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

Getting Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Appeals Guide with Forms and External Review

Answer Box: Getting Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in Pennsylvania

Zanzalintinib (XL092) is an investigational multi-target TKI from Exelixis with no FDA approval, making Blue Cross Blue Shield coverage challenging but not impossible. Fastest path: Submit a medical necessity appeal through your Blue Cross Blue Shield plan's internal process, emphasizing failed standard therapies and clinical trial data. If denied, Pennsylvania's external review program overturns roughly 50% of denials. Start today: Have your oncologist contact Exelixis Medical Affairs for expanded access while pursuing insurance coverage through Pennsylvania's appeals system.

Table of Contents

  1. Understanding Blue Cross Blue Shield Coverage for Investigational Drugs
  2. Reading Your Denial Letter
  3. First-Level Appeal Strategy
  4. Medical Necessity Letter Template
  5. Peer-to-Peer Call Preparation
  6. Pennsylvania External Review Process
  7. Alternative Access Pathways
  8. Common Denial Reasons & Solutions
  9. Timeline and Tracking
  10. Frequently Asked Questions

Understanding Blue Cross Blue Shield Coverage for Investigational Drugs

Blue Cross Blue Shield plans in Pennsylvania—primarily Highmark (western/central PA) and Independence Blue Cross (Philadelphia region)—generally exclude investigational drugs from coverage. However, both plans maintain formulary exception processes that can sometimes succeed when standard therapies have failed.

Coverage Landscape in Pennsylvania

Pennsylvania's health insurance market is dominated by regional Blue Cross Blue Shield plans, with Highmark holding approximately 31% of the commercial market. The state recently strengthened its appeals system with a new external review program that has shown promising results for patients.

Key Coverage Challenges:

  • Zanzalintinib lacks FDA approval for any indication
  • Most Blue Cross Blue Shield medical policies classify non-approved drugs as "investigational"
  • Standard formulary exception criteria require evidence of medical necessity

Success Factors:

  • Strong clinical trial data (STELLAR-303 showed survival benefit in colorectal cancer)
  • Documented failure of all standard therapies
  • Compelling medical necessity documentation
  • Proper use of Pennsylvania's external review system
Note: Counterforce Health specializes in turning insurance denials into evidence-backed appeals, helping patients navigate complex prior authorization processes for investigational drugs like Zanzalintinib.

Reading Your Denial Letter

Your Blue Cross Blue Shield denial letter contains critical information for planning your appeal strategy. Look for these key elements:

Essential Information to Extract

Administrative Details:

  • Member ID and group number
  • Reference or case number
  • Date of denial
  • Prescribing physician information

Denial Reasoning:

  • "Investigational/experimental"
  • "Not medically necessary"
  • "Not a covered benefit"
  • "Formulary exclusion"

Appeal Rights Section:

  • Internal appeal deadline (typically 180 days for commercial plans)
  • Required forms or submission methods
  • Contact information for appeals department

Plan-Specific Considerations

Highmark Plans:

  • Use "Prescription Drug Medication Request/Drug Exception Form"
  • Fax numbers vary by region (e.g., 412-544-7546 for many commercial lines)
  • Expedited review available for urgent cases

Independence Blue Cross:

  • Premium Formulary exclusions exception process
  • Medical necessity verification required
  • Plan-specific appeal forms available on provider portal

First-Level Appeal Strategy

Your initial appeal is crucial—it sets the foundation for all subsequent reviews. Focus on three core arguments:

1. Medical Necessity Argument

Document why Zanzalintinib is medically necessary for your specific condition:

  • Exhaustion of all standard therapies
  • Contraindications to covered alternatives
  • Disease progression requiring intervention
  • Alignment with clinical trial populations showing benefit

2. Evidence-Based Support

Leverage available clinical data:

  • STELLAR-303 trial: Demonstrated overall survival benefit in metastatic colorectal cancer
  • STELLAR-304 trial: Ongoing Phase 3 study in non-clear cell renal cell carcinoma
  • Multi-target TKI mechanism addressing resistance pathways
  • Safety profile from Phase 1/2 studies

3. Standard of Care Context

Position the request within accepted medical practice:

  • Use in major cancer centers
  • Inclusion in clinical guidelines (where applicable)
  • Compassionate use programs indicating therapeutic potential
  • Lack of equivalent alternatives

Medical Necessity Letter Template

Use this structure for your physician's appeal letter:

Header Information

[Provider Letterhead]
Date: [Current Date]
To: Blue Cross Blue Shield Appeals Department
Re: Clinical Appeal - Zanzalintinib (XL092)
Member: [Full Name]
Member ID: [ID Number]
Reference: [Denial Reference Number]

Clinical Summary Section

"[Patient Name] is a [age]-year-old [gender] with [diagnosis and staging] who has exhausted standard therapeutic options. Disease course includes [brief progression timeline] with documented failure of [list specific therapies tried]."

Prior Treatment Documentation

Create a chronological table:

Therapy Duration Outcome Reason for Discontinuation
[Drug 1] [Dates] [Response] [Failure/toxicity details]
[Drug 2] [Dates] [Response] [Failure/toxicity details]

Medical Necessity Justification

"Zanzalintinib represents the most appropriate next-line therapy because:

  1. Multi-target mechanism addresses resistance pathways
  2. STELLAR-303 trial demonstrated survival benefit in similar patients
  3. No equivalent covered alternatives remain
  4. Delay risks disease progression and functional decline"

Supporting Evidence

Include:

  • Relevant clinical trial abstracts
  • Imaging showing disease progression
  • Laboratory values supporting need
  • Performance status documentation

Peer-to-Peer Call Preparation

Most Blue Cross Blue Shield plans offer peer-to-peer review opportunities. Use this checklist:

Before the Call

  • Review denial letter and specific policy cited
  • Prepare one-sentence clinical summary
  • Have treatment timeline with dates and outcomes
  • Gather key trial data and outcomes
  • Identify covered alternatives and why they're inadequate

During the Call

Opening: "I'm requesting coverage for Zanzalintinib for my patient with [diagnosis] who has failed [number] standard regimens."

Key Points to Emphasize:

  • Exhaustion of covered alternatives
  • Clinical trial evidence supporting benefit
  • Patient-specific factors favoring this therapy
  • Risk of delay or disease progression

Questions to Ask:

  • "What specific evidence would support coverage approval?"
  • "Are there additional clinical data points needed?"
  • "What covered alternatives do you recommend, and why?"

Documentation

Record:

  • Date and time of call
  • Reviewer name and credentials
  • Key discussion points
  • Agreed-upon next steps
  • Timeline for decision

Pennsylvania External Review Process

Pennsylvania's Independent External Review program offers a powerful appeal option with approximately 50% success rates.

Eligibility Requirements

  • Must complete internal Blue Cross Blue Shield appeals first
  • Receive Final Adverse Benefit Determination (FABD) letter
  • File within 4 months of FABD date
  • Applies to fully insured plans (not Medicare or Medicaid)

How to File

Standard Review:

  1. Complete Pennsylvania Insurance Department external review form
  2. Submit online, by email, or fax
  3. Include all denial letters and supporting documentation
  4. Add medical records within 15 days of IRO assignment

Expedited Review:

  • Available for life-threatening situations
  • Requires Physician Certification Form
  • Can be filed immediately after initial denial
  • Shorter timeline for IRO decision

Timeline

  • Day 1: PID sends request to insurer for eligibility confirmation
  • Day 5: Insurer confirms eligibility
  • Day 6: IRO assigned
  • Day 21: Deadline for additional documentation
  • Day 45: IRO decision issued

Success Strategies

Based on Pennsylvania's external review outcomes, strengthen your case with:

  • Detailed medical necessity documentation
  • Evidence of no effective covered alternatives
  • Strong clinical literature support
  • Clear demonstration of potential benefit
From our advocates: We've seen investigational drug appeals succeed when families submit comprehensive evidence packages that directly address the plan's medical policy criteria. One key is showing that standard alternatives have been genuinely exhausted, not just tried briefly. Success often comes down to the quality of clinical documentation and how well it matches the independent reviewers' medical training.

Alternative Access Pathways

While pursuing insurance coverage, consider these parallel approaches:

Expanded Access Program

Exelixis Compassionate Use:

  • Contact Exelixis Medical Affairs at 1-888-224-2017
  • Requires physician-initiated request
  • FDA Form 3926 submission
  • IRB approval at treating institution
  • Drug typically provided at no cost

Clinical Trial Enrollment

Active Studies:

  • NCT05425940: XL092 + atezolizumab vs regorafenib in colorectal cancer
  • NCT06698250: XL092 + durvalumab + tremelimumab in solid tumors
  • Search ClinicalTrials.gov for "XL092" or "zanzalintinib"

Financial Assistance

  • Exelixis Access Services (EASE): 1-888-224-2017
  • Cancer-specific foundations (PAN Foundation, CancerCare)
  • State pharmaceutical assistance programs

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Key Documents
"Investigational/Experimental" Show clinical trial evidence, guideline support STELLAR trial data, medical necessity letter
"Not medically necessary" Document failed alternatives, disease progression Treatment timeline, imaging results
"Not a covered benefit" Request formulary exception, cite medical necessity Exception request form, clinical justification
"Lack of FDA approval" Emphasize compassionate use criteria, unmet need FDA expanded access guidance, clinical evidence

Timeline and Tracking

Key Deadlines

  • Internal Appeal: 180 days from denial (commercial plans)
  • External Review: 4 months from Final Adverse Benefit Determination
  • Expedited Appeals: 72 hours for urgent cases
  • Peer-to-Peer: Request within internal appeal timeframe

Tracking Template

Create a log with:

  • Date of each submission
  • Method used (fax, portal, mail)
  • Confirmation numbers
  • Response deadlines
  • Follow-up actions needed

Escalation Points

If appeals fail:

  • File complaint with Pennsylvania Insurance Department
  • Contact patient advocacy organizations
  • Consider legal consultation for complex cases
  • Explore alternative drug access programs

Frequently Asked Questions

Q: How long does Blue Cross Blue Shield prior authorization take in Pennsylvania? A: Standard prior authorization decisions are typically made within 15 business days. Expedited reviews for urgent cases can be completed within 72 hours.

Q: What if Zanzalintinib is completely excluded from my formulary? A: You can still request a formulary exception through your plan's medical necessity process. Both Highmark and Independence Blue Cross have exception pathways for non-formulary drugs.

Q: Can I request an expedited appeal for Zanzalintinib? A: Yes, if your physician documents that delay would compromise your life, health, or ability to regain maximum function. Submit expedited appeal forms with physician certification.

Q: Does step therapy apply to investigational drugs? A: Step therapy typically doesn't apply to non-formulary drugs, but you'll need to document failure of standard therapies as part of the medical necessity requirement.

Q: What happens if Pennsylvania external review denies my appeal? A: The IRO decision is binding on your insurer. If overturned in your favor, Blue Cross Blue Shield must provide coverage. If denied, explore expanded access programs or clinical trials.

Q: How much does Zanzalintinib cost if I pay out of pocket? A: As an investigational drug, Zanzalintinib isn't commercially available. Access is through clinical trials (typically no cost) or expanded access programs (often provided free by manufacturer).

Q: Can I appeal to federal authorities if my state appeal fails? A: For fully insured plans, Pennsylvania's external review is typically the final step. However, you can file complaints with federal agencies for potential violations of coverage requirements.

Q: What documentation strengthens an investigational drug appeal? A: Key documents include detailed treatment history, clinical trial data, medical necessity letters, imaging showing progression, and evidence that standard alternatives have been exhausted or are contraindicated.

Navigating insurance coverage for investigational drugs like Zanzalintinib requires persistence and strategic documentation. Pennsylvania's strengthened external review process provides meaningful recourse when internal appeals fail. Counterforce Health can help transform denial letters into targeted, evidence-backed appeals that align with payer requirements and maximize approval chances.

Remember that expanded access programs often provide the most reliable pathway to investigational drugs while insurance appeals proceed. Working with your oncologist to pursue both tracks simultaneously—insurance coverage and compassionate use—gives you the best chance of accessing needed treatment.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and appeal processes may vary by specific Blue Cross Blue Shield plan and can change over time.

Sources & Further Reading

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