By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (quizartinib) Covered by UnitedHealthcare in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Vanflyta Covered by UnitedHealthcare in Pennsylvania

UnitedHealthcare requires prior authorization for Vanflyta (quizartinib) through OptumRx, with specific criteria including confirmed FLT3-ITD mutation, baseline EKG showing QTc ≤450ms, and use in newly diagnosed AML. Submit via the OptumRx provider portal with complete documentation. If denied, Pennsylvania's new Independent External Review process has a 53% overturn rate for appeals filed within 4 months at pa.gov/reviewmyclaim.

First step today: Have your oncologist gather your FLT3-ITD lab results, recent EKG, and treatment plan, then submit the PA request through OptumRx at 1-800-711-4555.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Documentation Checklist
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Pennsylvania
  6. Costs and Financial Assistance
  7. Frequently Asked Questions
  8. When to Contact Pennsylvania Regulators

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Vanflyta prescriptions OptumRx portal or call 1-800-711-4555 UHC Provider Guide
FLT3-ITD Positive Confirmed mutation via FDA-approved test Lab report from Quest, LabCorp, or ARUP OptumRx Criteria
Baseline EKG QTc ≤450ms (men) or ≤470ms (women) Cardiology or oncology notes FDA Label
Newly Diagnosed AML Adult patients, induction/consolidation/maintenance Medical records with diagnosis date OptumRx Criteria
Oncologist Prescriber Hematology/oncology specialist Provider credentials in submission UHC Provider Guide

Step-by-Step: Fastest Path to Approval

1. Confirm FLT3-ITD Status (Patient/Clinic)

What you need: FDA-approved test results showing positive FLT3-ITD mutation Timeline: If not done, order immediately (3-5 business days for results) Action: Contact your oncologist to ensure results are documented in your chart

2. Obtain Baseline EKG (Clinic)

What you need: EKG showing QTc ≤450ms within 30 days of treatment start Timeline: Same-day if done in clinic Action: Schedule with cardiology if QTc monitoring concerns exist

3. Gather Treatment Documentation (Clinic)

What you need: AML diagnosis, staging, prior therapies (if any), treatment plan Timeline: 1-2 business days to compile Action: Medical assistant pulls relevant chart notes and lab results

4. Submit Prior Authorization (Oncologist)

Who does it: Your oncologist's office How to submit: OptumRx provider portal or call 1-800-711-4555 Timeline: 3-5 business days for review (faster if automated approval) Documents needed: Complete PA form, clinical notes, lab results, EKG

5. Monitor Status (Patient/Clinic)

Where to check: OptumRx member portal at optumrx.com Timeline: Updates within 24-48 hours of submission Action: Call OptumRx at 1-844-368-8740 if no update after 5 business days

6. Receive Decision (Patient/Clinic)

Approval: Authorization letter sent to patient and prescriber; proceed to specialty pharmacy Denial: Letter includes specific reasons and appeal instructions Timeline: Most decisions within 5 business days

7. Fill Prescription or Appeal (Patient/Clinic)

If approved: Use UnitedHealthcare's specialty pharmacy network or home delivery If denied: Begin internal appeal process immediately (see Appeals section below) Timeline: Appeals must be filed within 180 days of denial

Required Documentation Checklist

Tip: Gather these documents before starting the PA process to avoid delays.

Essential Clinical Documentation:

  • FLT3-ITD mutation test results (positive)
  • AML diagnosis with ICD-10 code (typically C92.00)
  • Baseline EKG with QTc measurement
  • Complete blood count and metabolic panel
  • Treatment phase specification (induction, consolidation, or maintenance)
  • Prior therapy history (if applicable)

Administrative Documents:

  • UnitedHealthcare member ID card
  • Prescriber NPI and credentials
  • Treatment plan with dosing schedule
  • Site of care information
  • Patient weight and BSA calculations

For Appeals (if needed):

  • Original denial letter
  • Additional clinical evidence
  • NCCN guideline citations
  • Peer-reviewed literature supporting use

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"FLT3-ITD status not documented" Submit FDA-approved lab report Quest 39786, LabCorp 485010, or ARUP results
"Baseline cardiac evaluation missing" Provide EKG with QTc measurement Cardiology report or oncology EKG
"Step therapy required" Document contraindications to alternatives Medical necessity letter citing intolerance
"Not for maintenance phase" Clarify treatment timeline Treatment plan showing post-consolidation use
"Prescriber not qualified" Verify oncology credentials Board certification documentation

Medical Necessity Letter Template Elements:

  • Patient's FLT3-ITD positive AML diagnosis
  • Prior treatment failures or contraindications
  • NCCN guideline support for FLT3 inhibitors
  • Monitoring plan for cardiac safety
  • Treatment goals and expected outcomes

Appeals Process in Pennsylvania

Pennsylvania's new Independent External Review (IER) process, launched in January 2024, has proven highly effective for overturning insurance denials.

Internal Appeals (Required First Step)

Timeline: Must complete UnitedHealthcare's internal appeal within 180 days of denial How to file:

  • Online: UnitedHealthcare member portal
  • Phone: Number on denial letter
  • Mail: Address provided in denial notice

Required documents:

  • Original denial letter
  • Additional clinical evidence
  • Medical necessity letter from oncologist
  • Supporting literature or guidelines

Pennsylvania External Review Process

After completing internal appeals and receiving a "Final Adverse Benefit Determination" letter:

Timeline: File within 4 months of final denial letter Success rate: 53% of appeals overturned in first six months How to file: pa.gov/reviewmyclaim Cost: Free to consumers

Process Timeline:

Step Deadline
Submit IER request Within 4 months of final denial
PID forwards to insurer 1 business day
Insurer confirms eligibility 5 business days
Independent Review Organization (IRO) assigned 1 business day
Submit additional evidence to IRO 15 business days
IRO decision issued 45 days from assignment

For urgent cases (life-threatening situations):

  • IRO decision within 72 hours
  • Expedited timeline throughout process
From our advocates: "We've seen several Pennsylvania patients successfully overturn Vanflyta denials by emphasizing the time-sensitive nature of newly diagnosed AML and the specific need for FLT3-targeted therapy. The key is providing comprehensive documentation upfront and clearly explaining why alternatives aren't appropriate."

Costs and Financial Assistance

Estimated Costs:

  • Cash price: ~$16,100–$17,900 per 28-day supply
  • With insurance: Varies by plan, typically $10-$100 copay for specialty tiers

Financial Assistance Options:

  • Daiichi Sankyo Patient Support: Check manufacturer website for copay assistance programs
  • Cancer Financial Assistance Coalition: Multiple foundation grants available
  • Pennsylvania CHIP: For eligible families with children
  • Medicaid: Enhanced coverage through Pennsylvania's expanded Medicaid program

Counterforce Health helps patients navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned with payer policies, significantly improving approval rates for specialty medications like Vanflyta.

Frequently Asked Questions

How long does UnitedHealthcare PA take in Pennsylvania? Standard review takes 3-5 business days. Electronic submissions through the OptumRx portal are often faster, with some automated approvals in under 24 hours.

What if Vanflyta is non-formulary on my plan? Request a formulary exception by demonstrating medical necessity. Your oncologist can submit a letter explaining why formulary alternatives aren't appropriate for FLT3-ITD positive AML.

Can I request an expedited appeal? Yes, if your condition is life-threatening or could seriously jeopardize your health. Newly diagnosed AML often qualifies for expedited review.

Does step therapy apply if I've failed other treatments outside Pennsylvania? Document all prior therapies with dates, doses, and outcomes. Out-of-state treatment failures should count toward step therapy requirements.

What happens if Pennsylvania's external review overturns the denial? The decision is binding. UnitedHealthcare must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal.

How do I prove FLT3-ITD positive status? You need results from an FDA-approved test. Common labs include Quest Diagnostics (test 39786), LabCorp (test 485010), or ARUP Laboratories (test 3001161).

What if my EKG shows QTc >450ms? Vanflyta cannot be initiated with elevated QTc. Work with cardio-oncology to optimize conditions and recheck. Consider alternative FLT3 inhibitors if cardiac risks persist.

Can I appeal directly to Pennsylvania regulators? Only after completing UnitedHealthcare's internal appeals and receiving a final denial. Pennsylvania's external review is the next step, not a direct complaint to regulators.

When to Contact Pennsylvania Regulators

Contact the Pennsylvania Insurance Department if:

  • UnitedHealthcare fails to respond within required timelines
  • You need help understanding the external review process
  • You suspect unfair claims practices

Pennsylvania Insurance Department:

The state's Consumer Services team can provide guidance throughout the appeals process and ensure insurers comply with Pennsylvania regulations.

For complex cases requiring detailed appeal strategies, Counterforce Health specializes in turning insurance denials into successful approvals by leveraging payer-specific workflows and evidence-based appeal letters.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact qualified professionals for legal guidance on insurance matters. Coverage policies may vary by specific plan and can change over time.

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