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

Renewing Zanzalintinib (XL092) Coverage with Humana in Washington: Timeline, Documentation & Appeal Steps

Answer Box: Renewing Zanzalintinib (XL092) Coverage with Humana in Washington

Zanzalintinib (XL092) is an investigational drug requiring compassionate use program enrollment through Exelixis, as it's not FDA-approved. Humana typically covers investigational drugs only within clinical trials or approved compassionate use programs. To renew coverage: (1) Confirm continued eligibility in the compassionate use program with ECOG performance status 0-2 and documented disease progression, (2) Submit renewal application 60-90 days before current approval expires with updated clinical documentation, and (3) If denied, file a Humana internal appeal within 65 days, followed by Washington's external review process if needed.

Table of Contents

  1. Renewal Triggers: When to Start the Process
  2. Evidence Updates: What Documentation You Need
  3. Renewal Packet: Must-Include Documents
  4. Timeline: Submission Deadlines and Decision Windows
  5. If Coverage Lapses: Bridge Options and Next Steps
  6. Annual Changes: Formulary Updates to Monitor
  7. Personal Tracker: Organizing Your Renewal
  8. Appeals Playbook for Washington
  9. FAQ: Common Renewal Questions

Renewal Triggers: When to Start the Process

Early Warning Signs

Start your renewal process 60-90 days before your current compassionate use approval expires. Key triggers include:

  • Performance status changes: Any decline in ECOG status from 0-2 requires immediate documentation
  • Disease progression: New scans showing progression may actually support continued need for investigational therapy
  • Treatment response: Stable disease or partial response strengthens your renewal case
  • Formulary notifications: Humana sends annual formulary change notices 30 days before changes affecting specialty drugs
Tip: Set calendar reminders 90, 60, and 30 days before your compassionate use program expiration date.

Humana-Specific Timing

For Medicare Advantage members, Humana's formulary exception renewals typically expire at the end of each plan year and must be renewed annually. However, compassionate use programs operate on their own timeline, often requiring renewal every 6-12 months.

Evidence Updates: What Documentation You Need

Clinical Status Requirements

Your renewal must demonstrate continued medical necessity with these key elements:

Performance Status: Document current ECOG performance status of 0-2. Any deterioration may affect renewal eligibility, but doesn't automatically disqualify you if the investigational drug remains the best option.

Disease Monitoring: Include recent imaging studies (CT, MRI, or PET scans) showing:

  • Disease progression on prior approved therapies
  • Current disease status while on Zanzalintinib
  • At least one measurable lesion per RECIST v1.1 criteria

Prior Treatment History: Update documentation of:

  • All prior targeted therapies tried and failed
  • Specific reasons for treatment failures (progression, intolerance, contraindications)
  • Timeline of treatments to show exhaustion of approved options

Biomarker and Laboratory Updates

Genomic Testing: Provide updated tumor tissue analysis or liquid biopsy results from FDA-approved tests performed in certified laboratories. This supports the rationale for continued targeted therapy.

Safety Monitoring: Include recent laboratory results showing:

  • Complete blood count
  • Comprehensive metabolic panel
  • Liver function tests
  • Any drug-specific monitoring parameters required by the compassionate use protocol

Renewal Packet: Must-Include Documents

Core Documentation Checklist

✓ Updated Letter of Medical Necessity from your oncologist including:

  • Current diagnosis with ICD-10 codes
  • ECOG performance status assessment
  • Recent imaging results and disease status
  • Prior treatment failures with specific dates and reasons
  • Clinical rationale for continued investigational therapy

✓ Compassionate Use Program Confirmation from Exelixis showing:

  • Current enrollment status
  • Renewal eligibility confirmation
  • Updated safety monitoring requirements

✓ Recent Clinical Records (last 3-6 months):

  • Oncology visit notes
  • Laboratory results
  • Imaging reports
  • Adverse event documentation

✓ Insurance Documentation:

  • Current Humana member ID card
  • Previous approval letters
  • Any prior denial letters if applicable

Letter of Medical Necessity Structure

Your physician's renewal letter should follow this evidence-based format:

  1. Patient identification and current clinical status
  2. Treatment history with specific outcomes and failure reasons
  3. Current disease status with objective measures
  4. Rationale for continuation based on clinical response or lack of alternatives
  5. Safety monitoring plan and adverse event management
  6. Treatment goals and expected duration of therapy

Timeline: Submission Deadlines and Decision Windows

Humana Decision Timelines

Request Type Timeline Expedited Option
Standard Prior Authorization 72 hours 24 hours if urgent
Formulary Exception Renewal 72 hours standard 24 hours expedited
Internal Appeal Up to 30 days 72 hours if urgent

Submission Methods

Provider Portal: Most efficient method through Humana's provider portal (verify current link with your clinic)

Phone: Call Humana customer service at the number on your member ID card

Fax: Submit to the prior authorization fax number listed in your plan documents

Note: Always request confirmation of receipt when submitting renewal applications.

Critical Deadlines

  • Renewal submission: 60-90 days before expiration
  • Appeal deadline: 65 days from denial notice for Medicare Advantage
  • External review: 180 days from final internal denial in Washington

If Coverage Lapses: Bridge Options and Next Steps

Immediate Actions

If your Zanzalintinib coverage lapses:

  1. Contact Exelixis immediately to discuss compassionate use program continuation
  2. File expedited appeal with Humana citing urgent medical need
  3. Request bridge supply through the manufacturer's patient assistance program
  4. Consider temporary alternative therapy as recommended by your oncologist

Bridge Therapy Considerations

Since Zanzalintinib is investigational, traditional bridge therapy options are limited. Discuss these alternatives with your oncologist:

  • Similar approved TKIs (cabozantinib, lenvatinib) as temporary measures
  • Clinical trial enrollment in other investigational programs
  • Compassionate use programs for similar investigational agents

Escalation Steps

  1. Peer-to-peer review: Request direct physician consultation
  2. Expedited internal appeal with urgent clinical justification
  3. Washington external review through certified IRO
  4. State insurance commissioner complaint if procedural violations occur

Annual Changes: Formulary Updates to Monitor

Humana's Annual Process

Humana updates its formulary annually, with changes typically effective January 1. Key monitoring points:

Specialty Tier Changes: Investigational drugs may be moved to different coverage categories

Prior Authorization Updates: New requirements may be added for similar therapeutic classes

Coverage Criteria Changes: Medical necessity standards may be updated based on new clinical evidence

2025 Medicare Part D Changes

The elimination of the coverage gap in 2025 may indirectly benefit patients by reducing overall medication costs, though investigational drugs typically require separate coverage determination.

Proactive Monitoring

  • Review annual formulary notices from Humana
  • Check for updates to compassionate use program criteria
  • Monitor FDA approval status of Zanzalintinib
  • Track clinical trial results that may affect coverage policies

Personal Tracker: Organizing Your Renewal

Renewal Timeline Tracker

Create a simple tracking system with these key dates:

Date Action Item Status Notes
[90 days before] Start renewal preparation ☐ Gather recent records
[60 days before] Submit renewal application ☐ Confirm receipt
[30 days before] Follow up on decision ☐ Request expedited if needed
[Expiration date] Coverage ends if not renewed ☐ Have backup plan ready

Contact Information Log

Maintain current contact information for:

  • Humana customer service: Number on member ID card
  • Prescribing oncologist: Direct office line and after-hours contact
  • Exelixis compassionate use program: Program coordinator contact
  • Washington Insurance Commissioner: 1-800-562-6900

Appeals Playbook for Washington

Internal Appeals with Humana

Level 1 - Standard Appeal:

  • Deadline: 65 days from denial notice
  • Method: Online portal, phone, or written request
  • Timeline: Up to 30 days for decision
  • Required: Copy of denial letter, updated medical records, physician statement

Expedited Appeal:

  • When to use: If delay could seriously jeopardize health
  • Timeline: 72 hours for decision
  • Documentation: Physician attestation of urgency required

Washington External Review Process

If Humana denies your internal appeal, Washington's external review law (RCW 48.43.535) provides additional protection:

Process:

  1. Request external review within 180 days of final denial
  2. Independent Review Organization (IRO) assigns specialist reviewer
  3. IRO can override Humana's medical necessity determination
  4. Decision is binding on Humana

2025 Enhancement: Under Washington's new Specialist Care Access Act, oncology cases must be reviewed by practicing oncology specialists, ensuring peer-level expertise.

From our advocates: "We've seen Washington's external review process successfully overturn denials for investigational cancer drugs when the clinical documentation clearly showed no effective alternatives. The key is having your oncologist provide detailed evidence about why approved therapies failed and why the investigational drug represents the best remaining option. One case involved a patient whose insurer initially denied coverage for an investigational TKI, but the external reviewer—a practicing oncologist—understood the clinical rationale and ordered coverage within two weeks."

FAQ: Common Renewal Questions

Q: How long does Humana take to decide on Zanzalintinib renewal? A: Standard requests receive decisions within 72 hours, while expedited requests are decided within 24 hours if urgent medical need is documented.

Q: What if Zanzalintinib moves to a non-covered status? A: Since it's investigational, coverage depends on compassionate use program enrollment rather than formulary status. Focus on maintaining program eligibility and documenting continued medical necessity.

Q: Can I request an expedited renewal? A: Yes, if delay in coverage could seriously jeopardize your health. Your oncologist must provide written attestation of the urgent medical need.

Q: Does Washington's external review apply to investigational drugs? A: Yes, Washington's IRO process applies to all medical necessity disputes, including investigational treatments, with specialist reviewers evaluating the clinical evidence.

Q: What happens if the compassionate use program ends? A: Contact Exelixis immediately about transition options, explore clinical trial enrollment, and work with your oncologist to identify alternative approved therapies.

Q: How do I track my renewal application status? A: Use Humana's member portal or call customer service. Always request confirmation numbers for submitted applications and appeals.

About Counterforce Health

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex insurance appeals for prescription drugs. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with each payer's specific requirements. For investigational drugs like Zanzalintinib, we help identify the precise documentation needed to demonstrate medical necessity and guide families through the appeals process when coverage is denied.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan terms, and current policies. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with insurance appeals in Washington, contact the Washington State Insurance Commissioner at 1-800-562-6900.

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