By Counterforce Health Team in Defitelio (defibrotide) —

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

Quick Answer: Defitelio (defibrotide) requires prior authorization from Aetna CVS Health for FDA-approved hepatic VOD/SOS treatment post-HSCT. Submit clinical documentation showing VOD diagnosis plus renal/pulmonary dysfunction through CVS Specialty Pharmacy. If denied, use Washington's external review process within 180 days. Start by gathering transplant records, diagnosis codes, and prescriber attestation today.

Table of Contents

Plan Types & Coverage Implications

Your Aetna plan type affects how you access Defitelio (defibrotide) coverage in Washington:

HMO Plans: Require a primary care physician (PCP) referral to hematology/oncology specialists who can prescribe Defitelio. All specialty medications need PCP coordination.

PPO Plans: No referral needed to see transplant specialists directly. You can access both in-network and out-of-network providers, though costs are higher out-of-network.

EPO Plans: No PCP selection or referrals required, but all care must be from in-network providers except emergencies.

Note: Defitelio is typically administered in hospital settings during transplant complications, so emergency coverage rules may apply regardless of plan type.

Formulary Status & Tier Placement

Defitelio appears on Aetna's specialty drug formulary as a high-tier specialty medication requiring prior authorization. The drug uses HCPCS code J3490 and NDC codes 68727-800-01 (single vial) and 68727-800-02 (case of 10 vials).

Coverage Criteria:

  • FDA-approved indication: Hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT
  • Age: All ages (pediatric and adult patients)
  • Maximum duration: Up to 60 days per treatment course
  • Administration: Hospital/infusion center setting only

Non-Covered Uses: Off-label prophylaxis without high-risk criteria or VOD treatment without documented organ dysfunction.

Prior Authorization Requirements

Aetna CVS Health requires comprehensive documentation for Defitelio approval:

Required Clinical Information

  • Diagnosis: Hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
  • ICD-10 Code: K76.5 (hepatic veno-occlusive disease)
  • HSCT Details: Type of transplant, date performed, conditioning regimen
  • Organ Dysfunction: Laboratory evidence of renal impairment (creatinine elevation) or pulmonary dysfunction (oxygen requirements, imaging)

Documentation Checklist

  • Transplant center records confirming HSCT
  • Laboratory values showing bilirubin elevation and organ dysfunction
  • Prescriber attestation from hematology/oncology specialist
  • Proposed dosing plan: 6.25 mg/kg IV every 6 hours
  • Treatment duration justification (typically 21 days median)
Clinician Corner: Medical necessity letters should reference the FDA approval criteria and include specific lab values demonstrating multi-organ dysfunction. Survival data showing 38-45% Day +100 survival with Defitelio versus 21-31% with supportive care alone strengthens the case.

CVS Specialty Pharmacy Enrollment

Defitelio must be dispensed through CVS Specialty Pharmacy for subsequent fills beyond hospital initiation.

Enrollment Process

  1. Download Forms: Complete the CVS Specialty Pharmacy Services Enrollment Form
  2. Required Information:
    • Patient demographics and contact preferences
    • Prescriber NPI, DEA, and state license numbers
    • Insurance details including member ID
    • Clinical justification and prescription details
  3. Submission: Fax with wet signature (no stamps accepted) or submit electronically
  4. Timeline: Allow 2 weeks for processing and prior authorization review

Patient Setup Requirements

  • Full legal name, DOB, address, and preferred contact method
  • Insurance card information and any secondary coverage
  • Emergency contact and caregiver details if applicable
  • Language preference and communication needs

Fastest Path to Approval

Follow these steps for the quickest Defitelio approval:

  1. Confirm Eligibility (Day 1): Verify patient has VOD/SOS diagnosis with renal or pulmonary dysfunction post-HSCT
  2. Gather Records (Days 1-2): Collect transplant documentation, current labs, and imaging showing organ dysfunction
  3. Submit PA Request (Day 3): File through Aetna provider portal or fax with complete clinical package
  4. CVS Specialty Enrollment (Day 3): Simultaneously submit specialty pharmacy enrollment forms
  5. Follow Up (Day 5): Confirm receipt and provide any additional documentation requested
  6. Decision Timeline: Standard review takes 30-45 days; expedited review available for urgent cases (≤72 hours)
  7. If Approved: Coordinate with hospital pharmacy for initial doses, CVS Specialty for ongoing supply
Tip: For patients with urgent VOD/SOS, request expedited review citing medical emergency. Include documentation of rapid clinical deterioration.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Not FDA-approved indication" Confirm VOD/SOS with organ dysfunction Transplant records + lab values showing renal/pulmonary impairment
"Experimental/investigational" Cite FDA approval date (March 2016) FDA approval announcement
"No prior authorization submitted" Resubmit with complete clinical package All required forms with prescriber signatures
"Insufficient medical necessity" Provide detailed clinical rationale Survival data, treatment guidelines, specialist attestation
"Site of care restriction" Confirm hospital/infusion center setting Administration plan with facility details

Washington Appeals Process

If Aetna denies your Defitelio request, Washington state provides strong consumer protections:

Internal Appeals

  • Timeline: Submit within 180 days of denial
  • Process: Contact Aetna member services or submit through online portal
  • Documentation: Include all clinical records and prescriber support letters
  • Decision: 30-45 days for standard review, ≤72 hours for urgent cases

External Review (IRO)

Washington's external review process provides independent oversight:

  • Eligibility: After completing internal appeals (or simultaneously for urgent cases)
  • Timeline:
    • Urgent cases: 72 hours
    • Fully insured plans: 15 days after all information received
    • Self-insured plans: 45 days after IRO assignment
  • Process: State-approved Independent Review Organization (IRO) conducts binding review
  • Cost: Free to consumers (small filing fee ≤$25 in rare cases)
  • Outcome: If overturned, Aetna must provide coverage

Washington State Resources

  • Consumer Advocacy: 1-800-562-6900 (Office of the Insurance Commissioner)
  • Appeals Guidance: Washington appeals guide
  • IRO Database: Review similar case outcomes for guidance

Cost-Sharing & Financial Assistance

Defitelio costs vary by plan design but typically involves high specialty drug cost-sharing:

Typical Cost Structure

  • Specialty tier copay: Often $500+ per 30-day supply
  • Coinsurance: 20-40% of drug cost after deductible
  • Hospital administration: May be covered under medical benefit with different cost-sharing

Financial Assistance Options

  • Manufacturer Support: Check Defitelio.com for patient assistance programs
  • Foundation Grants: Organizations supporting rare disease patients
  • Hospital Financial Aid: Many transplant centers offer charity care programs
  • State Programs: Washington Apple Health (Medicaid) for eligible patients
From Our Advocates: "We've seen families successfully appeal Defitelio denials by emphasizing the life-threatening nature of VOD and the lack of alternative treatments. The key is comprehensive documentation showing both the transplant history and current organ dysfunction. While outcomes aren't guaranteed, thorough appeals often succeed when clinical criteria are clearly met."

Frequently Asked Questions

How long does Aetna prior authorization take for Defitelio in Washington? Standard review takes 30-45 days, but expedited review is available for urgent cases (≤72 hours). Submit requests early when VOD/SOS is suspected.

What if Defitelio is non-formulary on my plan? Request a formulary exception with clinical documentation. Emphasize FDA approval and lack of therapeutic alternatives for VOD/SOS.

Can I request an expedited appeal in Washington? Yes. For urgent medical needs, both internal and external appeals can be expedited. Decisions come within 72 hours for urgent cases.

Does step therapy apply to Defitelio? Typically no, since Defitelio is the only FDA-approved treatment for VOD/SOS with organ dysfunction. However, plans may require documentation of supportive care attempts.

What happens if the external review upholds the denial? The IRO decision is binding. Further recourse would be legal action, though this is rare for FDA-approved indications with proper documentation.

Do I need a transplant center specialist to prescribe Defitelio? While not strictly required, hematology/oncology specialists familiar with HSCT complications provide the strongest medical necessity justification.

How do I verify my provider is in-network for Defitelio administration? Check Aetna's provider directory online or call member services. Hospital-based administration is typically covered as medical benefit rather than pharmacy.

Can I appeal if I live in Washington but have coverage from another state? Washington's external review process applies to residents with Washington-regulated plans. Self-funded employer plans follow federal ERISA rules but may voluntarily use state processes.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts targeted rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Defitelio approvals, we help ensure submissions include all required documentation—from FDA labeling and survival data to precise dosing plans and administration details.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and insurance coverage. Coverage policies may change; verify current requirements with Aetna CVS Health and Washington state regulators.

Sources & Further Reading

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