By Counterforce Health Team in Xospata (gilteritinib) —

The Requirements Checklist to Get Xospata (Gilteritinib) Covered by Cigna in Georgia: Forms, Appeals, and Success Tips

Answer Box: Fastest Path to Xospata Coverage

To get Xospata (gilteritinib) covered by Cigna in Georgia, you need prior authorization with FLT3 mutation testing, documented relapsed/refractory AML, and prescriber specialty verification. Submit through Express Scripts/Accredo with complete clinical documentation. If denied, Georgia allows 60 days for external review through the Georgia Department of Insurance. Start today: Call Cigna at 1-800-244-6224 to confirm your plan's specialty pharmacy requirements and obtain the current prior authorization form.

Table of Contents

Who Should Use This Guide

This checklist is designed for Georgia residents with Cigna coverage who need Xospata (gilteritinib) for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutation. Whether you're a patient, caregiver, or healthcare provider, this guide walks through Cigna's specific requirements and Georgia's appeal process.

Expected Outcome: With complete documentation, most prior authorizations are approved within 15 business days. If initially denied, appeals succeed in approximately 40-50% of cases when proper medical necessity is demonstrated.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics with Cigna Member Services at 1-800-244-6224:

  • Active coverage through December 31, 2025
  • Plan type: HMO, PPO, or Medicare Advantage
  • Specialty pharmacy requirement: Express Scripts/Accredo mandatory
  • Deductible status: High-deductible plans may require meeting deductible first
  • Prior authorization requirement: Required for all Cigna plans

Cost Expectations

Xospata's wholesale acquisition cost is approximately $28,979 for a 30-day supply (90 × 40mg tablets). Your out-of-pocket cost depends on your specific plan's specialty tier copayment or coinsurance.

Clinical Criteria Requirements

Primary Indication (FDA-Approved)

✓ Confirmed diagnosis: Relapsed/refractory AML in adults (≥18 years)
✓ FLT3 mutation positive: Confirmed by FDA-approved test (LeukoStrat CDx FLT3 Mutation Assay)
✓ Prior therapy documentation: Evidence of treatment failure, intolerance, or disease progression
✓ Prescriber qualification: Hematologist or oncologist

Alternative Indication

Cigna may cover Xospata for myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement per recognized compendia, but this requires additional documentation.

Coding & Documentation Hygiene

ICD-10 Diagnosis Codes

Code Description When to Use
C92.02 Acute myeloblastic leukemia, in relapse Most common for Xospata coverage
C92.00 AML, not having achieved remission Active disease, treatment-naive
C92.01 AML, in remission Currently in remission

Drug Identification

  • NDC Code: 00469-1425-90 (90-count bottle)
  • Standard Dosing: 120mg once daily (three 40mg tablets)
  • HCPCS: J8999 (oral chemotherapeutic, NOS) for medical benefit claims

Documentation Packet Essentials

Medical Necessity Letter Components

Your hematologist/oncologist must provide a comprehensive letter including:

  1. Patient demographics and confirmed AML diagnosis
  2. FLT3 mutation test results with lab name, date, and method
  3. Complete treatment history: Prior therapies, dates, outcomes, reasons for discontinuation
  4. Clinical rationale: Why Xospata is medically necessary
  5. Monitoring plan: Including differentiation syndrome surveillance
  6. NCCN Guidelines reference: Category 1/2A recommendation for relapsed/refractory FLT3+ AML

Required Attachments

  • FLT3 mutation test report from CLIA-certified laboratory
  • Complete medical records documenting prior AML treatments
  • Current laboratory results (CBC, comprehensive metabolic panel)
  • Bone marrow biopsy results confirming relapsed/refractory disease
  • Prescriber's CV or board certification documentation
From our advocates: We've seen cases where incomplete prior therapy documentation caused unnecessary delays. One patient's approval was expedited by 10 days when their oncologist provided a detailed timeline showing specific chemotherapy regimens, dates, and clear documentation of disease progression. Always include the "why" behind treatment changes, not just the "what."

Submission Mechanics

Correct Form & Process

  1. Obtain current PA form: Call Cigna Provider Services at 1-800-882-4462 or access through the Cigna provider portal
  2. Complete all required fields: Patient demographics, prescriber NPI, diagnosis codes, drug information
  3. Submit via preferred method: Provider portal (fastest) or fax to specialty pharmacy department

Common Rejection Causes

  • Incomplete prescriber information (missing NPI or specialty)
  • Missing FLT3 mutation test results
  • Inadequate prior therapy documentation
  • Wrong diagnosis code (using C92.00 instead of C92.02 for relapsed disease)

Specialty Pharmacy Routing

Express Scripts/Accredo Transfer Process

Once prior authorization is approved:

  1. Call Accredo: 877-826-7657 (Mon-Fri 7am-10pm CST)
  2. Provide information: Cigna member ID, prescriber details, current pharmacy
  3. Coordinate transfer: Accredo handles prescription transfer and shipment setup
  4. Expect contact: Clinical team calls within 24-48 hours for enrollment
  5. Shipment delivery: Typically 1-2 business days after enrollment

Temperature-Controlled Shipping

Xospata requires standard room temperature storage. Accredo provides appropriate packaging and tracking for all shipments to your preferred address in Georgia.

After Submission: Tracking & Follow-Up

Timeline Expectations

  • Standard review: Up to 15 business days
  • Expedited review: 72 hours (requires urgent medical necessity documentation)
  • Confirmation: Record your submission confirmation number
  • Status checks: Call Cigna every 5-7 business days for updates

What to Record

  • Submission date and confirmation number
  • Cigna representative name and reference number
  • Any additional documentation requests
  • Decision date and outcome

Denial-Prevention Tips

Five Common Pitfalls & Solutions

  1. Missing FLT3 mutation documentation
    • Fix: Ensure test results clearly state ITD or TKD mutation subtype
  2. Insufficient prior therapy details
    • Fix: Include specific regimen names, cycle counts, and response assessment
  3. Non-specialist prescriber
    • Fix: Add hematology/oncology consultation or co-signature
  4. Incomplete monitoring plan
    • Fix: Address differentiation syndrome surveillance per FDA labeling
  5. Generic medical necessity language
    • Fix: Reference specific NCCN Guidelines and patient-specific factors

Appeals Playbook for Georgia

If Cigna denies your initial request, Georgia law provides multiple appeal levels:

Internal Appeal Process

  • Timeline: 180 days from denial date to file
  • Method: Submit through Cigna member portal or mail to address on denial letter
  • Documentation: Include additional clinical evidence, updated lab results, or specialist consultation
  • Decision: Cigna has 30 days for standard appeals, 72 hours for expedited

External Review (Georgia Department of Insurance)

If internal appeal fails:

  • Timeline: 60 days from final internal denial to request external review
  • Contact: Georgia Office of Commissioner of Insurance at 1-800-656-2298
  • Cost: Free to consumers
  • Process: Independent medical review by specialists in same field
  • Decision: Binding on Cigna if approved
Note: Georgia allows concurrent external review with expedited internal appeals for urgent medical situations.

Printable Checklist

Before Submission

☐ Confirm active Cigna coverage and specialty pharmacy requirement
☐ Obtain current prior authorization form
☐ Verify prescriber is hematologist/oncologist
☐ Collect FLT3 mutation test results from FDA-approved assay
☐ Document complete prior therapy history with outcomes
☐ Prepare comprehensive medical necessity letter

During Submission

☐ Complete all required form fields
☐ Attach all supporting documentation
☐ Submit via provider portal or confirmed fax number
☐ Record confirmation number and submission date
☐ Schedule follow-up call in 5-7 business days

After Decision

☐ If approved: Contact Accredo for prescription transfer
☐ If denied: Review denial reason and gather additional evidence
☐ File internal appeal within 180 days
☐ If needed: Request external review within 60 days of final denial

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform helps patients and providers navigate complex prior authorization requirements and appeal processes for specialty medications like Xospata. Learn more about our coverage advocacy services.

Frequently Asked Questions

How long does Cigna prior authorization take for Xospata in Georgia?
Standard reviews take up to 15 business days. Expedited reviews for urgent cases are completed within 72 hours when proper medical necessity is documented.

What if Xospata is non-formulary on my Cigna plan?
You can request a formulary exception through the prior authorization process. Include clinical justification for why formulary alternatives are inappropriate.

Can I request an expedited appeal if my condition is urgent?
Yes. Georgia allows expedited internal appeals (72 hours) and expedited external reviews for urgent medical situations that could seriously endanger your health.

Does step therapy apply to Xospata?
Cigna typically requires documentation of prior AML therapy failure rather than specific step therapy protocols, since Xospata is indicated for relapsed/refractory disease.

What happens if I move out of Georgia during treatment?
Your Cigna coverage continues, but appeal rights may change based on your new state's insurance regulations. Contact the new state's insurance department for guidance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal deadlines and processes may vary by plan type and individual circumstances.

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