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

The Requirements Checklist to Get Zanzalintinib (XL092) Covered by Humana in Georgia: Clinical Trials, Appeals, and Compassionate Use Pathways

Answer Box: Getting Zanzalintinib (XL092) Coverage in Georgia

Zanzalintinib (XL092) is investigational with no FDA approval, making standard Humana coverage unlikely. Your fastest path: 1) Check eligibility for active clinical trials (drug provided free), 2) Contact Exelixis Medical Affairs for compassionate use if trial-ineligible, or 3) Submit prior authorization with robust medical necessity documentation citing STELLAR trial data. First step today: Call your oncologist to discuss trial screening and gather complete treatment history for any coverage request. Georgia residents have 60 days for external appeals through the Georgia Department of Insurance if denied.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Coverage
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Clinical Trial Access
  8. After Submission: Tracking Your Request
  9. Appeals Playbook for Georgia
  10. Denial Prevention Tips
  11. FAQ

Who Should Use This Guide

This checklist helps Georgia patients and their care teams navigate coverage requests for Zanzalintinib (XL092), an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Currently in Phase 1-3 trials through the STELLAR program, this oral TKI has no FDA approvals as of 2025.

Expected scenarios:

  • Advanced solid tumors after standard therapy failure
  • Compassionate use requests for trial-ineligible patients
  • Appeals of initial Humana denials
  • Clinical trial cost coverage (routine care only)

Realistic outcomes: Standard formulary coverage is extremely unlikely due to investigational status. Success typically comes through clinical trial enrollment (drug provided free) or manufacturer compassionate use programs rather than insurance approval.

Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying denial basis and crafting point-by-point rebuttals aligned to plan policies.

Member & Plan Basics

Verify Active Humana Coverage

Check these details first:

  • Member ID and plan type (Medicare Advantage, Part D, commercial)
  • Current deductible status and specialty tier cost-sharing
  • Prior authorization requirements via Humana's PA Search Tool

Plan-Specific Requirements

Plan Type PA Process Timeline Appeals Deadline
Medicare Advantage Medical PA via Availity or fax 14 days standard, 72 hours expedited 65 days from denial
Part D Coverage determination form 72 hours standard, 24 hours expedited 65 days from denial
Commercial Provider portal or fax Varies by plan 180 days internal, 60 days external

Clinical Criteria for Coverage

Medical Necessity Standards

For investigational drug requests, Humana requires demonstration that:

  1. All FDA-approved alternatives have failed or are contraindicated
  2. Patient has life-threatening condition with poor prognosis
  3. Potential benefit outweighs risks based on available data
  4. Use aligns with current clinical evidence or guidelines

Documentation Requirements

Essential clinical elements:

  • Cancer type, stage, and molecular markers
  • Complete treatment history with dates, doses, duration, and reason for discontinuation
  • Current performance status (ECOG 0-2 typically required)
  • Recent labs showing adequate organ function
  • Prognosis and treatment goals
Clinician Corner: Include STELLAR trial data in your medical necessity letter, noting that while STELLAR-303 did not meet its primary overall survival endpoint, subset analyses may support use in specific patient populations.

Coding Requirements

ICD-10 Diagnosis Codes

Primary malignancy codes (examples):

  • C78.xx - Secondary malignant neoplasm of other sites
  • C80.1 - Malignant neoplasm, unspecified
  • Z51.11 - Encounter for antineoplastic chemotherapy

Supporting codes:

  • Z00.6 - Encounter for examination for normal comparison and control in clinical research program (for trial patients)
  • Z87.891 - Personal history of nicotine dependence (if relevant)

HCPCS/Billing Considerations

No specific J-code exists for Zanzalintinib. If billing is attempted:

  • J3490 - Unclassified drugs (oral)
  • J9999 - Not otherwise classified, antineoplastic drugs
Important: Most investigational drugs are sponsor-provided and not billable to insurance. Verify with trial protocol before attempting to bill.

Documentation Packet

Medical Necessity Letter Components

Required elements for strongest appeal:

  1. Patient identification - Name, DOB, Member ID, diagnosis with ICD-10
  2. Clinical status - Stage, performance status, comorbidities affecting treatment selection
  3. Treatment history - All prior therapies with specific dates, doses, response, and reason for discontinuation
  4. Rationale for Zanzalintinib - Mechanism of action, STELLAR trial data, potential benefit in this patient
  5. Alternative assessment - Why approved options are inappropriate or exhausted
  6. Monitoring plan - Safety assessments, efficacy measures, duration

Supporting Documents Checklist

  • Complete oncology notes from last 3 months
  • Pathology reports with molecular testing
  • Recent imaging (within 30 days)
  • Laboratory results showing organ function
  • Prior authorization denials for other agents
  • Clinical trial screening results (if applicable)

Submission Process

Humana Submission Channels

For Medicare Advantage (Part B drugs):

  • Preferred: Availity portal for electronic PA
  • Alternative: Fax medical PA forms (verify current fax with plan)
  • Phone: Provider services number on member ID card

For Part D (oral drugs):

  • Electronic: CoverMyMeds platform
  • Fax: Request for Medicare Prescription Drug Coverage Determination to 877-486-2621
  • Member portal: Humana member website for patient-initiated requests

Required Fields That Cause Rejections

Common missing elements:

  • Incomplete member identification (missing plan year or product type)
  • Vague diagnosis coding (use most specific ICD-10 available)
  • Insufficient prior therapy documentation (need dates and outcomes)
  • Missing prescriber NPI or specialty designation
  • Unclear dosing or duration request

Clinical Trial Access

Active Zanzalintinib Trials

Check ClinicalTrials.gov for:

  • NCT06191796 - STELLAR-303 (Phase 3)
  • NCT06863311 - Combination studies
  • NCT06571734 - Biomarker-selected populations

Eligibility typically requires:

  • ECOG performance status 0-2
  • Adequate organ function (labs within 14-30 days)
  • Measurable disease by RECIST 1.1
  • Specific prior therapy requirements by trial

Trial Cost Coverage

Medicare covers routine trial costs including:

  • Office visits and consultations
  • Laboratory tests and imaging
  • Supportive care medications
  • Not covered: The investigational drug itself (sponsor-provided)

Use ICD-10 Z00.6 and appropriate modifiers (Q0/Q1) for trial-related billing.

After Submission: Tracking Your Request

Timeline Expectations

Request Type Standard Decision Expedited Decision What to Track
Medicare Advantage PA 14 days 72 hours Confirmation number, reviewer contact
Part D Coverage Determination 72 hours 24 hours Case number, submission date
Commercial PA Plan-specific 72 hours urgent Authorization number if approved

Status Monitoring

Weekly check protocol:

  1. Call provider services with confirmation number
  2. Document all interactions (date, representative name, status)
  3. Request written confirmation of any verbal approvals
  4. Escalate if deadlines are missed

Appeals Playbook for Georgia

Internal Appeals Process

Humana internal appeal requirements:

  • Submit within 65 days of denial notice
  • Include additional clinical evidence
  • Request peer-to-peer review if available
  • Consider expedited appeal for urgent situations

Georgia External Review

When internal appeals fail:

  1. Timeline: Must file within 60 days of final internal denial (verify exact deadline in your denial letter)
  2. Process: Submit application to Georgia Office of Commissioner of Insurance
  3. Cost: Free to consumer
  4. Decision: Binding on insurer, typically within 30 days (72 hours if expedited)

Required documentation:

  • Copy of all denial letters
  • Medical records supporting necessity
  • Independent medical review if available
  • Completed external review application

When to Contact Georgia DOI

File a consumer complaint if:

  • Humana misses decision deadlines
  • Denial reasons are unclear or inconsistent
  • External review decision is ignored
  • Contact: 1-800-656-2298 or online complaint form

Denial Prevention Tips

Five Common Pitfalls and Solutions

  1. Insufficient prior therapy documentation
    • Solution: Include complete treatment grid with dates, doses, duration, and specific reason for discontinuation
  2. Missing investigational use justification
    • Solution: Cite STELLAR trial data and explain why patient profile matches study population
  3. Vague medical necessity language
    • Solution: Use specific clinical criteria language from Humana policies when possible
  4. Wrong submission channel
    • Solution: Verify Part B vs. Part D coverage and use appropriate forms/portals
  5. Inadequate urgency documentation
    • Solution: Include physician statement that delay would "seriously jeopardize life, health, or ability to regain maximum function"

FAQ

How long does Humana prior authorization take for investigational drugs? Standard timeframes apply: 14 days for Medicare Advantage, 72 hours for Part D. However, expect longer review times due to investigational status requiring additional medical director review.

What if Zanzalintinib is not on Humana's formulary? It won't be, as it's investigational. You'll need to request a formulary exception with robust medical necessity documentation showing all approved alternatives have failed.

Can I request an expedited appeal in Georgia? Yes, if delay would seriously jeopardize your health. Both Humana internal appeals and Georgia external review offer expedited options with 72-hour decision timeframes.

Does Humana cover clinical trial costs? Medicare Advantage plans must cover routine costs in qualifying clinical trials, but not the investigational drug itself. Submit trial-related services with appropriate modifiers and diagnosis codes.

What's the difference between compassionate use and clinical trials? Clinical trials are research studies with specific eligibility criteria. Compassionate use (expanded access) provides investigational drugs to patients who can't enroll in trials, typically requiring FDA approval and manufacturer agreement.

How does Counterforce Health help with appeals? The platform analyzes denial letters and plan policies to draft targeted appeals with evidence-backed rebuttals, helping patients, clinicians, and specialty pharmacies turn denials into approvals through systematic documentation.

Sources & Further Reading

Disclaimer: This guide provides educational information only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and clinical factors. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional support with insurance appeals and coverage determination, consider consulting with patient advocacy organizations or legal resources in Georgia.

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