By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (inotuzumab ozogamicin) Covered by Aetna (CVS Health) in Virginia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Besponsa Covered in Virginia

Aetna (CVS Health) requires prior authorization for Besponsa (inotuzumab ozogamicin) in Virginia. The fastest path to approval: 1) Confirm CD22-positive B-cell ALL with ≥5% blasts via flow cytometry, 2) Document relapsed/refractory status after ≥1 prior therapy, 3) Submit complete PA packet to CVS Specialty Pharmacy via fax (888-267-3277) or phone (866-752-7021). Standard approval takes 3-5 business days; expedited decisions available within 24-72 hours. If denied, Virginia residents have 180 days to appeal internally and can access external review through the State Corporation Commission's Bureau of Insurance.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Documentation
  4. Common Denial Reasons & Solutions
  5. Virginia Appeals Process
  6. Cost Assistance Options
  7. FAQ
  8. Sources & Further Reading

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Yes, required for all plans Aetna Precertification List
Diagnosis CD22+ B-cell precursor ALL Flow cytometry or IHC report
Disease Status Relapsed/refractory after ≥1 therapy Treatment history documentation
Age Requirement ≥1 year (FDA-approved) FDA Label
Prescriber Hematologist/oncologist Specialty training verification
Appeal Deadline 180 days from denial Aetna Appeals Process

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility (Patient/Clinic)

  • Document required: CD22+ status via flow cytometry showing ≥5% CD22 expression
  • Timeline: Same day if results available
  • Submit to: Include in PA packet

2. Gather Treatment History (Clinic)

  • Document required: Complete prior therapy records with dates and outcomes
  • Timeline: 1-2 business days
  • Key details: Prior induction regimens, salvage attempts, TKI history for Ph+ patients

3. Complete Laboratory Requirements (Clinic)

  • Document required: Baseline liver function tests (AST, ALT, bilirubin) within 30 days
  • Timeline: 1-2 days for lab processing
  • Include: CBC with differential, comprehensive metabolic panel

4. Draft Medical Necessity Letter (Prescriber)

  • Document required: Letter addressing PA criteria point-by-point
  • Timeline: 1 business day
  • Must include: Hepatic monitoring plan and VOD prevention protocol

5. Submit to CVS Specialty (Clinic)

  • How to submit: Fax 888-267-3277 (commercial) or call 866-752-7021
  • Timeline: Standard 3-5 days; expedited 24-72 hours
  • Required: Complete PA form with all supporting documents

6. Follow Up (Patient/Clinic)

  • Action: Check status via CVS Specialty portal or phone
  • Timeline: Within 5 business days of submission
  • Escalate if: No response within standard timeframe

7. Appeal if Denied (Patient/Clinic)

  • Action: Submit internal appeal within 180 days
  • Include: Additional clinical evidence, peer-to-peer request
  • Virginia option: External review via State Corporation Commission

Medical Necessity Documentation

Core Clinical Requirements

Your hematologist/oncologist must provide comprehensive documentation addressing Aetna's specific criteria:

Diagnosis Confirmation

  • Pathology report confirming CD22-positive B-cell precursor ALL
  • Flow cytometry or immunohistochemistry showing ≥5% CD22+ blasts
  • Bone marrow biopsy demonstrating relapsed/refractory disease

Treatment History Documentation

  • Complete record of prior therapies with specific dates
  • Documentation of treatment failures or inadequate responses
  • For Philadelphia chromosome-positive patients: prior TKI trials (imatinib, dasatinib, nilotinib, or ponatinib)

Safety Monitoring Plan The hepatotoxicity and veno-occlusive disease (VOD) monitoring plan is critical for approval. Include:

  • Baseline liver function tests with documented values
  • Ongoing monitoring schedule with specific frequency
  • Provider attestation confirming hepatic monitoring capabilities
  • VOD prevention protocol, especially for patients considering HSCT
Clinician Corner: Based on the INO-VATE ALL trial data, emphasize the 35.8% complete remission rate compared to 17.4% with standard chemotherapy, and the 89.7% MRD-negativity rate in responding patients. These endpoints support medical necessity arguments.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"CD22+ status not confirmed" Submit flow cytometry or IHC report showing ≥5% CD22 expression with lab reference ranges
"Step therapy not met" Document prior therapy failures with dates, outcomes, and clinical rationale for each attempt
"Hepatic safety concerns" Provide comprehensive monitoring plan with baseline labs, monitoring schedule, and safety protocols
"Not medically necessary" Reference FDA approval, NCCN guidelines, and trial data (INO-VATE ALL, ITCC-059) showing superior outcomes
"Experimental/investigational" Cite FDA approval dates (adults: August 2017, pediatric: March 2024) and orphan drug designation

Peer-to-Peer Review Strategy

If your initial PA is denied, request a peer-to-peer review with an Aetna medical director. Key talking points:

  • Trial data: INO-VATE ALL showed 35.8% CR rate vs. 17.4% with chemotherapy
  • MRD clearance: 89.7% of CR patients achieved MRD-negativity
  • HSCT bridging: Besponsa enables transplant eligibility in previously ineligible patients
  • Safety profile: Manageable with proper monitoring and 2-cycle pre-HSCT limit

Virginia Appeals Process

Virginia provides robust appeal rights through the State Corporation Commission's Bureau of Insurance. Here's your roadmap:

Internal Appeals (First Step)

  • Deadline: 180 days from denial notice
  • Timeline: Standard decisions within 30-45 days; expedited within 72 hours
  • Submit to: Aetna member services or provider portal
  • Include: Additional clinical evidence, updated labs, peer-reviewed literature

External Review (After Internal Appeal)

Virginia's external review process offers an independent second opinion:

Eligibility Requirements

  • Must complete Aetna's internal appeal process first
  • Denial must be based on medical necessity or experimental/investigational determination
  • Must be a Virginia-issued plan or opted-in self-funded plan

How to File

  • Deadline: 120 days from final internal denial
  • Contact: Virginia State Corporation Commission Bureau of Insurance at 1-877-310-6560
  • Forms: Form 216-A (External Review Request) available on SCC website
  • Cost: Free to consumers

Timeline

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent cases where delay could jeopardize health
  • Decision: Binding on Aetna; must authorize coverage within 1-3 days if overturned
From our advocates: We've seen Virginia patients successfully overturn Besponsa denials by emphasizing the drug's FDA approval for their specific indication and providing comprehensive treatment failure documentation. The key is often demonstrating that standard chemotherapy options have been exhausted or are contraindicated due to the patient's clinical status.

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes by analyzing denial letters, identifying specific payer criteria, and drafting targeted, evidence-backed appeals. Our platform streamlines the documentation process and improves approval rates for specialty medications like Besponsa.

Virginia-Specific Resources

  • Managed Care Ombudsman: Available through SCC Consumer Services (1-877-310-6560)
  • Virginia Poverty Law Center: Provides legal assistance for healthcare coverage issues
  • No cost: Virginia does not charge for external review services

Cost Assistance Options

Manufacturer Support

Pfizer Besponsa Co-Pay Program

  • Eligible patients may pay as little as $25 per month
  • Income and insurance requirements apply
  • Apply at besponsa.pfizerpro.com or call 1-877-744-5675

Foundation Assistance

  • Leukemia & Lymphoma Society: Patient aid program for blood cancer treatments
  • National Organization for Rare Disorders (NORD): Rare Disease Assistance Programs
  • CancerCare: Financial assistance and co-payment support

Virginia State Resources

Since Virginia expanded Medicaid in 2019, more patients have coverage options. The uninsured rate dropped to 6.4% in 2023, improving access to specialty medications.

FAQ

How long does Aetna (CVS Health) prior authorization take in Virginia? Standard PA decisions take 3-5 business days. Expedited reviews for urgent cases are completed within 24-72 hours.

What if Besponsa is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Aetna must provide a decision within 72 hours for standard requests, 24 hours for expedited.

Can I request an expedited appeal in Virginia? Yes. If your doctor certifies that waiting could jeopardize your health, both Aetna and Virginia's external review process offer expedited timelines.

Does step therapy apply if I've failed treatments outside Virginia? Treatment history from any location counts. Provide documentation of prior therapy failures regardless of where treatment occurred.

What happens if my appeal is denied? Virginia's external review decision is binding on Aetna. If upheld, consider consulting an attorney or exploring alternative funding sources.

Who can help me file an external review in Virginia? The State Corporation Commission's Bureau of Insurance provides free guidance. Call 1-877-310-6560 for assistance with forms and process.

For additional support navigating the appeals process, Counterforce Health offers specialized assistance in turning insurance denials into successful appeals through targeted, evidence-based documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. For official Virginia insurance regulations and appeal procedures, contact the State Corporation Commission's Bureau of Insurance at 1-877-310-6560.

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