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

Getting Zanzalintinib (XL092) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

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

Zanzalintinib (XL092) is investigational and typically not covered by Cigna outside clinical trials or compassionate use programs. Your fastest path: 1) Check if you qualify for an Exelixis expanded access program, 2) Have your oncologist submit a detailed prior authorization with medical necessity documentation, 3) If denied, file an internal appeal within 180 days, then request Michigan DIFS external review within 127 days. Start today by asking your doctor to contact Exelixis about single-patient compassionate use while simultaneously beginning the PA process with Cigna.

Table of Contents

Understanding Zanzalintinib Coverage Challenges

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. As of 2025, it has no FDA approvals and remains in clinical trials through the STELLAR program. This creates significant coverage challenges with Cigna and other insurers.

Why Coverage is Difficult:

  • Cigna's standard policy excludes experimental or investigational drugs from pharmacy benefits
  • Express Scripts (Cigna's PBM) typically requires FDA approval or recognized compendia support
  • Most coverage is limited to clinical trial participation or formal compassionate use programs

When Coverage Might Be Possible:

  • Active enrollment in an approved clinical trial where routine care costs are covered
  • Exelixis-approved single-patient expanded access (compassionate use)
  • Rare case-by-case exceptions for life-threatening conditions with no alternatives

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed rebuttals aligned to each plan's own rules and medical policies.

Step-by-Step: Fastest Path to Approval

1. Verify Your Cigna Plan Details

Who does it: You or your clinic
Document needed: Insurance card, Summary of Benefits
Timeline: Same day
How: Call Cigna member services or check online portal

Who does it: Your oncologist
Document needed: ClinicalTrials.gov search results
Timeline: 1-2 days
How: Search "XL092" or "zanzalintinib" and document any ineligibility reasons

3. Request Exelixis Expanded Access

Who does it: Your oncologist
Document needed: Clinical package with treatment history
Timeline: 2-4 weeks
How: Contact Exelixis Medical Affairs for single-patient IND process

4. Submit Cigna Prior Authorization

Who does it: Your oncologist's office
Document needed: PA form plus medical necessity letter
Timeline: 72 hours for standard, 24 hours for expedited
How: Electronic submission via CoverMyMeds or fax

5. Prepare for Likely Denial

Who does it: You and your care team
Document needed: Comprehensive appeal packet
Timeline: Within 180 days of denial
How: Gather all clinical evidence, guidelines, and response documentation

6. File Internal Appeal

Who does it: You or authorized representative
Document needed: Updated medical necessity letter
Timeline: Cigna has 30 days to respond
How: Written appeal with additional clinical evidence

7. Request Michigan External Review

Who does it: You
Document needed: DIFS Form FIS 0018
Timeline: Within 127 days of final denial
How: Online or mail to Michigan DIFS

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Clinical Trial Coverage Routine costs may be covered in qualifying trials Plan benefits summary Cigna Clinical Trials Policy
Prior Authorization Required for all investigational uses Cigna formulary PA Forms
Medical Necessity Must demonstrate no reasonable alternatives Plan policy documents Coverage Determination Process
Expanded Access FDA single-patient IND required FDA guidance FDA Expanded Access
Appeals Deadline 180 days for internal, 127 days for external Michigan law DIFS External Review

Medical Necessity Documentation

Essential Components for Your Physician's Letter

Patient Information:

  • Full diagnosis with ICD-10 codes
  • Disease stage and prognosis
  • Current performance status (ECOG 0-2 typically required)

Treatment History:

  • Complete list of prior therapies with dates
  • Specific reasons for discontinuation (progression, toxicity, contraindications)
  • Documentation of treatment failures with objective measures

Clinical Rationale:

  • Why standard FDA-approved options are inadequate
  • Mechanism of action supporting XL092 use for your specific condition
  • Published trial data or case reports supporting potential benefit

Risk-Benefit Analysis:

  • Potential risks of continued disease progression without treatment
  • XL092 safety profile from available trial data
  • Why potential benefits outweigh risks for this patient

Supporting Documentation Checklist

  • Recent imaging studies showing disease status
  • Laboratory values (CBC, comprehensive metabolic panel, liver function)
  • Pathology reports with molecular markers if applicable
  • Prior treatment summary with response assessments
  • Performance status documentation
  • Relevant clinical trial publications or abstracts

Common Denial Reasons & How to Overturn Them

Denial Reason How to Overturn Required Documents
"Experimental/Investigational" Demonstrate compassionate use approval or argue medical necessity FDA IND approval, Exelixis agreement, clinical evidence
"Not Medically Necessary" Show failed standard therapies and unique clinical circumstances Treatment history, response data, contraindication documentation
"No Clinical Evidence" Provide published trial data and mechanism rationale STELLAR trial data, peer-reviewed publications, expert opinions
"Alternative Treatments Available" Document failures, intolerances, or contraindications to alternatives Detailed treatment history with specific failure reasons
Tip: Request a peer-to-peer review with Cigna's medical director. This allows your oncologist to discuss the case directly with the reviewing physician and often leads to approval reversals.

Michigan Appeals Process

Internal Appeals with Cigna

Timeline: Must file within 180 days of denial Process: Submit written appeal with additional clinical evidence Decision time: 30 days for pre-service, 60 days for post-service Expedited option: 72 hours if delay could seriously jeopardize health

Michigan DIFS External Review

Michigan's Patient's Right to Independent Review Act provides binding external review through Independent Review Organizations (IROs).

Eligibility:

  • Final adverse determination from Cigna
  • Filed within 127 days of final denial
  • Involves medical necessity or experimental/investigational determination

Required Forms:

  • DIFS Form FIS 0018
  • Treating Provider Certification for Experimental/Investigational Denials (if applicable)

Timeline:

  • Standard review: 60 days maximum
  • Expedited review: 72 hours (requires physician attestation of serious jeopardy)

Contact Information: Michigan DIFS Consumer Services: 877-999-6442

Scripts for Common Situations

Calling Cigna for PA Status: "I'm calling to check the status of prior authorization request [reference number] for Zanzalintinib XL092 for patient [name]. Can you tell me the current status and if any additional information is needed?"

Requesting Peer-to-Peer Review: "We received a denial for our XL092 request. We'd like to request a peer-to-peer review between Dr. [name] and your medical director to discuss the clinical circumstances that make this medication medically necessary."

Alternative Access Options

Exelixis Expanded Access Program

Eligibility Requirements:

  • Life-threatening cancer with no curative options
  • Standard therapies exhausted or contraindicated
  • ECOG performance status 0-2
  • Adequate organ function
  • Not eligible for active XL092 clinical trials

Process:

  1. Oncologist contacts Exelixis Medical Affairs
  2. Submit clinical package with treatment history
  3. File FDA Form 3926 for single-patient IND
  4. Obtain IRB approval (can be expedited)
  5. Drug supplied at no cost by Exelixis

Clinical Trial Participation

Current XL092 trials include studies in:

  • MSS colorectal cancer
  • Renal cell carcinoma
  • Leiomyosarcoma
  • Neuroendocrine tumors
  • Prostate cancer

Search ClinicalTrials.gov for "XL092" or "zanzalintinib" for current opportunities.

Frequently Asked Questions

Q: How long does Cigna prior authorization take for investigational drugs? A: Standard PA decisions are made within 72 hours, expedited within 24 hours. However, investigational drug requests often require additional review and may take longer.

Q: What if Zanzalintinib is not on Cigna's formulary? A: As an investigational drug, XL092 won't appear on standard formularies. You'll need to request coverage through the non-formulary exception process.

Q: Can I get expedited review in Michigan? A: Yes, both Cigna internal appeals and Michigan DIFS external reviews offer expedited processes (72 hours or less) when delay would seriously jeopardize health.

Q: Does Cigna cover routine costs if I'm in a clinical trial? A: Many Cigna plans cover routine patient care costs (visits, labs, imaging) in qualifying clinical trials, but not the investigational drug itself.

Q: What happens if my appeal is denied? A: After exhausting Cigna's internal appeals, you can file for binding external review through Michigan DIFS within 127 days.

Q: Are there patient assistance programs for XL092? A: Since XL092 is investigational, traditional copay assistance isn't available. Access is primarily through clinical trials or Exelixis expanded access programs.

What Counterforce Health Can Do

Counterforce Health transforms insurance denials into successful approvals by ingesting denial letters, plan policies, and clinical notes to identify the specific denial basis. Our platform drafts point-by-point rebuttals aligned to Cigna's own rules, pulling the right citations from FDA labeling, peer-reviewed studies, and specialty guidelines.

For investigational drugs like Zanzalintinib, we help navigate the complex intersection of clinical trial coverage, compassionate use documentation, and medical necessity appeals. Our system tracks Michigan-specific deadlines and procedural requirements while producing letters that meet both Cigna's coverage determination standards and DIFS external review criteria.

When to Escalate

Contact Michigan DIFS Consumer Services (877-999-6442) if:

  • Cigna misses decision deadlines
  • You need help understanding your appeal rights
  • You're unsure about external review eligibility
  • You encounter procedural barriers

For complex cases involving investigational drugs, consider consulting with healthcare advocates familiar with Michigan's insurance laws and Cigna's specific policies.

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 documents for specific coverage details. Insurance policies and state regulations may change.

Sources & Further Reading

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