By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (Quizartinib) Covered by Aetna CVS Health in California: Complete Appeal Guide with Forms and Timelines

Answer Box: Getting Vanflyta Covered by Aetna CVS Health in California

Vanflyta (quizartinib) requires prior authorization from Aetna CVS Health for FLT3-ITD positive AML. Key requirements: confirmed FLT3-ITD mutation via FDA-approved test, baseline EKG with QTc ≤450ms, and oncologist prescription. If denied, California residents can appeal internally within 180 days, then request Independent Medical Review (IMR) through DMHC with 73% success rate.

First step today: Contact your oncologist to gather FLT3-ITD test results, EKG, and treatment phase documentation, then submit PA via CVS Caremark portal or fax to 1-888-267-3277.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process in California
  5. Medical Necessity Letter Template
  6. California DMHC Independent Medical Review
  7. Costs and Patient Assistance
  8. FAQ: Vanflyta Coverage Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing CVS Caremark portal or fax Aetna PA Forms
FLT3-ITD Positive PCR-based assay confirmation Lab report from FDA-approved test Aetna Policy
Baseline EKG QTc ≤450ms within 30 days Cardiology or oncology notes FDA Label Requirements
Treatment Phase Induction, consolidation, or maintenance Treatment plan documentation Aetna Clinical Criteria
Specialty Pharmacy CVS Specialty dispensing required Prescription routing CVS Caremark Specialty
Appeals Deadline 180 days from denial Denial letter California Insurance Code

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Requirements

Who: Patient or clinic staff
Document needed: Insurance card and member ID
How: Call Aetna member services at number on card
Timeline: 10-15 minutes
Verify: Formulary status, PA requirements, specialty pharmacy routing

2. Gather Required Clinical Documentation

Who: Oncologist and clinic staff
Documents needed:

  • FLT3-ITD mutation test results (FDA-approved assay)
  • AML diagnosis with ICD-10 code C92.00
  • Baseline EKG showing QTc ≤450ms
  • Treatment phase (induction/consolidation/maintenance)
  • Prior therapy history if applicable Timeline: 1-2 business days

3. Submit Prior Authorization

Who: Prescriber or authorized staff
How to submit:

4. Monitor Status and Respond to Requests

Who: Clinic staff
Action: Check portal daily, respond to information requests within 24 hours
Timeline: Standard review 30-45 days, expedited 72 hours for urgent cases

5. If Approved: Coordinate Dispensing

Who: Patient and clinic
Action: Ensure prescription is sent to CVS Specialty Pharmacy
Timeline: 2-3 business days for specialty drug delivery

6. If Denied: Initiate Appeal Process

Who: Prescriber with patient consent
Action: Request peer-to-peer review, prepare appeal documentation
Timeline: Must appeal within 180 days of denial

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing FLT3-ITD confirmation Submit FDA-approved test results Lab report with mutation status and assay method
No baseline cardiac monitoring Provide EKG with QTc measurement EKG report dated within 30 days of treatment start
Step therapy not attempted Document contraindications or failures Clinical notes showing why alternatives inappropriate
"Not medically necessary" Submit comprehensive medical necessity letter Treatment history, guidelines, clinical rationale
Incorrect treatment phase Clarify induction/consolidation/maintenance Treatment protocol and current phase documentation
Missing diagnosis code Include ICD-10 C92.00 Pathology report confirming AML diagnosis
Tip: The most common fixable denial is missing FLT3-ITD documentation. Ensure your lab report specifically states the mutation was detected via an FDA-approved PCR-based assay.

Appeals Process in California

California provides robust appeal rights through both internal insurer processes and state oversight via the Department of Managed Health Care (DMHC).

Internal Appeal with Aetna CVS Health

Timeline: Must file within 180 days of denial
Process:

  1. Submit written appeal with supporting documentation
  2. Request peer-to-peer review if available
  3. Await determination (30-45 days standard, 72 hours expedited)

Required documents:

  • Original denial letter
  • Medical necessity letter from prescriber
  • All supporting clinical documentation
  • Patient consent for appeal

Peer-to-Peer Review

Schedule by calling the number on your denial letter or 1-855-240-0535. Prepare talking points:

  • Patient's specific FLT3-ITD mutation status
  • Why formulary alternatives are inappropriate
  • Treatment phase and protocol requirements
  • Monitoring plan for QTc and cytopenias

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

Medical Necessity Letter Template

Key Components for Vanflyta Appeal

Opening Statement: "I am writing to appeal the denial of Vanflyta (quizartinib) for [Patient Name], DOB [Date], Member ID [Number]. This medication is medically necessary for the treatment of newly diagnosed FLT3-ITD positive acute myeloid leukemia."

Clinical Justification:

  • Confirm FLT3-ITD positivity: "FLT3-ITD mutation was confirmed by [Lab Name] on [Date] using an FDA-approved assay."
  • Reference FDA approval: "Vanflyta is FDA-approved for newly diagnosed FLT3-ITD positive AML in combination with standard induction and consolidation chemotherapy."
  • Cite NCCN Guidelines: "Per NCCN Guidelines, FLT3 inhibition is recommended as standard of care for this molecular subtype."

Safety Monitoring Plan:

  • "Baseline EKG performed on [Date] showing QTc of [Value] ms (≤450ms required)."
  • "Patient will undergo EKG monitoring on days 8 and 15 of cycle 1, then before each subsequent cycle per FDA labeling."
  • "Complete blood counts will be monitored per protocol for cytopenias."

Alternative Therapy Documentation: If step therapy applies, document why alternatives are inappropriate:

  • Prior failures or intolerances
  • Contraindications
  • Clinical reasons for preferring Vanflyta

Download the official letter template from Daiichi Sankyo Access Central.

California DMHC Independent Medical Review

If Aetna upholds the denial after internal appeal, California residents can request Independent Medical Review (IMR) through the Department of Managed Health Care.

IMR Process and Success Rates

Eligibility: Available after completing internal appeal or if plan fails to respond within 30 days
Success Rate: 73% of patients receive requested treatment through IMR
Timeline: 6-8 days after DMHC receives medical records, less than 30 days total
Cost: No fee to patient

How to Request IMR

Contact DMHC Help Center:

Required Documentation:

  • Completed internal appeal with Aetna
  • All medical records and clinical documentation
  • Denial letters from each appeal level
  • Statement of why treatment is medically necessary
Note: For urgent oncology cases, clearly indicate urgency in your IMR request. Expedited reviews are completed within 72 hours for situations where delay could jeopardize patient health.

The platform offered by Counterforce Health helps patients and clinicians navigate complex appeal processes by identifying denial basis and drafting evidence-backed rebuttals that align with California's regulatory requirements.

DMHC Enforcement

California's DMHC actively enforces appeal rights. In 2025, DMHC issued 169 enforcement actions and fines up to $550,000 against health plans for improper denials and delays. Health plans must authorize approved treatments within 5 working days of receiving a favorable IMR decision.

Costs and Patient Assistance

Vanflyta Pricing

  • Cash price: $16,100-$17,900 per 28-day supply (varies by strength)
  • Annual cost: Approximately $200,000+ for full treatment course

Financial Assistance Options

Manufacturer Support:

  • Daiichi Sankyo Access Central: dsiaccesscentral.com
  • Patient assistance programs for qualifying patients
  • Copay support for insured patients

Foundation Grants:

  • Leukemia & Lymphoma Society
  • CancerCare Co-Payment Assistance Foundation
  • Patient Advocate Foundation

California-Specific Programs:

  • Medi-Cal coverage for eligible patients
  • Covered California premium subsidies
  • County indigent care programs

FAQ: Vanflyta Coverage Questions

How long does Aetna CVS Health prior authorization take in California? Standard PA decisions take 30-45 days. Electronic submissions through the CVS Caremark portal are typically reviewed within 24-48 hours. Urgent cases can be expedited to 72 hours.

What if Vanflyta is non-formulary on my plan? You can request a formulary exception with clinical documentation showing medical necessity. Include evidence that formulary alternatives are inappropriate due to contraindications, prior failures, or clinical factors specific to FLT3-ITD positive AML.

Can I request an expedited appeal in California? Yes. If your oncologist determines that delay could jeopardize your health, request expedited review. Aetna must respond within 72 hours for urgent appeals. For IMR, DMHC provides expedited review within 72 hours for urgent medical situations.

Does step therapy apply if I've failed treatments outside California? Treatment history from other states should be accepted. Provide documentation of prior therapies, including dates, dosages, and reasons for discontinuation (failure or intolerance). Your oncologist's clinical notes supporting why Vanflyta is appropriate should reference this history.

What happens if both internal appeals and IMR are denied? While IMR decisions are binding on health plans, you may have additional options including legal consultation, seeking care at academic medical centers with financial assistance programs, or exploring clinical trials. Contact patient advocacy organizations for guidance.

How do I track my appeal status? Keep detailed records of all submissions, reference numbers, and communications. Aetna provides case numbers for tracking. For DMHC IMR, you'll receive confirmation and status updates throughout the process.

Can I switch to a different Aetna plan with better Vanflyta coverage? Plan changes are typically allowed during open enrollment periods or qualifying life events. Review formularies carefully, as coverage may vary between Aetna products. Consult with a licensed insurance agent for plan comparison.

What if I'm already receiving Vanflyta and coverage is terminated? Contact your oncologist immediately to request a continuity of care exception. California law provides protections for ongoing treatment. File an urgent appeal and contact DMHC if Aetna attempts to discontinue medically necessary ongoing therapy.

From our advocates: We've seen cases where patients initially denied for Vanflyta successfully obtained coverage after submitting comprehensive FLT3-ITD documentation and cardiac monitoring plans. The key is ensuring all clinical requirements are clearly documented upfront—missing EKG results or incomplete mutation testing are the most common fixable issues in PA submissions. While outcomes vary by individual case, thorough preparation significantly improves approval odds.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by individual plan and can change. Always verify current requirements with your specific Aetna plan and consult with your healthcare provider for medical decisions. For personalized assistance with insurance appeals, contact the California DMHC Help Center or consult with qualified patient advocates.

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