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

Getting Zanzalintinib (XL092) Covered by Aetna CVS Health in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Started

Zanzalintinib (XL092) is an investigational TKI that requires prior authorization from Aetna CVS Health in Pennsylvania. Since it's not FDA-approved, coverage is typically limited to clinical trials or compassionate use programs. Your fastest path: Have your oncologist submit a prior authorization request with clinical trial documentation or Exelixis compassionate use approval, complete treatment history showing standard therapy failures, and medical necessity justification. If denied, Pennsylvania's external review program overturns about 50% of appeals. Start today: Contact your oncologist to gather clinical documentation and begin the PA process.

Table of Contents

  1. Plan Types & Network Requirements
  2. Formulary Status & Coverage Basics
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Process
  5. Appeals Strategy for Pennsylvania
  6. Cost & Financial Assistance
  7. Common Denial Reasons & Solutions
  8. Clinician Documentation Guide
  9. When to Escalate
  10. FAQ

Plan Types & Network Requirements

Aetna CVS Health offers three main plan types in Pennsylvania, each with different implications for accessing investigational treatments like Zanzalintinib.

HMO Plans: Traditionally require primary care physician (PCP) referrals to specialists. However, Pennsylvania's Custom HMO for 2026 eliminated referral requirements, allowing direct access to network oncologists. Coverage is limited to network providers only, except for emergencies.

PPO Plans: Provide the most flexibility with both in-network and out-of-network coverage. No referrals needed for specialists. Basic PPO has $1,500 single/$3,000 family deductibles, while Choice PPO has $400 single/$800 family deductibles. Out-of-network benefits include separate deductibles and higher coinsurance.

EPO Plans: Offer in-network-only coverage without referral requirements. The Aetna Open Access Elect Choice EPO provides comprehensive benefits but limits coverage to network providers except for emergencies.

Note: For investigational drugs, verify your preferred oncologist and treatment facility participate in your specific plan's network, as network adequacy varies significantly between plan types.

Formulary Status & Coverage Basics

Zanzalintinib (XL092) is not on Aetna's standard formularies because it lacks FDA approval. As an investigational multi-targeted tyrosine kinase inhibitor developed by Exelixis, it's currently in multiple Phase 1/2/3 studies under the STELLAR program.

Coverage Pathways:

  • Clinical trial enrollment (most common approval path)
  • Compassionate use/expanded access programs
  • Formulary exception requests (rare for investigational drugs)

Medical vs. Pharmacy Benefit: Investigational drugs typically route through the medical benefit rather than pharmacy benefit, requiring HCPCS J-codes for billing rather than standard NDC numbers.

Prior Authorization Requirements

All Aetna CVS Health plans require prior authorization for Zanzalintinib. The PA process requires detailed clinical justification and proof of compassionate use or clinical trial enrollment.

Essential Documentation

Clinical Justification Must Include:

  • Complete diagnosis with ICD-10 codes
  • Detailed treatment history showing failure of or contraindications to FDA-approved alternatives
  • Clinical rationale explaining why investigational therapy is medically necessary
  • Physician attestation of medical necessity

Investigational Drug-Specific Requirements:

  • Clinical trial enrollment documentation OR
  • Exelixis compassionate use approval letter
  • Evidence of attempted enrollment in available clinical trials (if seeking compassionate use)
  • Molecular profiling results supporting the targeted approach

Submission Process:

Specialty Pharmacy Process

Zanzalintinib distribution likely requires specialty pharmacy dispensing through CVS Specialty or other contracted networks, as many Exelixis products use limited distribution networks.

CVS Specialty Process

  1. Benefits Verification: CVS Specialty reviews both pharmacy and medical insurance to confirm coverage and estimate out-of-pocket costs
  2. Prior Authorization Coordination: Specialty medications almost always require PA before dispensing. CVS works with providers to gather and submit clinical documentation, with reviews typically taking 5-10 business days.
  3. Manufacturer Program Coordination: CVS staff help identify and enroll eligible patients in Exelixis assistance programs during benefits investigation
  4. Dispensing and Monitoring: Once approved, CVS ships directly to patients with clinical support and adherence monitoring.

Appeals Strategy for Pennsylvania

Pennsylvania offers one of the strongest external review programs in the nation, with a 50% success rate for overturning insurance denials.

Internal Appeals (Required First Step)

Timeline: 180 days from initial denial to file internal appeal Process: Submit additional clinical documentation, peer-reviewed studies supporting investigational use, and detailed medical necessity justification

Pennsylvania External Review

Pennsylvania launched an enhanced external review program in 2024 specifically designed to handle experimental/investigational treatment disputes.

Key Features:

  • Free to consumers - no filing fees
  • Four-month window to file after final internal denial
  • 45-day standard review (20 days for experimental treatments)
  • 72-hour expedited review for urgent situations
  • Binding decisions on insurance companies

Contact Information:

  • Online: insurance.pa.gov/externalreview
  • Phone: 1-888-466-2787 or 1-877-881-6388
  • Email: [email protected]

Success Rate: In 2024, approximately 50% of appealed denials were overturned, with 259 successful reversals out of 517 cases filed

Cost & Financial Assistance

Since Zanzalintinib is investigational, traditional pricing doesn't apply. However, several assistance options exist:

Exelixis Programs:

  • Compassionate use programs (free drug for qualifying patients)
  • Clinical trial sponsor coverage
  • Patient assistance programs for eligible individuals

General Assistance:

  • Foundation grants for investigational treatments
  • State pharmaceutical assistance programs
  • Hospital financial assistance programs

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Experimental/Investigational" Submit clinical trial enrollment proof or compassionate use approval
"Not medically necessary" Provide detailed treatment history showing standard therapy failures
"No FDA approval" Document participation in FDA-approved expanded access program
"Alternative treatments available" Show contraindications or failures with approved TKIs

Clinician Documentation Guide

Medical Necessity Letter Checklist

Problem Statement:

  • Specific diagnosis with staging/molecular markers
  • Treatment urgency and prognosis without intervention

Prior Treatment History:

  • Complete list of previous therapies with dates
  • Specific reasons for discontinuation (progression, toxicity, contraindications)
  • Objective response measurements where available

Clinical Rationale:

  • Why Zanzalintinib is appropriate for this patient's molecular profile
  • Expected benefits based on clinical trial data
  • Monitoring and safety plans

Supporting Evidence:

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned to payer policies, pulling the right citations and clinical facts to support your case. Learn more about our services.

When to Escalate

Contact the Pennsylvania Insurance Department if:

  • Internal appeals are denied without proper review
  • Aetna fails to meet response deadlines
  • You need assistance navigating the external review process

Additional Resources:

  • Pennsylvania Health Law Project (free legal assistance)
  • Pennsylvania Insurance Department Consumer Services: 1-877-881-6388

FAQ

How long does Aetna CVS Health prior authorization take for investigational drugs? Standard PA decisions take 30-45 days. Expedited reviews for urgent situations are completed within 72 hours.

What if Zanzalintinib isn't covered under my plan? Request a formulary exception with clinical justification, or pursue compassionate use through Exelixis while appealing the coverage decision.

Can I get expedited review for my appeal? Yes, if your physician certifies that delays would significantly impact your health outcomes. Pennsylvania offers 72-hour expedited external reviews.

Do I need referrals to see an oncologist with Aetna HMO? Pennsylvania's Custom HMO eliminated referral requirements for 2026, allowing direct specialist access.

What happens if Pennsylvania's external review rules in my favor? The decision is binding - Aetna must approve coverage within 24 hours, including retroactive coverage if you paid out-of-pocket.

Are there alternatives if Zanzalintinib is denied? Yes, FDA-approved alternatives include cabozantinib, lenvatinib, and other TKIs based on your specific tumor type and molecular profile.

How much does Pennsylvania's external review cost? The external review program is completely free to consumers - no filing fees required.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance processes and is not medical advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance policies and procedures may change - verify current requirements with Aetna CVS Health and the Pennsylvania Insurance Department. For personalized assistance with complex appeals, consider consulting with coverage advocates like those at Counterforce Health.

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