By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by Humana in California: Complete PA Guide with Appeals Process

Quick Answer: Getting Vanflyta Covered by Humana in California

Vanflyta (quizartinib) is not on Humana's 2024 formulary, requiring a formulary exception with prior authorization (PA). Success requires: (1) Confirmed FLT3-ITD positive AML diagnosis with lab reports, (2) Documentation of medical necessity from a REMS-certified oncologist, (3) Baseline EKG showing QTc ≤450ms. Submit through Humana's provider portal within 72 hours for standard decisions. If denied, California residents can pursue Independent Medical Review (IMR) after internal appeals for binding external review. Start by calling Humana member services (number on your card) to verify your plan's exact requirements and obtain the PA form.

Table of Contents

Humana Plan Types & Coverage Implications

Humana offers several plan types in California, each with different coverage rules for specialty drugs like Vanflyta:

Medicare Advantage Plans: Most common Humana offering in California. These plans have restrictive formularies for high-cost oncology drugs, typically requiring extensive prior authorization documentation. Humana's Medicare Advantage denial rate is approximately 3.5% (2023)—among the lowest of major insurers—but denials often occur due to incomplete documentation.

Medicare Part D: Standalone prescription coverage that follows CMS guidelines. Vanflyta falls under specialty tier coverage (typically Tier 5) with 25-33% coinsurance after deductible.

Commercial Plans: Employer-sponsored plans may have different formulary placement and PA requirements. Check your specific plan documents through Humana's member portal.

Note: All Humana plans require REMS-certified prescribers and pharmacies for Vanflyta due to QT prolongation risks.

Vanflyta Formulary Status & Alternatives

Current Formulary Placement

Vanflyta (quizartinib) is NOT listed on Humana's 2024-2025 Medicare formularies, placing it in non-formulary status. This means:

  • Requires formulary exception request
  • Higher out-of-pocket costs until approved
  • Extensive clinical documentation needed
  • Potential step therapy requirements

Preferred Alternatives

Humana typically prefers these FLT3 inhibitors when clinically appropriate:

Drug Indication Formulary Status
Midostaurin (Rydapt) Newly diagnosed FLT3+ AML Often preferred for induction
Gilteritinib (Xospata) Relapsed/refractory FLT3+ AML May require step therapy

Prior Authorization Requirements

Required Documentation

Submit the following through Humana's provider portal:

Clinical Documentation:

  • FLT3-ITD mutation confirmation via FDA-approved diagnostic test
  • Complete lab report with allelic ratio if available
  • AML diagnosis with ICD-10 codes
  • Treatment history and prior therapy failures/intolerances
  • Baseline EKG showing QTc ≤450ms
  • Oncologist medical necessity letter

Prescriber Requirements:

  • REMS certification for Vanflyta prescribing
  • Board certification in hematology/oncology
  • Detailed treatment plan including monitoring protocols

Medical Necessity Criteria

Your oncologist's letter should address:

  1. Confirmed FLT3-ITD positive status with specific mutation details
  2. Treatment phase: Newly diagnosed AML requiring induction/consolidation
  3. Prior therapy history: Document failures or contraindications to preferred alternatives
  4. Clinical rationale: Why Vanflyta is medically necessary over formulary options
  5. Safety monitoring plan: EKG monitoring schedule, dose modifications

Specialty Pharmacy Network

REMS-Certified Pharmacies

Vanflyta requires dispensing through REMS-certified specialty pharmacies only:

Pharmacy Phone Services
Biologics by McKesson 1-800-850-4306 Benefits investigation, PA assistance, copay enrollment
Onco360 Oncology Pharmacy 1-877-662-6633 REMS compliance, patient support
CenterWell Specialty Pharmacy (Verify with Humana) Humana preferred network
Tip: Contact your chosen pharmacy before PA submission. They can assist with benefits verification and enrollment in manufacturer support programs.

Step-by-Step Approval Process

Days 1-2: Preparation

  1. Call Humana member services (number on insurance card) to:
    • Verify your plan's PA requirements
    • Request the formulary exception form
    • Confirm REMS pharmacy network options
  2. Gather clinical documentation:
    • FLT3-ITD lab results
    • Recent EKG (within 30 days)
    • Complete treatment history
    • AML diagnosis confirmation

Days 3-5: Submission

  1. Oncologist submits PA through Humana provider portal with:
    • Completed formulary exception form
    • Medical necessity letter
    • All supporting clinical documents
    • Request expedited review if urgent (72-hour decision)
  2. Coordinate with specialty pharmacy:
    • Forward prescription to REMS-certified pharmacy
    • Enroll in manufacturer support programs
    • Set up patient monitoring protocols

Days 6-10: Follow-up

  1. Track PA status through provider portal or member services
  2. Respond to additional information requests promptly
  3. Prepare for potential peer-to-peer review if initial submission is incomplete

Appeals Process in California

Internal Appeals (Humana)

Timeline: File within 65 calendar days of denial notice

Standard Appeal: 7 calendar days for decision Expedited Appeal: 72 hours if health at risk

Submission Methods:

  • Online: Humana member portal (exceptions-and-appeals section)
  • Phone: 800-867-6601 (expedited requests)
  • Mail: Grievances/Appeals, Humana Health Plans, P.O. Box 14165, Lexington, KY 40512-4165
  • Fax: 1-877-556-7005 (Part D appeals)

California Independent Medical Review (IMR)

If Humana denies your appeal, California residents can request binding external review:

Who Can File: Patient, family member, or physician on patient's behalf

Timeline:

  • File within 6 months of final Humana denial
  • Standard IMR: 45 days for decision
  • Expedited IMR: 72 hours for urgent cases

How to File:

Required Documents:

  • Copy of Humana's denial letter
  • Medical records supporting necessity
  • Physician statement
Important: IMR decisions are binding on Humana. California has high success rates for medically necessary specialty drug appeals.

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient FLT3-ITD documentation Submit complete lab report with mutation details and allelic ratio
Step therapy not completed Document medical necessity for Vanflyta over preferred alternatives
Missing safety monitoring Include baseline EKG, monitoring plan, and REMS certification
Non-formulary status Request formulary exception with detailed medical necessity letter
Prescriber not certified Ensure oncologist completes REMS training before resubmission

Cost Considerations & Support Programs

Manufacturer Support

VANFLYTA Copay Program: Eligible commercial patients may pay as little as $5 per month

Patient Assistance Program: For uninsured or low-income patients

  • Income-based eligibility
  • May provide drug at no cost

Estimated Costs

  • Cash price: $16,100–$17,900 per 28-day supply
  • Humana Tier 5 coinsurance: Typically 25-33% after deductible
  • Medicare Part D coverage gap: May apply until catastrophic coverage

When navigating complex prior authorization requirements like those for Vanflyta, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons and draft point-by-point rebuttals using the right clinical evidence and payer-specific requirements.

FAQ

How long does Humana PA take for Vanflyta in California? Standard PA decisions: 72 hours for Part D, 15 business days for Medicare Advantage. Expedited decisions: 24 hours if health is jeopardized.

What if Vanflyta is denied as "not medically necessary"? File an internal appeal within 65 days, then request California IMR for binding external review. Include updated clinical documentation addressing specific denial reasons.

Can I get Vanflyta while PA is pending? Request expedited review if treatment delay risks health. Some plans provide temporary coverage during expedited appeals.

Does step therapy apply if I've failed other FLT3 inhibitors? Document prior failures or intolerances to midostaurin or gilteritinib in your PA submission. This may satisfy step therapy requirements.

What counts as medical necessity for Vanflyta? Confirmed FLT3-ITD positive AML, appropriate treatment phase (newly diagnosed), and clinical rationale for choosing Vanflyta over formulary alternatives.

Who can prescribe Vanflyta through Humana? Only REMS-certified hematologists/oncologists can prescribe. Prescriber must complete manufacturer training program.

Sources & Further Reading

For additional support with complex insurance appeals and prior authorization requirements, Counterforce Health provides specialized assistance in turning denials into successful approvals using evidence-based appeal strategies tailored to specific payer policies.

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 formularies change frequently; verify current requirements with Humana directly.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.