By Counterforce Health Team in Vanflyta (quizartinib) —

The Complete Guide to Getting Vanflyta (Quizartinib) Covered by Cigna in Pennsylvania: Prior Authorization Forms, Appeals Process, and Medical Necessity Requirements

Answer Box: Getting Vanflyta Covered by Cigna in Pennsylvania

Prior authorization is required for Vanflyta (quizartinib) under Cigna Health Plans in Pennsylvania. The fastest path to approval requires: (1) FLT3-ITD mutation confirmation via FDA-approved test, (2) baseline ECG with QTc <450ms, and (3) submission through CoverMyMeds or Cigna's provider portal. If denied, Pennsylvania's new Independent External Review Program has overturned 53% of appealed denials in 2024. Start today: Contact your oncologist to verify FLT3-ITD testing and submit the prior authorization with complete cardiac monitoring documentation.

Table of Contents

Who Should Use This Guide

This guide is designed for Pennsylvania patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML) and their healthcare teams seeking Cigna coverage for Vanflyta (quizartinib). You'll also find this helpful if you've received a denial and need to navigate Pennsylvania's appeals process.

Expected outcome: With proper documentation, most prior authorization requests for FDA-approved indications are approved within 5-7 business days. If initially denied, Pennsylvania's external review process has shown a 53% success rate for overturning coverage denials.

Member & Plan Basics

Coverage Requirements

Active Cigna Coverage: Ensure your Pennsylvania Cigna plan is active and verify whether you have a commercial plan or Medicare Advantage. Self-funded employer plans may have different requirements.

Plan Type Considerations:

  • Commercial plans: Follow standard Cigna prior authorization process
  • Medicare Advantage: May have additional step therapy requirements
  • Express Scripts integration: Most Cigna plans use Express Scripts for specialty drug management

Deductible and Authorization: Vanflyta requires prior authorization regardless of deductible status. The medication typically falls under specialty pharmacy benefits with potential copay assistance available.

Clinical Criteria for Approval

FDA-Approved Indication

Vanflyta is approved for adult patients (≥18 years) with newly diagnosed FLT3-ITD-positive AML in combination with standard chemotherapy, followed by maintenance therapy. Cigna's coverage policy requires:

Required Clinical Elements

Requirement Specifics Documentation Needed
Age ≥18 years Date of birth verification
FLT3-ITD Mutation Confirmed positive via FDA-approved test Laboratory report from CLIA-certified lab
Diagnosis Newly diagnosed AML Pathology report with bone marrow biopsy
Cardiac Safety Baseline QTc <450ms ECG within 30 days of treatment
Treatment Phase Induction, consolidation, or maintenance Treatment plan documentation

Step Therapy Considerations

Currently, Cigna does not mandate specific step therapy between FLT3 inhibitors (Vanflyta, gilteritinib, midostaurin) for their respective FDA-approved indications. However, documentation of any prior therapy failures or contraindications strengthens your case.

Coding and Billing Requirements

ICD-10 Diagnosis Codes

Primary Code: C92.0 (Acute myeloblastic leukemia) Alternative: C92.A0 (Acute myeloid leukemia with multilineage dysplasia, not in remission)

HCPCS and NDC Information

HCPCS Code: J9999 (Not otherwise classified, antineoplastic drug) - verify with your payer as permanent codes may be assigned NDC: Contact Daiichi Sankyo or check VANFLYTA REMS portal for current NDC numbers Units: Based on prescribed strength (17.7 mg, 26.5 mg, or 35.4 mg tablets)

Documentation Packet Essentials

Medical Necessity Letter Components

Your oncologist's letter should include:

Patient Information:

  • Full name, date of birth, Cigna member ID
  • Diagnosis with ICD-10 code and date of diagnosis

Clinical Justification:

  • FLT3-ITD mutation status with specific testing details
  • Treatment history and any prior therapy failures
  • Rationale for why Vanflyta is medically necessary
  • Expected treatment duration and monitoring plan

Supporting Evidence:

  • Reference to FDA labeling and approval
  • Relevant clinical guidelines (NCCN, ELN)
  • Peer-reviewed literature supporting use

Required Attachments

  1. FLT3-ITD Test Results: From FDA-approved assay, CLIA-certified laboratory
  2. Baseline ECG: With QTc measurement and interpretation
  3. Bone Marrow Biopsy Report: Confirming AML diagnosis
  4. Treatment History: Documentation of any prior therapies
  5. REMS Certification: Proof of enrollment in VANFLYTA REMS program

Submission Process

Electronic Submission (Preferred)

CoverMyMeds Portal: Submit through CoverMyMeds for fastest processing Provider Portal: Use Cigna's provider portal for direct submission SureScripts: Available through most EHR systems

Alternative Submission Methods

Phone: 1-800-882-4462 (1-800-88-CIGNA) for urgent requests Fax: 855-840-1678 using standard medication prior authorization form

Required Form Fields

Ensure all fields are complete to avoid processing delays:

  • Patient demographics and insurance information
  • Prescriber details and NPI number
  • Medication name, strength, and dosing schedule
  • Duration of therapy and quantity requested
  • Primary and secondary diagnoses with ICD-10 codes

Specialty Pharmacy Routing

Cigna's Preferred Network

Express Scripts/Accredo: Primary specialty pharmacy for most Cigna plans Verification Steps: Confirm your plan's preferred pharmacy network Transfer Process: Your prescriber can initiate transfer if currently using a different pharmacy

Shipment Coordination

  • Verify shipping address and contact information
  • Confirm refrigeration requirements if applicable
  • Schedule delivery for when someone will be available

After Submission: Tracking Your Request

Confirmation and Timeline

Confirmation Number: Record your submission confirmation number Standard Timeline: 5-7 business days for routine requests Expedited Timeline: 24-72 hours for urgent medical situations

Status Monitoring

Online Portal: Check status through Cigna member portal or CoverMyMeds Phone Follow-up: Call Cigna customer service with your confirmation number Documentation: Keep records of all communications and reference numbers

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy
Missing FLT3-ITD Documentation Submit certified lab report from FDA-approved assay
Inadequate Cardiac Monitoring Include baseline ECG with QTc measurement and monitoring plan
Incomplete Prior Therapy History Document all previous treatments, even if none required
Wrong Treatment Phase Clearly specify induction, consolidation, or maintenance phase
REMS Non-compliance Complete VANFLYTA REMS certification before submission
Tip: The most common reason for denial is incomplete FLT3-ITD mutation documentation. Ensure your test results clearly state "FLT3-ITD positive" and include the testing methodology.

Appeals Process in Pennsylvania

Internal Appeals with Cigna

Timeline: 180 days from denial date to file internal appeal Levels: First-level and second-level internal reviews available Expedited Process: Available for urgent medical situations

Pennsylvania's Independent External Review

Pennsylvania launched its Independent External Review Program in January 2024, which has overturned 53% of appealed denials.

Eligibility: Must complete Cigna's internal appeal process first Timeline: File within 4 months of final internal denial Process:

  1. Submit request at pa.gov/reviewmyclaim
  2. Pennsylvania Insurance Department confirms eligibility within 5 business days
  3. Independent Review Organization (IRO) assigned within 1 business day
  4. Decision rendered within 45 calendar days (or 72 hours for expedited)

Success Factors: Submit comprehensive medical records, peer-reviewed literature, and clear clinical rationale supporting medical necessity.

Quick Reference Checklist

Before You Start

  • Active Cigna coverage verified
  • FLT3-ITD test results from FDA-approved assay
  • Baseline ECG with QTc measurement
  • AML diagnosis confirmation
  • VANFLYTA REMS enrollment completed

Submission Checklist

  • Complete prior authorization form
  • Medical necessity letter from oncologist
  • All required attachments included
  • Submission via preferred method (CoverMyMeds/portal)
  • Confirmation number recorded

If Denied

  • Review denial letter for specific reasons
  • Gather additional supporting documentation
  • File internal appeal within 180 days
  • Consider Pennsylvania external review if internal appeals unsuccessful

FAQ

Q: How long does Cigna prior authorization take for Vanflyta in Pennsylvania? A: Standard requests take 5-7 business days. Expedited requests for urgent situations are processed within 24-72 hours.

Q: What if Vanflyta is not on Cigna's formulary? A: You can request a formulary exception with clinical justification. The FDA approval and lack of therapeutic alternatives strengthen your case.

Q: Can I get an expedited appeal if my condition is urgent? A: Yes, both Cigna and Pennsylvania's external review process offer expedited pathways for urgent medical situations.

Q: Does step therapy apply if I've tried other treatments outside Pennsylvania? A: Prior therapy history from any location should be documented and can support your case, even if not required by current Cigna policies.

Q: What's the cost of Vanflyta without insurance? A: Cash prices range from approximately $16,100-$17,900 per 28 days. Manufacturer assistance programs may be available.

Q: Who can help me with the appeals process in Pennsylvania? A: Contact the Pennsylvania Insurance Department's consumer services at 1-877-881-6388 or the Pennsylvania Health Law Project for free assistance.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific documentation that meets each plan's unique requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and appeal denials with targeted, professional-grade submissions.

When facing a Vanflyta denial from Cigna, having the right documentation strategy can make the difference between coverage and costly out-of-pocket expenses. Counterforce Health's approach focuses on understanding each payer's specific criteria and building compelling cases that address their exact requirements.

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department or qualified healthcare advocates.

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