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

How to Get Zanzalintinib (XL092) Covered by Aetna CVS Health in Washington: Clinical Trial Access, Appeals & Timelines

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

Zanzalintinib (XL092) is an investigational drug not FDA-approved, so standard Aetna CVS Health coverage is typically denied. The fastest path is through clinical trials (drug provided free by Exelixis) or compassionate use programs where Aetna may cover routine care costs. In Washington, you have 180 days to appeal denials and can request external review through the Office of Insurance Commissioner. First step today: Search ClinicalTrials.gov for STELLAR program trials (NCT05425940, NCT06943755) and contact your oncologist to assess eligibility.

Table of Contents

  1. What Affects Zanzalintinib Coverage Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window & Outcomes
  6. If Denied: Washington Appeals Process
  7. Clinical Trial Access Path
  8. Timeline Visual & Milestones
  9. Time-Saving Tips
  10. FAQ

What Affects Zanzalintinib Coverage Timing

Several factors determine how quickly Aetna CVS Health processes requests for investigational drugs like Zanzalintinib (XL092):

Benefit Type Complexity

  • Medical vs. Pharmacy Benefit: Investigational drugs often fall under medical benefit (buy-and-bill) requiring different prior authorization pathways than standard pharmacy benefit drugs
  • Specialty Tier Status: As an investigational TKI, Zanzalintinib would likely require CVS Specialty Pharmacy handling if covered

Documentation Completeness

  • Clinical Trial Enrollment: Complete trial documentation speeds approval for routine care costs
  • Compassionate Use Authorization: FDA expanded access approval and IRB documentation required
  • Medical Necessity Evidence: Comprehensive prior treatment history and failure documentation
Note: Washington state mandates 3 calendar days for standard prior authorization decisions and 1 calendar day for urgent requests under prior authorization modernization laws.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

For Clinical Trial Coverage:

  • IRB-approved informed consent form
  • Trial protocol synopsis with NCT number
  • Confirmation drug is sponsor-provided at no cost
  • Treating physician letter supporting trial participation

For Compassionate Use Requests:

  • FDA Form 3926 (expanded access IND)
  • IRB approval for single-patient use
  • Comprehensive medical necessity letter
  • Prior treatment history with failure documentation
  • Molecular/biomarker testing results
  • Current staging and performance status

Verify Coverage Type

Contact Aetna Member Services to confirm whether Zanzalintinib would process under:

  • Medical benefit (buy-and-bill infusion)
  • Pharmacy benefit (oral specialty medication)
  • Clinical trial routine care coverage

Submission to Initial Review (1-5 Days)

Washington State Requirements

Aetna must provide decisions within 3 calendar days for standard requests or 1 calendar day for urgent medical necessity cases under Washington's prior authorization laws.

Submission Methods

  1. Electronic Portal: Availity for providers
  2. CVS Caremark ePA: For pharmacy benefit submissions
  3. Specialty Fax: 1-866-249-6155 for medical exception requests
  4. Phone: Provider services for urgent cases

Initial Review Process

Aetna reviewers first check:

  • Member eligibility and benefit coverage
  • Whether drug requires prior authorization
  • Submission completeness and clinical documentation
  • Investigational status and policy exclusions
Tip: Mark submissions as "expedited/urgent medical necessity" if delay could seriously harm patient health, especially for progressive cancer cases.

Additional Information Requests (1-7 Days)

If Aetna requests additional information, respond within 14 days to avoid case closure. Common requests for investigational drugs include:

Frequently Requested Documents

  • Clinical trial protocol details and sponsor contact information
  • FDA breakthrough therapy designation status (if applicable)
  • Peer-reviewed literature supporting multi-target TKI use
  • NCCN guideline citations for similar approved TKIs
  • Biomarker testing results justifying targeted therapy

Rapid Response Strategy

  • Assign clinic staff to monitor requests daily
  • Maintain ready access to molecular pathology reports
  • Prepare template responses for common information gaps
  • Use fax confirmation for time-sensitive submissions

Decision Window & Outcomes

Typical Aetna Decision Timeframes

Request Type Standard Timeline Washington Mandate Expedited Timeline
Clinical Trial Routine Care 14-30 days 3 calendar days 24-72 hours
Compassionate Use 30-45 days 3 calendar days 24-72 hours
Medical Exception 45 days 3 calendar days 24 hours

Reading Your Decision Letter

Approval: Look for specific coverage terms, quantity limits, and renewal requirements Denial: Note specific denial codes and reasons (experimental/investigational, medical necessity, formulary status) Partial Approval: May cover routine care but not the investigational drug itself

If Denied: Washington Appeals Process

Washington provides robust appeal rights with binding external review through Independent Review Organizations (IROs).

Internal Appeals Timeline

Level Filing Deadline Aetna Response Time How to File
First Internal 180 days from denial 30 days Aetna Appeals Portal
Second Internal 30 days from first denial 30 days Written appeal with additional evidence

External Review (IRO)

Strengthening Your Appeal

Include these elements in appeal documentation:

  • FDA expanded access approval (if obtained)
  • Clinical trial enrollment confirmation
  • Peer-reviewed studies on multi-target TKIs
  • NCCN pathway evidence for similar approved therapies
  • Patient-specific factors making standard alternatives inappropriate
From our advocates: We've seen investigational cancer drug appeals succeed when families combined clinical trial enrollment documentation with detailed prior treatment failure records and molecular testing results showing why standard therapies weren't suitable. The key was demonstrating medical necessity for the specific patient's situation.

Clinical Trial Access Path

Current Zanzalintinib Trials

Search ClinicalTrials.gov for active studies:

  • STELLAR-303: Advanced solid tumors (NCT05425940)
  • STELLAR-304: Specific cancer types (NCT06943755)

Trial Benefits

  • Drug provided free by Exelixis
  • Routine care costs typically covered by insurance
  • Access to cutting-edge treatment before FDA approval
  • Close monitoring and expert care

Eligibility Requirements

Most trials require:

  • Confirmed cancer diagnosis with measurable disease
  • Prior treatment failure or intolerance
  • Adequate organ function (labs, cardiac function)
  • ECOG performance status 0-2
  • Informed consent capability

Enrollment Process

  1. Contact trial site directly using ClinicalTrials.gov information
  2. Submit medical records for preliminary screening
  3. Schedule screening visit if eligible
  4. Complete informed consent process
  5. Begin treatment once all requirements met

Timeline Visual & Milestones

Typical Approval Journey

Days 0-2: Preparation

  • Gather documentation
  • Verify benefit type
  • Choose submission method

Days 1-5: Initial Review

  • Submit complete request
  • Aetna preliminary review
  • Information requests (if needed)

Days 3-7: Decision

  • Standard decision (Washington: 3 days)
  • Urgent decision (Washington: 1 day)
  • Approval or denial notification

Days 8-45: Appeals (if denied)

  • Internal appeal submission
  • Peer-to-peer review option
  • Second-level internal appeal

Days 46-75: External Review

  • IRO filing with Washington OIC
  • Independent medical review
  • Binding decision

Time-Saving Tips

Portal Optimization

  • Use electronic submission whenever possible for faster processing
  • Upload all documents in a single submission to avoid delays
  • Track submission status through member/provider portals

Evidence Bundling

  • Combine clinical trial and compassionate use applications
  • Include molecular testing results with initial submission
  • Attach peer-reviewed literature supporting multi-target TKI use

Direct Specialty Routing

  • Contact CVS Specialty Pharmacy early in the process
  • Verify specialty tier requirements and restrictions
  • Coordinate with oncology team for seamless transitions

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies specific denial criteria, and drafts point-by-point rebuttals aligned to Aetna's policies. For complex investigational drug cases like Zanzalintinib, we help gather the right clinical evidence and regulatory documentation to strengthen your appeal.

FAQ

How long does Aetna CVS Health prior authorization take in Washington? Washington mandates 3 calendar days for standard decisions and 1 calendar day for urgent requests. Aetna typically processes 95% of eligible PAs within 24 hours nationally.

What if Zanzalintinib is denied as experimental? You can appeal citing FDA expanded access approval, clinical trial enrollment, or compassionate use authorization. Washington's external review process has strong success rates for specialty drug appeals.

Can I request expedited review for cancer progression? Yes. If delay risks disease progression, hospitalization, or severe clinical deterioration, request urgent processing. Include physician documentation of time-sensitive medical need.

Does step therapy apply to investigational drugs? Typically no, since investigational drugs aren't on formulary. However, Aetna may require documentation of prior treatment failures with approved alternatives.

What costs are covered for clinical trial participation? Aetna generally covers routine patient care costs (office visits, labs, imaging) for approved clinical trials. The investigational drug is provided free by the sponsor.

How do I contact Exelixis for compassionate use? Visit Exelixis Medical Affairs or contact through their patient assistance programs. Your oncologist must initiate the request.

What if my plan is self-funded ERISA? Washington state laws may not apply to self-funded employer plans. Contact the U.S. Department of Labor for ERISA appeals guidance, though many employers voluntarily use external review processes.

Can I appeal if routine trial costs are denied? Yes. Clinical trial coverage is required under many insurance policies. Use Washington's appeal process and cite federal clinical trial coverage requirements.

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 company for specific coverage decisions. For personalized assistance with complex appeals, consider working with Counterforce Health to strengthen your documentation and improve approval chances.

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