) approval letter
  • IRB approval from treating institution
  • Manufacturer agreement to provide drug
  • Clinical trial enrollment documentation (if applicable)

Prescriber Requirements:

  • Board certification in oncology/relevant specialty
  • Hospital/clinic affiliation
  • Detailed medical necessity letter

Submission Process

  1. Download forms from Aetna provider portal
  2. Submit via:
    • Electronic: Aetna provider portal
    • Fax: Check current fax number on forms
    • Phone: 1-855-240-0536 for urgent requests

Timeline: Standard decisions within 15 business days; expedited (urgent) within 72 hours.

Specialty Pharmacy Setup

If approved, Zanzalintinib will be dispensed through CVS Specialty Pharmacy due to its complex handling requirements.

Enrollment Process

  1. Complete CVS Specialty enrollment form - download condition-specific form from CVS Specialty enrollment page
  2. Required Information:
    • Patient demographics and insurance details
    • Prescriber information and NPI
    • Complete medication parameters
    • Special handling instructions for investigational use
  3. Submit Documentation:
  4. Patient Contact: CVS CareTeam will contact patient within 24-48 hours to complete setup and arrange delivery
Tip: For investigational drugs, annotate enrollment forms as "expanded access" or "compassionate use" for proper tracking.

Appeals Process in Virginia

Virginia offers robust appeal rights for insurance denials, especially for investigational treatments.

Internal Appeals (Aetna)

Timeline: 180 days from denial date to file Process:

  • Submit written appeal with additional clinical evidence
  • Include peer-reviewed literature supporting use
  • Request peer-to-peer review if available Decision: 30 days for standard; 72 hours for expedited

External Review (Virginia SCC)

If internal appeal is denied, Virginia's State Corporation Commission Bureau of Insurance provides independent review.

Eligibility: Medical necessity denials, experimental treatment exclusions Timeline: 120 days from final internal denial to file Forms: External Review Request Form 216-A Decision Time: 45 days standard; 72 hours expedited for urgent cases

Contact Information:

  • Phone: 1-877-310-6560
  • Managed Care Ombudsman: 1-804-371-9032

Counterforce Health specializes in turning insurance denials into evidence-backed appeals. Their platform analyzes denial letters and plan policies to create targeted rebuttals with the right clinical evidence and regulatory citations. For complex investigational drug cases like Zanzalintinib, having expert appeal support can significantly improve approval chances.

Cost Considerations

Insurance Coverage: Typically $0 if approved (investigational drugs often covered at 100% when authorized)

If Not Covered:

  • Manufacturer compassionate use programs may provide drug at no cost
  • Clinical trial participation covers drug costs
  • Patient assistance may be available through Exelixis

Appeal Costs: Virginia external review is free for consumers

Step-by-Step: Fastest Path to Approval

  1. Verify Clinical Trial Options (Patient/Physician)
    • Search ClinicalTrials.gov for Zanzalintinib studies
    • Contact study coordinators for eligibility screening
  2. Request Expanded Access (Physician)
    • Contact Exelixis medical affairs
    • Submit FDA Form 3926 for single-patient IND
    • Obtain IRB approval
  3. Submit Formulary Exception (Physician/Staff)
    • Download Aetna forms
    • Include all regulatory approvals and clinical justification
    • Submit within 5 business days of regulatory approval
  4. Enroll with CVS Specialty (Upon Approval)
  5. If Denied: File Internal Appeal (Patient/Physician)
    • Submit within 180 days with additional evidence
    • Request expedited review if clinically urgent
  6. External Review (Patient)
    • File with Virginia SCC within 120 days of final denial
    • Use expedited process for urgent medical necessity
  7. Ongoing Monitoring (Physician)
    • Document clinical response
    • Submit periodic updates to maintain authorization

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
"Investigational/Experimental" Provide FDA expanded access approval FDA IND approval letter, IRB consent
"No FDA Approval" Demonstrate compassionate use criteria Medical necessity letter, failed alternatives
"Not Medically Necessary" Submit peer-reviewed evidence Clinical studies, treatment guidelines
"Alternative Available" Document failures/contraindications Prior treatment records, intolerance documentation

When to Escalate

Contact Virginia Regulators When:

  • Aetna doesn't respond within required timeframes
  • Procedural violations occur during appeals
  • External review rights are denied

Virginia Bureau of Insurance:

  • Consumer Services: 1-877-310-6560
  • File complaints online or by mail
  • Free assistance with appeal preparation

Additional Resources:

  • Virginia Managed Care Ombudsman: 1-804-371-9032
  • Virginia Poverty Law Center Health Assistance Program
  • Legal Aid societies for complex cases

FAQ

How long does Aetna CVS Health prior authorization take for Zanzalintinib? Standard decisions within 15 business days; expedited (urgent) within 72 hours. Complex investigational drug requests may require additional clinical review.

What if Zanzalintinib is not on formulary? Submit a formulary exception request with detailed medical necessity documentation and regulatory approvals. Most investigational drugs require this process.

Can I request expedited appeal in Virginia? Yes, if your physician certifies that waiting could seriously jeopardize your health. Virginia provides 72-hour expedited external review for urgent cases.

Does step therapy apply to investigational drugs? Typically yes - you must document failures or contraindications to FDA-approved alternatives before investigational agents are considered.

What happens if external review denies coverage? The decision is final and binding. Consider consulting an attorney if you suspect procedural violations or discrimination.

Are clinical trial costs covered by Aetna? Routine care costs in clinical trials are often covered; investigational drugs are provided by the sponsor at no cost to patients.

How do I find Zanzalintinib clinical trials in Virginia? Search ClinicalTrials.gov using "Zanzalintinib" and "Virginia" as search terms. Contact study coordinators directly.

What documentation do I need for appeal? Complete medical records, prior treatment history, denial letters, physician attestation, and any regulatory approvals for expanded access use.

From our advocates: "We've seen investigational drug appeals succeed when families work closely with their oncologist to document every prior treatment attempt and gather strong clinical evidence. The key is showing that standard options have been exhausted and this represents the patient's best chance. Virginia's external review process has been particularly helpful for these complex cases."

For patients and clinicians navigating these complex approval processes, Counterforce Health offers specialized support in creating evidence-backed appeals that align with payer policies and regulatory requirements. Their platform helps transform denials into targeted, well-documented appeals that significantly improve approval odds.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan details, and clinical factors. Always consult your healthcare provider and insurance plan directly for coverage determinations. Virginia insurance regulations and Aetna policies may change; verify current requirements with official sources.

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