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

How to Get Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in Virginia: Clinical Trial Access and Compassionate Use Guide

Answer Box: Getting Zanzalintinib (XL092) Coverage in Virginia

Zanzalintinib (XL092) is not FDA-approved and typically isn't covered by Blue Cross Blue Shield Virginia outside clinical trials. Your fastest path: 1) Check ClinicalTrials.gov for ongoing STELLAR program studies, 2) Contact Exelixis directly about compassionate use programs, and 3) If denied, file an expedited external review with Virginia's Bureau of Insurance within 72 hours for urgent cases. Start by calling your Blue Cross Blue Shield member services number to confirm your plan's investigational drug policy.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Alternative Options
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network
  5. Cost-Share Dynamics
  6. Submission Process
  7. Appeals Process in Virginia
  8. Clinical Trial Access
  9. Compassionate Use Programs
  10. FAQ

Plan Types & Coverage Implications

Blue Cross Blue Shield Virginia (Anthem) offers several plan types that affect how investigational drugs like zanzalintinib are handled:

Commercial Plans: Include Essential Drug List, National Drug List, and Select Drug Lists for marketplace plans. Anthem's formularies are maintained by independent committees of practicing physicians and pharmacists who evaluate medications based on efficacy, patient value, and safety.

Medicaid Plans: Virginia Medicaid members have access to specialty pharmacy services through BioPlus Specialty Pharmacy, though investigational drugs typically require special approval processes.

Key Network Considerations:

  • HMO plans may require referrals for specialty oncology care
  • PPO plans offer more flexibility in choosing specialists
  • All plans require FDA approval for standard formulary coverage
Note: Investigational drugs fall outside standard formulary coverage regardless of plan type, requiring alternative access pathways.

Formulary Status & Alternative Options

Current Status: Zanzalintinib (XL092) is not on any Blue Cross Blue Shield Virginia formulary as it lacks FDA approval. The drug is currently in Phase 1/2/3 clinical trials through Exelixis's STELLAR program.

FDA-Approved Alternatives by tumor type:

  • Renal Cell Carcinoma: Cabozantinib, lenvatinib, nivolumab combinations
  • Thyroid Cancer: Lenvatinib, sorafenib, cabozantinib
  • Other Solid Tumors: Per NCCN guidelines based on specific diagnosis

Exception Pathways: Members can request formulary exceptions through their prescriber, though success rates for investigational drugs are typically low without clinical trial enrollment or compassionate use approval.

Prior Authorization Requirements

Standard Process: While zanzalintinib isn't formulary-listed, any coverage request would require extensive prior authorization documentation:

Required Elements:

  • Detailed diagnosis with ICD-10 codes
  • Documentation of failed FDA-approved therapies
  • Medical necessity justification
  • Clinical trial eligibility assessment
  • Contraindications to approved alternatives

Timeline: Anthem reviews PA requests within 24 hours for urgent cases, with 72-hour emergency supplies available during review.

Clinician Corner: Medical necessity letters should reference peer-reviewed literature supporting zanzalintinib's mechanism of action for the specific tumor type, document exhaustion of approved TKI options, and include detailed treatment goals with monitoring plans.

Specialty Pharmacy Network

In-Network Partners for investigational drug dispensing include:

Process: If coverage is approved, prescriptions must be routed through network specialty pharmacies. Patients typically need enrollment calls to set up delivery and monitoring services.

Limitations: Most specialty pharmacies cannot dispense truly investigational drugs without specific manufacturer partnerships or clinical trial protocols.

Cost-Share Dynamics

If Covered: Specialty tier medications typically have higher cost-sharing:

  • Deductible applies first
  • Coinsurance often 20-40% after deductible
  • Annual out-of-pocket maximums provide protection

Reality Check: Since zanzalintinib isn't commercially available, traditional cost-sharing doesn't apply. Clinical trial participants typically receive drug at no cost; compassionate use programs may involve manufacturer assistance.

Submission Process

For Coverage Requests:

  1. Provider initiates: Call Provider Services at number on member ID card
  2. Documentation: Submit via Anthem provider portal (verify current link)
  3. Required forms: Standard PA forms plus investigational drug justification
  4. Timeline: 24-72 hours for initial determination

Key Fields:

  • Member ID and plan details
  • Prescriber NPI and contact information
  • Detailed clinical rationale
  • Alternative therapy documentation

Appeals Process in Virginia

Internal Appeals: Start with Anthem's internal review process

  • Timeline: 72 hours for expedited cases
  • Required: Written appeal with supporting documentation
  • Contact: Member services number on ID card

External Review: Virginia's Bureau of Insurance provides independent review

How to File:

  1. Complete Form 216-A (External Review Request)
  2. Submit to Virginia Bureau of Insurance
  3. Include all medical records and denial letters
  4. Contact: 1-877-310-6560 for guidance
Virginia Advantage: The state allows expedited external review for cancer treatment denials without exhausting internal appeals in certain cases.

Clinical Trial Access

Active Studies: Zanzalintinib is being studied in multiple trials:

  • STELLAR-002: Phase 1b with nivolumab in metastatic renal cell carcinoma
  • EXACT trial: Post-adjuvant pembrolizumab progression
  • Phase II studies: Thyroid cancer, leiomyosarcoma, prostate cancer

How to Find Trials:

  1. Search ClinicalTrials.gov for "zanzalintinib" or "XL092"
  2. Contact your oncologist about referral opportunities
  3. Reach out to study sites directly

Insurance Considerations: Clinical trial costs are typically covered by sponsors, though routine care costs may still apply to your insurance.

Compassionate Use Programs

Manufacturer Programs: Contact Exelixis directly about expanded access:

  • Check Exelixis website for patient assistance information
  • Work with your oncologist to submit expanded access requests
  • Consider FDA's Expanded Access Program pathway

Requirements: Typically need:

  • Life-threatening condition
  • No comparable approved therapy options
  • Unable to participate in clinical trials
  • Potential benefit outweighs risks

Timeline: FDA expanded access requests can be processed within days for emergency situations.

Coverage at a Glance

Requirement Status Where to Verify Source
FDA Approval No - investigational only FDA Orange Book FDA
Formulary Listed No Anthem Drug Lists Anthem
PA Required Yes, if coverage attempted Member services Anthem
Step Therapy N/A - not formulary Policy documents Anthem
External Appeal Available Yes Virginia BOI VA SCC
Clinical Trial Coverage Sponsor-funded ClinicalTrials.gov NIH

When to Escalate

State Resources:

  • Virginia Bureau of Insurance: 1-877-310-6560 for coverage disputes
  • Managed Care Ombudsman: Part of State Corporation Commission for HMO issues
  • Virginia Poverty Law Center: Health assistance for complex cases

Federal Options:

  • CMS: For Medicare Advantage plans
  • Department of Labor: For ERISA-governed employer plans

Frequently Asked Questions

Q: How long does Blue Cross Blue Shield PA take in Virginia? A: Standard requests are processed within 24 hours, with 72-hour emergency supplies available during review.

Q: What if zanzalintinib is completely non-formulary? A: You'll need either clinical trial enrollment, FDA expanded access approval, or successful external appeal demonstrating medical necessity.

Q: Can I request an expedited appeal for cancer treatment? A: Yes, Virginia allows 72-hour expedited external reviews for urgent cancer cases.

Q: Does step therapy apply to investigational drugs? A: No, but you'll need to document failure/intolerance of approved alternatives to justify investigational access.

Q: What's my best chance of coverage? A: Clinical trial participation offers the highest likelihood of access, followed by FDA expanded access programs.

Q: Who pays for routine care during clinical trials? A: Your insurance typically covers standard care costs; the trial sponsor covers investigational drug and research-specific procedures.

Scripts & Templates

Patient Phone Script for Blue Cross Blue Shield: "I'm calling about coverage for an investigational drug called zanzalintinib for my [cancer type]. My doctor believes this is medically necessary because [brief reason]. Can you tell me about your investigational drug policy and any forms needed for a coverage request?"

Clinician Peer-to-Peer Request: "I'm requesting coverage for zanzalintinib (XL092) for my patient with [diagnosis]. They've failed [list prior therapies] and are not eligible for current clinical trials due to [reason]. The drug targets [mechanism] which is relevant to their tumor biology based on [testing results]."

Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed submissions that align with each plan's specific requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and appeal denials systematically. For challenging cases like investigational drug coverage, having expert support can make the difference between denial and approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan details, and medical necessity. Always consult with your healthcare provider and insurance plan directly for coverage determinations. For personalized assistance with complex coverage cases, consider working with organizations like Counterforce Health that specialize in insurance appeals and prior authorization support.

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