By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by Cigna in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Vanflyta (Quizartinib) Covered by Cigna in Texas

Vanflyta (quizartinib) requires prior authorization from Cigna and typically involves step therapy requirements. Most approvals take 7-14 days with complete documentation. Fastest path: 1) Confirm FLT3-ITD positive AML diagnosis with genetic testing results, 2) Document failure/intolerance of preferred FLT3 inhibitors (midostaurin, potentially gilteritinib), 3) Submit PA through Cigna provider portal with comprehensive medical necessity letter. If denied, Texas law guarantees internal appeal (180 days) and external review (120 days after internal denial). Start by gathering your genetic test results and prior therapy records today.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Billing Requirements
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: Tracking Your Request
  9. Common Denial Reasons & How to Prevent Them
  10. Appeals Process in Texas
  11. Quick Reference Checklist
  12. FAQ

Who Should Use This Guide

This guide is for Texas patients with FLT3-ITD positive acute myeloid leukemia (AML) whose doctors have prescribed Vanflyta (quizartinib) and need Cigna coverage approval. You'll also find this helpful if you've already received a denial and need to appeal.

Expected outcomes: With proper documentation, most medically appropriate Vanflyta requests get approved within 2-3 weeks. If initially denied, about 60-70% of well-documented appeals succeed in Texas, particularly when step therapy exceptions are properly justified.

When to use this: Before your first Vanflyta prescription, after receiving a denial letter, or when preparing for an appeal. This applies to all Cigna plan types in Texas, including employer plans and Medicare Advantage.

Member & Plan Basics

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Vanflyta prescriptions Cigna formulary documents Cigna PA Lists
Step Therapy Must try preferred FLT3 inhibitors first Plan-specific formulary Step Therapy Policy
Specialty Pharmacy Required through Express Scripts/Accredo Member ID card or portal Cigna Specialty Pharmacy
Formulary Tier Non-preferred (higher copay) Annual formulary guide 2025 Formulary

Plan Type Verification

Check your Cigna member ID card to determine your plan type:

  • Commercial/Employer plans: Follow standard PA process
  • Medicare Advantage: May have additional CMS requirements
  • Medicaid managed care: Different appeal rights apply
Tip: Call the member services number on your card to confirm your exact formulary and PA requirements, as these can vary by plan year and employer group.

Clinical Criteria for Approval

FDA-Approved Indication

Vanflyta is approved for newly diagnosed FLT3-ITD positive AML in combination with standard induction and consolidation chemotherapy, followed by single-agent maintenance therapy. Your diagnosis must match this exact indication for coverage.

Required Clinical Documentation

Genetic Testing Results:

  • FLT3-ITD mutation confirmed by validated molecular testing (PCR with capillary electrophoresis)
  • Results must show positive FLT3-ITD status with allelic ratio if available
  • Testing performed at CLIA-certified laboratory

Disease Status:

  • Newly diagnosed AML confirmed by bone marrow biopsy
  • Appropriate for intensive chemotherapy
  • No contraindications to FLT3 inhibitor therapy

Step Therapy Requirements: Based on current Cigna policies, you typically must first try:

  1. Midostaurin (Rydapt) - preferred first-line FLT3 inhibitor
  2. Gilteritinib (Xospata) - may be required for certain scenarios

Medical Necessity Criteria

Your oncologist must document:

  • Why Vanflyta is medically necessary for your specific case
  • Failure, intolerance, or contraindication to preferred alternatives
  • Treatment plan including monitoring for QTc prolongation and cytopenias
  • Expected duration of therapy

Coding and Billing Requirements

Drug Identification Codes

NDC Numbers:

  • 17.7 mg, 28-count: 65597-504-28
  • 17.7 mg, 14-count: 65597-504-04
  • 26.5 mg, 28-count: 65597-511-28
  • 26.5 mg, 14-count: 65597-511-04

HCPCS/J-Code:

  • No specific J-code assigned yet
  • Use J3490 (Unclassified drugs) or J9999 (Not otherwise classified, antineoplastic)
  • Include full NDC on all claims

ICD-10 Diagnosis Code:

  • C92.0 - Acute myeloid leukemia, not having achieved remission
  • Additional codes may be needed for FLT3 mutation status
Note: Always verify current codes with your billing department, as new drugs like Vanflyta may receive specific J-codes after initial launch.

Documentation Packet Checklist

Provider Medical Necessity Letter Must Include:

Patient Information:

  • Full name, DOB, member ID
  • Diagnosis with ICD-10 code (C92.0)
  • Date of AML diagnosis

Clinical Justification:

  • FLT3-ITD positive test results with lab name and date
  • Bone marrow biopsy confirming AML
  • Treatment phase (induction, consolidation, or maintenance)
  • Prior FLT3 inhibitor trials and outcomes
  • Contraindications or intolerances to preferred agents

Treatment Plan:

  • Vanflyta dosing and duration
  • Monitoring plan for cardiac and hematologic toxicities
  • Integration with chemotherapy regimen
  • Treatment goals and expected outcomes

Required Attachments:

  • Genetic testing report showing FLT3-ITD positivity
  • Bone marrow pathology report
  • Recent CBC with differential
  • EKG results (baseline QTc interval)
  • Documentation of prior therapy failures/intolerances
  • Completed PA form
Clinician Corner: Reference the FDA prescribing information and NCCN Guidelines for AML to strengthen your medical necessity argument. Cigna reviewers expect evidence-based justification aligned with professional guidelines.

Submission Process

Step-by-Step: Fastest Path to Approval

Step 1: Gather Documentation (Patient + Clinic)

  • Collect all genetic testing and pathology reports
  • Document prior therapy history
  • Obtain current lab values and EKG
  • Timeline: 1-2 days

Step 2: Complete PA Form (Clinic)

  • Download current Cigna PA form from provider portal
  • Complete all required clinical sections
  • Attach supporting documentation
  • Timeline: 1 day

Step 3: Submit Request (Clinic)

  • Submit through Cigna provider portal (preferred) or fax
  • Obtain confirmation number
  • Timeline: Same day

Step 4: Follow Up (Patient + Clinic)

  • Check status after 5-7 business days
  • Respond promptly to any requests for additional information
  • Timeline: 7-14 days for decision

Submission Channels

Cigna Provider Portal: Log in to submit electronically (fastest processing) Fax: Use PA-specific fax number from your denial letter or member services Mail: Only if electronic submission unavailable

Important: Always keep copies of all submissions and obtain confirmation numbers for tracking.

Specialty Pharmacy Coordination

Vanflyta must be dispensed through Cigna's preferred specialty pharmacy network, typically Express Scripts Specialty or Accredo.

Transfer Process:

  1. After PA approval, contact the specialty pharmacy
  2. Provide prescription, insurance information, and approval confirmation
  3. Coordinate delivery timing with treatment schedule
  4. Verify REMS program enrollment (required for Vanflyta)

Key Contacts:

  • Express Scripts Specialty: Contact through member portal
  • Accredo: Verify current phone number on member ID card

After Submission: Tracking Your Request

Status Check Schedule:

  • Day 3: Confirm receipt with confirmation number
  • Day 7: Check for any additional information requests
  • Day 14: Follow up if no decision received
  • Day 21: Consider expedited review request if urgent

What to Record:

  • Submission date and confirmation number
  • Representative names and reference numbers
  • All communication dates and outcomes
  • Any additional documentation requested

For patients: Counterforce Health helps patients navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Their platform can analyze your denial letter and draft point-by-point rebuttals aligned to your plan's specific rules.

Common Denial Reasons & How to Prevent Them

Denial Reason Prevention Strategy Required Documentation
No FLT3-ITD documentation Submit genetic test results with PA Lab report from CLIA-certified facility
Step therapy not completed Document failure/intolerance of midostaurin Prior therapy records, adverse event notes
Insufficient medical necessity Comprehensive oncologist letter Treatment rationale, guidelines references
Missing cardiac monitoring plan Include EKG and monitoring protocol Baseline EKG, cardiologist clearance if needed
Incorrect treatment phase Clarify induction vs. maintenance use Treatment timeline, current therapy status

From Our Advocates

"We've seen Vanflyta approvals go much smoother when the genetic testing lab report clearly states 'FLT3-ITD positive' rather than just listing mutation details. Make sure your oncologist's letter explicitly connects the genetic results to the treatment choice—Cigna reviewers aren't always oncology specialists." This represents common patterns we've observed, not guaranteed outcomes.

Appeals Process in Texas

If your initial PA request is denied, Texas law provides strong appeal rights with specific timelines.

Internal Appeal (Level 1)

Timeline: Submit within 180 calendar days of denial Process:

  1. Submit written appeal with denial letter
  2. Include additional medical documentation
  3. Request peer-to-peer review with oncologist Decision time: 30 days standard, 72 hours if expedited

External Review (IRO)

Timeline: Submit within 120 days after internal appeal denial Process:

  1. Request Independent Review Organization review
  2. Submit all medical records and denial correspondence
  3. IRO decision is binding on Cigna Decision time: 20 days standard, 72 hours if expedited
Texas-Specific: The Texas Department of Insurance oversees the external review process. Call 1-800-252-3439 for assistance with appeal procedures.

When to Request Expedited Review

Mark appeals as "EXPEDITED" when:

  • Delay could seriously endanger health
  • Treatment timing is critical for AML management
  • Standard timeline would compromise care

For comprehensive appeals assistance, Counterforce Health specializes in transforming insurance denials into successful appeals by identifying denial basis and crafting evidence-backed responses using the right clinical citations and payer-specific workflows.

Quick Reference Checklist

Before Starting:

  • Confirm FLT3-ITD positive AML diagnosis
  • Gather genetic testing and pathology reports
  • Document prior FLT3 inhibitor trials
  • Obtain baseline EKG and labs
  • Verify Cigna plan details and formulary

For PA Submission:

  • Complete current Cigna PA form
  • Comprehensive medical necessity letter
  • All supporting clinical documentation
  • Submit through preferred channel
  • Obtain confirmation number

If Denied:

  • Review denial reason carefully
  • Gather additional supporting evidence
  • Submit internal appeal within 180 days
  • Consider peer-to-peer review request
  • Prepare for external review if needed

FAQ

How long does Cigna PA take in Texas? Standard PA decisions are made within 14 business days. Expedited reviews (for urgent cases) must be completed within 72 hours.

What if Vanflyta is non-formulary on my plan? You can request a formulary exception with strong medical necessity documentation. Focus on why preferred alternatives are inappropriate for your specific case.

Can I request an expedited appeal? Yes, if delays would seriously jeopardize your health. Mark all communications as "EXPEDITED" and provide clinical justification for urgency.

Does step therapy apply if I tried other FLT3 inhibitors outside Texas? Yes, prior therapy from any location counts toward step therapy requirements. Provide complete documentation from all treating facilities.

What's the cost of Vanflyta without insurance? Cash prices range from $16,100-$17,900 per 28-day supply. Manufacturer assistance programs may be available through Daiichi Sankyo Access Central.

Who can help with appeals in Texas? Contact the Texas Department of Insurance (1-800-252-3439) or Office of Public Insurance Counsel (1-877-611-6742) for assistance with appeal procedures.

Sources & Further Reading

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 for specific coverage decisions. Insurance policies and requirements can change; verify current information with official sources before making decisions.

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