By Counterforce Health Team in Xospata (gilteritinib) —

How to Get Xospata (gilteritinib) Covered by Blue Cross Blue Shield in Florida: Prior Authorization, Appeals, and Success Strategies

Quick Answer: Blue Cross Blue Shield in Florida covers Xospata (gilteritinib) for relapsed/refractory FLT3-mutated AML with prior authorization. You'll need documented FLT3 mutation testing, prior therapy history, and a hematologist-oncologist prescription. Start by checking your plan's medication guide for PA requirements, then submit through your provider's portal with complete clinical documentation. If denied, you have 180 days to appeal with additional evidence.

Table of Contents

Florida Blue's Coverage Policy Overview

Blue Cross Blue Shield of Florida (Florida Blue) treats Xospata (gilteritinib) as a specialty medication requiring prior authorization across all plan types. The drug appears on formularies as a covered benefit but with strict utilization management controls.

Plan Types and Coverage Variations

Commercial and ACA Plans: Xospata is listed on ValueScript, NetResults, and CareChoices formularies as a specialty tier drug with PA and quantity limit (QL) flags. Coverage applies when medical necessity criteria are met.

Medicare Advantage: Florida Blue Medicare plans include Xospata in their Part D specialty tier with standard Medicare PA requirements and cost-sharing structures.

Self-Funded Groups: Employer groups using Florida Blue networks may have modified PA criteria, but the baseline requirement for FLT3 mutation documentation and relapsed/refractory status typically remains.

You can verify your specific plan's coverage by accessing Florida Blue's Medication Guide portal and searching for "Xospata" or "gilteritinib."

Medical Necessity Requirements

Florida Blue considers Xospata medically necessary only for FDA-approved indications with proper documentation. Here's what must be established:

Core Eligibility Criteria

Requirement Documentation Needed Source
Adult AML diagnosis Pathology report confirming AML (excluding APL) FDA Label
FLT3 mutation status FDA-approved test showing FLT3-ITD or TKD mutation LeukoStrat CDx
Relapsed/refractory disease Documentation of disease progression or failure to achieve remission Clinical notes
Specialist prescriber Hematologist-oncologist with NPI and practice details Provider credentials

Clinical Documentation Standards

Your hematologist-oncologist must provide:

  • Disease timeline: Date of initial AML diagnosis, cytogenetic/molecular findings, and disease status
  • Prior therapy history: All previous AML treatments with dates, responses, and reasons for discontinuation
  • Current status: Recent bone marrow biopsy, CBC, performance status, and treatment goals
  • Safety assessment: Baseline ECG, liver function tests, and comorbidity evaluation

Step Therapy and Exception Pathways

Florida Blue typically requires documentation of prior therapy rather than mandating specific step-through requirements for relapsed/refractory AML, recognizing the urgent nature of this indication.

Medical Exception Criteria

Step therapy exceptions are granted when:

  • Prior intolerance: Documented severe adverse reactions to preferred agents
  • Contraindications: Medical conditions preventing use of first-line FLT3 inhibitors
  • Clinical ineffectiveness: Disease progression despite adequate trial of preferred therapy

Exception Documentation

Include specific details about:

  1. Which agents were tried and for how long
  2. Specific adverse events or contraindications
  3. Clinical rationale for choosing Xospata over alternatives
  4. Treatment urgency based on disease progression

Quantity Limits and Renewal Process

Standard Quantity Limits

  • Initial approval: Typically 30-day supply (90 tablets of 40mg for standard 120mg daily dosing)
  • Refill timing: Usually allows refills when 75% of current supply is used
  • Dose modifications: Higher or lower doses require clinical justification

Renewal Requirements

Reauthorization typically occurs every 3-6 months and requires:

  • Updated clinic notes documenting treatment response
  • Current laboratory values and safety monitoring
  • Confirmation of continued FLT3-mutated AML diagnosis
  • Assessment of treatment tolerance and adherence

Set calendar reminders 30 days before your current authorization expires to ensure uninterrupted therapy.

Required Diagnostic Documentation

FLT3 Mutation Testing

Florida Blue requires FLT3 mutation confirmation using an FDA-approved assay. The LeukoStrat CDx FLT3 Mutation Assay is the primary FDA-approved companion diagnostic for gilteritinib.

Testing Requirements:

  • Must detect both FLT3-ITD and TKD mutations
  • Performed on bone marrow or peripheral blood
  • Results must be from initial diagnosis or at relapse
  • Report must include specific mutation type and allelic ratio when applicable

Supporting Laboratory Values

Include recent results for:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Liver function tests (AST, ALT, bilirubin)
  • Baseline ECG (QTc interval assessment)
  • Bone marrow biopsy with cytogenetics

Specialty Pharmacy Requirements

Xospata must be dispensed through Florida Blue's contracted specialty pharmacy network for coverage under the pharmacy benefit.

Preferred Specialty Pharmacies

  • Accredo Specialty Pharmacy
  • CVS Specialty Pharmacy
  • Other contracted specialty providers (verify with your plan)

Dispensing Process

  1. Prior authorization approval must be in place before first shipment
  2. Specialty pharmacy enrollment requires patient registration and insurance verification
  3. Home delivery is typically required; retail pharmacy fills are generally not covered
  4. Coordination of care includes medication counseling and adherence monitoring

Contact your plan's specialty pharmacy coordinator to initiate enrollment once PA is approved.

Evidence to Support Medical Necessity

Guideline Support

Reference these authoritative sources in your medical necessity documentation:

FDA Labeling: Xospata is FDA-approved for adults with relapsed or refractory AML with FLT3-ITD or TKD mutations, providing the strongest evidence base for coverage.

NCCN Guidelines: The National Comprehensive Cancer Network includes gilteritinib as a Category 1 recommendation for relapsed/refractory FLT3-mutated AML.

Clinical Evidence: The ADMIRAL study demonstrated superior overall survival compared to salvage chemotherapy in this patient population.

Documentation Strategy

When preparing medical necessity letters:

  • Lead with FDA-approved indication alignment
  • Cite specific NCCN guideline recommendations
  • Reference peer-reviewed efficacy data (without copying copyrighted text)
  • Emphasize the urgency of treatment in progressive AML

Appeals Process for Florida

If Florida Blue denies your initial prior authorization, you have well-defined appeal rights under Florida law.

Internal Appeal Process

Timeline: 180 days from denial notice to file internal appeal Decision timeframe: 30 days for standard review, 72 hours for expedited urgent cases Submission: Through Florida Blue's provider portal or member services

Required Appeal Documentation

  • Copy of original denial letter
  • Updated medical necessity letter addressing specific denial reasons
  • Additional clinical documentation (labs, imaging, consultant notes)
  • Relevant guideline excerpts or citations
  • Completed appeal form

External Review Process

If internal appeal fails, Florida offers independent external review through the Department of Financial Services.

Timeline: 4 months after final internal denial to request external review Process: Contact Florida Division of Consumer Services at 1-877-693-5236 Cost: No charge to consumers Decision: Binding on the insurer if reviewer finds in your favor

From our advocates: We've seen Florida Blue denials overturned when appeals included comprehensive FLT3 mutation reports and detailed prior therapy documentation. The key is addressing each specific denial reason with targeted clinical evidence rather than submitting generic form letters.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Documentation to Include
"Not FDA-approved for this indication" Emphasize relapsed/refractory FLT3+ AML aligns with label FDA prescribing information excerpt
"Insufficient prior therapy documentation" Provide detailed treatment history timeline Clinic notes with dates, agents, responses
"FLT3 mutation not confirmed" Submit FDA-approved test results LeukoStrat CDx or equivalent lab report
"Prescriber not qualified" Verify hematology-oncology specialty Provider NPI lookup and credentials
"Experimental/investigational" Clarify on-label use with guideline support NCCN guideline citation for R/R AML

Peer-to-Peer Review Strategy

Request a peer-to-peer review between your hematologist-oncologist and Florida Blue's medical director when:

  • Initial denial cites complex clinical factors
  • Multiple prior therapies create nuanced treatment history
  • Timing considerations make expedited review critical

Your oncologist should prepare to discuss specific FLT3 mutation characteristics, prior therapy responses, and treatment urgency during the call.

Costs and Patient Assistance

Expected Out-of-Pocket Costs

With a wholesale acquisition cost of approximately $28,979 for a 30-day supply, patient responsibility varies significantly by plan design:

  • Commercial plans: Typically $50-$500/month after specialty tier deductible
  • Medicare Advantage: Subject to Part D catastrophic coverage thresholds
  • High-deductible plans: May require meeting full deductible before coverage begins

Manufacturer Support Programs

Astellas Pharma Support Solutions offers:

  • Copay assistance: Up to $25,000 annually for eligible commercial patients
  • Patient assistance program: Free drug for qualifying uninsured/underinsured patients
  • Prior authorization support: Dedicated case managers to assist with PA submissions

Additional Resources

  • Leukemia & Lymphoma Society: Financial assistance grants and copay support
  • CancerCare: Limited financial assistance for cancer medications
  • State pharmaceutical assistance programs: Florida residents may qualify for additional state-sponsored support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex specialty medications like Xospata. Their platform helps identify denial basis and drafts point-by-point rebuttals aligned to your plan's specific requirements, pulling the right clinical citations and operational details that payers expect for FLT3-targeted therapies.

FAQ

How long does Florida Blue prior authorization take for Xospata? Standard PA decisions are typically made within 5-7 business days. Expedited reviews for urgent cases can be completed within 24-72 hours when clinical urgency is documented.

What if Xospata isn't on my formulary? Request a formulary exception through Florida Blue's Protocol Exemption process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I get expedited appeals in Florida? Yes, Florida follows federal guidelines allowing expedited appeals when delay could seriously jeopardize life or health. Your oncologist must document the urgent clinical need.

Does step therapy apply if I've failed therapies outside Florida? Prior therapy history from other states or health systems counts toward step therapy requirements. Ensure complete documentation of all previous treatments regardless of location.

What if my employer's plan has different rules? Self-funded employer plans may have modified PA criteria, but they cannot exclude FDA-approved cancer treatments without alternative coverage. Check your Summary Plan Description for specific provisions.

How often do Florida Blue Xospata appeals succeed? While specific success rates aren't published, oncology appeals generally have higher success rates (40-50% at external review) when complete clinical documentation supports FDA-approved indications.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently, and individual circumstances vary. Always verify current coverage requirements with your specific Florida Blue plan and consult with your healthcare team for medical decisions. For assistance with insurance complaints or appeals, contact the Florida Division of Consumer Services at 1-877-693-5236.

When facing complex prior authorization challenges, Counterforce Health offers specialized support in developing evidence-backed appeals that address payer-specific requirements and improve approval rates for targeted therapies like Xospata.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.