By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by UnitedHealthcare in Virginia: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Vanflyta Covered by UnitedHealthcare in Virginia

Vanflyta (quizartinib) requires prior authorization from UnitedHealthcare for FLT3-ITD positive AML. The fastest path to approval: (1) Submit complete PA with FLT3-ITD test results, baseline EKG showing QTc ≤450ms, and medical necessity letter addressing step therapy, (2) If denied, file internal appeal within 180 days, (3) Request Virginia external review within 120 days of final denial through the State Corporation Commission Bureau of Insurance. Start today by gathering your FLT3 mutation report and recent cardiac assessment.

Table of Contents

Coverage Policy Overview

UnitedHealthcare covers Vanflyta (quizartinib) through its specialty pharmacy benefit with mandatory prior authorization across all plan types—commercial, Medicare Advantage, and ACA marketplace plans. OptumRx manages pharmacy benefits for most UnitedHealthcare members and applies drug-specific clinical criteria for oncology medications.

Plan Types and Coverage Structure:

  • Commercial Plans: Vanflyta typically placed on specialty tier with 20-40% coinsurance
  • Medicare Advantage: Subject to Part D formulary rules with potential step therapy requirements
  • ACA Marketplace: Prior authorization required with essential health benefits coverage

The medication is available only through UnitedHealthcare's designated specialty pharmacies due to the Vanflyta REMS program requirements for QT monitoring and safety oversight.

Medical Necessity Requirements

FDA-Approved Indication

Vanflyta is approved for newly diagnosed FLT3-ITD positive acute myeloid leukemia in combination with standard induction and consolidation therapy, followed by single-agent maintenance. UnitedHealthcare requires documentation that the prescription aligns with this FDA-approved indication.

Core Clinical Criteria

Diagnosis Requirements:

  • Confirmed acute myeloid leukemia diagnosis with pathology report
  • FLT3-ITD mutation positive documented by FDA-approved testing from certified laboratory
  • ICD-10 codes: C92.0 (Acute myeloblastic leukemia) with appropriate specificity

Cardiac Safety Documentation:

  • Baseline EKG showing QTcF ≤450ms (required per FDA labeling)
  • Plan for weekly EKG monitoring during treatment
  • Electrolyte levels (potassium, magnesium) within normal range

Treatment Phase Specification:

  • Clear documentation of induction, consolidation, or maintenance phase
  • Combination therapy details for induction/consolidation phases
  • Single-agent rationale for maintenance therapy
Clinician Corner: Medical necessity letters should reference NCCN Guidelines for AML and include specific FLT3-ITD allelic ratio if available, as higher ratios may strengthen the clinical case for targeted therapy.

Step Therapy and Exceptions

UnitedHealthcare may require trial of preferred FLT3 inhibitors before approving Vanflyta. Common step therapy requirements include:

Preferred Agents (typically required first):

  • Midostaurin (Rydapt) for newly diagnosed FLT3+ AML
  • Gilteritinib (Xospata) for relapsed/refractory disease

Exception Pathways

Medical Contraindications:

  • Prior intolerance or severe adverse reactions to preferred agents
  • Cardiac contraindications specific to alternative FLT3 inhibitors
  • Drug interactions with required concomitant medications
  • Clinical urgency where delay for step therapy would be harmful

Clinical Inappropriateness:

  • Disease characteristics making Vanflyta more appropriate first-line choice
  • Transplant timing considerations
  • Prior treatment history making alternatives unsuitable

Documentation for Step Therapy Exception:

  • Detailed prior therapy history with outcomes and toxicities
  • Specific contraindications with supporting clinical evidence
  • Timeline urgency with oncologist attestation
  • Comparative risk-benefit analysis between FLT3 inhibitors

Counterforce Health helps patients and clinicians navigate these complex step therapy requirements by analyzing denial letters and crafting targeted appeals that address UnitedHealthcare's specific criteria with evidence-backed clinical justification.

Required Documentation Checklist

Essential Documents

Laboratory and Diagnostic Reports:

  • FLT3 mutation analysis confirming ITD positivity from certified laboratory
  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Baseline EKG with QTc measurement ≤450ms
  • Bone marrow biopsy report confirming AML diagnosis

Clinical Documentation:

  • Oncology consultation note detailing treatment plan
  • Medical necessity letter addressing indication and alternatives
  • Prior therapy history with outcomes (if applicable)
  • Performance status assessment (ECOG or Karnofsky)
  • Cardiac risk assessment and monitoring plan

Administrative Forms:

  • UnitedHealthcare prior authorization form (obtain from provider portal)
  • Prescriber attestation for REMS compliance
  • Insurance card copy and member ID verification
Tip: Submit all documentation simultaneously to avoid delays. UnitedHealthcare's automated PA system can approve complete submissions within 24-72 hours when criteria are clearly met.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"No FLT3-ITD documentation" Submit certified lab report Original mutation analysis from FDA-approved test
"EKG/QT monitoring not addressed" Provide cardiac assessment Baseline EKG ≤450ms + monitoring plan
"Step therapy not completed" Request medical exception Contraindication documentation or clinical urgency
"Not medically necessary" Strengthen clinical justification NCCN citations + detailed treatment rationale
"Quantity limits exceeded" Document appropriate dosing FDA labeling reference + weight-based calculations

Appeals Strategy

Peer-to-Peer Review Request: Contact UnitedHealthcare at 1-800-711-4555 to request physician-to-physician discussion. This often resolves denials when the medical director can discuss clinical nuances directly with the prescribing oncologist.

Medical Literature Support: Include recent peer-reviewed studies demonstrating Vanflyta's efficacy in FLT3-ITD positive AML, particularly data from the QuANTUM-First trial published in major hematology journals.

Appeals Process in Virginia

Internal Appeals Timeline

First Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Decision Timeline: 30 days for non-urgent, 72 hours for urgent
  • Submission: UnitedHealthcare member portal or mail to address on denial letter

Second Level Internal Appeal:

  • Deadline: 60 days from first-level denial
  • Decision Timeline: 30 days standard review
  • Requirements: New clinical information or additional supporting evidence

Virginia External Review

After exhausting internal appeals, Virginia residents can request independent external review through the State Corporation Commission Bureau of Insurance.

External Review Process:

Expedited External Review: Available when physician certifies that waiting 45 days could seriously jeopardize health. Cancer treatment denials often qualify for expedited review in Virginia.

Required Documentation for External Review:

  • Completed Form 216-A
  • All medical records supporting the request
  • Healthcare provider recommendation letter
  • Insurance plan documents and denial letters
  • Any additional clinical evidence
From our advocates: We've seen many Virginia patients succeed in external review by including updated treatment response data and current clinical status. The independent medical reviewers often overturn denials when presented with complete clinical pictures showing ongoing benefit or medical necessity.

Contact Information

Virginia Bureau of Insurance Consumer Services:

Virginia Managed Care Ombudsman: Available through the same SCC Consumer Services number to help navigate HMO and managed care plan issues.

Cost and Patient Support Options

Manufacturer Support Programs

Daiichi Sankyo Patient Support:

  • DSAccessCentral4U provides prior authorization support
  • Financial assistance programs for eligible patients
  • Copay assistance cards (verify current availability and eligibility)

Financial Assistance Resources

Foundation Support:

  • Leukemia & Lymphoma Society Patient Aid Program
  • CancerCare Financial Assistance Program
  • Patient Access Network Foundation

State Resources: Virginia expanded Medicaid in 2019, significantly improving access to specialty medications for eligible residents. The uninsured rate in Virginia dropped to approximately 6.4% by 2023.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Vanflyta in Virginia? Standard PA decisions are issued within 72 hours for complete submissions. Incomplete requests may take 5-7 business days while additional information is gathered.

What if Vanflyta is non-formulary on my UnitedHealthcare plan? Non-formulary medications can still be covered through medical exception processes. Submit comprehensive medical necessity documentation emphasizing lack of formulary alternatives for FLT3-ITD positive AML.

Can I request expedited appeal in Virginia? Yes, both UnitedHealthcare internal appeals and Virginia external review offer expedited processes when physician certifies medical urgency. Cancer treatment delays often qualify.

Does step therapy apply if I've failed other FLT3 inhibitors outside Virginia? Prior treatment history from any location counts toward step therapy requirements. Document all previous FLT3 inhibitor use with outcomes and toxicities.

What happens if UnitedHealthcare denies my Vanflyta appeal? After exhausting internal appeals, you have 120 days to file external review with Virginia's Bureau of Insurance. External review decisions are binding on the insurer.

How much does Vanflyta cost without insurance? Cash prices range from approximately $16,100-$17,900 per 28-day supply, depending on strength and quantity. Patient support programs may significantly reduce out-of-pocket costs.

Can my oncologist request peer-to-peer review? Yes, contact UnitedHealthcare provider services to schedule physician-to-physician discussion. This often resolves complex clinical scenarios more efficiently than written appeals.

What if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, federal external review through HHS may be available. The Virginia Bureau of Insurance can help determine the appropriate pathway.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-backed responses. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for medications like Vanflyta, ensuring proper documentation and targeted appeals that address each insurer's specific criteria.

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 clinical circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For additional support with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance Consumer Services at 1-877-310-6560.

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