By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

Besponsa (Inotuzumab Ozogamicin) Approval with Aetna CVS Health in New York: Complete Guide to Prior Authorization, Appeals, and State Protections

Answer Box: Getting Besponsa Covered by Aetna CVS Health in New York

Yes, Aetna CVS Health covers Besponsa (inotuzumab ozogamicin) in New York with prior authorization for CD22-positive B-cell precursor ALL. The fastest path to approval: (1) Your oncologist submits the Aetna Besponsa precertification form electronically with CD22+ lab results and prior therapy documentation, (2) CVS Specialty coordinates fulfillment after approval (typically 1-5 business days), and (3) if denied, you have strong appeal rights including New York's binding external review through the Department of Financial Services. Start today by having your oncologist gather your pathology reports confirming CD22 positivity and document any prior ALL treatments.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Continuing Treatment
  8. CVS Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Besponsa covered by Aetna CVS Health?

Yes, Aetna covers Besponsa for its FDA-approved indication: relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and pediatric patients ≥1 year old. Coverage requires prior authorization regardless of your specific Aetna plan.

Which Aetna plans include Besponsa?

All Aetna commercial, Medicare Advantage, and Medicaid managed care plans in New York include Besponsa on their specialty formularies, typically on the highest cost-sharing tier. The drug is dispensed exclusively through CVS Specialty Pharmacy for most Aetna members.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Oncologist gathers documentation (1-2 days)
    • CD22-positive pathology/flow cytometry results
    • Prior ALL treatment history and outcomes
    • Current lab values (CBC, comprehensive metabolic panel, liver function tests)
  2. Submit Aetna precertification form (same day)
  3. Aetna reviews submission (1-5 business days)
    • Standard review: up to 5 business days
    • Expedited review: 72 hours for urgent cases
    • Notification sent to prescriber and patient
  4. If approved, CVS Specialty coordinates (1-3 days)
    • Patient enrollment in specialty pharmacy
    • Insurance verification and copay assistance enrollment
    • Scheduling of infusion appointments

Required Documentation Checklist

  • Completed Aetna Besponsa precertification form
  • Pathology report confirming CD22+ B-cell precursor ALL
  • Documentation of prior therapies and treatment failures/intolerance
  • Recent laboratory results (within 30 days)
  • Oncologist attestation of medical necessity
  • Patient demographics and insurance information

Timing and Urgency

Standard Timeline:

  • Electronic submission: 1-2 business days
  • Fax submission: 3-5 business days
  • Phone follow-up available during business hours

Expedited Review: For urgent cases where delay could jeopardize health, request expedited review. Aetna must respond within 72 hours for expedited requests with proper clinical justification.

Tip: Include specific clinical details about disease progression, infection risk, or other time-sensitive factors when requesting expedited review.

Clinical Criteria

Coverage Requirements

Requirement Details Documentation Needed
Diagnosis CD22-positive B-cell precursor ALL Pathology/immunophenotyping report
Disease Status Relapsed or refractory Prior treatment records
Prescriber Oncologist or hematologist Provider credentials
Age ≥1 year old Patient demographics
Cycle Limit Maximum 6 cycles per lifetime Treatment plan
Safety Monitoring Hepatic function assessment Lab results, monitoring plan

Step Therapy and Prior Treatments

Aetna typically requires documentation of:

  • Prior standard ALL induction therapy (unless contraindicated)
  • Specific reasons for treatment failure or intolerance
  • Current disease status and response to previous treatments

Counterforce Health specializes in helping patients and clinicians navigate these complex step therapy requirements by identifying exactly what documentation payers need and crafting targeted appeals when standard treatments haven't worked.

Costs and Financial Assistance

Typical Cost-Sharing:

  • Specialty tier coinsurance: 20-33% for commercial plans
  • Medicare Advantage: typically 25% coinsurance
  • Estimated out-of-pocket per vial: $1,740-$2,871 (based on ~$8,700 wholesale cost)

Financial Assistance Options:

  • Pfizer Patient Assistance Program for eligible patients
  • Copay cards for commercial insurance (Medicare/Medicaid ineligible)
  • Foundation grants through organizations like the Leukemia & Lymphoma Society
  • New York State pharmaceutical assistance programs for qualifying residents

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
CD22 status not documented Submit pathology report Flow cytometry or immunohistochemistry results
Prior therapy not attempted Document treatment failures Detailed treatment history with dates and outcomes
Not medically necessary Provide clinical rationale Oncologist letter with guidelines citations
Experimental/investigational Cite FDA approval FDA label, NCCN guidelines

New York Appeal Rights

Internal Appeals with Aetna:

  • Deadline: 180 days from denial notice
  • Standard decision: 30 days
  • Expedited decision: 72 hours for urgent cases
  • Submit via Aetna member portal or mail

New York External Review: After internal appeal denial, New York residents can request binding external review through the Department of Financial Services:

  • Deadline: 4 months from final internal denial
  • Filing fee: $25 maximum (waived for financial hardship/Medicaid)
  • Decision time: 30 days standard, 72 hours expedited
  • Binding decision: If overturned, Aetna must cover treatment
Note: New York's external appeal program has a strong track record of overturning denials for specialty oncology drugs when proper medical evidence is provided.

For complex appeals requiring detailed medical literature and payer-specific arguments, Counterforce Health helps transform denials into targeted, evidence-backed appeals that address each payer's specific criteria and procedural requirements.

Renewals and Continuing Treatment

Reauthorization Requirements:

  • Typically required every 6 cycles or 6 months
  • Must demonstrate continued medical necessity
  • No disease progression or unacceptable toxicity
  • Updated lab results and clinical assessment

Documentation for Renewal:

  • Treatment response evaluation
  • Current disease status
  • Toxicity assessment and management
  • Plan for remaining cycles (maximum 6 total)

CVS Specialty Pharmacy Requirements

Why CVS Specialty? Most Aetna plans require specialty medications like Besponsa to be dispensed through CVS Specialty Pharmacy for:

  • Insurance coordination and copay assistance
  • Clinical monitoring and support
  • Coordination with infusion centers
  • Adherence tracking and patient education

Enrollment Process:

  1. CVS Specialty contacts patient after PA approval
  2. Insurance verification and benefits review
  3. Copay assistance program enrollment
  4. Scheduling and delivery coordination
  5. Ongoing clinical support throughout treatment

Troubleshooting Common Issues

Portal Access Problems:

  • Use Availity or direct Aetna provider portals
  • Contact CVS Caremark PA department: verify current phone number with member services

Missing Forms:

Communication Delays:

  • Electronic submission provides confirmation receipts
  • Follow up within 2-3 business days if no acknowledgment
  • Keep copies of all submitted documentation

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in New York? Standard review takes 1-5 business days depending on submission method. Electronic submissions are fastest (1-2 days), while fax submissions may take 3-5 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Besponsa is non-formulary on my plan? Besponsa is typically covered on Aetna's specialty formulary but may require formulary exception requests for certain plan designs. Work with your oncologist to document medical necessity and lack of suitable alternatives.

Can I request an expedited appeal in New York? Yes, both Aetna internal appeals and New York external appeals offer expedited processing for urgent medical situations. Clinical documentation of urgency is required, such as rapidly progressing disease or risk to patient safety.

Does step therapy apply if I received prior treatment outside New York? Yes, prior treatments received anywhere are considered when evaluating step therapy requirements. Ensure your oncologist documents all previous ALL treatments, including dates, responses, and reasons for discontinuation.

What happens if I reach the 6-cycle limit? Aetna follows FDA labeling limiting Besponsa to 6 cycles maximum. Additional cycles are not covered unless proceeding to hematopoietic stem cell transplant, where 2-3 cycles may be appropriate as a bridge to transplant.

How do I check my prior authorization status? Check status through the Aetna member portal, mobile app, or by calling member services. Your oncologist's office can also check status through provider portals or by calling the prior authorization department directly.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current coverage policies and medical recommendations. Coverage policies and requirements may change; verify current information with Aetna CVS Health and relevant New York state agencies.

For personalized assistance with complex prior authorizations and appeals, Community Health Advocates offers free counseling for New York residents at 888-614-5400.

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