By Counterforce Health Team in Defitelio (defibrotide) —

Get Defitelio (Defibrotide) Covered by Aetna CVS Health in New York: Prior Authorization Guide & Appeals Process

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

Defitelio (defibrotide) requires prior authorization from Aetna CVS Health for hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) with organ dysfunction post-transplant. Key requirements: documented VOD/SOS diagnosis using Baltimore or Cairo criteria, evidence of renal or pulmonary dysfunction, HSCT records, and specialist attestation. If denied, New York offers robust external appeals through the Department of Financial Services with 57-60% success rates for specialty drugs. First step: Have your transplant team submit complete documentation including lab values, imaging, and medical necessity letter through Aetna's provider portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing Aetna Precertification List Aetna Policy
Formulary Status Not listed as preferred Aetna Specialty Drug List Aetna Formulary
Site of Care Hospital/infusion center only FDA labeling requirements FDA Package Insert
Age Limits All ages (pediatric & adult) FDA indication FDA Approval
Diagnosis Code K76.5 (Hepatic VOD/SOS) ICD-10 classification Medical coding
Appeals Deadline 180 days after denial New York state law NY DFS External Appeals

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis & Gather Documentation

  • Who: Transplant team/hematology-oncology
  • Documents: VOD/SOS diagnosis using Baltimore or Cairo criteria, lab values (bilirubin ≥2 mg/dL, creatinine elevation), imaging showing hepatomegaly/ascites
  • Timeline: Complete before PA submission
  • Source: Defitelio Diagnostic Criteria

2. Document Organ Dysfunction

  • Who: Clinical team
  • Evidence: Renal dysfunction (creatinine elevation) OR pulmonary dysfunction (oxygen requirements, abnormal chest imaging)
  • Required: Objective measurements and dates
  • Timeline: Current/recent values

3. Compile HSCT Records

  • Who: Transplant center
  • Documents: Type and date of transplant, conditioning regimen, center notes
  • Timeline: From transplant through VOD onset
  • Note: Essential for establishing post-HSCT context

4. Submit Prior Authorization

  • Who: Prescriber or clinic staff
  • Method: Aetna provider portal or fax
  • Documents: Complete clinical package, medical necessity letter, ICD-10 K76.5
  • Timeline: Standard review 30-45 days; expedited ≤72 hours for urgent cases
  • Source: Aetna Provider Resources

5. Coordinate with CVS Specialty

  • Who: Patient or clinic
  • Action: Enroll in specialty pharmacy program simultaneously
  • Requirement: Hospital/infusion center administration only
  • Contact: CVS Specialty Pharmacy

6. Monitor Decision Timeline

  • Standard: 30-45 days for non-urgent
  • Expedited: ≤72 hours for urgent medical need
  • Action: Follow up if no response within expected timeframe

7. Prepare for Potential Appeal

  • Documents: Keep copies of all submissions, gather additional supporting literature
  • Timeline: Begin appeal preparation if no approval within standard timeframe

When Alternatives Make Sense

Defitelio is the only FDA-approved treatment for VOD/SOS with organ dysfunction, making alternatives limited and generally inappropriate for active disease. However, understanding the treatment landscape helps inform discussions with your care team and insurance appeals.

Alternatives are NOT recommended for established VOD/SOS because:

  • No other medication has proven efficacy for treating active disease
  • Supportive care alone has poor outcomes in severe cases
  • Prophylactic agents don't reverse established VOD/SOS

When to consider the treatment approach:

  • Defitelio remains first-line therapy per EBMT guidelines
  • Early initiation is critical for optimal outcomes
  • No acceptable substitutes exist for severe disease

Typical Treatment Alternatives

While no true alternatives exist for treating established VOD/SOS, understanding related therapies helps contextualize Defitelio's unique role:

Prophylactic Agents (Prevention Only)

Ursodiol (Ursodeoxycholic Acid)

  • Role: Prevention before transplant, not treatment
  • Efficacy: Reduces VOD/SOS incidence but ineffective for active disease
  • Coverage: Generally covered for prophylaxis
  • Monitoring: Routine liver function tests

Low-dose Heparin

  • Role: Historical prophylaxis approach
  • Current Status: Not routinely recommended due to bleeding risk and lack of proven benefit
  • Guidelines: Most centers have moved away from this approach

Supportive Care Measures

  • Fluid management: Careful balance of restriction and support
  • Diuretics: For fluid overload management
  • Dialysis: For severe renal dysfunction
  • Respiratory support: For pulmonary complications
Important: These supportive measures complement but do not replace Defitelio therapy in established VOD/SOS with organ dysfunction.

Exception Strategy for Defitelio

Since Defitelio is not listed on Aetna's preferred formulary, most cases require a formulary exception combined with prior authorization. Here's how to strengthen your request:

Medical Necessity Documentation

Essential Elements:

  • Detailed VOD/SOS diagnosis with specific criteria met
  • Timeline from transplant to VOD onset
  • Objective evidence of organ dysfunction
  • Statement that no alternatives exist for this FDA indication
  • Reference to published outcomes data

Clinician Corner: Medical Necessity Letter Checklist ✓ Patient demographics and insurance information
✓ Clear VOD/SOS diagnosis with criteria (Baltimore/Cairo)
✓ HSCT details (type, date, conditioning regimen)
✓ Objective organ dysfunction evidence
✓ Statement: "Defitelio is the only FDA-approved treatment"
✓ Proposed dosing: 6.25 mg/kg IV every 6 hours
✓ Expected duration: minimum 21 days, maximum 60 days
✓ Hospital/infusion center administration plan
✓ Specialist signature and credentials

Supporting Evidence

  • FDA labeling: Reference specific indication and approval
  • Clinical guidelines: EBMT recommendations for early treatment
  • Published data: Survival outcomes with Defitelio vs. supportive care
  • Specialist attestation: Board-certified hematology/oncology or transplant physician

Appeals Process in New York

New York offers one of the strongest patient appeal systems in the nation, with 57-60% success rates for specialty drug appeals under 2025 regulations.

Internal Appeal (First Level)

  • Timeline: File within 180 days of denial
  • Process: Submit through Aetna member portal or mail
  • Decision: 30 days standard, 72 hours expedited
  • Required: Denial letter, additional clinical evidence, provider support

External Review (New York DFS)

  • Automatic: Cases proceed to external review after internal denial
  • Reviewer: Independent specialist in relevant field
  • Timeline: 30 days standard, 72 hours urgent, 24 hours crisis
  • Binding: Decision is enforceable with penalties up to $50,000 for non-compliance
  • Cost: No patient fees
  • Source: NY DFS External Appeals

Getting Help

Community Health Advocates

  • Phone: 888-614-5400
  • Service: Free counseling on insurance denials and appeals
  • Coverage: All New York residents

New York Healthcare Appeals Ombudsman

  • Phone: 1-800-NYS-APPEAL
  • Service: Case assistance for complex appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Key Documents
"Not medically necessary" Provide FDA indication, specialist letter, outcomes data Medical necessity letter, published studies, guidelines
"Experimental/investigational" Reference FDA approval date and indication FDA label, approval documentation
"Not on formulary" File formulary exception with no-alternative statement Exception request form, clinical justification
"Insufficient documentation" Resubmit complete clinical package All lab values, imaging, HSCT records
"Site of care restriction" Confirm hospital/infusion center administration Facility verification, administration plan

Scripts for Common Situations

Patient Phone Script for Aetna: "I'm calling about prior authorization for Defitelio for hepatic VOD after stem cell transplant. This is the only FDA-approved treatment for my condition. Can you tell me the exact documentation needed and confirm the review timeline?"

Clinic Script for Peer-to-Peer: "I'm requesting a peer-to-peer review for Defitelio prior authorization. The patient has documented VOD/SOS with renal dysfunction post-HSCT. This is an FDA-approved indication with no therapeutic alternatives. When can we schedule the clinical discussion?"

Cost Assistance Programs

Jazz Pharmaceuticals Patient Support

  • Program: JAZZ Cares Patient Assistance Program
  • Eligibility: Income-based for uninsured/underinsured patients
  • Coverage: May provide medication at no cost
  • Application: Through healthcare provider

Hospital Financial Assistance

  • Coverage: Many transplant centers offer charity care programs
  • Eligibility: Varies by institution and patient income
  • Application: Hospital financial counselor

State Programs

  • New York: Medicaid expansion covers many low-income residents
  • Essential Plan: Low-cost coverage for those above Medicaid limits
  • Child Health Plus: Coverage for children in moderate-income families
From our advocates: "In complex VOD/SOS cases, we've seen success when the transplant center's financial team coordinates directly with the specialty pharmacy and insurance medical director. This three-way communication often resolves coverage issues faster than standard appeals, especially when the clinical urgency is clearly documented."

FAQ

How long does Aetna CVS Health prior authorization take for Defitelio in New York? Standard review takes 30-45 days. For urgent cases with immediate medical need, request expedited review for decisions within 72 hours.

What if Defitelio is not on my Aetna formulary? File a formulary exception request along with prior authorization. Emphasize that Defitelio is the only FDA-approved treatment for VOD/SOS with organ dysfunction.

Can I get Defitelio administered at home in New York? No. Defitelio requires hospital or specialized infusion center administration due to the need for frequent dosing (every 6 hours) and intensive monitoring for adverse events.

Does step therapy apply to Defitelio? Step therapy typically doesn't apply because no other medications are approved for treating established VOD/SOS. However, some plans may require documentation of the diagnosis and organ dysfunction.

What happens if my external appeal is approved in New York? The decision is binding on Aetna. They must provide coverage and may need to refund your appeal filing fee. Treatment should begin promptly after approval.

How much does Defitelio cost without insurance? Defitelio is a high-cost specialty medication dispensed through hospital buy-and-bill programs. Exact costs vary by institution and contract pricing. Work with your transplant center's financial team for specific estimates.

Can I appeal if I was initially approved but later denied continued treatment? Yes. If Aetna denies continued treatment before the recommended minimum 21-day course, you can appeal based on medical necessity and FDA labeling for complete treatment courses.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Defitelio. Our platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that align with each plan's specific requirements. For patients facing Defitelio denials, we help identify the exact denial basis and craft point-by-point rebuttals supported by FDA labeling, clinical guidelines, and peer-reviewed evidence. The system streamlines the appeals process for patients, clinicians, and specialty pharmacies while tracking deadlines and required documentation.

When dealing with rare disease treatments like Defitelio, having expert support can make the difference between a successful appeal and continued denial. Counterforce Health provides the specialized knowledge needed to navigate complex prior authorization requirements and appeals processes effectively.

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 plan for specific coverage decisions. Insurance policies and state regulations may change. For personalized assistance with New York insurance appeals, contact Community Health Advocates at 888-614-5400 or the NY Healthcare Appeals Ombudsman at 1-800-NYS-APPEAL.

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