By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

Blue Cross Blue Shield Florida Besponsa Coverage: Prior Authorization Guide & Appeal Strategies

Answer Box: Getting Besponsa Covered in Florida

To get Besponsa (inotuzumab ozogamicin) covered by Blue Cross Blue Shield in Florida: Submit prior authorization through your oncologist with CD22+ B-cell ALL documentation, relapsed/refractory status proof, baseline liver function tests, and hepatic monitoring plan. Use participating specialty pharmacies (Accredo, CVS/Caremark, Alliance Rx Walgreens Prime). If denied, file internal appeal within 180 days, then external review through Florida Department of Financial Services if needed.

First step today: Contact your oncologist to initiate prior authorization via Florida Blue's provider portal or call (877) 719-2583.

Table of Contents

  1. Florida Blue Policy Overview
  2. Medical Necessity Requirements
  3. Specialty Pharmacy Network
  4. Prior Authorization Process
  5. Common Denial Reasons & Solutions
  6. Appeals Process in Florida
  7. Cost Support Programs
  8. FAQ
  9. Sources & Further Reading

Florida Blue Policy Overview

Florida Blue (Blue Cross Blue Shield of Florida) requires prior authorization for Besponsa across all plan types—HMO, PPO, and Medicare Advantage. The drug falls under their specialty pharmacy benefit, meaning it cannot be dispensed through retail pharmacies or administered as a buy-and-bill therapy in physician offices.

Key Policy Elements:

  • Prior authorization required before first fill
  • Specialty pharmacy dispensing only through contracted network
  • Medical necessity criteria aligned with FDA labeling
  • Hepatic monitoring requirements due to boxed warning

Find current policies at Florida Blue's medical policy portal.

Medical Necessity Requirements

Core Eligibility Criteria

Besponsa coverage requires documentation of:

Diagnosis & Disease Status:

  • Confirmed B-cell precursor acute lymphoblastic leukemia (ICD-10: C91.00 or C91.02 for relapsed)
  • CD22-positive status via flow cytometry or immunophenotyping (≥70% expression per typical insurer criteria)
  • Relapsed or refractory disease after at least one prior therapy

Safety Requirements:

  • Baseline liver function tests (ALT, AST, total bilirubin, alkaline phosphatase)
  • Hepatitis screening panel
  • Veno-occlusive disease (VOD) risk assessment
  • Detailed hepatic monitoring protocol
Note: Besponsa carries a boxed warning for hepatotoxicity, including fatal hepatic veno-occlusive disease occurring in 14% of patients in clinical trials.

Documentation Checklist

Requirement Documentation Needed Source
B-cell ALL diagnosis Pathology/hematopathology report Hospital/lab records
CD22 positivity Flow cytometry showing ≥70% expression Immunophenotyping report
Prior therapy failure Treatment dates, response, discontinuation reason Medical records
Baseline safety LFTs, hepatitis screen, performance status Recent lab results
Prescriber qualification Oncologist or hematologist Provider credentials

Specialty Pharmacy Network

Besponsa must be obtained through Florida Blue's contracted specialty pharmacies:

  • Accredo: (888) 425-5970
  • CVS/Caremark Specialty Pharmacy: (866) 278-5108
  • Alliance Rx Walgreens Prime: (877) 627-6337

Your oncologist will coordinate with one of these pharmacies after prior authorization approval. The specialty pharmacy will handle insurance billing, patient education, and delivery logistics.

Tip: Enroll with your preferred specialty pharmacy early in the process to avoid delays once approval comes through.

Prior Authorization Process

Step-by-Step Submission

1. Oncologist Initiates Request

  • Submit via Florida Blue provider portal or call (877) 719-2583
  • Include all required documentation listed above
  • Timeline: 7-14 business days for standard review

2. Clinical Review

  • Florida Blue's pharmacy team evaluates medical necessity
  • May request additional documentation
  • Expedited review available for urgent cases (72 hours)

3. Determination

  • Approval: Pharmacy can dispense immediately
  • Denial: Written explanation provided with appeal rights

Medical Necessity Letter Template

When your oncologist submits the prior authorization, the letter should include:

"Patient has relapsed/refractory CD22-positive B-cell precursor ALL confirmed by [pathology date] with CD22 expression of [X%] by flow cytometry. Previous therapy with [specific regimen] from [dates] resulted in [response/failure reason]. Patient meets FDA labeling criteria for Besponsa treatment. Baseline liver function tests obtained [date] show [values]. Comprehensive hepatic monitoring protocol established per prescribing information, including pre-dose LFTs and VOD surveillance. Treatment plan: [X cycles] with goal of [remission/bridge to transplant]."

Common Denial Reasons & Solutions

Denial Reason Solution Documentation to Submit
CD22 status not documented Resubmit with flow cytometry report Immunophenotyping showing ≥70% CD22+
Insufficient prior therapy Document all previous treatments Treatment timeline with responses/failures
Missing hepatic monitoring plan Submit detailed safety protocol Baseline LFTs + monitoring schedule
Off-label use concerns Cite FDA indication FDA label highlighting approved use
Alternative therapy not tried Request medical exception Contraindication/intolerance documentation

Appeals Process in Florida

Internal Appeal (First Level)

Timeline: 180 days from denial notice to file How to file:

  • Written request to Florida Blue
  • Include denial letter and new supporting evidence
  • Expedited appeals: Available for urgent medical situations

Contact: Member Services at number on your insurance card

External Review (Second Level)

If internal appeal fails, Florida law provides independent external review:

Eligibility: Must complete internal appeal first (with exceptions for urgent cases) Timeline: 4 months after final internal denial to request How to file: Submit request to Florida Department of Financial Services Cost: Free to consumers

Contact: Florida Insurance Consumer Helpline: (877) 693-5236

From our advocates: We've seen Besponsa appeals succeed when families included peer-reviewed evidence from the pivotal INO-VATE trial alongside detailed documentation of CD22 positivity and prior treatment failures. The key is methodically addressing each denial reason with clinical facts rather than emotional appeals.

Required Documents for Appeals

  • Original denial letter
  • Updated clinical notes
  • Peer-reviewed literature supporting medical necessity
  • Provider letter explaining why Besponsa is appropriate
  • Any new lab results or imaging

Cost Support Programs

Manufacturer Assistance

Pfizer Oncology Together

  • Copay assistance for eligible patients
  • Patient navigation services
  • Financial counseling
  • Contact: Visit Pfizer Oncology Together or call (877) 744-5675

Foundation Grants

Several organizations provide grants for cancer medication costs:

  • Leukemia & Lymphoma Society
  • CancerCare Co-Payment Assistance Foundation
  • Patient Advocate Foundation

Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals tailored to specific payer requirements. Their platform analyzes denial letters and generates targeted rebuttals using the right clinical documentation and peer-reviewed evidence.

FAQ

How long does Florida Blue prior authorization take? Standard review: 7-14 business days. Expedited review for urgent cases: 72 hours. (Verify current timelines with Florida Blue)

What if Besponsa isn't on my formulary? Request a formulary exception through the prior authorization process. Your oncologist must demonstrate medical necessity and lack of suitable alternatives.

Can I appeal if I'm denied for step therapy requirements? Yes. Document contraindications or previous failures with required step therapy drugs to request a medical exception.

Does Florida Blue cover Besponsa for pediatric patients? Coverage follows FDA labeling for patients ≥1 year old with appropriate clinical documentation.

What happens if I need Besponsa urgently? Request expedited prior authorization and appeal processes. For life-threatening situations, external review can be expedited to 72 hours.

How do I find my specific plan's coverage details? Check your plan documents or call the member services number on your insurance card for plan-specific formulary and coverage information.

Can I use Besponsa manufacturer support with Florida Blue coverage? Yes, Pfizer's copay assistance can typically be combined with insurance coverage to reduce out-of-pocket costs.

What if my oncologist is out-of-network? Prior authorization must come from an in-network provider, but you may be able to get a referral or work with Florida Blue to establish coverage for out-of-network specialty care.

Sources & Further Reading

Getting Besponsa covered requires thorough documentation and persistence, but Florida's robust appeal protections ensure you have multiple pathways to access this important treatment. Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting evidence-backed responses that align with payer policies.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria may change. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For assistance with insurance issues in Florida, contact the Department of Financial Services at (877) 693-5236.

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