By Counterforce Health Team in Defitelio (defibrotide) —

How to Get Defitelio (defibrotide) Covered by Aetna CVS Health in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Defitelio Covered by Aetna CVS Health in Ohio

Defitelio (defibrotide) requires prior authorization from Aetna CVS Health for hepatic VOD/SOS with organ dysfunction post-HSCT. Your transplant team must submit comprehensive documentation including VOD/SOS diagnosis per Baltimore/Cairo criteria, evidence of renal or pulmonary dysfunction, and HSCT records. If denied, Ohio residents have 180 days to request external review through an Independent Review Organization (IRO). Success rates for well-documented appeals range from 57-75%.

First step: Contact your transplant center's financial coordinator to initiate the prior authorization process through Aetna's provider portal while simultaneously enrolling with CVS Specialty Pharmacy.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Patient Assistance
  6. Denials and Appeals in Ohio
  7. Renewals and Reauthorization
  8. CVS Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Defitelio Covered by Aetna CVS Health?

Defitelio (defibrotide) is not on Aetna's preferred formulary but can be covered through a formulary exception for FDA-approved indications. Coverage is restricted to treatment of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) with concurrent renal or pulmonary dysfunction following hematopoietic stem cell transplant (HSCT).

Coverage Requirement Details Source
Prior Authorization Required for all plans Aetna Precertification List
Formulary Status Non-preferred/requires exception Aetna Drug Guides
Site of Care Hospital/infusion center only FDA Label
ICD-10 Code K76.5 (VOD/SOS) Clinical documentation required

Which Aetna Plans Cover Defitelio?

All Aetna commercial plans, Medicare Advantage, and Medicaid managed care plans in Ohio require prior authorization. Coverage criteria remain consistent across plan types, though copay structures vary significantly.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Patient/Family)
    • Insurance card and member ID
    • Complete HSCT records and transplant summary
    • Recent lab results showing organ dysfunction
    • Timeline: Same day
  2. Clinical Assessment (Transplant Team)
    • Confirm VOD/SOS diagnosis per Baltimore or Cairo criteria
    • Document renal dysfunction (elevated creatinine) or pulmonary dysfunction (oxygen requirements, imaging)
    • Timeline: 1-2 days
  3. Submit Prior Authorization (Provider)
    • Complete Aetna provider portal submission
    • Include medical necessity letter from hematologist/oncologist
    • Attach all supporting clinical documentation
    • Timeline: Same day submission
  4. CVS Specialty Enrollment (Concurrent)
  5. Follow Up (Provider/Patient)
    • Track authorization status through Aetna portal
    • Respond promptly to requests for additional information
    • Timeline: Monitor daily
  6. Approval Confirmation (All parties)
    • Verify coverage details and duration
    • Confirm administration logistics with hospital
    • Timeline: Upon approval
  7. Appeal if Denied (If needed)
    • File internal appeal within 180 days
    • Prepare for external review if necessary
    • Timeline: Begin immediately upon denial

Timing and Urgency

Standard Authorization Timeline

  • Standard review: 30-45 days from complete submission
  • Expedited review: 72 hours for urgent cases requiring physician certification
  • Incomplete submissions: Additional 15-30 days for missing documentation

When to Request Expedited Review

Request expedited review when:

  • VOD/SOS is rapidly progressing
  • Multi-organ dysfunction is present
  • Delay would seriously jeopardize patient health

Your physician must certify that standard review timelines would seriously jeopardize your life or ability to regain maximum function.

Medical Necessity Criteria

Clinician Corner: Medical Necessity Letter Requirements

Your transplant team's medical necessity letter must include:

Required Clinical Elements:

  • Confirmed VOD/SOS diagnosis using Baltimore or Cairo criteria
  • Bilirubin ≥2 mg/dL plus hepatomegaly and/or ascites
  • Evidence of renal dysfunction (creatinine elevation) or pulmonary dysfunction
  • Complete HSCT details: date, type, conditioning regimen
  • Statement that Defitelio is the only FDA-approved treatment for this indication

Supporting Documentation:

  • Recent laboratory values and imaging
  • Treatment goals and expected duration (minimum 21 days, up to 60 days)
  • Confirmation of hospital-based administration plan
  • Reference to published survival data (38-45% with Defitelio vs. 21-31% supportive care)

Key Diagnostic Criteria

Baltimore Criteria (2 of 3 by day +21 post-HSCT):

  • Total bilirubin ≥2 mg/dL
  • Hepatomegaly or right upper quadrant pain
  • Weight gain >5% from baseline

Cairo Criteria (2 of 3 by day +21 post-HSCT):

  • Hyperbilirubinemia (≥2 mg/dL)
  • Painful hepatomegaly
  • Ascites and/or unexplained weight gain

Costs and Patient Assistance

Understanding Your Costs

Defitelio is classified as a specialty drug under most Aetna plans, typically placing it in the highest cost-sharing tier. Before assistance programs:

  • Commercial plans: Often 20-40% coinsurance after deductible
  • Medicare Advantage: Varies by plan, may have monthly caps
  • High-deductible plans: Full cost until deductible met

Manufacturer Support Programs

Jazz Pharmaceuticals offers patient support services including:

  • Copay assistance programs for eligible patients
  • Patient navigation and insurance support
  • Financial hardship programs for uninsured/underinsured patients

To enroll: Contact Jazz patient support directly through their official website or ask your transplant team's financial coordinator to initiate enrollment.

Tip: Start the manufacturer assistance application process immediately upon Defitelio prescription, even before insurance approval, to avoid delays.

Denials and Appeals in Ohio

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Insufficient medical necessity Strengthen clinical justification Enhanced lab values, imaging, specialist attestation
Missing HSCT documentation Provide complete transplant records Transplant summary, conditioning regimen details
Off-label use concerns Emphasize FDA approval for VOD/SOS FDA label excerpts, indication-specific data
Site of care restrictions Confirm hospital administration Hospital pharmacy coordination letter

Ohio External Review Process

Ohio residents have strong appeal rights under state law:

Internal Appeals (First Level):

  • Must be filed within 180 days of denial
  • Submit through Aetna appeals process
  • Decision within 30 days (72 hours if expedited)

External Review (Independent Review):

  • Available after internal appeal denial
  • Request within 180 days of final internal denial
  • Conducted by Independent Review Organization (IRO)
  • Decision within 30 days (72 hours if expedited)
  • Binding on Aetna if approved

Ohio Department of Insurance Support:

Appeals Success Rates

  • Specialty drug appeals nationally: 67-75% success with strong documentation
  • Ohio external reviews: Binding decisions favor patients in well-documented cases
  • Optimized appeals process: Up to 89% success when criteria are precisely addressed

Renewals and Reauthorization

When Reauthorization is Needed

Defitelio treatment courses are typically approved for:

  • Initial duration: 21-60 days based on clinical response
  • Reauthorization triggers: Extension beyond approved duration, treatment interruption >7 days, change in clinical status

What Changes Require New Authorization

  • Dosing modifications outside FDA parameters
  • Site of care changes
  • Treatment gaps exceeding one week
  • New insurance plan or policy changes

Counterforce Health helps patients and clinicians navigate complex reauthorization requirements by analyzing payer policies and drafting targeted appeals that align with specific plan criteria.

CVS Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Defitelio must be dispensed through CVS Specialty Pharmacy for Aetna members due to:

  • Complex storage and handling requirements
  • Hospital-only administration protocols
  • Specialized patient monitoring needs
  • Insurance coordination requirements

Enrollment Process

  1. Complete CVS Specialty enrollment forms (available through your transplant center)
  2. Coordinate with hospital pharmacy for delivery and administration
  3. Verify insurance benefits and copay assistance enrollment
  4. Establish delivery logistics to treatment facility
Note: CVS Specialty Pharmacy enrollment can occur simultaneously with prior authorization to prevent delays.

Troubleshooting Common Issues

Portal and System Issues

Aetna Provider Portal Down:

  • Use backup fax submission methods
  • Contact Aetna provider services for alternative submission
  • Document submission attempts for appeal purposes

Missing Required Forms:

  • Access current forms through Aetna provider resources
  • Verify form versions are current year
  • Contact transplant center case management for assistance

Communication Breakdowns

Delayed Responses:

  • Follow up every 2-3 business days during review
  • Escalate to Aetna member services if necessary
  • Document all communication for potential appeals

Conflicting Information:

  • Request written clarification of requirements
  • Involve transplant center financial coordinator
  • Consider peer-to-peer review with Aetna medical director

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Defitelio in Ohio?

Standard prior authorization takes 30-45 days from complete submission. Expedited reviews for urgent cases are completed within 72 hours when physician certification of urgency is provided.

What if Defitelio is non-formulary on my Aetna plan?

Non-formulary status requires a formulary exception, which is routinely granted for FDA-approved indications when medical necessity is demonstrated. Your transplant team must document that no formulary alternatives are appropriate for VOD/SOS treatment.

Can I request an expedited appeal in Ohio?

Yes, expedited appeals are available when delay would seriously jeopardize your health. Your physician must certify the urgency, and decisions are rendered within 72 hours for both internal and external reviews.

Does step therapy apply to Defitelio?

Step therapy typically does not apply to Defitelio because it's the only FDA-approved treatment for VOD/SOS with organ dysfunction. However, documentation of supportive care measures and their inadequacy strengthens prior authorization requests.

What happens if my external review is denied in Ohio?

External review decisions are binding on insurance companies. If your external review is approved, Aetna must provide coverage. If denied, you retain rights to seek other remedies including regulatory complaints or legal action, though the external review is usually the final administrative step.

How do I find help with my appeal in Ohio?

Contact the Ohio Department of Insurance at 1-800-686-1526 for guidance. UHCAN Ohio (Universal Health Care Action Network) also provides consumer assistance for insurance appeals.

Can my doctor request a peer-to-peer review?

Yes, peer-to-peer reviews allow your transplant physician to discuss the case directly with Aetna's medical director. These reviews often resolve complex cases and can be requested at any stage of the authorization or appeal process.

What if I need Defitelio while traveling outside Ohio?

Coordinate with your transplant center and CVS Specialty Pharmacy before travel. Hospital administration requirements may complicate out-of-state treatment, and prior authorization may need modification for different facilities.

From Our Advocates

We've seen transplant families successfully navigate Defitelio approvals by maintaining organized documentation and starting manufacturer assistance applications early. One family in the Midwest faced an initial denial but succeeded on appeal by providing detailed HSCT records and a comprehensive medical necessity letter that directly addressed each coverage criterion. The key was persistence and thorough documentation—external review ultimately approved coverage within the standard 30-day timeframe.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical documentation to craft evidence-based rebuttals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for specialty medications like Defitelio.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions are made by individual payers based on specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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