By Counterforce Health Team in Xospata (gilteritinib) —

How to Get Xospata (Gilteritinib) Covered by Aetna CVS Health in New York: Complete Appeals Guide

Quick Answer: Getting Xospata (Gilteritinib) Covered by Aetna CVS Health in New York

Xospata (gilteritinib) is covered on Aetna formularies as a specialty oncology drug requiring prior authorization, FLT3 mutation testing, and specialty pharmacy dispensing. Your fastest path to approval: 1) Confirm your Aetna plan covers Xospata via the member portal, 2) Have your oncologist submit prior authorization with FLT3 mutation test results and prior therapy documentation, 3) Enroll in Astellas OnePath patient support program for copay assistance. If denied, New York residents have strong appeal rights including expedited external review through the NY Department of Financial Services within 72 hours for urgent cases.

First step today: Log into your Aetna member portal or call 1-800-ASK-AETNA to verify Xospata coverage on your specific plan.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Coverage Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Xospata (Gilteritinib) Covered by Aetna CVS Health?

Yes, Xospata appears on Aetna's 2024 Specialty Drug List as a covered specialty medication for oncology. However, coverage varies by specific plan type:

Plan Type Coverage Status Requirements
Advanced Control Plan CE (Copay Exception) or N7 (PSP) PA, PSP enrollment, QL (90 tablets/30 days)
Standard Opt-Out CE with PA, N7 (PSP), QL Same as above
Medicaid (Aetna Better Health) Possible PA/ST/QL if covered Higher scrutiny for specialty drugs

What This Means: Xospata is formulary-covered but requires prior authorization (PA), patient support program (PSP) enrollment, and has quantity limits. The "CE" designation means lower copays are possible with proper approval.

Which Aetna Plans Cover Xospata?

Most Aetna commercial plans include Xospata, but you'll need to verify your specific formulary. Check coverage by:

  • Logging into your Aetna member portal and searching "Xospata"
  • Calling 1-800-ASK-AETNA with your member ID
  • Reviewing your plan's drug guide (usually available online)

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically a hematologist or oncologist) must submit the prior authorization request to Aetna. Patients cannot submit PA requests directly.

Step-by-Step: Fastest Path to Approval

  1. Confirm FLT3 Mutation Status (Your oncologist)
    • Order FDA-approved LeukoStrat CDx FLT3 Mutation Assay
    • Document ITD or TKD mutations (D835, I836) in medical record
    • Timeline: 1-2 business days for results
  2. Gather Required Documentation (Clinic staff)
    • AML diagnosis with ICD-10 code (C92.0x)
    • Prior therapy history and failures/intolerance
    • Current disease status (relapsed/refractory)
    • Prescriber credentials (board-certified hematology/oncology)
  3. Submit PA Request (Your oncologist's office)
    • Use Aetna provider portal or fax PA form
    • Include all supporting documentation
    • Request expedited review if clinically urgent
    • Timeline: Submit within 1-2 business days
  4. Enroll in Patient Support (You or clinic)
    • Call Astellas OnePath: 1-800-736-3795
    • Provide insurance information for benefits verification
    • Timeline: Same day enrollment possible
  5. Follow Up on Decision (Clinic staff)
    • Standard PA decisions: 30 days
    • Expedited decisions: 72 hours
    • Check status via Aetna provider portal
Tip: Request peer-to-peer review immediately if the initial PA is denied. This allows your oncologist to speak directly with Aetna's medical director.

Timing and Urgency

How Long Does Prior Authorization Take?

  • Standard review: 30 days maximum
  • Expedited review: 72 hours for urgent cases
  • Peer-to-peer review: Usually scheduled within 1-2 business days

What Qualifies for Expedited Review?

Request expedited review if:

  • Delay would seriously jeopardize your health
  • You're currently hospitalized
  • Standard timeline would cause significant deterioration
  • You need to start treatment immediately due to disease progression

How to request: Your oncologist should call Aetna and specifically request "expedited prior authorization" citing clinical urgency.

Coverage Criteria

What Documentation Does Aetna Require?

Based on FDA labeling and typical payer requirements, Aetna likely requires:

Essential Requirements:

  • Confirmed AML diagnosis
  • FLT3 mutation confirmation (ITD or TKD) via FDA-approved testing
  • Relapsed or refractory disease status
  • Prior therapy documentation and failures
  • Prescriber specialty (hematology/oncology preferred)

Clinical Documentation:

  • Bone marrow biopsy results
  • Cytogenetics and molecular testing
  • Prior chemotherapy regimens and responses
  • Current performance status
  • Treatment goals and monitoring plan

FLT3 Mutation Testing Requirements

The LeukoStrat CDx FLT3 Mutation Assay is the FDA-approved companion diagnostic for Xospata. Testing must confirm:

  • FLT3-ITD mutations, OR
  • FLT3-TKD mutations (D835 or I836)

Sample requirements: Peripheral blood or bone marrow mononuclear cells

Clinician Corner: Include the specific FLT3 mutation type and allelic ratio in your medical necessity letter. Higher ITD allelic ratios (>0.5) may strengthen the case for targeted therapy.

Costs and Financial Assistance

What Will Xospata Cost with Aetna?

Costs vary significantly by plan:

  • Wholesale Acquisition Cost: $28,979.13 for 90 × 40 mg tablets (≈ one 30-day supply at 120 mg/day)
  • With Copay Exception (CE): Potentially $0-$50 copay
  • Without CE: 20-33% coinsurance typical for specialty tiers ($5,800-$9,600+ monthly)
  • Quantity limit: 90 tablets per 30 days

Financial Assistance Options

Astellas OnePath Patient Support Program

  • Copay assistance up to $25,000 per year for eligible patients
  • Income restrictions may apply
  • Phone: 1-800-736-3795
  • Program details (verify with source)

Additional Resources:

  • Patient Access Network (PAN) Foundation
  • Leukemia & Lymphoma Society financial assistance
  • CancerCare copay assistance program

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Missing FLT3 mutation Submit FDA-approved test results LeukoStrat CDx assay report
"Experimental/investigational" Cite FDA approval and NCCN guidelines FDA label, peer-reviewed studies
Non-formulary status Request formulary exception Medical necessity letter, prior failures
Lack of prior therapy Document treatment history Chemotherapy records, response data

New York Appeal Rights

New York residents have exceptionally strong appeal rights:

Internal Appeal with Aetna (Required First Step)

  • Timeline to file: 60 days from denial notice
  • Decision timeline: 30 days standard, 72 hours expedited
  • How to file: Via Aetna member portal or appeals address on denial letter

External Appeal through NY Department of Financial Services

  • Timeline to file: 4 months after final internal denial
  • Decision timeline: 30 days standard, 72 hours expedited
  • Cost: Up to $25 (waived for Medicaid/financial hardship, refunded if successful)
  • Process: Submit NY DFS External Appeal Application
Note: External appeal decisions are binding on Aetna. New York's external appeal success rate is particularly high for oncology drugs with FDA approval.

When to Request Expedited Appeals

Request expedited appeals if:

  • Standard timeline would jeopardize your health
  • You're experiencing disease progression
  • Treatment delay could affect transplant eligibility
  • You're currently hospitalized

How to request: Call Aetna immediately and state "I need an expedited appeal for urgent medical care."

Renewals and Reauthorization

When Is Reauthorization Required?

While specific Aetna reauthorization timelines aren't publicly available, typical requirements include:

  • Annual reauthorization for most specialty drugs
  • Response assessment with bone marrow evaluation
  • Retesting FLT3 status at disease progression
  • Updated clinical documentation showing continued benefit

What Documentation Is Needed for Renewal?

  • Current response status (complete remission, partial response, stable disease)
  • Recent laboratory values and imaging
  • Tolerability assessment and side effect management
  • Continued medical necessity justification
  • Updated FLT3 testing if disease has progressed
From our advocates: We've seen cases where patients on stable Xospata therapy faced renewal denials due to incomplete response documentation. Always ensure your oncologist includes specific response criteria (CR, CRh, PR) and future treatment plans in renewal requests.

Specialty Pharmacy Requirements

Why Must Xospata Come from a Specialty Pharmacy?

Aetna requires Xospata to be dispensed through specialty pharmacies due to:

  • High cost and need for specialized handling
  • Required patient monitoring and education
  • Insurance verification and prior authorization coordination
  • Patient support program enrollment

CVS Specialty Pharmacy Process

Most Aetna members use CVS Specialty:

  • Phone: 1-800-237-2767
  • Home delivery standard for New York residents
  • Coordination with Astellas OnePath program
  • Clinical support from specialty pharmacists

What to expect: CVS Specialty will contact you within 1-2 business days of PA approval to coordinate delivery and provide medication counseling.

Troubleshooting Common Issues

Portal or System Issues

  • Aetna member portal down: Call 1-800-ASK-AETNA for phone-based services
  • Missing PA forms: Contact your oncologist's office; they have access to provider-specific forms
  • CVS Specialty delays: Call CVS Specialty directly and reference your PA approval

Documentation Problems

  • Missing FLT3 test: Contact the lab that performed your bone marrow biopsy
  • Incomplete prior therapy records: Request records from previous oncologists or hospitals
  • Insurance verification issues: Provide your current Aetna member ID and group number

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Xospata in New York? A: Standard review takes up to 30 days, but expedited review for urgent cases is completed within 72 hours. Most oncology PAs are processed faster due to the urgent nature of cancer care.

Q: What if Xospata is non-formulary on my Aetna plan? A: Request a formulary exception with medical necessity documentation. Provide evidence that formulary alternatives are inappropriate or have failed.

Q: Can I request an expedited appeal if my Xospata is denied? A: Yes, if the delay would seriously jeopardize your health. Both Aetna internal appeals and NY external appeals offer expedited timelines (72 hours).

Q: Does step therapy apply to Xospata? A: Step therapy requirements vary by plan, but Xospata is typically approved for relapsed/refractory AML after documenting prior therapy failures, which often satisfies step therapy requirements.

Q: What if I move from another state to New York while on Xospata? A: New York has continuity of care protections. Contact Aetna immediately to ensure uninterrupted coverage during your transition.

Q: How do I find out my exact copay for Xospata? A: Log into your Aetna member portal and use the drug cost estimator, or call member services with your specific plan details.

Getting Help with Your Xospata Appeal

Navigating insurance approvals for specialty cancer medications can feel overwhelming, especially when you're focused on treatment. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed rebuttals. Their platform identifies the specific denial basis—whether it's prior authorization criteria, step therapy requirements, or "not medically necessary" determinations—and drafts point-by-point responses aligned to your plan's own rules.

For complex cases involving specialty oncology drugs like Xospata, having expert support can significantly improve your chances of approval and reduce the time to access your medication.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurance plan and healthcare provider. For personalized assistance with insurance appeals and coverage issues, consult with qualified professionals or contact Counterforce Health for expert support with your specific case.

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