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

If Zanzalintinib (XL092) Isn't Approved by UnitedHealthcare in California: Formulary Alternatives & Exception Paths

Answer Box: Getting Zanzalintinib (XL092) Covered by UnitedHealthcare in California

Zanzalintinib (XL092) is investigational and typically not covered by UnitedHealthcare outside clinical trials. Your fastest paths: 1) Request compassionate use through Exelixis (drug provided free), 2) Try covered multi-target TKI alternatives like cabozantinib or lenvatinib with prior authorization, or 3) Appeal using clinical trial data and medical necessity documentation. California's Independent Medical Review (IMR) provides external appeal rights, though experimental drug overturns are rare (10-50% success rate). Start by contacting your oncologist to explore covered alternatives or initiate compassionate use requests.

Table of Contents

When Alternatives Make Sense

Since Zanzalintinib (XL092) remains investigational with no FDA approval, UnitedHealthcare typically denies coverage outside clinical trials. However, several FDA-approved multi-target tyrosine kinase inhibitors (TKIs) offer similar mechanisms of action and may be appropriate alternatives depending on your specific cancer type and treatment history.

Coverage Criteria for Alternatives:

  • Must have FDA approval for your specific indication
  • Prior authorization required for all TKIs on UnitedHealthcare formulary
  • Step therapy may require trying preferred agents first
  • Documentation of diagnosis, staging, and prior treatment failures needed

When to Consider Alternatives:

  • Zanzalintinib denied as experimental/investigational
  • No available clinical trials in your area
  • Compassionate use application denied or pending
  • Need immediate treatment initiation

Typical UnitedHealthcare Formulary Alternatives

Based on UnitedHealthcare's 2025 formulary, these multi-target TKIs are typically covered with prior authorization:

Renal Cell Carcinoma (RCC)

Drug Formulary Tier Step Therapy Specialty Pharmacy Required
Cabozantinib (Cabometyx) Tier 3-4 Often required Yes
Lenvatinib (Lenvima) Tier 3-4 Often required Yes
Sunitinib (Sutent) Tier 3-4 May be preferred Yes
Axitinib (Inlyta) Tier 3-4 Often required Yes
Pazopanib (Votrient) Tier 3-4 May be preferred Yes

Hepatocellular Carcinoma (HCC)

Drug Formulary Tier Step Therapy Specialty Pharmacy Required
Sorafenib (Nexavar) Tier 3-4 Often preferred Yes
Lenvatinib (Lenvima) Tier 3-4 Often required Yes
Regorafenib (Stivarga) Tier 3-4 Often required Yes
Cabozantinib (Cabometyx) Tier 3-4 Often required Yes
Note: All TKIs require prior authorization and specialty pharmacy dispensing per UnitedHealthcare's July 2025 formulary updates.

Pros and Cons Overview

Approved TKI Alternatives

Pros:

  • FDA-approved with established efficacy data
  • Covered by insurance with prior authorization
  • Extensive safety monitoring protocols
  • Multiple dosing options available
  • Established drug interaction profiles

Cons:

  • May require step therapy (trying preferred agents first)
  • Higher out-of-pocket costs (Tier 3-4 medications)
  • Different side effect profiles than Zanzalintinib
  • May not target identical pathways as XL092

Compassionate Use Program

Pros:

  • Drug provided free by Exelixis
  • Access to cutting-edge therapy
  • Close monitoring by research team
  • May bridge to future FDA approval

Cons:

  • Limited availability and strict eligibility
  • Requires extensive documentation
  • Insurance won't cover ancillary costs
  • No guarantee of approval

Exception Strategy for Zanzalintinib

If you want to pursue Zanzalintinib coverage despite its investigational status, here's your strategy:

Step 1: Gather Supporting Evidence

  • Clinical trial data from Exelixis STELLAR program studies
  • Medical necessity letter from your oncologist explaining why approved alternatives are inadequate
  • Compendia listings (if any) supporting off-label or investigational use
  • Prior treatment history documenting failures or intolerances

Step 2: Request Step Therapy Exception

Contact OptumRx Prior Authorization at 1-800-711-4555 to request an exception if:

  • Approved alternatives are contraindicated
  • You've previously failed approved TKIs
  • Your oncologist documents expected superior efficacy

Step 3: Submit Prior Authorization Request

Include these documents:

  • Completed UnitedHealthcare prior authorization form
  • Detailed medical necessity letter
  • Clinical trial publications supporting efficacy
  • Pathology reports confirming diagnosis
  • Treatment history with outcomes
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to your plan's specific policies.

Switching Logistics

Coordinating with Your Care Team

Before Starting an Alternative:

  1. Oncologist consultation to review mechanism of action differences
  2. Pharmacy coordination for specialty medication delivery
  3. Insurance verification of prior authorization status
  4. Baseline testing as required by new drug protocol

Timeline Expectations:

  • Prior authorization: 5-15 business days
  • Specialty pharmacy setup: 3-7 business days
  • First dose delivery: 1-2 weeks after approval

Managing the Transition

From Zanzalintinib (if in compassionate use) to Alternative:

  • Coordinate timing with research team
  • Plan for washout period if required
  • Monitor for withdrawal effects
  • Adjust supportive care medications

From One TKI to Another:

  • Consider overlapping toxicities
  • Adjust dosing for prior side effects
  • Monitor drug interactions
  • Plan supportive care modifications

Re-trying for Zanzalintinib Later

Document Everything During Alternative Treatment

Clinical Response Data:

  • Imaging results and response assessments
  • Biomarker changes (if applicable)
  • Quality of life measurements
  • Toxicity profiles and management

Treatment Failures:

  • Progression documentation with dates
  • Dose modifications due to side effects
  • Treatment discontinuation reasons
  • Alternative therapy outcomes

When to Resubmit for Zanzalintinib

Stronger Cases Include:

  • Clear progression on approved alternatives
  • New clinical trial data supporting efficacy
  • FDA breakthrough therapy designation
  • Expanded access program availability

California Appeals Process

If UnitedHealthcare denies Zanzalintinib coverage, California offers robust appeal rights through the Department of Managed Health Care (DMHC).

Internal Appeals (Required First Step)

  • Timeline: Submit within 180 days of denial
  • Process: UnitedHealthcare internal review
  • Documentation: Medical records, clinical justification, supporting literature

Independent Medical Review (IMR)

After internal appeal denial, request IMR through DMHC:

  • Success rates: 10-13% overall for all denials; experimental drugs have lower success rates
  • Timeline: 30-45 days for standard review; 72 hours for urgent cases
  • Cost: Free to patients
  • Decision: Binding on UnitedHealthcare
Note: While IMR success rates for experimental drugs are low, strong clinical documentation and evidence of treatment failure with alternatives can improve chances.

Compassionate Use Program

Exelixis may provide Zanzalintinib through expanded access for patients who cannot access clinical trials.

Eligibility Requirements

  • Serious or life-threatening condition
  • No satisfactory alternative treatments
  • Ineligible for ongoing clinical trials
  • Potential benefits outweigh risks per treating physician

Application Process

  1. Physician initiates request through Exelixis Medical Affairs
  2. IRB approval required (even for single patients)
  3. FDA expanded access application submission
  4. Patient informed consent documentation

Insurance Coordination

  • Drug cost: Provided free by Exelixis
  • Related expenses: Office visits, labs, monitoring may be covered by insurance
  • Pre-authorization: May be required for supportive care services

From our advocates: One patient successfully obtained compassionate use access after their oncologist documented progression on three prior TKIs and provided detailed rationale for why Zanzalintinib's unique target profile offered the best remaining option. The key was comprehensive documentation of prior treatment failures and clear medical justification.

FAQ

How long does UnitedHealthcare prior authorization take for TKI alternatives? Typically 5-15 business days for standard review. Urgent cases may qualify for expedited 72-hour review if medically necessary.

What if my preferred alternative is non-formulary? Request a formulary exception with medical necessity documentation. UnitedHealthcare may approve non-formulary drugs with strong clinical justification.

Can I appeal to California if UnitedHealthcare denies my TKI alternative? Yes. California's IMR process provides external review rights. Success rates for medical necessity denials are higher than for experimental drugs.

Does step therapy apply if I failed TKIs outside California? Treatment history from any state typically counts toward step therapy requirements. Provide documentation of prior failures or intolerances.

How do I access Exelixis compassionate use program? Contact your oncologist to initiate the request through Exelixis Medical Affairs. The physician must submit the expanded access application.

What counts as medical necessity for investigational drugs? Generally requires documented failure of approved alternatives, contraindications to standard therapy, or unique clinical circumstances where the investigational drug offers superior benefit-risk profile.

Getting the right medication coverage can feel overwhelming, but you're not alone in this process. Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by analyzing your specific denial reasons and crafting evidence-backed responses that align with your insurer's own policies. Whether you're pursuing coverage for Zanzalintinib or navigating alternatives, having expert support can make the difference between approval and denial.

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 for specific coverage determinations. Coverage policies and formularies change frequently; verify current requirements with UnitedHealthcare directly.

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