By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by Aetna CVS Health in Pennsylvania: Complete ICD-10, HCPCS, and Appeals Guide

Answer Box: Get Vanflyta Approved by Aetna CVS Health in Pennsylvania

Eligibility: Vanflyta (quizartinib) requires prior authorization from Aetna CVS Health for newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). Fastest path: Submit PA request with FLT3-ITD lab report, baseline EKG showing QTc ≤450ms, and AML diagnosis using ICD-10 code C92.00. First step today: Download the current Aetna Vanflyta PA form from the CVS Caremark provider portal and gather required documentation. If denied, Pennsylvania's external review program has overturned roughly 50% of denials in 2024.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for FLT3-ITD Positive AML
  3. Product Coding: HCPCS, J-Codes, and NDC Numbers
  4. Clean Prior Authorization Request Anatomy
  5. Frequent Billing and PA Pitfalls
  6. Verification Steps with Aetna CVS Health
  7. Pennsylvania Appeals Process
  8. Quick Pre-Submission Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Vanflyta (quizartinib) is an oral FLT3 inhibitor that can be billed under either the medical benefit or pharmacy benefit, depending on your Aetna plan structure and site of care.

Pharmacy Benefit Path

  • Most common for oral oncology drugs
  • Requires prior authorization through CVS Caremark
  • Dispensed via CVS Specialty Pharmacy network
  • Uses NDC-based billing with quantity limits

Medical Benefit Path

  • Used when administered in hospital outpatient or infusion center settings
  • Bills using miscellaneous HCPCS codes (typically J8999)
  • May require separate medical necessity review
  • Often applies when drug is part of inpatient or observation stay
Tip: Verify your specific Aetna plan's coverage pathway by calling the member services number on your insurance card or checking the CVS Caremark formulary.

ICD-10 Mapping for FLT3-ITD Positive AML

Accurate diagnosis coding is critical for Vanflyta approval, as the drug is specifically indicated for FLT3-ITD positive AML.

Primary ICD-10 Code

C92.00 - Acute myeloblastic leukemia, not having achieved remission

This code should be used for newly diagnosed patients who haven't yet achieved remission status.

Documentation Requirements

Your medical record must explicitly include:

  • Disease phase: "Newly diagnosed" or "not having achieved remission"
  • Molecular findings: "FLT3-ITD positive" with allelic ratio if available
  • Diagnostic confirmation: Bone marrow biopsy results with morphology and immunophenotyping
  • Cytogenetic context: Risk category (often cytogenetically normal AML for FLT3-ITD cases)

Supporting Documentation Words

Include these specific phrases in clinical notes to support coding:

  • "Acute myeloid leukemia with FLT3-ITD mutation"
  • "FLT3 internal tandem duplication positive"
  • "Newly diagnosed AML, not in remission"
  • "Candidate for FLT3 inhibitor therapy"

Product Coding: HCPCS, J-Codes, and NDC Numbers

HCPCS/J-Code Status

As of 2025, Vanflyta does not have a permanent HCPCS J-code. For medical benefit billing, use:

  • J8999 - Oral chemotherapy drug, not otherwise specified
  • C9399 - Unclassified drugs (alternative in some settings)

NDC Numbers and Tablet Strengths

Vanflyta is available in two strengths:

  • 17.7 mg tablets
  • 26.5 mg tablets
Critical: Always use the exact NDC from the product packaging. NDC numbers are strength-specific and using the wrong NDC is a common cause of claim rejection.

Units and Billing Math

  • Bill by "each tablet" dispensed, not total milligrams
  • Typical dosing: 35.4 mg daily (induction/consolidation), 26.5-53 mg daily (maintenance)
  • Example: For 35.4 mg daily dose = 1 tablet of 26.5 mg + 1 tablet of 17.7 mg = 2 tablets per day

Clean Prior Authorization Request Anatomy

A successful Aetna CVS Health PA request for Vanflyta must include these specific elements:

Required Clinical Documentation

  1. FLT3-ITD positive lab report from PCR-based assay or equivalent genetic test
  2. Baseline EKG documenting QTc interval ≤450 ms (cardiac safety requirement)
  3. AML diagnosis confirmation with bone marrow biopsy results
  4. Treatment plan specifying phase (induction, consolidation, maintenance) and duration
  5. Electrolyte panel if baseline abnormalities were present and corrected

Submission Methods (Fastest to Slowest)

  1. CoverMyMeds portal - 24-48 hour review time
  2. CVS Caremark Provider Portal - 24-48 hours
  3. Direct EHR integration - 24-48 hours
  4. Fax submission - 2-3 business days
Note: For specialty drugs, call 1-866-814-5506 (prescribers only) for status updates or urgent cases.

Frequent Billing and PA Pitfalls

Common Coding Errors

Error Consequence Solution
Mixing tablet strengths on same claim Payment delays, audit triggers List each strength separately with correct NDC
Using total mg instead of tablet count Significant over/underbilling Specify both tablet strength and quantity
Wrong NDC for strength dispensed Claim rejection Double-check NDC matches exact tablet strength

Prior Authorization Mistakes

  • Missing FLT3-ITD status: PA requests must explicitly document FLT3-ITD positivity
  • Incomplete treatment phase documentation: Specify if induction, consolidation, or maintenance
  • No cardiac monitoring plan: QTc prolongation risk requires EKG documentation
  • Incorrect regimen details: Must mention combination with standard chemotherapy for induction/consolidation

Verification Steps with Aetna CVS Health

Before submitting your PA request, verify these key details:

Plan-Specific Checks

  1. Formulary status: Check if Vanflyta is covered under your specific Aetna plan
  2. Tier placement: Determine copay/coinsurance requirements
  3. Quantity limits: Verify maximum days supply allowed
  4. Site of care restrictions: Confirm if CVS Specialty Pharmacy is required

Cross-Reference Resources

Pennsylvania Appeals Process

If Aetna CVS Health denies your Vanflyta request, Pennsylvania offers robust appeal rights with a new state-supervised external review program.

Internal Appeal Timeline

  • Filing deadline: 180 days from denial notice
  • Standard review: 30-45 days for decision
  • Expedited review: ≤72 hours for urgent cases

Pennsylvania External Review Process

Pennsylvania launched its Independent External Review Program in January 2024, with impressive results:

Success Rate: Approximately 50% of external reviews result in overturned denials

External Review Timeline

  1. File within 4 months of Final Adverse Benefit Determination
  2. Submit online or by mail using Pennsylvania Insurance Department forms
  3. Standard review: 45 days from IRO assignment
  4. Expedited review: 72 hours for urgent cases
  5. Decision is binding on both insurer and patient

How to File External Review

From our advocates: We've seen cases where patients initially denied for Vanflyta had their coverage approved through Pennsylvania's external review process after submitting additional FLT3-ITD documentation and cardiac monitoring plans. The key was providing comprehensive clinical rationale that the independent physicians could clearly evaluate.

Quick Pre-Submission Audit Checklist

Before submitting your Vanflyta PA request or claim, verify:

Clinical Documentation ✓

  • FLT3-ITD positive lab report attached
  • Baseline EKG shows QTc ≤450 ms
  • AML diagnosis confirmed with ICD-10 code C92.00
  • Treatment phase clearly specified
  • Prescriber NPI and contact information current

Coding Accuracy ✓

  • Correct NDC for tablet strength prescribed
  • Quantity matches dosing schedule
  • Units specified as "tablets" not "mg"
  • HCPCS J8999 used for medical benefit claims

Submission Details ✓

  • Most current PA form version used
  • Aetna member ID included
  • All required signatures present
  • Submission method confirmed (portal preferred)

FAQ

How long does Aetna CVS Health PA take for Vanflyta in Pennsylvania? Standard PA decisions typically take 30-45 days. Electronic submissions through CoverMyMeds or the CVS Caremark portal are processed in 24-48 hours.

What if Vanflyta is non-formulary on my Aetna plan? You can request a formulary exception by demonstrating medical necessity and providing documentation of failed alternatives or contraindications to preferred agents.

Can I request an expedited appeal in Pennsylvania? Yes, if your physician certifies that delay poses serious risk to your health. Expedited appeals must be decided within 72 hours.

Does step therapy apply to Vanflyta? Many Aetna plans require trial of preferred FLT3 inhibitors first. Document any failures, intolerances, or contraindications to other agents.

What costs should I expect for Vanflyta? Cash prices range from $16,100-$17,900 per 28 days. Check with Daiichi Sankyo's patient support program for potential copay assistance.

How do I find my specific Aetna formulary? Log into your member portal or call the number on your insurance card. CVS Caremark manages most Aetna specialty drug coverage.

When facing insurance denials for specialty medications like Vanflyta, having the right documentation and understanding the appeals process can make all the difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements.

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 company for specific coverage decisions. Insurance policies and requirements may change. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department Consumer Services Bureau at 1-877-881-6388.

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