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

Work With Your Doctor to Get Zanzalintinib (XL092) Approved by UnitedHealthcare in Virginia: Clinical Evidence, Appeals, and Expanded Access

Answer Box: Getting Started

Zanzalintinib (XL092) is investigational and typically requires expanded access through Exelixis rather than insurance coverage. However, if your oncologist believes insurance coverage for routine care costs is appropriate, here's your fastest path:

  1. Visit prep: Gather your complete treatment history, molecular testing results, and ECOG performance status
  2. Evidence kit: Help your doctor compile Phase I/II trial data supporting XL092 for your specific cancer type
  3. Submit request: Your oncologist files a medical necessity letter with UnitedHealthcare citing exhausted alternatives and clinical rationale

Start today: Schedule an appointment with your oncologist to discuss Exelixis expanded access eligibility and concurrent insurance coverage strategies.

Table of Contents

  1. Set Your Goal: Understanding Approval Requirements
  2. Visit Prep: What to Bring Your Doctor
  3. Evidence Kit: Building Your Clinical Case
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After-Visit Documentation
  7. Respectful Persistence: Following Up
  8. Virginia Appeals Process
  9. Expanded Access Through Exelixis
  10. FAQ

Set Your Goal: Understanding Approval Requirements

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor from Exelixis currently in Phase I-III trials. Since it's not FDA-approved, UnitedHealthcare typically won't cover the drug itself. However, your oncologist can pursue two parallel paths:

Path 1: Expanded Access Program

Exelixis offers compassionate use access for eligible patients who can't access clinical trials. The manufacturer typically provides the drug free, while insurance may cover routine care costs (office visits, labs, imaging, side effect management).

Path 2: Insurance Coverage for Routine Care

Even when the drug comes through expanded access, UnitedHealthcare can still be billed for:

  • Oncology visits and monitoring
  • Laboratory tests and imaging
  • Management of treatment-related side effects
  • Supportive care medications

Your partnership goal: Help your oncologist build a compelling case that demonstrates medical necessity for either approach, emphasizing exhausted standard options and strong clinical rationale.

Visit Prep: What to Bring Your Doctor

Come prepared with organized information that saves your oncologist time and strengthens your case.

Essential Documents

  • Insurance cards (primary and secondary)
  • Complete treatment timeline with dates, doses, responses, and reasons for stopping each therapy
  • Recent lab results and imaging reports
  • Pathology reports including molecular testing (NGS, biomarker panels)
  • Current symptoms log noting functional impact and ECOG performance status changes

Treatment History Summary

Create a simple table for your doctor:

Treatment Dates Best Response Reason Stopped Side Effects
[Regimen 1] MM/YY-MM/YY Partial response Progression Grade 2 nausea
[Regimen 2] MM/YY-MM/YY Stable disease Intolerance Grade 3 neuropathy

Current Status Notes

Document:

  • Functional changes: Can you work? Exercise? Perform daily activities?
  • Symptom progression: Pain levels, fatigue, appetite changes
  • Performance status: How much time do you spend in bed during waking hours?
  • Urgent concerns: Any symptoms requiring immediate attention
Tip: Use your patient portal to message these details to your oncologist 24-48 hours before your appointment so they can review in advance.

Evidence Kit: Building Your Clinical Case

Your oncologist needs specific evidence to justify XL092 use. Here's how you can help them gather it.

Clinical Trial Data

Research and print key studies showing XL092 efficacy in your cancer type:

  • STELLAR program trials (verify current status at ClinicalTrials.gov)
  • Phase I/II data in similar tumor types or biomarker profiles
  • Mechanism of action studies showing relevant target inhibition

Guideline Support

Help locate references to multi-target TKIs in:

  • NCCN Guidelines for your specific cancer type
  • ASCO/ESMO recommendations for refractory disease
  • Specialty society guidance (e.g., lung, kidney, liver cancer societies)

Biomarker Documentation

Ensure your molecular testing results clearly show:

  • Targetable alterations (VEGFR, FGFR, RET pathways)
  • Resistance patterns to prior targeted therapies
  • Tumor mutational burden or other relevant markers
Note: Even if guidelines don't specifically mention XL092, they may support the therapeutic approach or class of drugs, which strengthens your case.

Medical Necessity Letter Structure

A strong letter of medical necessity follows this evidence-based template that addresses UnitedHealthcare's coverage criteria:

Header Section

[Practice letterhead]
[Date]
UnitedHealthcare Medical Director
[Member name, DOB, ID number]
Request: Authorization for Zanzalintinib (XL092) - Investigational Multi-Target TKI
Diagnosis: [Cancer type, stage] - ICD-10: [code]

Clinical Summary (2-3 paragraphs)

  • Diagnosis details: Cancer type, stage, molecular profile, sites of disease
  • Treatment history: Each prior therapy with dates, responses, toxicities
  • Current status: Disease progression, performance status, functional decline

Medical Necessity Rationale

Your doctor should address:

  1. Exhausted alternatives: "All NCCN-recommended therapies have been tried and failed/are contraindicated"
  2. Biological rationale: "XL092 targets [specific pathways] activated in this patient's tumor"
  3. Clinical evidence: "Phase I/II trials show [response rates] in heavily pretreated patients"
  4. Risk of delay: "Progressive disease threatens [organ function/performance status]"

Supporting Documentation Checklist

  • Recent clinic notes and imaging reports
  • Molecular testing results
  • Treatment timeline with outcomes
  • Relevant clinical trial publications
  • NCCN guideline sections (if applicable)

Counterforce Health specializes in turning insurance denials into evidence-backed appeals. Their platform helps clinicians identify the specific denial basis and draft targeted rebuttals aligned to each plan's coverage criteria, significantly improving approval rates for complex oncology cases like investigational drug requests.

Peer-to-Peer Review Support

If UnitedHealthcare requests a peer-to-peer (P2P) review, you can support your oncologist's preparation.

Before the Call

Help your doctor prepare a 10-minute summary covering:

  • Patient's cancer journey in 2 minutes
  • Why XL092 is the best next option (3 minutes)
  • Clinical trial evidence supporting use (3 minutes)
  • Risks of denial vs. benefits of approval (2 minutes)

Key Talking Points to Discuss

  • "Standard therapies exhausted with documented progression/intolerance"
  • "XL092 targets [biomarker] confirmed by [test name, date]"
  • "Phase [I/II] data shows [X]% response rate in similar patients"
  • "Delay risks [specific clinical consequences]"

Your Role

  • Provide availability windows when you can be reached for additional questions
  • Prepare a one-page summary of your treatment journey
  • Stay accessible during business hours in case the reviewer needs clarification
From our advocates: "One patient helped their oncologist prepare for a P2P by creating a simple timeline showing how each treatment failed and why XL092's mechanism addressed their specific resistance pattern. The reviewer appreciated the clear documentation and approved the request the same day."

After-Visit Documentation

Maintain organized records that support ongoing approval efforts and potential appeals.

Save Everything

  • Visit summaries with treatment plans and rationale
  • Portal messages discussing your case
  • Lab and imaging results showing disease status
  • Side effect reports documenting tolerability issues
  • Insurance correspondence including denials and approvals

Communication Strategy

Use your patient portal effectively:

  • Message key updates (new symptoms, side effects, functional changes)
  • Ask specific questions rather than general "how am I doing?"
  • Request copies of letters sent to insurance
  • Confirm next steps after each interaction

Documentation for Appeals

Keep a chronological file including:

  • Original prior authorization request
  • Insurance denial letter with specific reasons
  • All supporting clinical documentation
  • Correspondence between your doctor and UnitedHealthcare

Respectful Persistence: Following Up

Effective follow-up requires balance between advocacy and professionalism.

Timing Your Outreach

  • Week 1: Confirm submission and expected timeline
  • Week 2: Check status if no response received
  • Week 3: Request update and discuss next steps
  • Month 1+: Escalate to appeals process if needed

Professional Communication

When messaging your oncologist's office:

  • Be specific: "Checking on XL092 prior authorization submitted [date]"
  • Offer help: "Happy to provide additional information if needed"
  • Stay solution-focused: "What can I do to move this forward?"
  • Express appreciation: "Thank you for your advocacy on my behalf"

When to Escalate

Consider escalation if:

  • No response after 30 days
  • Denial without clear clinical rationale
  • Request for information you've already provided
  • Delays that risk disease progression

Virginia Appeals Process

Virginia provides strong consumer protections for insurance denials, including experimental treatment appeals.

Internal Appeals (Required First Step)

  • Timeline: 180 days from denial to file internal appeal
  • Process: Submit written appeal to UnitedHealthcare with supporting documentation
  • Decision timeframe: 30 days for pre-service, 60 days for post-service

External Review Through Virginia Bureau of Insurance

After internal appeals are exhausted:

Expedited Review Criteria

Request expedited external review if delay would:

  • Seriously jeopardize your life or health
  • Threaten your ability to regain maximum function
  • Leave you in an inpatient facility

Contact Information

  • Virginia Bureau of Insurance Consumer Services: 1-877-310-6560
  • Managed Care Ombudsman: Available through same number for additional support
Note: Virginia allows expedited external review for cancer treatment denials without exhausting internal appeals in certain circumstances, reflecting the state's commitment to timely care.

Expanded Access Through Exelixis

Since XL092 is investigational, expanded access may be more practical than insurance coverage.

Eligibility Criteria

Exelixis typically requires:

  • Life-threatening cancer with no curative options
  • Exhausted standard treatments or documented contraindications
  • Clinical trial ineligibility due to geography, enrollment, or medical factors
  • ECOG performance status 0-2
  • Treating oncologist assessment that benefits outweigh risks

Application Process

Your oncologist must:

  1. Contact Exelixis Medical Affairs to confirm program availability
  2. Prepare clinical documentation (diagnosis, treatment history, current status)
  3. Obtain IRB approval for single-patient use
  4. Submit FDA Form 3926 for expanded access IND
  5. Coordinate drug supply and monitoring plan

Timeline and Costs

  • Standard processing: 2-4 weeks from initial request
  • Emergency processing: May be expedited for urgent cases
  • Drug cost: Typically provided free by Exelixis
  • Routine care costs: May be covered by insurance with proper documentation

Counterforce Health's platform can help identify which routine care costs are most likely to be covered by UnitedHealthcare during expanded access treatment, maximizing your insurance benefits while accessing investigational therapy.

FAQ

How long does UnitedHealthcare prior authorization take in Virginia? Standard prior authorization typically takes 15-30 days. Urgent requests may be processed within 72 hours if clinical urgency is documented.

What if XL092 is considered experimental by UnitedHealthcare? Most investigational drugs are excluded from standard coverage. Focus on expanded access programs and insurance coverage for routine care costs during treatment.

Can I request expedited review if my cancer is progressing rapidly? Yes. Your oncologist can request urgent prior authorization and, if denied, expedited internal appeals and external review through Virginia's process.

Does UnitedHealthcare's step therapy apply to investigational drugs? Step therapy typically applies to approved drugs. For investigational agents, the focus is on medical necessity and exhausted alternatives.

What documentation strengthens my case? Comprehensive treatment history, molecular testing results, clinical trial data supporting XL092's mechanism, and clear documentation of why standard options are inadequate.

How much will this cost me? Through expanded access, the drug is typically free. Insurance may cover routine care costs. Out-of-pocket expenses usually include copays for visits and standard supportive care.

What if my employer plan is self-funded? Self-funded ERISA plans may opt into Virginia's external review process. Check your plan documents or contact the Virginia Bureau of Insurance for guidance.

Can I appeal if expanded access is denied? Expanded access denials are typically sponsor decisions and not appealable through insurance. However, you can appeal insurance denials for routine care costs during expanded access treatment.

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 plan documents for guidance specific to your situation. Coverage decisions depend on individual plan terms and clinical circumstances.

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