By Counterforce Health Team in Xospata (gilteritinib) —

How to Get Xospata (Gilteritinib) Covered by Humana in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Your Path to Xospata Coverage

Getting Xospata (gilteritinib) covered by Humana in Pennsylvania requires prior authorization through your pharmacy benefit. You'll need documented FLT3-mutated relapsed/refractory AML, an FDA-approved FLT3 test report, and prior therapy documentation. Submit Humana's Medicare prescription drug coverage determination form via fax (877-486-2621) or online portal. Standard decisions take 72 hours; expedited requests 24 hours. If denied, you have 65 days for internal appeals, then can pursue Medicare's external review process (not Pennsylvania's state program for Medicare Advantage plans).

Start today: Verify your plan covers Xospata as a specialty drug and gather your FLT3 mutation test results.

Table of Contents

  1. Before You Start: Verify Your Coverage
  2. What You Need to Gather
  3. Submit Your Prior Authorization Request
  4. Understanding Timelines and Follow-Up
  5. If You Need More Information
  6. When Your Request Gets Denied
  7. Renewal and Re-Authorization
  8. Costs and Patient Assistance
  9. Quick Reference Checklist
  10. Frequently Asked Questions

Before You Start: Verify Your Coverage

Confirm Your Plan Type

First, check whether you have Humana Medicare Advantage or a commercial Humana plan. Look at your insurance card—Medicare Advantage plans often include "Gold Plus," "Choice," or "PPO" in the name. This matters because:

  • Medicare Advantage: Appeals go through federal Medicare rules, not Pennsylvania's state external review
  • Commercial plans: Can use Pennsylvania's Independent External Review after internal appeals

Check Xospata's Status

Use Humana's Prior Authorization Search Tool to verify:

  • Prior authorization is required
  • Formulary tier (typically specialty tier with 25-33% coinsurance)
  • Which specialty pharmacy you must use
Tip: Xospata is covered under the pharmacy benefit, not medical benefit, because it's an oral medication you take at home.

Verify Network Status

Confirm your oncologist is in-network and that you're using a Humana-contracted specialty pharmacy. Using out-of-network providers can result in denials or higher costs.

What You Need to Gather

Essential Documentation

Clinical Records:

  • Pathology report confirming acute myeloid leukemia (AML)
  • FLT3 mutation test results from FDA-approved assay (LeukoStrat CDx preferred)
  • Documentation of relapsed or refractory disease status
  • Complete prior therapy history with dates, responses, and reasons for discontinuation

Safety Documentation:

  • Recent ECG showing QTc < 500 ms
  • Comprehensive metabolic panel (kidney and liver function)
  • ECOG performance status assessment
  • Pregnancy test (if applicable) and contraception counseling documentation

Prior Therapy Requirements

Counterforce Health helps patients navigate complex prior authorization requirements by turning denials into targeted appeals. For Xospata, you must document that your AML is truly relapsed or refractory by showing:

  1. Previous AML treatment such as:
    • Standard induction chemotherapy (cytarabine + anthracycline)
    • Low-intensity therapy (hypomethylating agents ± venetoclax)
    • Previous stem cell transplant with subsequent relapse
  2. Treatment outcome showing:
    • Disease didn't achieve remission (refractory)
    • Achieved remission but disease returned (relapsed)
    • Intolerance to previous therapy preventing continuation

Submit Your Prior Authorization Request

Get the Correct Form

Download Humana's "Request for Medicare Prescription Drug Coverage Determination" form for Medicare members, or the appropriate commercial plan form if you have employer-sponsored coverage.

Complete Key Sections

Drug Information:

  • Generic name: gilteritinib
  • Brand name: Xospata
  • Strength: 40 mg tablets
  • Typical dose: 120 mg (3 tablets) once daily
  • NDC number from your prescription

Medical Justification:

  • Diagnosis: Relapsed/refractory acute myeloid leukemia
  • ICD-10 code: C92.00 (verify with your oncologist)
  • FLT3 mutation type (ITD, TKD, or both)
  • Date of FLT3 test and laboratory

Submit Your Request

Primary submission methods:

  • Fax: 877-486-2621 (for Medicare Part D determinations)
  • Online: Through Humana member portal or provider Availity system
  • Mail: Address provided on the PA form

Include these attachments:

  • Completed PA form
  • Oncologist's medical necessity letter
  • FLT3 mutation lab report
  • Prior therapy documentation
  • Recent progress notes
Clinician Corner: Your medical necessity letter should explicitly state that the patient has "relapsed or refractory AML with FLT3 mutation as detected by an FDA-approved test," referencing the FDA label indication. Include NCCN guideline support and explain why alternative therapies aren't appropriate.

Understanding Timelines and Follow-Up

Standard Processing Times

  • Standard requests: 72 hours for Medicare Part D
  • Expedited requests: 24 hours when delay risks serious harm
  • Commercial plans: May have different timelines (verify with your specific plan)

When to Follow Up

Call Humana after 48 hours if you haven't received a decision. Have ready:

  • Member ID number
  • Prior authorization reference number
  • Prescriber name and NPI

Sample phone script: "I'm calling to check the status of a prior authorization request for Xospata submitted on [date]. My member ID is [number] and the reference number is [if available]. Can you tell me the current status and expected decision date?"

If You Need More Information

Common Information Requests

Humana may ask for:

  • Additional FLT3 mutation details or confirmatory testing
  • More detailed prior therapy documentation
  • Updated lab values or imaging
  • Peer-to-peer review with your oncologist

Handling Peer-to-Peer Reviews

If Humana requests a peer-to-peer discussion:

  • Schedule promptly (usually within 72 hours)
  • Prepare key clinical points: FLT3 mutation status, prior therapies, current disease burden
  • Have guideline references ready
  • Document the conversation date and outcome

When Your Request Gets Denied

Common Denial Reasons and Solutions

Denial Reason How to Fix
Missing FLT3 mutation report Submit FDA-approved test results with mutation type
Insufficient prior therapy documentation Provide detailed treatment history with dates and outcomes
Non-oncology prescriber Have hematologist/oncologist submit or co-sign request
Off-label use concerns Emphasize FDA-approved indication for R/R FLT3+ AML

Internal Appeals Process

For Medicare Advantage plans:

  1. Level 1 - Redetermination: File within 65 days of denial
  2. Level 2 - Independent Review Entity: If Level 1 upholds denial
  3. Higher levels: ALJ hearing, Medicare Appeals Council

For commercial plans:

  1. Internal appeal: Follow plan's process (typically 30-60 days to file)
  2. Pennsylvania External Review: After internal appeal exhausted

Pennsylvania-Specific Appeals Rights

If you have a commercial Humana plan (not Medicare Advantage), you can use Pennsylvania's Independent External Review:

  • Must complete internal appeals first
  • File within 4 months of final denial
  • Free to consumers
  • 53% success rate in first year of program
  • Submit through Pennsylvania Insurance Department
Important: Medicare Advantage appeals use federal Medicare rules, not Pennsylvania's state external review process.

Renewal and Re-Authorization

When to Resubmit

Most Humana plans require reauthorization every 6-12 months. Calendar a reminder 30 days before your current authorization expires.

Renewal Documentation

Include:

  • Updated progress notes showing clinical benefit
  • Recent labs confirming tolerability
  • Confirmation of ongoing FLT3+ AML status
  • Documentation that disease hasn't progressed

Costs and Patient Assistance

Understanding Your Costs

With 2025 Medicare Part D changes, there's now a $2,000 annual out-of-pocket cap for covered drugs, significantly limiting your total costs for Xospata.

Typical cost structure:

  • Specialty tier coinsurance: 25-33%
  • WAC price: ~$28,979 for 30-day supply
  • Your cost depends on plan design and where you are in coverage phases

Patient Assistance Options

Astellas Support Programs:

  • Xospata copay savings program: Up to $7,000/year for eligible commercial patients
  • Astellas Patient Assistance Program: For uninsured/underinsured patients meeting income requirements

Additional Resources:

  • Leukemia & Lymphoma Society financial assistance
  • CancerCare co-payment assistance
  • State pharmaceutical assistance programs

Quick Reference Checklist

Before submitting:

  • Verify PA required and specialty pharmacy network
  • Gather FLT3 mutation test results (FDA-approved assay)
  • Document relapsed/refractory AML status
  • Complete prior therapy history with outcomes
  • Obtain recent safety labs and ECG
  • Download correct Humana PA form

When submitting:

  • Complete all form sections
  • Attach medical necessity letter
  • Include all required documentation
  • Submit via correct method (fax/portal)
  • Document submission date and reference number

After submission:

  • Follow up within 48 hours
  • Respond promptly to information requests
  • Calendar reauthorization reminder
  • Know your appeal rights and deadlines

Frequently Asked Questions

How long does Humana prior authorization take for Xospata in Pennsylvania? Standard requests: 72 hours for Medicare Part D. Expedited requests when delay risks serious harm: 24 hours.

What if Xospata isn't on my Humana formulary? You can request a formulary exception through the same PA process, emphasizing medical necessity and lack of appropriate alternatives.

Can I get an expedited appeal in Pennsylvania? Yes, if delay in treatment could seriously harm your health. Mark your request as urgent and have your doctor document the medical urgency.

Does Pennsylvania's external review apply to Humana Medicare Advantage? No, Medicare Advantage appeals use federal Medicare rules. Pennsylvania's state external review only applies to commercial insurance plans.

What counts as adequate prior therapy documentation? Include specific regimen names, start/stop dates, best response achieved, and reason for discontinuation (progression, relapse, intolerance).

How much will Xospata cost with Humana coverage? Costs vary by plan, but the 2025 Medicare Part D redesign caps annual out-of-pocket costs at $2,000 for covered drugs.

What if my oncologist isn't familiar with Humana's requirements? Counterforce Health specializes in helping clinicians navigate complex prior authorization requirements and can assist with evidence-backed appeals when denials occur.

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan and medical circumstances. Consult your healthcare provider for medical guidance and contact Humana directly for definitive coverage information.

Need Help? Contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 for assistance with insurance issues, or call 1-800-MEDICARE for Medicare-related questions.

Sources & Further Reading

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