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

Getting Zanzalintinib (XL092) Covered by UnitedHealthcare in Pennsylvania: Clinical Trial Access and Compassionate Use Appeals Guide

Answer Box: Your Fastest Path to Zanzalintinib Coverage

Getting Zanzalintinib (XL092) covered by UnitedHealthcare in Pennsylvania requires clinical trial enrollment or compassionate use approval, since this investigational TKI has no FDA approval. Your three options: (1) Enroll in an active STELLAR program trial where UnitedHealthcare covers routine monitoring costs, (2) Apply for Exelixis's compassionate use program (drug provided free, insurance covers supportive care), or (3) Appeal a denial with strong medical necessity documentation. Start today: Contact your oncologist to check ClinicalTrials.gov for XL092 studies or reach out to Exelixis Medical Affairs for expanded access eligibility.

Table of Contents

UnitedHealthcare's Coverage Policy Overview

UnitedHealthcare classifies Zanzalintinib (XL092) as experimental and investigational, meaning the drug itself is not covered outside specific clinical trial exceptions. However, this doesn't mean you're out of options.

What UnitedHealthcare Will Cover

Plan Type Clinical Trial Coverage What's Included What's Excluded
Commercial/Exchange Phase I-IV trials for cancer/life-threatening conditions with IRB approval Routine monitoring, lab tests, imaging for complications, standard care visits The investigational drug itself, non-routine administration costs
Medicare Advantage CMS-approved trials per NCD 310.1 Routine patient costs, complication management Experimental devices (Category A), non-approved trials
Medicaid Phase I-IV for cancer/life-threatening conditions Standard monitoring, prevention of complications Items solely for investigational purposes
Note: UnitedHealthcare requires prior authorization for services in clinical trials. Submit via the UHC provider portal with trial protocol, IRB approval, and member eligibility documentation.

Clinical Trial Coverage: What UnitedHealthcare Pays For

The key to getting coverage is understanding that while UnitedHealthcare won't pay for Zanzalintinib itself, they will cover the routine medical care you need while on the trial.

Covered Services in STELLAR Program Trials

  • Monitoring visits and oncology consultations
  • Laboratory tests (CBC, comprehensive metabolic panel, liver function)
  • Imaging studies (CT scans, MRIs for disease assessment)
  • Management of side effects and complications
  • Supportive care medications (anti-nausea, infection prevention)

Required Documentation for Trial Coverage

Your oncologist must submit a prior authorization request including:

  • Complete trial protocol and IRB approval letter
  • Documentation of your eligibility per protocol criteria
  • Confirmation that the trial meets UnitedHealthcare's qualifying criteria
  • Expected duration and monitoring schedule
Tip: Use the UnitedHealthcare provider portal at UHCprovider.com for PA submissions and status tracking.

Compassionate Use Program Through Exelixis

If you're not eligible for clinical trials, Exelixis offers Zanzalintinib through their expanded access program for patients with life-threatening cancers who have exhausted standard treatments.

Eligibility Requirements

  • Life-threatening or seriously debilitating cancer with no curative options
  • Failed or unable to tolerate standard FDA-approved therapies
  • ECOG performance status 0-2 (able to care for yourself)
  • Adequate organ function confirmed by recent lab work
  • No suitable clinical trials available for your condition
  • Treating oncologist confirms potential benefit outweighs risks

Documentation Package for Compassionate Use

Your oncologist will need to compile:

  • Complete treatment history with dates, outcomes, and reasons for discontinuation
  • Pathology reports and molecular testing results
  • Recent imaging and staging information
  • Laboratory results within 30 days (CBC, metabolic panel, organ function)
  • FDA Form 3926 for Individual Patient Expanded Access IND
  • Informed consent and expedited IRB approval
From our advocates: We've seen patients successfully obtain compassionate use approval within 3-4 weeks when their oncologist proactively gathers all documentation upfront and emphasizes the urgency in their medical necessity letter. The key is demonstrating that approved alternatives have been tried and failed, with clear documentation of each attempt.

Step-by-Step: Fastest Path to Coverage

Option 1: Clinical Trial Route (Preferred)

  1. Search active trials at ClinicalTrials.gov using "XL092" or "Zanzalintinib"
  2. Contact trial sites to discuss eligibility and enrollment timeline
  3. Submit PA request to UnitedHealthcare for routine care coverage
  4. Enroll and begin treatment with covered supportive services

Option 2: Compassionate Use Program

  1. Contact Exelixis Medical Affairs to discuss eligibility and drug availability
  2. Compile documentation package with your oncologist (Week 1-2)
  3. Submit FDA Form 3926 and obtain IRB approval (Week 2-3)
  4. Receive drug approval and shipment from Exelixis (Week 3-4)
  5. Request PA from UnitedHealthcare for monitoring and supportive care costs

Option 3: Direct Appeal Route

  1. Obtain formal denial letter from UnitedHealthcare
  2. Gather medical necessity evidence (treatment history, peer-reviewed studies)
  3. Submit internal appeal within UnitedHealthcare's deadline
  4. Escalate to external review through Pennsylvania if denied

Appeals Playbook for Pennsylvania

Pennsylvania's strengthened external review system gives you powerful options when UnitedHealthcare denies coverage.

Internal Appeals Timeline

  • Level 1 Appeal: Submit within 180 days of denial
  • Standard review: 15 days for non-urgent cases
  • Expedited review: 72 hours for urgent medical situations
  • Level 2 Appeal: Available if Level 1 is denied

Pennsylvania External Review Process

After exhausting internal appeals, you can request an Independent External Review through the Pennsylvania Insurance Department:

Timeline Action Required Notes
Within 4 months Request external review after final denial Use PA Insurance Department online portal
Within 1 business day PID forwards to UnitedHealthcare for eligibility Automatic process
Within 15 days Submit additional supporting evidence Critical window for new documentation
Within 45 days Independent review organization issues decision About 50% of appeals are approved
Key advantage: Pennsylvania's external review program has overturned approximately 50% of insurance denials in its first year, making it a powerful tool for complex cases like investigational drugs.

Medical Necessity Documentation Requirements

When appealing to UnitedHealthcare or preparing for external review, your medical necessity letter should include:

Clinical Justification Checklist

  • Diagnosis with ICD-10 codes and staging information
  • Complete prior treatment history with specific drugs, doses, duration, and outcomes
  • Documentation of treatment failures including progression dates and imaging
  • Contraindications or intolerances to approved alternatives
  • Current performance status and prognosis without treatment
  • Peer-reviewed evidence supporting Zanzalintinib's efficacy in your cancer type

Supporting Evidence to Include

  • Chart notes documenting diagnosis and treatment timeline
  • Pathology reports and molecular testing (if relevant to Zanzalintinib's targets)
  • Recent imaging showing disease progression
  • Laboratory results confirming adequate organ function
  • Literature citations from PubMed supporting off-label or investigational use

Common Denial Reasons & How to Fix Them

Denial Reason UnitedHealthcare's Concern How to Address
"Experimental/Investigational" Drug lacks FDA approval Cite compassionate use approval, peer-reviewed efficacy data, and medical necessity
"Not medically necessary" Insufficient clinical justification Document failed standard therapies, contraindications, and expected benefit
"Alternative treatments available" Step therapy not completed Provide detailed history of tried/failed alternatives with specific outcomes
"Insufficient documentation" Missing clinical evidence Submit complete treatment records, recent labs/imaging, and literature support

Counterforce Health's Evidence-Based Approach

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted rebuttals. For investigational drugs like Zanzalintinib, their platform helps gather the right clinical evidence—from FDA guidance to peer-reviewed studies—and weaves them into appeals that address payers' specific concerns about experimental treatments.

Costs and Financial Assistance Options

If You Gain Coverage

  • Clinical trials: Zanzalintinib provided free; UnitedHealthcare covers routine care
  • Compassionate use: Drug free from Exelixis; insurance covers monitoring
  • Approved appeal: Standard copay/coinsurance applies to covered services

Financial Assistance Resources

  • Exelixis Patient Support: Contact for expanded access program enrollment
  • Clinical trial support: Many STELLAR program sites provide travel assistance
  • Pennsylvania resources: Contact the Pennsylvania Insurance Department for consumer assistance

When to Escalate: Pennsylvania External Review

If UnitedHealthcare denies your internal appeals, Pennsylvania's external review offers strong consumer protections:

When to Use External Review

  • UnitedHealthcare has issued a Final Adverse Benefit Determination
  • You have strong medical evidence supporting necessity
  • The case involves medical necessity or experimental treatment disputes
  • Standard timeline allows for 4 months from final denial

How to Submit

  1. Online portal: Visit pa.gov and search "external review"
  2. Required documents: Final denial letter, insurance card, medical records
  3. Additional evidence: Submit within 15 days of IRO assignment
  4. Decision timeline: 45 days for standard cases, 72 hours for urgent
Success rate: Pennsylvania's external review program has overturned approximately 50% of insurance denials, making it particularly valuable for complex investigational drug cases.

FAQ: Your Most Common Questions

Q: How long does UnitedHealthcare prior authorization take for clinical trial coverage? A: Standard PA decisions are made within 72 hours, expedited reviews within 24 hours for urgent cases.

Q: Can I get Zanzalintinib covered if I live in Pennsylvania but get care out-of-state? A: Yes, if you're enrolled in a qualifying clinical trial or have compassionate use approval. UnitedHealthcare covers routine care costs regardless of location for approved programs.

Q: What if Zanzalintinib becomes FDA-approved while I'm appealing? A: FDA approval would significantly strengthen your case. Counterforce Health can help update your appeal with new regulatory status and coverage arguments.

Q: Does step therapy apply to investigational drugs? A: UnitedHealthcare's step therapy requirements focus on approved alternatives. For investigational drugs, the focus shifts to whether standard treatments have been tried and failed.

Q: Can I request an expedited appeal for Zanzalintinib? A: Yes, if your condition is life-threatening or rapidly progressing. Your oncologist must provide documentation supporting the urgent medical need.

Q: What happens if the STELLAR program ends while I'm on treatment? A: Contact Exelixis Medical Affairs immediately about continuation options, including potential compassionate use transition.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies may vary by plan type and individual circumstances.

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