By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (quizartinib) Covered by Cigna in Florida: ICD-10, HCPCS, and Appeal Guide

Answer Box: Getting Vanflyta (quizartinib) Covered by Cigna in Florida

Vanflyta requires prior authorization from Cigna in Florida. The fastest path: Submit PA with FLT3-ITD lab results, ICD-10 code C92.00 (AML not in remission), and HCPCS J8999 for billing. If denied, you have 180 days for internal appeal, then 120 days for external review through Florida Department of Financial Services. Start today: Contact your oncologist to request FLT3-ITD mutation documentation and begin the Cigna prior authorization process.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for FLT3-ITD AML
  3. Product Coding: HCPCS, NDCs, and Units
  4. Clean Prior Authorization Request
  5. Frequent Coding Pitfalls
  6. Verification with Cigna Resources
  7. Quick Audit Checklist
  8. Appeals Playbook for Florida
  9. Common Denial Reasons & Solutions
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Vanflyta (quizartinib) is an oral FLT3 inhibitor for newly diagnosed FLT3-ITD-positive AML. Understanding how Cigna processes this drug is crucial for coverage success.

Medical Benefit Path (Most Common):

  • Used when administered in clinical settings or requires special handling
  • Billed using HCPCS codes (J8999 for Vanflyta)
  • Requires prior authorization through Cigna's medical management
  • Higher approval rates when properly documented

Pharmacy Benefit Path:

  • Processed through Express Scripts/Accredo specialty pharmacy
  • Uses NDC codes for dispensing
  • Subject to formulary restrictions and step therapy
  • May require formulary exception if non-formulary
Tip: Most Cigna plans in Florida route Vanflyta through the medical benefit due to its specialized administration requirements and REMS program restrictions.

ICD-10 Mapping for FLT3-ITD AML

Accurate diagnosis coding is essential for Vanflyta approval. Cigna requires specific documentation of FLT3-ITD-positive AML.

Primary ICD-10 Codes

Code Description When to Use
C92.00 Acute myeloblastic leukemia, not having achieved remission Initial treatment, induction phase
C92.01 Acute myeloblastic leukemia, in remission Maintenance therapy
C92.02 Acute myeloblastic leukemia, in relapse Relapsed/refractory cases

Documentation Requirements

Your medical records must include:

  • FLT3-ITD mutation test results with positive findings
  • Cytogenetic analysis confirming AML diagnosis
  • Treatment phase (induction, consolidation, maintenance)
  • Prior therapy history including response and tolerability
Note: Avoid using unspecified codes like C92.9, as they often trigger automatic denials and may require additional documentation.

Product Coding: HCPCS, NDCs, and Units

HCPCS/J-Code Information

Current Status: Vanflyta does not have a permanent J-code as of 2025.

Billing Code: Use J8999 (oral chemotherapy, not otherwise specified)

Alternative: C9399 (unclassified drugs) may be accepted for certain claims

NDC Codes by Strength

Strength Package Size NDC
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

Units and Dosing Calculations

Standard Dosing:

  • Induction: 35.4 mg daily (2 × 17.7 mg tablets)
  • Maintenance: 26.5 mg daily (1 × 26.5 mg tablet)

Billing Units: Always bill by total daily dose in milligrams, not tablet count.

Example: For 35.4 mg daily dose:

  • Quantity: 2 tablets
  • Days Supply: 28 days
  • Total Units: 56 tablets (2 × 28)

Clean Prior Authorization Request

A complete PA request significantly improves approval odds. Here's the anatomy of a successful submission:

Required Documentation Checklist

  • Patient Demographics: Name, DOB, Cigna member ID
  • Diagnosis: ICD-10 code C92.00/C92.01/C92.02 with supporting documentation
  • FLT3-ITD Lab Results: Positive mutation confirmation
  • Treatment History: Prior therapies, dates, outcomes, reasons for discontinuation
  • Clinical Rationale: Why Vanflyta is medically necessary
  • Prescriber Information: NPI, DEA, contact information
  • Product Details: Exact NDC, strength, quantity, days supply
  • REMS Compliance: Confirmation of prescriber enrollment

Sample Clinical Rationale

"Patient is an 18-year-old with newly diagnosed FLT3-ITD-positive AML confirmed by molecular testing on [date]. Per NCCN guidelines and FDA labeling, quizartinib in combination with standard chemotherapy is indicated for this patient population. Alternative FLT3 inhibitors are not appropriate due to [specific clinical reason]."

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting evidence-backed appeals tailored to each payer's specific policies.

Frequent Coding Pitfalls

Common Mistakes That Trigger Denials

Unit Conversion Errors:

  • Billing by tablet count instead of total daily dose
  • Wrong NDC for dispensed strength
  • Mismatched quantity and days supply calculations

Documentation Gaps:

  • Missing FLT3-ITD mutation proof
  • Incorrect treatment phase designation
  • Inadequate prior therapy documentation

Administrative Issues:

  • Incomplete PA forms
  • Missing prescriber attestations
  • Exceeding plan quantity limits

How to Avoid These Pitfalls

  1. Double-check all calculations before submission
  2. Verify NDC matches the actual product dispensed
  3. Include complete lab reports showing FLT3-ITD positivity
  4. Document treatment phase clearly in clinical notes
  5. Use exact language from FDA prescribing information

Verification with Cigna Resources

Before submitting your PA request, verify requirements using Cigna's official resources:

Key Verification Steps

  1. Check Formulary Status: Visit Cigna's drug list portal to confirm current formulary tier
  2. Review PA Requirements: Download the latest Vanflyta PA form from Cigna's provider portal
  3. Confirm Billing Codes: Cross-reference HCPCS and NDC codes with Cigna's coverage policies
  4. Validate Clinical Criteria: Review Cigna's medical necessity criteria for FLT3 inhibitors

Cigna-Specific Resources

  • Provider Portal: CignaforHCP.com for PA forms and policies
  • Member Services: 1-800-CIGNA24 for coverage verification
  • Express Scripts: For specialty pharmacy requirements (verify with source linked below)

Quick Audit Checklist

Use this checklist before submitting any Vanflyta request:

Pre-Submission Review

  • Patient eligibility confirmed with Cigna
  • Diagnosis code matches clinical documentation
  • FLT3-ITD results attached and clearly positive
  • NDC and units calculated correctly
  • Prior authorization form completely filled out
  • Clinical rationale includes guideline references
  • Prescriber information complete and accurate
  • REMS compliance documented
  • Timeline allows for processing (submit 5-7 days before needed)

Appeals Playbook for Florida

If Cigna denies your Vanflyta request, Florida law provides specific appeal rights with binding external review.

Internal Appeal Process

Timeline: 180 days from denial notice Levels: First and second-level internal review available Submission: Via Cigna member portal or written request Decision: 30 days for standard, 72 hours for expedited

External Review Process

Eligibility: After exhausting internal appeals Timeline: 120 days from final internal denial Authority: Florida Department of Financial Services Contact: 1-877-MY-FL-CFO (1-877-693-5236) Decision: 45 days standard, 72 hours expedited Cost: Free to consumer

Required Appeal Documents

  • Final denial letter from Cigna
  • Medical necessity letter from prescriber
  • FLT3-ITD lab results
  • Treatment history documentation
  • FDA prescribing information
  • Relevant clinical guidelines (NCCN, etc.)
From our advocates: We've seen Cigna appeals succeed most often when they include peer-reviewed studies specifically addressing FLT3-ITD mutations and detailed documentation of why alternative therapies aren't suitable. The key is matching your clinical story to Cigna's specific denial reasons.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
No FLT3-ITD documentation Submit lab results Molecular testing report with positive FLT3-ITD
Step therapy not met Request override Prior therapy failure/intolerance documentation
Not medically necessary Provide clinical rationale NCCN guidelines, FDA label, peer-reviewed studies
Quantity limit exceeded Request exception Clinical justification for higher dose/duration
Non-formulary status Request formulary exception Medical necessity letter, alternative failure documentation

Step Therapy Override Template

When Cigna requires trying other FLT3 inhibitors first, use this approach:

"Patient has newly diagnosed FLT3-ITD-positive AML requiring immediate, appropriate therapy per NCCN guidelines. Delaying optimal treatment with quizartinib to trial alternative agents would compromise patient outcomes and is not clinically appropriate given the aggressive nature of this malignancy."

Counterforce Health's platform can help identify the specific denial basis and craft targeted rebuttals aligned with Cigna's own coverage policies, turning denials into successful appeals with evidence-backed arguments.

FAQ

How long does Cigna prior authorization take in Florida? Standard PA decisions are made within 72 hours to 15 days. Expedited requests (for urgent medical needs) are processed within 72 hours.

What if Vanflyta is non-formulary on my Cigna plan? Request a formulary exception by submitting clinical documentation showing medical necessity and why formulary alternatives aren't appropriate.

Can I request an expedited appeal in Florida? Yes, if delay would seriously jeopardize your health or treatment efficacy. Both internal and external expedited appeals are available with 72-hour decision timelines.

Does step therapy apply if I've tried other FLT3 inhibitors outside Florida? Yes, document all prior therapies regardless of where they were tried. Out-of-state treatment history counts toward step therapy requirements.

What's the success rate for Vanflyta appeals with Cigna? While specific rates aren't published, oncology appeals with complete clinical documentation and guideline support have higher success rates, especially when rare disease evidence is provided.

How much does Vanflyta cost without insurance? Cash prices range from approximately $16,100-$17,900 per 28-day supply, depending on strength and pharmacy (verify with GoodRx or manufacturer).

Are there patient assistance programs available? Yes, Daiichi Sankyo offers patient support programs. Contact their access center for eligibility requirements and application assistance.

What happens if my external review is successful? The decision is binding on Cigna. They must cover Vanflyta as requested and may need to reimburse any costs you paid out-of-pocket during the appeal process.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance.

Sources & Further Reading

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