By Counterforce Health Team in Xospata (gilteritinib) —

Do You Qualify for Xospata (Gilteritinib) Coverage by UnitedHealthcare in Ohio? Decision Tree & Next Steps

Answer Box: Quick Path to Xospata Coverage

Xospata (gilteritinib) requires prior authorization from UnitedHealthcare in Ohio. You're likely eligible if you have relapsed/refractory AML with confirmed FLT3 mutation and failed prior therapy. Your first step today: Gather your FLT3 test results and prior treatment records. Submit PA through the UnitedHealthcare Provider Portal or call OptumRx at 888-397-8129. If denied, Ohio allows two internal appeals plus external review through the Ohio Department of Insurance within 180 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternative Options
  6. If Denied - Ohio Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. FAQ: Ohio-Specific Questions
  10. Resources & Contact Information

How to Use This Decision Tree

This guide helps you determine whether Xospata (gilteritinib) will likely be covered by UnitedHealthcare in Ohio, what documentation you need, and your next steps if denied. Work through each section systematically with your healthcare team.

Before you start, gather these key documents:

  • Insurance card and policy information
  • Complete diagnosis and staging records
  • FLT3 mutation test results
  • Prior treatment history and outcomes
  • Most recent lab results and imaging

Eligibility Triage: Do You Qualify?

✅ Likely Eligible

You check ALL these boxes:

  • ✅ Diagnosed with acute myeloid leukemia (AML)
  • ✅ Have confirmed FLT3 mutation (ITD or TKD) by FDA-approved test
  • ✅ Disease is relapsed or refractory (came back or didn't respond to treatment)
  • ✅ Have tried at least one prior therapy for AML
  • ✅ Prescribed by an oncologist or hematologist

Your path: Skip to the Document Checklist section.

⚠️ Possibly Eligible

You have SOME of these factors:

  • ⚠️ AML diagnosis confirmed, but FLT3 testing incomplete
  • ⚠️ FLT3-positive but unclear if relapsed/refractory
  • ⚠️ Prior therapy history not well-documented
  • ⚠️ Prescribed by non-oncology specialist

Your path: See Tests to Request section.

❌ Not Yet Eligible

You have these barriers:

  • ❌ Newly diagnosed AML (not relapsed/refractory)
  • ❌ No confirmed FLT3 mutation
  • ❌ Haven't tried standard first-line therapy
  • ❌ Different cancer type

Your path: Review Alternative Options section.

If "Likely Eligible" - Document Checklist

Required Documentation for UnitedHealthcare PA

Submit these through the UnitedHealthcare Provider Portal or fax to OptumRx:

✅ Core Medical Records

  • Complete pathology report with AML diagnosis
  • FLT3 mutation test results (must specify ITD or TKD mutation)
  • Staging and cytogenetics reports
  • Current performance status (ECOG score)

✅ Prior Therapy Documentation

  • List of all previous AML treatments with dates
  • Response to each treatment (complete remission, partial, refractory)
  • Reasons for discontinuation (progression, toxicity, intolerance)
  • Most recent bone marrow biopsy results

✅ Current Clinical Status

  • Recent lab results (CBC, comprehensive metabolic panel, LFTs)
  • Cardiac assessment (EKG, ECHO if indicated)
  • Letter of medical necessity from prescribing oncologist

Submission Timeline

Start 3-4 weeks before needed treatment date to allow for:

  • Initial PA review: 5-15 business days
  • Possible peer-to-peer review: 2-5 business days
  • Appeal process if denied: 30-180 days
Tip: UnitedHealthcare's Gold Card program doesn't exempt oral chemotherapy like Xospata from PA requirements.

If "Possibly Eligible" - Tests to Request

Missing FLT3 Testing

Request from your oncologist:

  • LeukoStrat CDx FLT3 Mutation Assay (FDA-approved companion diagnostic)
  • Results must specify mutation type (ITD, TKD, or both)
  • Timeline: Usually 5-10 business days for results

Unclear Treatment History

Documentation needed:

  • Complete treatment timeline with dates, doses, duration
  • Response assessment for each regimen (imaging, bone marrow results)
  • Toxicity or intolerance documentation if applicable

Refractory vs. Relapsed Status

Clarify with your team:

  • Refractory: Never achieved complete remission with standard therapy
  • Relapsed: Achieved remission but disease returned
  • Both qualify for Xospata coverage

Timeline to reapply: Allow 2-3 weeks after gathering missing documentation.

If "Not Yet" - Alternative Options

First-Line Treatment Required

UnitedHealthcare typically requires trying standard first-line therapy before approving Xospata, unless contraindicated.

Discuss with your oncologist:

  • Midostaurin (Rydapt) with induction chemotherapy
  • Clinical trial participation
  • Exception request for contraindications to standard therapy

Non-FLT3 Mutated AML

Alternative targeted therapies to discuss:

  • IDH1/IDH2 inhibitors if applicable mutations present
  • CD33-targeted therapy (gemtuzumab ozogamicin)
  • Standard chemotherapy regimens per NCCN guidelines

Preparing Exception Requests

Work with Counterforce Health or your healthcare team to prepare appeals based on:

  • Medical contraindications to first-line therapy
  • Compelling clinical circumstances
  • Strong supporting literature for off-label use

If Denied - Ohio Appeal Path Chooser

Step 1: Internal Appeals with UnitedHealthcare

Timeline: Must file within 180 days of denial

Level 1 Internal Appeal

Level 2 Internal Appeal (if Level 1 denied)

  • Same submission process
  • Additional peer-to-peer review available
  • Decision timeline: 30 days (standard), 72 hours (expedited)

Step 2: External Review Through Ohio

After exhausting internal appeals, you have 180 days to request external review.

Ohio Department of Insurance External Review

  • File request through your insurer (they forward to ODI)
  • Independent Review Organization (IRO) assigned
  • Decision timeline: 30 days (standard), 72 hours (expedited)
  • Decision is binding on UnitedHealthcare

Contact for help: Ohio Department of Insurance Consumer Hotline at 800-686-1526

When to Request Expedited Review

Expedited appeals (72-hour decisions) available when:

  • Delay would seriously jeopardize life or health
  • Delay would significantly increase pain or suffering
  • Physician certifies urgency in writing

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization PA required before dispensing UnitedHealthcare Provider Portal UHC PA Requirements
FLT3 Mutation Must have ITD or TKD mutation Lab report from FDA-approved test FDA Access Data
Relapsed/Refractory Disease came back or never responded Oncologist documentation FDA Label
Prior Therapy Must have tried standard treatment Treatment history records UHC Medical Policy
Specialist Prescriber Oncologist or hematologist Provider credentials UHC Medical Policy

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
"Missing FLT3 mutation documentation" Submit FDA-approved test results LeukoStrat CDx assay report
"Not relapsed/refractory" Provide treatment history showing progression Bone marrow biopsy, imaging
"Insufficient prior therapy" Document failed first-line treatment Treatment records with outcomes
"Non-formulary drug" Request formulary exception Medical necessity letter
"Step therapy not completed" Show contraindication to required steps Clinical notes, allergy records

FAQ: Ohio-Specific Questions

Q: How long does UnitedHealthcare PA take in Ohio? A: Standard PA decisions take 5-15 business days. Expedited reviews (for urgent cases) take up to 72 hours. Source: UHC Provider Manual

Q: What if Xospata is non-formulary on my plan? A: You can request a formulary exception with medical necessity documentation. Success depends on demonstrating clinical superiority over formulary alternatives.

Q: Can I request expedited appeal in Ohio? A: Yes, if your physician certifies that delay would jeopardize your health. Both internal and external appeals offer expedited tracks with 72-hour decisions.

Q: Does Ohio have special protections for cancer patients? A: Ohio follows federal external review requirements. The Ohio Department of Insurance provides additional consumer protections and assistance.

Q: What happens if UnitedHealthcare still denies after external review? A: External review decisions are binding on the insurer. If overturned, UnitedHealthcare must cover the treatment. If upheld, you may have other legal remedies to explore.

Q: Are there cost assistance programs for Xospata in Ohio? A: Yes, Astellas offers patient assistance programs. Check eligibility at Xospata.com or contact their patient support at 1-800-727-8355.

Resources & Contact Information

UnitedHealthcare Contacts

  • Provider Portal: uhcprovider.com
  • OptumRx PA Line: 888-397-8129
  • Member Services: Number on your insurance card

Ohio State Resources

Clinical Resources

Professional Support

For complex appeals or denials, consider working with Counterforce Health, which specializes in turning insurance denials into evidence-backed appeals. Their platform analyzes denial letters and payer policies to create targeted rebuttals aligned with UnitedHealthcare's specific requirements.

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Coverage decisions depend on your specific policy terms and clinical circumstances. Always verify current requirements with UnitedHealthcare and consult your healthcare team for medical decisions. For official appeals guidance, contact the Ohio Department of Insurance at 800-686-1526.

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