By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Aetna CVS Health in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Besponsa Covered by Aetna CVS Health in Washington

Aetna CVS Health requires prior authorization for Besponsa (inotuzumab ozogamicin) in Washington. Coverage is approved for CD22-positive B-cell precursor ALL (relapsed/refractory) with documented prior therapy failures. Fastest path: Your oncologist submits the Aetna Besponsa precertification form with CD22+ pathology, treatment history, and liver monitoring plan to (866) 752-7021 or fax (888) 267-3277. If denied, Washington residents can appeal internally within 60-180 days, then request Independent Review Organization (IRO) review through the Office of the Insurance Commissioner within 120 days.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Requirements
  5. Cost-Share Basics
  6. Step-by-Step: Fastest Path to Approval
  7. Common Denial Reasons & How to Fix Them
  8. Washington Appeals Process
  9. Clinical Documentation Checklist
  10. FAQ
  11. Sources & Further Reading

Plan Types & Coverage Implications

Aetna CVS Health offers multiple plan types in Washington, each with different authorization requirements for Besponsa:

Commercial Plans (Individual & Group)

  • HMO/EPO: May require oncology referral before Besponsa authorization
  • PPO: Direct specialist access, but prior authorization still mandatory
  • All commercial plans route specialty drugs through CVS Specialty Pharmacy

Medicare Advantage

Medicaid (Apple Health)

  • Coverage varies by managed care plan
  • Additional state Medicaid criteria may apply beyond Aetna's requirements

Formulary Status & Tier Placement

Coverage at a Glance

Requirement Details Where to Verify Source
Prior Authorization Required for all plans Aetna precert list Aetna Provider
Formulary Tier Specialty tier (high cost-sharing) Plan-specific formulary Member Services
Step Therapy Prior therapy failures required Clinical policy bulletin Aetna Policy
Quantity Limits Maximum 6 cycles total Clinical policy Aetna Policy
Age Restrictions ≥1 year old FDA labeling Aetna Policy
Specialty Pharmacy CVS Specialty required Member materials CVS Caremark

Besponsa is classified as a specialty medication requiring specialized handling and monitoring. It's typically placed on the highest formulary tier with coinsurance rather than flat copays.

Prior Authorization Requirements

Medical Necessity Criteria

Aetna approves Besponsa for:

  • CD22-positive B-cell precursor acute lymphoblastic leukemia
  • Relapsed or refractory disease after standard induction therapy
  • Age ≥1 year
  • No active hepatic veno-occlusive disease (VOD)
  • Prescription by hematologist/oncologist

Step Therapy Requirements

Before Besponsa approval, patients must have documented:

  1. Failed initial induction therapy (e.g., hyper-CVAD, standard ALL protocols)
  2. For Philadelphia chromosome-positive (Ph+) ALL: Prior tyrosine kinase inhibitor failure (imatinib, dasatinib, nilotinib, or ponatinib)
  3. Salvage therapy attempts when clinically appropriate

Exceptions granted for:

  • Contraindications to required prior therapies
  • Severe intolerance or life-threatening toxicities
  • Clinical urgency requiring immediate Besponsa initiation

Specialty Pharmacy Requirements

Aetna mandates CVS Specialty Pharmacy for Besponsa dispensing. Key requirements:

  • Provider must specify CVS Specialty on precertification form
  • Patient enrollment required before first shipment
  • Cold-chain shipping and specialized handling protocols
  • Clinical monitoring coordination between pharmacy and prescriber
Note: Using non-preferred specialty pharmacies may result in denial or higher out-of-pocket costs.

Cost-Share Basics

Besponsa cost-sharing varies by plan design:

Commercial Plans: Typically 20-40% coinsurance after deductible Medicare Advantage: Part B coinsurance (usually 20%) after deductible Medicaid: Minimal or no cost-sharing for covered members

Financial Assistance Options:

This is educational information only. Consult your plan documents for specific cost-sharing details.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and care team
Timeline: 1-2 days
Documents needed:

  • Pathology report confirming CD22-positive B-cell ALL
  • Complete treatment history with dates and outcomes
  • Recent bone marrow biopsy results
  • Baseline liver function tests

2. Complete Aetna Precertification Form

Who: Prescribing oncologist
Timeline: Same day
Action: Download and complete Aetna Besponsa precertification form

  • Section E-G: Include exact dosing, ICD-10 codes, clinical setting
  • Specify CVS Specialty as dispensing pharmacy

3. Submit Complete Package

Who: Clinic staff
Timeline: Same day
Submission methods:

  • Fax: (888) 267-3277
  • Phone: (866) 752-7021 for urgent cases
  • Electronic: Aetna provider portal

4. Follow Up on Decision

Who: Clinic or patient
Timeline:

  • Standard: 3-5 business days
  • Expedited: 24-72 hours Action: Contact Aetna if no response within expected timeframe

5. Coordinate with CVS Specialty (if approved)

Who: Patient with clinic support
Timeline: 1-2 days
Action: Complete patient enrollment and schedule delivery

Common Denial Reasons & How to Fix Them

Denial Reason Required Documentation Appeal Strategy
CD22 status not documented Flow cytometry or IHC showing CD22+ percentage Resubmit with detailed pathology report
Step therapy not met Prior treatment records with failure documentation Medical necessity letter citing contraindications
Hepatic risk concerns Baseline LFTs and monitoring plan Comprehensive hepatic safety protocol
Non-formulary status Clinical superiority evidence Formulary exception request with peer-reviewed studies
Experimental/investigational FDA approval documentation FDA labeling and indication citations
Tip: Most denials are overturned when complete clinical documentation is provided. Counterforce Health has seen approval rates above 95% with properly documented resubmissions.

Washington Appeals Process

Internal Appeals (Aetna CVS Health)

Filing Deadline: 60-180 days from denial notice (check your specific plan)
Decision Timeline:

  • Standard: 14 calendar days
  • Expedited/Urgent: 72 hours

Required Documentation:

  • Copy of original denial letter
  • Medical necessity letter from oncologist
  • All supporting clinical documentation
  • Patient impact statement

External Review (Washington IRO Process)

If Aetna upholds the denial after internal appeal, Washington residents can request Independent Review Organization (IRO) review:

Filing Deadline: 120 days from final internal denial
Decision Timeline:

  • Standard: 15 calendar days
  • Expedited: 72 hours

How to Request:

  1. Contact the Washington Office of the Insurance Commissioner at (800) 562-6900
  2. Submit Request for External Review form
  3. Include all denial letters and clinical documentation

IRO Review Process:

  • Independent physician reviewer specializing in oncology/hematology
  • Evidence-based medical necessity determination
  • Binding decision on Aetna CVS Health
  • No cost to patient
From our advocates: "We've seen Washington's IRO process successfully overturn Aetna denials for specialty cancer drugs when the clinical evidence clearly supported medical necessity. The key is providing comprehensive documentation that addresses each specific denial reason while emphasizing guideline-based care standards."

Clinical Documentation Checklist

Medical Necessity Letter Should Include:

Diagnosis & Disease Status

  • ✓ CD22-positive B-cell precursor ALL with percentage of CD22+ blasts
  • ✓ Current disease status (relapsed/refractory)
  • ✓ ICD-10 code (e.g., C91.0x for B-cell ALL)

Treatment History

  • ✓ All prior ALL therapies with dates, durations, and outcomes
  • ✓ Reasons for treatment failures or discontinuation
  • ✓ Documentation of Ph+ status and prior TKI use if applicable

Clinical Rationale

  • ✓ Why Besponsa is medically necessary for this patient
  • ✓ Contraindications or failures of alternative treatments
  • ✓ Treatment goals and expected outcomes

Safety Monitoring

  • ✓ Baseline liver function tests (AST, ALT, bilirubin, alkaline phosphatase)
  • ✓ Hepatic monitoring plan during treatment
  • ✓ VOD risk assessment and mitigation strategies

Dosing & Administration

  • ✓ Planned dosing regimen and cycle number
  • ✓ Total planned cycles (maximum 6)
  • ✓ Site of care and administration plan

Clinician Corner: Peer-to-Peer Strategy

When to Request: After initial denial or for urgent cases
Contact: Aetna medical director via (866) 752-7021
Best Practices:

  • Have complete patient chart available
  • Emphasize guideline-based treatment approach
  • Discuss alternative therapy limitations
  • Highlight patient-specific factors favoring Besponsa

Key Talking Points:

  • FDA-approved indication for CD22+ B-cell ALL
  • NCCN Guidelines inclusion for relapsed/refractory disease
  • Patient's specific treatment history and failures
  • Hepatic monitoring plan and VOD risk mitigation

FAQ

Q: How long does Aetna CVS Health prior authorization take in Washington?
A: Standard requests: 3-5 business days. Expedited/urgent requests: 24-72 hours after complete documentation is received.

Q: What if Besponsa is non-formulary on my plan?
A: Request a formulary exception with clinical documentation showing medical necessity and superiority over formulary alternatives.

Q: Can I request an expedited appeal if my condition is urgent?
A: Yes. Mark your appeal as "urgent" and have your oncologist provide written certification that delay could jeopardize your life or health.

Q: Does step therapy apply if I failed prior therapies outside Washington?
A: Yes. Treatment records from any state or healthcare system count toward step therapy requirements.

Q: What happens if CVS Specialty isn't available in my area?
A: Contact Aetna member services to identify alternative specialty pharmacy options within their network.

Q: How much will Besponsa cost with my Aetna plan?
A: Costs vary by plan. Expect specialty tier coinsurance (typically 20-40%) after deductible. Contact member services with J-code J9229 for specific cost estimates.

Q: Can I appeal to Washington state if Aetna denies coverage?
A: Yes. After exhausting Aetna's internal appeals, you can request Independent Review Organization (IRO) review through the Washington Office of the Insurance Commissioner.

Q: What if I'm on Medicare Advantage through Aetna?
A: Besponsa is covered under the medical benefit with prior authorization required. You have additional Medicare appeal rights beyond standard commercial appeals.

Counterforce Health specializes in turning insurance denials into successful appeals for patients seeking access to critical medications like Besponsa. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that align with each insurer's requirements. By combining clinical expertise with payer policy knowledge, we help patients and providers navigate complex prior authorization processes more effectively. Learn more about our services at counterforcehealth.org.

When to Escalate to Washington Regulators

Contact the Washington Office of the Insurance Commissioner if:

  • Aetna fails to meet required decision timelines
  • Your external review rights aren't clearly explained
  • You suspect improper denial practices
  • You need help navigating the appeals process

Consumer Advocacy Line: (800) 562-6900
Online Complaint Form: Available on OIC website

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized assistance with prior authorization and appeals, consider consulting with Counterforce Health or other qualified advocacy services.

Last updated: December 2024. Insurance policies and state regulations may change. Verify current requirements with Aetna CVS Health and Washington state regulators.

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