By Counterforce Health Team in Xospata (gilteritinib) —

How to Get Xospata (Gilteritinib) Covered by Humana in North Carolina: Prior Authorization, Appeals, and Cost-Saving Strategies

Answer Box: Getting Xospata (Gilteritinib) Covered by Humana in North Carolina

Xospata requires prior authorization from Humana and is placed on the specialty drug tier. For approval, you need: (1) confirmed FLT3 mutation test results from an FDA-approved assay, (2) documented relapsed/refractory AML diagnosis, and (3) prior therapy history. If denied, you have 65 days to appeal internally, then can request North Carolina's Smart NC external review within 120 days. First step today: Contact your hematologist/oncologist to gather FLT3 test results and prepare the medical necessity letter for Humana's prior authorization submission.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Always required for Xospata Humana formulary documents Humana Drug Lists
Formulary Tier Specialty drug tier (25-33% coinsurance) Plan Summary of Benefits Humana Medicare Coverage
FLT3 Mutation Test FDA-approved LeukoStrat CDx assay required Lab results from oncologist FDA Access Data
Prescriber Requirement Hematologist/oncologist preferred PA submission form Humana Provider Portal
Appeal Deadline 65 days from denial notice Medicare regulations CMS Appeals Process
External Review 120 days to file with Smart NC North Carolina DOI Smart NC External Review

Step-by-Step: Fastest Path to Approval

1. Confirm Your FLT3 Mutation Status

Who: Your hematologist/oncologist
What: Order LeukoStrat CDx FLT3 Mutation Assay if not already done
Timeline: 3-5 business days for results
Source: FDA-approved companion diagnostic

2. Gather Required Documentation

Who: Patient and care team
Documents needed:

  • FLT3 mutation test results (ITD or TKD mutations)
  • AML diagnosis confirmation with bone marrow biopsy
  • Documentation of relapsed/refractory status
  • History of prior AML treatments and outcomes

3. Submit Prior Authorization Request

Who: Prescribing oncologist
How: Humana provider portal or approved fax
Timeline: Standard decision within 72 hours
Expedited: 24 hours if urgently needed
Source: Humana Prior Authorization

4. Request Expedited Review if Needed

When: Patient's health would be seriously jeopardized by delay
Who: Prescriber must provide supporting statement
Timeline: 24-hour decision required

5. Follow Up on Decision

Standard timeline: 72 hours for determination
If approved: Proceed to specialty pharmacy fill
If denied: Review denial reason and prepare appeal within 65 days

6. Appeal if Denied

Internal appeal: File within 65 days of denial
Timeline: Humana responds within 7 days
External review: File with Smart NC within 120 days if internal appeals exhausted

7. Access Patient Assistance if Approved

Commercial insurance: Xospata Patient Savings Program (up to $7,000/year)
Medicare: Apply for Astellas Patient Assistance Program
Contact: 1-855-221-3493 (copay card) or 1-844-632-9272 (PAP)

Understanding Xospata Costs and Benefit Design

Xospata's wholesale acquisition cost is approximately $28,979 for a 30-day supply (90 × 40mg tablets for 120mg daily dosing). For Humana Medicare Advantage members, the drug sits on the specialty tier, meaning you'll typically pay 25-33% coinsurance after meeting any plan deductible.

What drives your out-of-pocket costs:

  • Formulary placement: Specialty tier vs. non-formulary status
  • Prior authorization: Required for all Xospata requests
  • Specialty pharmacy requirements: Must use approved network
  • Annual deductible: May apply before coinsurance kicks in
  • Out-of-pocket maximum: Protects against catastrophic costs
Note: Medicare Part D plans have an annual out-of-pocket maximum of $2,000 starting in 2025, which can significantly reduce your total costs for expensive specialty drugs like Xospata.

Investigating Your Humana Benefits

Before starting treatment, gather this information by calling the member services number on your insurance card:

Questions to ask Humana:

  1. "Is Xospata (gilteritinib) on my plan's formulary, and what tier?"
  2. "What's my specialty drug coinsurance percentage?"
  3. "Have I met my annual deductible, and does it apply to specialty drugs?"
  4. "Which specialty pharmacies are in-network for Xospata?"
  5. "What's my current progress toward the out-of-pocket maximum?"

Information to record:

  • Plan name and member ID
  • Specialty drug coinsurance rate
  • Annual deductible amount and status
  • Out-of-pocket maximum and current spending
  • In-network specialty pharmacy options
  • Prior authorization submission requirements

Assistance Options for Lowering Costs

For Commercial Insurance Patients

The Xospata Patient Savings Program can reduce your copay to as low as $0 per prescription, with annual assistance up to $7,000. You're eligible if you have commercial insurance (not Medicare, Medicaid, or other government programs).

How to apply: Visit Xospata.com patient assistance or call 1-855-221-3493.

For Medicare Patients

Since Medicare patients aren't eligible for manufacturer copay cards, consider:

Astellas Patient Assistance Program: Provides Xospata at no cost for qualifying uninsured or underinsured patients. Income requirements apply.
Contact: 1-844-632-9272
Application: Astellas Pharma Support Solutions

Independent charitable foundations:

  • PAN Foundation
  • Leukemia & Lymphoma Society
  • CancerCare Co-Payment Assistance Foundation
Tip: Apply for assistance programs as soon as your prescription is written. Many have waiting lists and funding limitations that operate on a first-come, first-served basis.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing FLT3 mutation test Submit FDA-approved test results LeukoStrat CDx FLT3 assay report
Front-line use (not relapsed/refractory) Provide treatment history Prior therapy records, progression documentation
Non-hematology prescriber Transfer to oncologist or provide consultation notes Hematologist/oncologist involvement
Insufficient medical necessity Enhanced clinical letter NCCN guidelines citation, treatment goals
Alternative therapies not tried Document contraindications or failures Prior medication trials, intolerance records

Key success factors: Ensure your medical necessity letter addresses Humana's specific criteria and includes citations to NCCN Guidelines and FDA labeling.

Appeals Playbook for Humana in North Carolina

Level 1: Internal Appeal (Redetermination)

Timeline: File within 65 days of denial
Humana response: 7 calendar days
How to file: Member portal, phone, or mail
Required: Completed appeal form and supporting documentation

Level 2: Independent Review Entity (IRE)

Timeline: File within 65 days of Level 1 denial
Response time: 7 calendar days
Automatic: Humana forwards if you request continuation

Level 3: Smart NC External Review

Eligibility: After exhausting internal appeals
Timeline: File within 120 days of final internal denial
Cost: Free to members
Response: 45 days (standard) or 72 hours (expedited)

How to file with Smart NC:

  1. Complete external review request form
  2. Attach medical records and denial letters
  3. Submit to NC Department of Insurance
  4. Smart NC assigns Independent Review Organization (IRO)
  5. IRO decision is binding on Humana
North Carolina Advantage: Smart NC provides free advocacy assistance at 1-855-408-1212 to help you navigate the external review process.

Specialty Pharmacy Requirements

Humana requires Xospata to be dispensed through their specialty pharmacy network. This typically includes:

In-network options:

  • Humana Pharmacy (mail-order specialty)
  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Express Scripts Specialty

Coordination tips:

  • Confirm your chosen pharmacy is in-network before transfer
  • Allow 3-5 business days for prescription transfer
  • Verify your shipping address and contact information
  • Ask about refill reminders and adherence support programs

Prior authorization transfer: Your PA approval follows the prescription to any in-network specialty pharmacy.

Scripts for Key Conversations

Calling Humana Member Services

"Hi, I'm calling about prior authorization for Xospata, generic name gilteritinib, for my relapsed AML with FLT3 mutation. Can you tell me the status of PA request [reference number] and what additional documentation might be needed?"

Requesting Peer-to-Peer Review

"This is Dr. [Name] requesting a peer-to-peer review for my patient's Xospata denial. The patient has documented FLT3-positive relapsed AML and has failed standard therapies. When can we schedule the clinical discussion?"

Pharmacy Coordination

"I need to transfer my Xospata prescription to an in-network specialty pharmacy for my Humana plan. Can you confirm which locations you work with and help coordinate the transfer with my current pharmacy?"

FAQ: Xospata Coverage in North Carolina

How long does Humana prior authorization take in North Carolina?
Standard requests: 72 hours. Expedited requests: 24 hours if prescriber documents urgent medical need.

What if Xospata is non-formulary on my plan?
You can request a formulary exception with prescriber support showing medical necessity and why covered alternatives aren't appropriate.

Can I request an expedited appeal in North Carolina?
Yes, both Humana internal appeals and Smart NC external review offer expedited processes for urgent situations.

Does step therapy apply to Xospata?
Typically no, since Xospata is indicated for relapsed/refractory disease after other therapies have failed.

What's Smart NC's success rate for oncology drug appeals?
Smart NC reports that approximately 61% of external reviews result in some change to the insurer's position, though specific oncology rates aren't published.

How much will I pay out-of-pocket?
With specialty tier placement, expect 25-33% coinsurance. Patient assistance programs can significantly reduce costs for eligible patients.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned to each payer's specific requirements, pulling the right clinical evidence and operational details to strengthen your case.

For complex cases like Xospata coverage, Counterforce Health can help streamline the prior authorization process by ensuring your submission includes all required elements from the start—FLT3 mutation documentation, prior therapy details, and payer-specific clinical justifications that reduce the likelihood of initial denials.

Sources & Further Reading

Disclaimer: This information is for educational purposes and doesn't constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always verify current requirements with your insurance provider and consult your healthcare team for medical decisions. For personalized assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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