How to Get Zanzalintinib (XL092) Covered by Cigna in New York: Complete Appeals Guide with Forms and Timelines

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

Fastest path: Zanzalintinib (XL092) requires prior authorization through Cigna's formulary exception process since it's investigational. Your oncologist must submit clinical rationale documenting medical necessity and failed standard treatments. If denied, file internal appeals within 180 days, then New York's external review within 4 months.

First step today: Contact your oncologist to initiate a formulary exception request and gather documentation of prior treatment failures. Cigna typically decides within 72 hours (24 hours expedited).

Table of Contents

  1. Understanding Zanzalintinib Coverage Requirements
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window and Outcomes
  6. If Denied: Appeals Process
  7. New York External Review Rights
  8. Timeline Overview and Milestones
  9. Time-Saving Strategies
  10. Frequently Asked Questions

Understanding Zanzalintinib Coverage Requirements

Zanzalintinib (XL092) is an investigational multi-target tyrosine kinase inhibitor developed by Exelixis. Since it lacks FDA approval, Cigna typically covers it only through compassionate use programs or clinical trials.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all investigational drugs Cigna member portal Cigna PA Policy
Formulary Status Non-formulary (requires exception) Prescription Drug List Cigna Formulary
Medical Necessity Must document failed standard treatments Provider letter required Exception Process
Step Therapy May require trying approved alternatives first Plan benefits Coverage Policies
Site of Care Typically outpatient oncology clinic Provider certification Contact Cigna directly

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization request, gather:

  • Insurance verification: Current Cigna member ID and policy details
  • Clinical documentation: Complete medical records showing diagnosis with ICD-10 codes
  • Treatment history: Detailed records of all prior therapies tried and failed
  • Prescriber information: Oncologist's credentials and contact information
  • Compassionate use enrollment: Documentation from Exelixis program if applicable

Medical Necessity Letter Requirements

Your oncologist must provide a comprehensive letter including:

  1. Patient diagnosis with specific ICD-10 codes
  2. Prior treatment failures with dates, dosages, and reasons for discontinuation
  3. Clinical rationale for Zanzalintinib based on tumor characteristics
  4. Treatment goals and expected outcomes
  5. Literature support from peer-reviewed studies or clinical trials
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by ingesting denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules.

Submission to Initial Review (1-5 Days)

New York Timeline Requirements

Under New York law, Cigna must complete prior authorization reviews within:

  • Standard requests: 72 hours of receiving complete documentation
  • Expedited requests: 24 hours for urgent cases

What Reviewers Check First

Cigna's utilization management team evaluates:

  1. Plan coverage: Whether investigational drugs are covered under your specific plan
  2. Medical necessity: Clinical justification for the requested treatment
  3. Step therapy compliance: Documentation of failed standard treatments
  4. Dosing appropriateness: Alignment with study protocols or guidelines
  5. Site of care: Appropriate setting for administration

Additional Information Requests (1-7 Days)

If Cigna requests additional information, respond immediately to avoid delays. Common requests include:

  • Additional clinical notes from recent appointments
  • Laboratory results or imaging studies
  • Peer-reviewed literature supporting off-label use
  • Compassionate use program documentation
  • Specialist consultation notes
Note: Incomplete responses can reset the review timeline, so ensure all requested documents are submitted together.

Decision Window and Outcomes

Typical Outcomes

Approval: Coverage granted with specific conditions (duration, quantity limits, monitoring requirements)

Denial: Most common reasons include:

  • Not medically necessary
  • Investigational/experimental
  • Step therapy requirements not met
  • Lack of supporting evidence

Partial approval: Coverage for a limited duration or quantity requiring reauthorization

Reading Your Decision Letter

Approved requests will specify:

  • Coverage effective dates
  • Quantity limits per fill
  • Required monitoring or documentation
  • Renewal requirements

Denied requests must include:

  • Specific reason for denial
  • Appeal rights and deadlines
  • Required documentation for appeals

If Denied: Appeals Process

Cigna Internal Appeals

You have 180 days from the denial date to file an internal appeal with Cigna.

First-level internal appeal:

  • Submit written appeal with additional clinical evidence
  • Include updated medical records or literature
  • Request peer-to-peer review with oncologist if appropriate

Second-level internal appeal:

  • Available if first-level appeal is denied
  • Reviewed by different medical director
  • Final internal determination

Expedited Appeals

For urgent cases where delays could jeopardize health:

  • Decision within 72 hours (or 24 hours for drug appeals)
  • Requires physician attestation of urgency
  • Same documentation requirements as standard appeals

New York External Review Rights

If Cigna denies your internal appeals, New York law provides strong external review rights through the Department of Financial Services (DFS).

External Appeal Process

Timeline: Must file within 4 months of Cigna's final denial

Fee: $25 per appeal (waived for Medicaid or financial hardship)

Decision timeline:

  • Standard review: 30 days
  • Expedited review: 72 hours (24 hours for non-formulary drugs)

Binding decision: External reviewer's decision is final and binding on Cigna

Filing Your External Appeal

Submit to New York DFS:

  • Complete external appeal application
  • Copy of Cigna's denial letter
  • All supporting medical documentation
  • Physician attestation for expedited review (if applicable)

Contact: DFS External Appeals or call 1-800-400-8882

Timeline Overview and Milestones

Milestone Timeline Key Actions Notes
Pre-submission 0-2 days Gather documentation Complete package reduces delays
Initial submission Day 1 Submit PA request Use Cigna provider portal
Cigna review 1-3 days Await decision 72 hours max by NY law
If denied Day 4 File internal appeal 180-day deadline starts
Internal review 7-14 days Provide additional evidence Can request expedited
External appeal 30-120 days File with NY DFS 4-month deadline from final denial
Final decision 30-60 days Binding determination Cigna must comply

Time-Saving Strategies

Portal Usage

  • Use Cigna's provider portal for fastest submission
  • Upload all documents simultaneously
  • Track status through online dashboard

Bundled Evidence

  • Submit comprehensive initial package
  • Include peer-reviewed studies upfront
  • Provide complete treatment history

Direct Specialty Routing

  • Request oncology specialist review
  • Utilize peer-to-peer consultation
  • Connect with Cigna's medical directors

The appeals process can be complex, which is why services like Counterforce Health help patients and clinicians navigate insurance denials by creating targeted appeals that identify the specific denial basis and draft point-by-point rebuttals using the right clinical evidence and citations.

Frequently Asked Questions

How long does Cigna prior authorization take in New York? Standard PA requests: 72 hours maximum under New York law. Expedited requests for urgent cases: 24 hours.

What if Zanzalintinib is non-formulary? You can request a formulary exception with clinical justification. Your oncologist must document medical necessity and failed standard treatments.

Can I request an expedited appeal? Yes, if delays would jeopardize your health. Requires physician attestation and results in 72-hour decision timeline (24 hours for drug appeals).

Does step therapy apply to investigational drugs? Cigna may require documented trials of approved alternatives before covering investigational treatments, depending on your specific cancer type.

What happens if my external appeal is approved? Cigna must provide coverage as determined by the external reviewer. The decision is binding and Cigna cannot appeal it.

Are there financial assistance options? For compassionate use programs, drug costs are typically covered by the manufacturer. Contact Exelixis directly for program details.

Who can help me with the appeals process? Community Health Advocates (888-614-5400) provides free assistance to New York residents with insurance appeals and denials.

What if I'm enrolled in a clinical trial? Clinical trial drugs are typically provided at no cost. Insurance may cover routine care costs associated with trial participation.

Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with appeals, contact Community Health Advocates at 888-614-5400 or the New York Department of Financial Services.

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