By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by Humana in Florida: Complete PA Guide with Forms and Appeals

Answer Box: Getting Vanflyta Covered by Humana in Florida

Vanflyta (quizartinib) is non-formulary on Humana Medicare Advantage plans, requiring a formulary exception and prior authorization for coverage. Your fastest path to approval: (1) Have your oncologist gather FLT3-ITD lab results and complete cardiac monitoring documentation, (2) Submit Humana's prior authorization form with medical necessity letter citing FDA approval for FLT3-ITD positive AML, and (3) Request expedited review if clinically urgent. In Florida, you have 65 days to appeal denials and can request external review through the Florida Department of Financial Services if internal appeals fail.

Table of Contents

Plan Types & Coverage Implications

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

Medicare Advantage Plans: Humana's largest Florida footprint. These plans follow Medicare Part D formulary rules and have standardized appeals processes. Prior authorization decisions typically take 30 days for non-urgent requests.

Commercial Plans: Include HMO, PPO, and EPO options. May have different formulary placement and step therapy requirements compared to Medicare plans. Network restrictions may apply for specialty pharmacy dispensing.

Medicaid Plans: In Florida, Humana participates in managed Medicaid. Coverage criteria often align with state Medicaid preferred drug lists and may require additional state-specific documentation.

Note: Your plan type affects which forms to use and appeal timelines. Check your insurance card for plan details before starting the prior authorization process.

Formulary Status & Tier Placement

Coverage at a Glance

Requirement Status What This Means Source
Formulary Status Non-formulary Requires formulary exception Humana Drug Lists
Prior Authorization Required Must submit PA form with clinical documentation Humana PA Lists
Step Therapy Yes Trial of midostaurin typically required first Humana Policy Guidelines
Specialty Pharmacy Required Must use REMS-certified specialty pharmacy VANFLYTA REMS
Appeals Deadline 65 days From date of denial notice Medicare Appeals

Vanflyta is classified as non-formulary on available 2024-2025 Humana formularies. This means it's not on their standard covered drug list, but coverage can be obtained through a formulary exception when medical necessity is demonstrated.

Preferred Alternatives

Humana typically prefers these FLT3 inhibitors on Medicare Advantage plans:

  • Midostaurin (Rydapt): Often preferred for newly diagnosed FLT3-positive AML
  • Gilteritinib (Xospata): Preferred for relapsed/refractory FLT3-positive AML

Your authorization request should include clinical justification for why these alternatives are inappropriate for your specific case.

Prior Authorization Requirements

Required Clinical Documentation

FLT3-ITD Test Results

  • Original lab report from CLIA-certified facility showing positive FLT3 internal tandem duplication
  • Specific test methodology and results must be included—summary documents alone are insufficient
  • Test date and methodology details should be documented

Baseline Safety Documentation

  • Recent EKG showing QTc ≤450ms (cardiac risk assessment)
  • Baseline cardiac function assessment with ongoing monitoring plan
  • Complete blood count and comprehensive metabolic panel

Treatment History

  • Documentation of failure, intolerance, or contraindications to preferred alternatives
  • Prior therapy dates, outcomes, and reasons for discontinuation
  • Complete AML diagnosis documentation with ICD-10 code C92.0

Medical Necessity Letter Requirements

Your oncologist must submit a comprehensive letter including:

  1. Patient demographics (name, DOB, Humana member ID)
  2. FLT3-ITD positive status with test date and methodology
  3. Diagnosis confirmation and current treatment phase
  4. Safety monitoring plan with baseline EKG results
  5. Clinical rationale referencing FDA labeling and NCCN guidelines
  6. Plan for ongoing cardiac and electrolyte monitoring
Clinician Corner: Include specific language like "Patient has FLT3-ITD positive AML confirmed by [test name] on [date]. Vanflyta is FDA-approved for this indication in combination with standard induction and consolidation chemotherapy, followed by single-agent maintenance therapy."

Step Therapy & Preferred Alternatives

Humana imposes step therapy requirements on FLT3 inhibitors, typically mandating trials of preferred agents before approving Vanflyta.

Step Therapy Sequence

  1. First-line preferred: Midostaurin (Rydapt) with induction/consolidation chemotherapy
  2. Alternative consideration: Gilteritinib (Xospata) for relapsed/refractory disease
  3. Non-preferred: Vanflyta requires documentation of failure or contraindication to preferred options

Step Therapy Exemptions

You may qualify for step therapy exemption if:

  • You've had paid claims for Vanflyta in the past 365 days
  • Preferred alternatives are contraindicated due to drug interactions or allergies
  • You've previously failed preferred agents with documented intolerance

Documentation for exemption: Submit records showing specific adverse reactions, drug interactions, or treatment failures with preferred FLT3 inhibitors.

Specialty Pharmacy Requirements

Vanflyta must be dispensed through a specialty pharmacy certified with the VANFLYTA REMS program.

REMS Certification Requirements

Any specialty pharmacy dispensing Vanflyta must:

  • Complete staff training on REMS requirements prior to dispensing
  • Establish processes to verify prescriber REMS certification
  • Enroll through the Pharmacy Enrollment Form

Patient Support Services

Specialty pharmacies can assist with:

  • Conducting benefits investigations
  • Completing prior authorization requests
  • Enrollment in VANFLYTA Copay Program for eligible commercially insured patients
  • Referral to patient assistance programs
Note: While Humana works with multiple specialty pharmacy networks, verify which pharmacies in Florida are both Humana-contracted and REMS-certified before filling your prescription.

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic)
    • FLT3-ITD lab results from CLIA-certified facility
    • Baseline EKG with QTc measurement
    • Prior therapy records and failure documentation
    • Complete AML diagnosis with pathology report
  2. Complete PA Form (Prescriber)
    • Submit through Humana provider portal
    • Include all required clinical documentation
    • Request expedited review if clinically urgent
  3. Medical Necessity Letter (Oncologist)
    • Reference FDA approval for FLT3-ITD positive AML
    • Document contraindications to preferred alternatives
    • Include safety monitoring plan
  4. Follow Up (Patient/Clinic)
    • Track submission status through provider portal
    • Respond promptly to requests for additional information
    • Prepare for potential peer-to-peer review

Timeline Expectations

  • Standard requests: 15 business days for Medicare Advantage pre-service requests
  • Expedited requests: 24 hours if clinical urgency is demonstrated
  • Automatic escalation: If no decision within standard timeframe

Appeals Process in Florida

Internal Appeals Timeline

Filing Deadline: You have 65 calendar days from the date of Humana's denial notice to file an appeal (updated as of November 2024).

Decision Timeline:

  • Standard appeal: 7 calendar days
  • Fast/expedited appeal: 72 hours
  • Automatic escalation to Independent Review Entity if Humana fails to decide within 7 days

Required Appeal Documentation

Your appeal must include:

  • Your name, address, and Medicare number
  • The specific drug being appealed (Vanflyta/quizartinib)
  • Detailed reason(s) for the appeal
  • Any supporting clinical information
  • Prescriber statement of medical necessity

External Review Process

If internal appeals fail, Florida offers external review through independent medical experts:

  • Request deadline: 4 months after final internal denial
  • Filing location: Florida Department of Financial Services
  • Cost: No charge to consumers
  • Timeline: Standard external review decisions within 45 days; expedited within 72 hours for urgent cases
When to Request Expedited Review: If delays in treatment could seriously jeopardize your health or ability to regain maximum function.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing FLT3-ITD documentation Submit original CLIA-certified lab report Full test results with methodology, not summaries
Step therapy not completed Document failure/contraindication to midostaurin Treatment records showing adverse events or inefficacy
Cardiac monitoring concerns Provide baseline EKG and monitoring plan EKG showing QTc ≤450ms with cardiologist clearance
Not medically necessary Strengthen clinical justification FDA labeling citation and NCCN guideline reference
REMS requirements not met Confirm prescriber and pharmacy certification REMS enrollment confirmation for both

Scripts for Common Situations

Patient Phone Script for Humana Member Services: "I'm calling about a prior authorization denial for Vanflyta for FLT3-ITD positive AML. My member ID is [number]. Can you tell me the specific reason for denial and what additional documentation is needed? I'd also like to request an expedited internal appeal due to the urgent nature of my cancer treatment."

Clinic Staff Script for Peer-to-Peer Review: "We're requesting a peer-to-peer review for Vanflyta prior authorization. The patient has FLT3-ITD positive AML confirmed by [test name]. Preferred alternatives are contraindicated due to [specific reason]. This is FDA-approved therapy for this exact indication."

When to Escalate

Contact Florida regulators if you experience:

  • Humana failing to respond within required timeframes
  • Improper denial of medically necessary treatment
  • Procedural violations in the appeals process

Florida Department of Financial Services

  • Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)
  • Online complaint form
  • Submit documentation: denial letters, appeal responses, clinical records

Costs & Savings Options

Cash Price Range: ~$16,100–$17,900 per 28 days depending on strength and quantity.

Financial Assistance Options:

  • VANFLYTA Copay Program: For eligible commercially insured patients
  • Patient assistance programs for uninsured patients
  • Manufacturer support through Daiichi Sankyo patient services
Educational Note: Copay assistance eligibility varies by plan type. Medicare patients typically cannot use manufacturer copay cards due to federal anti-kickback regulations.

From Our Advocates

We've seen success when patients work closely with their oncology team to document previous FLT3 inhibitor failures in detail. One effective approach is having the oncologist include specific adverse events or lack of response to midostaurin with exact dates and lab values. This clinical narrative, combined with current disease status and treatment urgency, creates a compelling medical necessity case that often leads to approval on appeal.

FAQ

How long does Humana prior authorization take in Florida? Standard requests take 15 business days for Medicare Advantage plans. Expedited requests are decided within 24 hours if clinical urgency is demonstrated.

What if Vanflyta is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity. This requires clinical documentation showing why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delays could seriously jeopardize your health. Include supporting documentation from your oncologist explaining the urgency.

Does step therapy apply if I failed treatments outside Florida? Yes, treatment failures from any location count toward step therapy requirements. Submit complete records from previous providers.

What happens if my internal appeal is denied? You can request external review through the Florida Department of Financial Services within 4 months of the final internal denial.

Who can help me navigate this process? Your oncology team, Humana member services, Florida's Insurance Consumer Helpline (1-877-693-5236), and organizations like Counterforce Health that specialize in insurance appeals for specialty medications.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules. For medications like Vanflyta, Counterforce Health pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with required clinical facts and operational details that payers expect.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with insurance appeals and prior authorization challenges, contact Counterforce Health or Florida's Insurance Consumer Helpline at 1-877-693-5236.

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