By Counterforce Health Team in Defitelio (defibrotide) —

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

Answer Box: Getting Defitelio Covered by Aetna CVS Health in New Jersey

Defitelio requires prior authorization from Aetna CVS Health for hepatic veno-occlusive disease (VOD) with organ dysfunction following stem cell transplant. Your transplant team must submit clinical documentation proving VOD diagnosis using Baltimore or Cairo criteria, plus evidence of renal or pulmonary dysfunction. If denied, New Jersey's IHCAP external review program through Maximus Federal Services provides binding decisions within 45 days. Start today: Contact your transplant center's financial coordinator to begin the prior authorization process while gathering transplant records and recent lab results.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all Aetna plans Complete PA form through provider portal
Formulary Status Non-preferred, requires exception Medical necessity letter
FDA Indication VOD/SOS with organ dysfunction post-HSCT Transplant records, diagnosis confirmation
Age Restrictions None (pediatric and adult) Patient age documentation
Duration Limit Up to 60 days per course Treatment timeline justification
Site of Care Hospital or infusion center only Facility certification

Source: Aetna Prior Authorization List

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis (Day 1)

Who does it: Your transplant team
What's needed: VOD/SOS diagnosis using Baltimore or Cairo criteria
Timeline: Same day as clinical assessment

2. Gather Required Documentation (Days 1-2)

Who does it: You and your care team
What's needed:

  • Complete transplant records
  • Recent laboratory results showing organ dysfunction
  • Imaging studies (ultrasound, CT if available)
  • Prior treatment history

3. Submit Prior Authorization (Day 3)

Who does it: Your transplant center's financial coordinator
How to submit: Through Aetna provider portal or CVS Specialty Pharmacy enrollment
Timeline: Decision typically within 24-48 hours for urgent cases

4. Track Authorization Status (Ongoing)

Who does it: You and your care team
How to check: Aetna member portal or provider portal
Follow-up: Respond immediately to requests for additional information

5. Prepare for Peer-to-Peer Review (If Needed)

Who does it: Your transplant physician
When: If initial authorization is questioned
Preparation: Clinical summary, treatment rationale, survival data

Working With Your Transplant Team

Your success depends on close collaboration with your transplant center's multidisciplinary team. Here's how to maximize this partnership:

Before Your Visit

  • Document your timeline: When did symptoms start? How have they progressed?
  • List all treatments tried: Include dates, dosages, and outcomes
  • Note functional impacts: How is VOD affecting your daily activities?
  • Bring insurance information: Policy number, group number, and prior authorization forms

During Your Appointment

Your transplant team should assess and document:

  • VOD diagnosis confirmation using established criteria
  • Evidence of organ dysfunction through laboratory and imaging studies
  • Treatment urgency and risks of delayed therapy
  • Monitoring plan for bleeding risks and treatment response

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to the plan's own rules.

Medical Necessity Documentation

Your transplant physician's medical necessity letter should include these essential elements:

Clinical Justification Checklist

  • VOD/SOS diagnosis confirmed using Baltimore or Cairo criteria
  • Transplant details: Date, type (autologous/allogeneic), conditioning regimen
  • Organ dysfunction evidence: Specific laboratory values and imaging findings
  • ICD-10 code: K76.5 (hepatic veno-occlusive disease)
  • FDA indication alignment: Statement that patient meets approved criteria
  • Lack of alternatives: Documentation that no other FDA-approved treatments exist
  • Dosing plan: 6.25 mg/kg IV every 6 hours for up to 60 days
  • Safety monitoring: Coagulation studies and bleeding assessment protocols
From our advocates: We've seen transplant centers strengthen their appeals by including specific bilirubin trends over time rather than single values, plus detailed descriptions of how organ dysfunction impacts the patient's transplant recovery. This clinical narrative helps medical reviewers understand the urgency beyond just meeting diagnostic criteria.

Supporting Evidence to Include

  • FDA prescribing information showing approved indication
  • Transplant center protocols for VOD management
  • Published survival data for untreated VOD with organ dysfunction
  • Specialist society guidelines (EBMT, ASBMT recommendations)

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Experimental/investigational" Emphasize FDA approval for exact indication FDA label, prescribing information
"Not medically necessary" Strengthen organ dysfunction evidence Serial lab values, imaging reports
"Alternative treatments available" Document lack of FDA-approved alternatives Literature review, clinical guidelines
"Off-label use" Prove on-label indication alignment Transplant records, diagnosis confirmation
"Site of care restrictions" Confirm appropriate facility Hospital/infusion center certification

Appeals Process in New Jersey

Internal Appeals with Aetna CVS Health

You have 180 days from the denial letter to file an internal appeal. Most commercial plans allow two levels of internal review before external appeal.

How to file: Submit through the Aetna member portal or mail to the address on your denial letter.

External Review Through IHCAP

If your internal appeals are denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review through Maximus Federal Services.

Timeline:

  • Filing deadline: 180 days from final internal denial
  • Preliminary review: Decision within 5 business days
  • Final decision: Within 45 calendar days (48 hours for urgent cases)

How to file: Submit directly to IHCAP through Maximus (verify current portal link)

Cost: Free to patients—insurers cover all review costs

Note: IHCAP decisions are binding on insurance companies. If the external reviewer approves coverage, Aetna must comply within 10 business days.

Cost-Saving Options

Manufacturer Support Programs

Jazz Pharmaceuticals offers patient assistance through Jazz Cares. Programs may include:

  • Copay assistance for eligible patients
  • Patient assistance programs for uninsured/underinsured
  • Free drug programs based on income criteria

Hospital Financial Assistance

Since Defitelio is administered in hospital settings, explore:

  • Hospital charity care programs
  • Payment plan options
  • Social work assistance with financial navigation

Foundation Grants

Organizations like the Patient Advocate Foundation and HealthWell Foundation may provide grants for specialty medications. Check eligibility requirements and application deadlines.

When to Escalate

Contact New Jersey Insurance Regulators

If you encounter persistent coverage issues, contact:

New Jersey Department of Banking and Insurance

  • Consumer Hotline: 1-800-446-7467
  • IHCAP-specific line: 1-888-393-1062
  • DOBI website for complaint forms

File a State Insurance Complaint

Document patterns of inappropriate denials or procedural violations. Include:

  • All denial letters and appeal responses
  • Clinical documentation supporting medical necessity
  • Timeline of interactions with Aetna CVS Health
  • Evidence of compliance with all requirements

Counterforce Health's platform can help identify procedural violations and draft targeted complaints that reference specific regulatory requirements.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Defitelio? Urgent cases are typically decided within 24-48 hours. Standard requests may take up to 5 business days. Over 95% of eligible prior authorizations are approved within 24 hours.

What if Defitelio is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity for the FDA-approved indication. Your transplant team must show that no preferred alternatives exist for treating VOD with organ dysfunction.

Can I request an expedited appeal if my condition is urgent? Yes. For urgent cases where delay could jeopardize life or health, both internal appeals and external IHCAP reviews have expedited timelines (often 48-72 hours).

Does step therapy apply to Defitelio? Step therapy typically doesn't apply since Defitelio is the only FDA-approved treatment for its indication. However, some plans may require documentation of supportive care attempts.

What happens if I'm denied at all levels? After exhausting internal appeals and IHCAP external review, you may have options through federal agencies (for Medicare plans) or legal consultation for potential bad faith denial claims.

How do I prepare for a peer-to-peer review? Your transplant physician should prepare a concise case summary emphasizing FDA indication alignment, lack of alternatives, and survival data. Offer flexible scheduling and have all clinical documentation readily available.

Sources & Further Reading

This article provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare providers about treatment decisions and work with your transplant team to navigate coverage requirements. For personalized assistance with insurance appeals, contact qualified patient advocates or legal professionals.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify denial reasons and draft point-by-point rebuttals aligned to each plan's specific requirements.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.