How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Humana in Washington: Complete Decision Tree & Appeals Guide
Answer Box: Your Path to Besponsa Coverage
Getting Besponsa (inotuzumab ozogamicin) covered by Humana in Washington requires meeting specific criteria for relapsed/refractory CD22-positive ALL. Most approvals happen within 72 hours if you submit complete documentation upfront.
Your first step today: Confirm CD22-positive status via flow cytometry and gather prior therapy records. Then have your oncologist submit a prior authorization request through Humana's provider portal with medical necessity documentation.
If denied: Washington residents can appeal through Humana's internal process, then request external review through an Independent Review Organization (IRO) via the Washington Office of Insurance Commissioner.
Table of Contents
- How to Use This Decision Tree
- Eligibility Triage: Do You Qualify?
- If "Likely Eligible": Your Action Plan
- If "Possibly Eligible": Tests and Timeline
- If "Not Yet": Alternatives and Exceptions
- If Denied: Washington Appeals Process
- Coverage Requirements at a Glance
- Common Denial Reasons & Solutions
- Frequently Asked Questions
- Sources & Further Reading
How to Use This Decision Tree
This guide helps patients with acute lymphoblastic leukemia (ALL) and their care teams navigate Humana's coverage process for Besponsa in Washington state. We'll walk through eligibility criteria, documentation requirements, and your appeal rights step by step.
Before you start: Have your insurance card, recent lab results, and treatment history ready. Besponsa is a high-cost specialty drug that requires prior authorization from Humana, but Washington's strong consumer protections give you multiple appeal options if initially denied.
Eligibility Triage: Do You Qualify?
✅ Likely Eligible if you have:
- Confirmed diagnosis: Adult B-cell precursor ALL that's relapsed or refractory
- CD22-positive status: ≥1% CD22+ blasts by flow cytometry (FDA labeling requirement)
- Prior therapy: At least one previous treatment regimen that failed
- Liver function: No active severe liver disease or prior veno-occlusive disease (VOD)
- Humana coverage: Active Medicare Advantage or Part D plan
⚠️ Possibly Eligible if you have:
- Recent ALL diagnosis but CD22 status not yet confirmed
- Liver function abnormalities that need evaluation
- Questions about prior therapy documentation
- Humana plan but unsure about specialty drug coverage
❌ Not Yet if you have:
- CD22-negative ALL (Besponsa won't work)
- Active severe liver disease or prior VOD
- Haven't tried standard first-line therapy
- No current Humana coverage
If "Likely Eligible": Your Action Plan
Step 1: Gather Required Documentation
Your oncologist needs these items for the prior authorization:
Medical Records:
- Pathology report confirming CD22-positive status
- Documentation of relapsed/refractory ALL diagnosis with ICD-10 codes
- Complete treatment history showing prior therapies and outcomes
- Current liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Treatment Plan:
- Proposed Besponsa dosing schedule per FDA labeling
- Monitoring plan for hepatotoxicity and VOD
- Site of care (typically hospital-based infusion center)
Step 2: Submit Prior Authorization
Timeline: Humana aims for decisions within 72 hours for complete requests (source).
How to submit:
- Provider portal: Humana provider website
- Phone: Provider services line on your insurance card
- Fax: Check current fax number on Humana's provider portal
Step 3: Track Your Request
Humana will send a determination letter within the standard timeframe. If approved, you can begin treatment. If denied, you have appeal rights under Washington state law.
Tip: Request expedited review if your condition is urgent. Humana must respond within 24 hours for expedited requests.
If "Possibly Eligible": Tests and Timeline
Missing CD22 Testing?
What to request: Flow cytometry to confirm CD22 expression on ALL blasts. Most labs can complete this within 3-5 business days.
Why it matters: Besponsa only works against CD22-positive ALL. Without this confirmation, Humana will deny coverage (medical necessity criteria).
Liver Function Concerns?
What to do: Complete hepatic panel and discuss VOD risk with your oncologist. If you have mild abnormalities, document the risk-benefit analysis in your prior authorization.
Timeline: Plan 1-2 weeks to complete testing and resubmit your request.
If "Not Yet": Alternatives and Exceptions
For CD22-Negative ALL
Alternative options:
- Blinatumomab (targets CD19)
- CAR-T cell therapy
- Clinical trials
Next steps: Discuss these options with your oncologist and check their coverage status with Humana.
For Liver Disease Concerns
If you have active liver disease, Besponsa may not be appropriate due to VOD risk. Your care team should explore safer alternatives first.
Exception Requests
For unique clinical situations, your doctor can request a formulary exception with detailed medical justification.
If Denied: Washington Appeals Process
Washington state provides strong consumer protections for insurance denials. Here's your step-by-step appeal path:
Level 1: Internal Appeal with Humana
Timeline: 65 days from denial notice to file How to file: Call member services or submit written appeal Decision time: 30 days (7 days if expedited)
Level 2: External Review (IRO)
If Humana upholds the denial, Washington residents can request independent review.
Timeline: 180 days from final internal denial to request external review How to file: Contact the Washington Office of Insurance Commissioner at 1-800-562-6900 Decision time:
- Standard: 20 days for fully insured plans
- Expedited: 72 hours for urgent cases
The IRO process: An independent medical expert reviews your case and can override Humana's decision. Their ruling is binding on the insurer.
Note: For self-funded employer plans, federal ERISA rules may apply instead of Washington state protections.
Coverage Requirements at a Glance
| Requirement | Details | Documentation Needed | Source |
|---|---|---|---|
| Prior Authorization | Required for all Humana plans | Complete PA form with medical records | Humana PA Lists |
| Diagnosis | Relapsed/refractory B-cell precursor ALL | Pathology report, treatment history | FDA Label |
| CD22 Status | Must be positive (≥1% blasts) | Flow cytometry results | Medical literature |
| Liver Function | No severe disease or prior VOD | LFTs, hepatic assessment | FDA Boxed Warning |
| Site of Care | Hospital or infusion center | Treatment plan with facility details | Plan policy |
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "CD22 status not documented" | Submit flow cytometry report | Lab results showing CD22+ blasts |
| "Not relapsed/refractory" | Provide treatment history | Records of prior therapy failure |
| "Liver risk not addressed" | Include hepatic assessment | LFTs and VOD risk evaluation |
| "Site of care inappropriate" | Justify hospital setting | Infusion center capabilities |
| "Step therapy required" | Document contraindications | Medical reasons to skip preferred drugs |
Frequently Asked Questions
How long does Humana's prior authorization take in Washington? Standard requests: 72 hours. Expedited requests: 24 hours. Humana has committed to processing 95% of electronic requests within one business day by 2026.
What if Besponsa isn't on Humana's formulary? You can request a formulary exception with medical necessity documentation. Decisions come within 72 hours.
Can I get expedited review if my ALL is progressing? Yes. Both Humana's internal process and Washington's external review offer expedited timelines for urgent medical needs.
Does step therapy apply to Besponsa? Possibly. If required to try other ALL treatments first, your doctor can request an exception based on medical contraindications or prior failures.
What's the cost of Besponsa? Wholesale acquisition cost is approximately $8,700 per 0.9mg vial. Your out-of-pocket cost depends on your specific Humana plan's coverage tier and copay structure.
Who can help me navigate the appeals process in Washington? The Washington Office of Insurance Commissioner provides free consumer assistance at 1-800-562-6900. They can help you understand your rights and file appeals.
Clinician Corner: Medical Necessity Documentation
When submitting prior authorization requests for Besponsa, include these key elements in your medical necessity letter:
Clinical Justification:
- Confirmed CD22-positive relapsed/refractory B-cell precursor ALL
- Documentation of prior therapy failures with specific regimens and outcomes
- Assessment of hepatic function and VOD risk factors
- Rationale for Besponsa over alternatives (blinatumomab, CAR-T, etc.)
Monitoring Plan:
- Pre-treatment liver function baseline
- Schedule for ongoing LFT monitoring during treatment
- VOD surveillance protocol
- Plan for post-treatment monitoring, especially if HSCT planned
Regulatory References:
- FDA prescribing information for approved indications
- NCCN or other evidence-based treatment guidelines
- Peer-reviewed literature supporting use in this clinical scenario
From Our Advocates
We've seen patients successfully overturn Besponsa denials by ensuring their CD22-positive status was clearly documented upfront. One common issue is when the flow cytometry report doesn't explicitly state the percentage of CD22+ blasts—make sure this number is prominent in your submission. Having complete prior therapy records, including dates and reasons for discontinuation, also strengthens your case significantly.
About Counterforce Health
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed rebuttals that address each payer's specific requirements. For complex cases like Besponsa coverage, we help ensure all medical necessity criteria are properly documented and presented.
Sources & Further Reading
- Humana Prior Authorization Lists and Requirements
- Washington Office of Insurance Commissioner Appeals Guide
- Besponsa (Inotuzumab Ozogamicin) FDA Prescribing Information
- Humana Member Exceptions and Appeals Process
- Washington State External Review Process (RCW 48.43.535)
- CMS Medicare Part D Appeals and Exceptions
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider about treatment options and contact Counterforce Health or the Washington Office of Insurance Commissioner for personalized assistance with appeals.
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