By Counterforce Health Team in Xospata (gilteritinib) —

Cigna's Coverage Criteria for Xospata (Gilteritinib) in Pennsylvania: What Counts as "Medically Necessary"?

Answer Box: Getting Xospata Covered by Cigna in Pennsylvania

Cigna requires prior authorization for Xospata (gilteritinib) in Pennsylvania. To qualify, you need: (1) confirmed relapsed/refractory AML with FLT3 mutation via FDA-approved test, (2) documented failure of prior AML therapy, and (3) prescription from a hematologist/oncologist. First step today: Have your doctor gather your FLT3 mutation report and prior treatment records, then submit Cigna's oncology PA form. If denied, Pennsylvania's new external review program overturns ~50% of appeals.

Table of Contents

Policy Overview: How Cigna Manages Xospata Coverage

Cigna covers Xospata (gilteritinib) across all plan types—HMO, PPO, and Medicare Advantage—but requires prior authorization regardless of your specific plan. The drug is typically managed through Express Scripts/Accredo specialty pharmacy, meaning you'll need to work through their system rather than your local pharmacy.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plans Cigna oncology PA policy
Formulary Tier Specialty tier (highest copay) Your plan's formulary document
Step Therapy Must document prior AML therapy failure PA form requirements
Quantity Limits 120 mg daily maximum FDA labeling guidelines
Site of Care Specialty pharmacy only Express Scripts/Accredo
Age Limits 18 years and older FDA approval criteria

In Pennsylvania, if Cigna denies your initial request, you have strong appeal rights through the state's new external review program, which has overturned roughly 50% of denials in its first year.

Indication Requirements: FDA Status and Mutation Testing

Xospata is FDA-approved specifically for relapsed or refractory AML in adults with confirmed FLT3 mutations. This narrow indication means Cigna will only cover it for patients who meet these exact criteria.

Required Mutation Testing Your doctor must order an FDA-approved FLT3 mutation test, such as the LeukoStrat CDx FLT3 Mutation Assay. The test must confirm either:

  • FLT3-ITD (internal tandem duplication) mutations
  • FLT3-TKD (tyrosine kinase domain) mutations
Note: Simply having AML isn't enough—the FLT3 mutation must be documented with lab results from an approved test.

Off-Label Use Challenges Cigna generally doesn't cover Xospata for:

  • Newly diagnosed (front-line) AML
  • AML without confirmed FLT3 mutations
  • Other blood cancers, even with FLT3 mutations

If your situation involves off-label use, you'll need strong evidence from drug compendia like NCCN guidelines to support your case.

Step Therapy & Medical Exceptions

Cigna requires documentation that you've tried and failed (or couldn't tolerate) prior AML therapy before approving Xospata. This isn't traditional "step therapy" since Xospata is specifically for relapsed/refractory disease, but you must prove your disease has relapsed or become refractory to treatment.

Required Prior Therapy Documentation:

  • Specific chemotherapy regimens tried (e.g., 7+3 induction, HiDAC consolidation)
  • Dates of treatment and duration
  • Response achieved (complete remission, partial response, stable disease, progression)
  • Reason for discontinuation (progression, intolerance, toxicity)
  • Current disease status confirming relapse or refractory nature

Medical Exception Pathways If you haven't had "standard" prior therapy due to medical contraindications, your doctor can request an exception by documenting:

  • Specific contraindications to standard AML therapies
  • Why Xospata is the most appropriate first-line treatment
  • Supporting literature or guidelines

Required Diagnostics and Documentation

Beyond the FLT3 mutation test, Cigna expects comprehensive clinical documentation to approve Xospata.

Essential Lab Work and Timing:

  • FLT3 mutation report (must be from FDA-approved test, within past 12 months)
  • Baseline ECG (Xospata can cause QT prolongation)
  • Liver function tests (ALT, AST, bilirubin)
  • Kidney function (creatinine, estimated GFR)
  • Complete blood count with differential

Clinical Documentation Requirements:

  • Pathology report confirming AML diagnosis
  • Bone marrow biopsy results showing current disease status
  • Treatment history with dates, regimens, and outcomes
  • Current performance status and life expectancy assessment
  • Plan for monitoring during Xospata therapy
Tip: Submit recent lab values (within 30 days) to avoid delays. Cigna may request updated labs if yours are too old.

Site of Care and Specialty Pharmacy Rules

Cigna requires Xospata to be dispensed through designated specialty pharmacies, typically Express Scripts/Accredo. You can't fill this prescription at your local pharmacy, even with prior authorization approval.

Specialty Pharmacy Process:

  1. Your doctor sends the prescription to the specialty pharmacy
  2. The pharmacy contacts you to coordinate delivery
  3. First shipment often requires a phone consultation with a pharmacist
  4. Ongoing refills are typically shipped to your home on a 30-day cycle

Important: Even with PA approval, there can be delays if the specialty pharmacy doesn't have your updated insurance information or if there are coordination issues between Cigna and Express Scripts.

Evidence to Support Medical Necessity

When your doctor submits the prior authorization request, including the right supporting evidence dramatically improves your chances of approval. Counterforce Health helps patients and clinicians identify exactly which evidence payers need and how to present it effectively in appeals.

Key Guidelines and References:

  • FDA prescribing information for Xospata (official indication and dosing)
  • NCCN Guidelines for AML (current version, specific recommendations for FLT3+ relapsed/refractory disease)
  • Peer-reviewed studies supporting Xospata efficacy in your specific situation
  • Drug compendia entries (if applicable for any off-label aspects)

How to Cite Evidence: Your doctor should reference specific guideline sections, not just general mentions. For example: "Per NCCN AML Guidelines v2.2024, gilteritinib is a Category 1 recommendation for relapsed/refractory FLT3-mutated AML" rather than "NCCN supports this treatment."

Sample "Meets Criteria" Narrative

Here's a template your doctor can adapt for the medical necessity section of Cigna's PA form:

"Patient is a 58-year-old with relapsed acute myeloid leukemia, FLT3-ITD positive confirmed by LeukoStrat CDx assay on [date]. Initially achieved complete remission with 7+3 induction therapy followed by HiDAC consolidation in [year]. Disease relapsed [timeframe] with [percentage] blasts on bone marrow biopsy dated [date]. Given documented FLT3-ITD mutation and relapsed disease status, patient meets FDA-approved indication for gilteritinib (Xospata) per prescribing information. NCCN AML Guidelines recommend gilteritinib as Category 1 therapy for this clinical scenario. Patient has adequate organ function and performance status for treatment. Request approval for gilteritinib 120 mg daily until disease progression or unacceptable toxicity."

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix It Required Documentation
"Missing FLT3 mutation testing" Submit FDA-approved test results LeukoStrat CDx or equivalent lab report
"Not relapsed/refractory disease" Document disease timeline and prior therapy Treatment records, response assessments, relapse documentation
"Prescriber not qualified" Add hematology/oncology consultation Specialist consultation notes or co-signature
"Insufficient prior therapy documentation" Provide complete treatment history Chemotherapy records, dates, outcomes, toxicities
"Not medically necessary" Submit comprehensive clinical rationale Guidelines citations, literature support, clinical notes

Pennsylvania Appeals Process

If Cigna denies your Xospata request, Pennsylvania offers one of the strongest appeal processes in the country through its new Independent External Review Program.

Step-by-Step Appeals Timeline:

  1. Internal Appeal (Start immediately after denial)
    • Submit within 180 days of denial letter
    • Cigna has up to 60 days to respond
    • Include additional medical evidence and doctor's letter
  2. External Review (After internal appeal denial)
    • File within 4 months of final internal denial
    • Submit through Pennsylvania Insurance Department
    • Independent medical reviewers make binding decision
    • Standard review: 45 days; Expedited: 72 hours
  3. Success Rate
    • Pennsylvania's external review program overturned ~50% of denials in 2024
    • Specialty drug appeals often succeed when proper documentation is provided
From our advocates: We've seen cases where patients received Cigna denials for missing one piece of documentation—like an outdated FLT3 test—but won their appeals by simply providing the updated lab work along with a clear medical necessity letter. The key is addressing the specific denial reason with concrete evidence.

For urgent situations, request expedited review if delay could seriously harm your health. Your doctor must complete a Physician Certification Form stating the urgency.

FAQ

How long does Cigna's prior authorization take for Xospata in Pennsylvania? Standard reviews take up to 15 business days. Expedited reviews (for urgent cases) are completed within 72 hours. Submit complete documentation upfront to avoid delays.

What if Xospata is non-formulary on my Cigna plan? You can request a formulary exception by having your doctor submit additional documentation explaining why formulary alternatives won't work for your specific case.

Can I request an expedited appeal if I'm getting sicker? Yes. If your health is deteriorating while waiting for coverage, your doctor can request expedited internal and external reviews with shortened timelines.

Does step therapy apply if I failed treatments outside Pennsylvania? No. Prior therapy documentation from any location counts toward meeting Cigna's requirements, as long as you have proper medical records.

How much will I pay out-of-pocket for Xospata with Cigna coverage? This varies by plan, but specialty tier medications typically have higher copays ($100-500+ per month) or coinsurance (20-40% of drug cost). Check your plan documents or call Cigna member services.

What happens if my appeal is denied at every level? After exhausting Pennsylvania's external review process, you may have options through federal appeals processes or working with patient advocacy organizations for alternative access programs.

Healthcare coverage decisions can feel overwhelming, but understanding Cigna's specific requirements for Xospata gives you the best chance of success. Counterforce Health specializes in turning insurance denials into successful appeals by identifying exactly what evidence payers need and presenting it in the most compelling way possible.

Disclaimer: This information is for educational purposes only and doesn't constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For personalized help with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

Sources & Further Reading

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