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

Work With Your Doctor to Get Zanzalintinib (XL092) Covered by Cigna in Ohio: Complete Approval Guide

Answer Box: Getting Zanzalintinib (XL092) Covered by Cigna in Ohio

Zanzalintinib (XL092) is investigational and not FDA-approved, so Cigna typically won't cover it outside clinical trials. Your fastest path is through Exelixis's compassionate use program combined with a prior authorization appeal. Start by having your oncologist contact Exelixis Medical Affairs to initiate expanded access, then file a medical necessity appeal with Cigna using the compassionate use approval as supporting evidence. Ohio residents have strong appeal rights including external review through independent medical experts if Cigna denies coverage.

First step today: Ask your oncologist to contact Exelixis Medical Affairs to begin the compassionate use application process.

Table of Contents

  1. Set Your Goal: Understanding What Approval Requires
  2. Visit Preparation: Documenting Your Medical Journey
  3. Building Your Evidence Kit
  4. Medical Necessity Letter Structure
  5. Supporting Your Doctor During Peer-to-Peer Review
  6. After-Visit Documentation
  7. Respectful Persistence: Following Up Effectively
  8. Appeals Process in Ohio
  9. Common Denial Reasons & Solutions
  10. Frequently Asked Questions

Set Your Goal: Understanding What Approval Requires

Since Zanzalintinib (XL092) is investigational with no FDA approval, getting Cigna coverage requires a two-pronged approach. First, you'll need access to the drug through Exelixis's compassionate use program. Second, you'll need to convince Cigna that covering the drug—even though investigational—meets medical necessity criteria.

Coverage Landscape for Investigational Drugs

Cigna's clinical trial policy explicitly excludes investigational drugs from coverage as routine patient care costs. However, compassionate use programs create a different pathway where the drug manufacturer provides access, and insurance may cover associated monitoring and administration costs.

Partnership Strategy

Your oncologist must drive both processes. They'll initiate the Exelixis compassionate use application and simultaneously prepare the medical necessity case for Cigna. This coordinated approach maximizes your chances of success.

Note: Counterforce Health specializes in turning insurance denials into targeted appeals by identifying specific denial reasons and crafting evidence-backed rebuttals aligned to each plan's policies.

Visit Preparation: Documenting Your Medical Journey

Come to your appointment with a comprehensive timeline that demonstrates why Zanzalintinib represents your best treatment option.

Symptom Timeline Documentation

Create a chronological record including:

  • Initial diagnosis date and staging
  • Symptom progression: Document functional decline, pain levels, and quality of life impacts
  • Performance status changes: Note ECOG score deterioration if applicable
  • Treatment urgency factors: Any rapid progression or concerning symptoms

Prior Treatment Documentation

Compile detailed records of all previous therapies:

  • Medication names and doses
  • Treatment duration for each regimen
  • Specific reasons for discontinuation (progression, toxicity, contraindications)
  • Response rates and durability
  • Side effects experienced

Functional Impact Assessment

Document how your condition affects daily activities:

  • Work capacity and limitations
  • Physical functioning changes
  • Cognitive impacts
  • Social and family life effects

Building Your Evidence Kit

Essential Clinical Documentation

Gather these materials before your appointment:

Laboratory and Imaging Results

  • Recent scans showing disease progression
  • Tumor marker trends
  • Organ function assessments (liver, kidney, cardiac)
  • Performance status evaluations

Treatment History Summary

  • Complete medication list with dates
  • Prior authorization approvals and denials
  • Documentation of treatment failures
  • Adverse event reports

Published Guidelines and Evidence

Your oncologist will reference:

  • NCCN Guidelines for your specific cancer type
  • Peer-reviewed studies on Zanzalintinib efficacy
  • FDA breakthrough therapy designations or fast-track status
  • Clinical trial data from the STELLAR program

Medical Necessity Letter Structure

Core Components for Investigational TKI Coverage

Your oncologist's letter of medical necessity should include:

Patient-Specific Clinical Rationale

  • Detailed diagnosis with ICD-10 codes
  • Disease stage and prognostic factors
  • ECOG performance status documentation
  • Specific clinical scenarios justifying this therapeutic choice

Prior Treatment Documentation

  • Complete treatment timeline with outcomes
  • Reasons for discontinuation of each prior therapy
  • Documentation of treatment failures or intolerances
  • Evidence that standard alternatives have been exhausted

Supporting Literature

  • Clinical trial data relevant to your tumor type
  • Peer-reviewed studies demonstrating efficacy
  • Treatment guidelines supporting the approach
  • Safety data from investigational studies

Functional Status Assessment

  • Current performance status measures
  • Quality of life indicators
  • Symptom burden documentation
  • Expected treatment benefits

Supporting Your Doctor During Peer-to-Peer Review

Preparation for Medical Director Calls

When Cigna requests a peer-to-peer review, help your oncologist prepare by:

Offering Scheduling Flexibility

  • Provide multiple availability windows
  • Be available for urgent calls if expedited review is needed
  • Ensure your oncologist has current contact information

Case Summary Preparation Help compile a concise summary including:

  • One-page treatment timeline
  • Key clinical decision points
  • Specific contraindications to preferred alternatives
  • Expected outcomes with Zanzalintinib

Key Talking Points for Your Oncologist

Clinical Evidence Foundation

  • Reference any NCCN recognition of multi-target TKIs
  • Distinguish between unproven and evidence-supported indications
  • Present published data on similar patient populations

Off-Label Use Justification

  • Document failed standard therapies
  • Explain contraindications to preferred agents
  • Reference peer-reviewed literature supporting the approach

After-Visit Documentation

What to Save and Organize

Medical Records

  • Copy of the medical necessity letter
  • Clinical notes from your appointment
  • Any new test results or imaging
  • Updated treatment recommendations

Communication Records

  • Portal messages with your care team
  • Phone call summaries
  • Email correspondence about your case
  • Prior authorization submission confirmations

Patient Portal Communication

Use your healthcare system's patient portal to:

  • Request copies of all documentation
  • Follow up on prior authorization status
  • Share additional information as needed
  • Maintain a record of all communications

Respectful Persistence: Following Up Effectively

Appropriate Follow-Up Cadence

Initial Submission Phase (First 2 weeks)

  • Contact clinic 3-5 business days after submission
  • Request confirmation that all materials were sent
  • Ask for reference numbers or tracking information

Review Period (Weeks 2-4)

  • Check status weekly through patient portal
  • Offer to provide additional information if needed
  • Maintain regular but not excessive contact

Escalation Guidelines

When to Escalate Politely

  • No response after stated review timeline
  • Request for additional documentation seems excessive
  • Denial without clear medical rationale
  • Procedural delays affecting treatment timeline

How to Escalate

  • Request supervisor review through patient portal
  • Ask clinic to contact Cigna medical director
  • Consider involving Counterforce Health for appeal assistance

Appeals Process in Ohio

Cigna Internal Appeals

First-Level Internal Appeal

  • Timeline: Submit within 180 days of denial
  • Response time: 72 hours for urgent, standard timeframes for non-urgent
  • Required documents: Original denial letter, medical records, physician attestation

Second-Level Internal Appeal

  • Available if first-level appeal is denied
  • Same documentation requirements
  • Independent medical review by different physician

Ohio External Review Process

If Cigna upholds the denial, Ohio residents can pursue external review through the Ohio Department of Insurance.

Eligibility Requirements

  • Must involve medical necessity determination
  • Internal appeals must be exhausted (with exceptions for urgent cases)
  • Request must be filed within 180 days of final denial

Process Timeline

  • Standard review: Decision within 30 days
  • Expedited review: Decision within 72 hours for urgent cases
  • Independent medical experts review your case
  • Binding decision on Cigna if overturned

Contact Information

  • Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
  • Submit requests through your health plan, which notifies ODI

Common Denial Reasons & Solutions

Denial Reason How to Overturn Supporting Documents
"Investigational/Experimental" Emphasize compassionate use approval; cite published efficacy data Exelixis compassionate use letter, peer-reviewed studies
"Not medically necessary" Document failed standard therapies; provide clinical rationale Treatment timeline, physician attestation, guidelines
"Not FDA approved" Reference off-label use statutes; show established safety profile State coverage mandates, safety data from trials
"Preferred alternatives available" Document contraindications or treatment failures with alternatives Medical records showing intolerances, progression notes

Frequently Asked Questions

How long does Cigna prior authorization take in Ohio? Cigna must respond within 72 hours for urgent requests and within standard timeframes for non-urgent requests. Start the process 3-4 weeks before anticipated treatment to account for potential appeals.

What if Zanzalintinib is completely non-formulary? Non-formulary status doesn't prevent coverage if medical necessity is established. Focus on the compassionate use pathway and comprehensive medical necessity documentation.

Can I request an expedited appeal in Ohio? Yes, if your physician certifies that delays could seriously jeopardize your health. Ohio allows expedited external reviews with decisions within 72 hours.

Does Cigna's step therapy apply to investigational drugs? Step therapy typically applies to FDA-approved alternatives. Document why approved TKIs failed or are contraindicated to bypass step therapy requirements.

What costs might insurance cover even if the drug is denied? Even if Cigna denies the drug itself, they may cover associated monitoring, lab work, imaging, and administration costs. Submit separate prior authorizations for these services.

How do I know if my plan is subject to Ohio external review? State-regulated plans (individual, small group, fully insured large group) are subject to Ohio external review. Self-funded employer plans follow federal ERISA rules but may voluntarily use similar processes.

From Our Advocates: We've seen cases where patients initially faced "investigational" denials but succeeded after their oncologists emphasized the compassionate use approval and documented why all FDA-approved alternatives had failed. The key was presenting Zanzalintinib not as experimental, but as the most appropriate available option given the patient's specific clinical circumstances and treatment history.

This guidance provides general information about insurance coverage processes and should not be considered medical advice. For specific medical decisions, consult with your healthcare provider. For insurance coverage questions specific to your plan, contact Cigna member services or consult with the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526.

Sources & Further Reading

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