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

Getting Zanzalintinib (XL092) Covered by Humana in Texas: Appeals Process and State Protections

Quick Answer: Getting Zanzalintinib (XL092) Covered by Humana in Texas

Zanzalintinib (XL092) is an investigational drug typically denied by Humana outside clinical trials. However, Texas law provides strong appeal rights for investigational treatments. Your fastest path: Request a formulary exception with clinical documentation, then if denied, file for Texas Independent Review Organization (IRO) external review within 4 months. Start by calling Humana at the number on your card to request prior authorization forms, then work with your oncologist to document medical necessity. Texas IRO decisions are binding and typically rendered within 20 days for standard cases, 3 days for urgent situations.

Table of Contents

Understanding Zanzalintinib and Coverage Challenges

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor (TKI) developed by Exelixis. Currently in multiple Phase 1, 2, and 3 clinical trials through the STELLAR program, this oral medication has no FDA approvals as of 2025.

Why Humana typically denies coverage:

  • No FDA approval for any indication
  • Classified as investigational/experimental
  • Limited to clinical trial access or potential compassionate use
  • No established list price or standard formulary placement

However, Texas provides unique protections for patients seeking investigational treatments when medically necessary, making appeals more likely to succeed than in many other states.

Texas State Rules That Help Your Case

Texas Insurance Code Chapter 1369 and the state's external review process create several advantages for patients seeking investigational drugs:

Medical Necessity Protections

Under Texas Insurance Code §1369.0546, insurers must grant step therapy overrides when:

  • Required alternatives are contraindicated
  • Standard drugs would cause adverse reactions
  • Prior therapies have failed
  • The required drug isn't FDA-approved for your condition

External Review Rights

Texas law mandates that denials based on medical necessity or experimental/investigational status can be reviewed by an Independent Review Organization (IRO). Key timelines:

  • Standard review: 20 days for decision
  • Expedited review: 3 days for urgent cases
  • Filing deadline: 4 months from final denial
  • Cost: Free to patients (insurer pays IRO fees)
Note: These protections apply to commercial plans regulated by Texas Department of Insurance. Medicare Advantage follows federal appeal rules, though similar external review options exist.

Humana's Prior Authorization Process

Humana requires formulary exceptions for non-covered drugs, including investigational medications. The process involves:

Documentation Requirements

  • Prescriber's supporting statement explaining medical necessity
  • Clinical rationale for why formulary alternatives won't work
  • Patient's medical history and prior treatment failures
  • Published medical literature supporting off-label or compassionate use

Decision Timeframes

  • Standard exception requests: 72 hours
  • Expedited requests: 24 hours
  • Appeal decisions: 65 days to file after denial

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documents

Who: Patient and clinic staff
What you need: Insurance card, diagnosis codes, prior treatment history, clinical notes
Timeline: 1-2 days

2. Request Prior Authorization Forms

Who: Patient or clinic
Action: Call Humana member services (number on your card) or access the provider portal
Timeline: Same day

3. Complete Medical Necessity Documentation

Who: Prescribing oncologist
Requirements:

  • Detailed clinical rationale
  • Documentation of failed standard therapies
  • Evidence supporting zanzalintinib for your specific cancer type
  • Reference to clinical trial data or compassionate use protocols Timeline: 3-5 days

4. Submit Initial Request

Who: Clinic staff
Method: Humana provider portal or fax (verify current number)
Timeline: 72 hours for standard decision

5. If Denied: File Internal Appeal

Who: Patient or authorized representative
Deadline: 65 days from denial notice
Method: Humana appeals portal or written request

6. If Still Denied: Texas IRO External Review

Who: Patient
Form: Texas IRO request form LHL009
Deadline: 4 months from final internal denial
Timeline: 20 days for decision (3 days if expedited)

Appeals Playbook for Humana in Texas

Internal Appeal Strategy

When filing your internal appeal, emphasize:

  • Medical necessity: Why zanzalintinib is essential for your specific situation
  • Failed alternatives: Document all standard TKIs tried and their outcomes
  • Clinical evidence: Reference peer-reviewed studies or FDA breakthrough therapy designations
  • Texas law compliance: Cite Insurance Code §1369.0546 if applicable

Required Documentation

  • Complete medical records showing diagnosis and staging
  • Documentation of prior therapy failures or contraindications
  • Prescriber letter detailing clinical rationale
  • Any relevant clinical trial protocols or compassionate use guidelines

When Standard Appeals Fail: Texas External Review

If Humana upholds their denial after internal appeal, Texas's Independent Review Organization process provides a final option.

Coverage at a Glance: Texas IRO Process

Requirement What it means Timeline Cost
Exhausted internal appeals Must complete Humana's process first 65 days max Free
IRO request form Use Texas form LHL009 Submit within 4 months Free
Medical documentation All clinical records supporting necessity Include with request Free
IRO decision Binding on both parties 20 days standard, 3 days expedited Insurer pays

Expedited Review Criteria

Request expedited review if delay would:

  • Seriously jeopardize your health
  • Compromise your ability to regain maximum function
  • Subject you to severe pain that can't be managed without the treatment

Common Denial Reasons and How to Counter Them

Denial Reason Counter-Strategy Documentation Needed
"Investigational/experimental" Cite medical necessity and lack of alternatives Clinical evidence, failed prior therapies
"Not FDA approved" Reference compassionate use protocols FDA guidance, clinical trial data
"Not medically necessary" Document specific clinical need Detailed physician letter, treatment history
"Formulary alternatives available" Prove alternatives failed or contraindicated Prior authorization denials, adverse reaction records

Scripts and Templates

Patient Phone Script for Humana

"Hello, I'm calling about prior authorization for zanzalintinib, also known as XL092, for [cancer type]. My doctor believes this investigational drug is medically necessary because [brief reason]. Can you please send me the formulary exception forms and tell me what documentation you'll need?"

Clinician Letter Template (Key Elements)

  • Patient demographics and diagnosis with ICD-10 codes
  • Detailed treatment history with specific drug names, dates, and outcomes
  • Clinical rationale for zanzalintinib based on mechanism of action
  • Reference to relevant clinical trial data or FDA guidance
  • Statement: "This request meets medical necessity criteria under Texas Insurance Code §1369.0546"

When to Escalate to State Regulators

If you believe Humana isn't following proper procedures, contact the Texas Department of Insurance:

TDI Consumer Help Line: 1-800-252-3439
Online complaint portal: File complaints and upload supporting documents
What to include: All denial letters, appeal responses, and correspondence with Humana

From our advocates: We've seen cases where patients successfully obtained coverage for investigational cancer drugs by combining strong clinical documentation with Texas's external review process. The key was having the oncologist clearly document why standard therapies failed and how the investigational drug addressed specific tumor characteristics. While outcomes aren't guaranteed, Texas's binding IRO process provides real leverage that many patients don't realize they have.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify the specific basis for denial, then drafts point-by-point rebuttals aligned to each payer's rules. For investigational drugs like zanzalintinib, we help clinicians and patients navigate the complex documentation requirements and appeal processes that can make the difference between coverage and denial.

FAQ

How long does Humana's prior authorization process take in Texas?
Standard formulary exception requests receive decisions within 72 hours. Expedited requests are decided within 24 hours. If denied, you have 65 days to file an internal appeal.

What if zanzalintinib isn't on Humana's formulary at all?
This is expected since it's investigational. You'll need to request a formulary exception with strong medical necessity documentation from your oncologist.

Can I request an expedited appeal if my cancer is progressing?
Yes. Both Humana's internal appeals and Texas IRO external review offer expedited timelines for urgent medical situations where delays could jeopardize your health.

Does step therapy apply to investigational drugs?
Typically no, but Humana may require documentation that you've tried and failed standard FDA-approved TKIs for your cancer type before approving an investigational alternative.

What happens if the Texas IRO approves coverage but Humana still refuses?
IRO decisions are legally binding. If Humana doesn't comply, contact the Texas Department of Insurance immediately at 1-800-252-3439 to file a complaint.

Are there any costs I should expect during this process?
The appeal processes are free, but you may need to pay for medical records or additional physician consultations to strengthen your case.

How do I know if my Humana plan is subject to Texas state laws?
Most individual and small group plans are regulated by Texas. Large employer self-funded plans follow federal ERISA rules instead, though they often have similar appeal processes.

What if I can't wait for the appeals process?
Ask your oncologist about clinical trial enrollment or contact Exelixis Medical Affairs to inquire about compassionate use programs.

Disclaimer: This information is for educational purposes and doesn't constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and specific plan terms. Always consult with your healthcare team and insurance representatives for guidance specific to your situation.

Sources & Further Reading

When navigating complex insurance appeals for investigational treatments, having expert support can make all the difference. Counterforce Health helps patients and clinicians build stronger cases by identifying the specific denial reasons and crafting targeted responses that speak directly to each insurer's policies and procedures.

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