By Counterforce Health Team in Defitelio (defibrotide) —

How to Get Defitelio (defibrotide) Covered by UnitedHealthcare in Texas: PA Requirements, Appeals, and Cost Assistance

Answer Box: Getting Defitelio Covered by UnitedHealthcare in Texas

Defitelio (defibrotide) is covered by UnitedHealthcare with prior authorization required. For hepatic VOD/SOS post-HSCT, no step therapy applies. Your fastest path: 1) Have your transplant team submit PA through Optum Specialty Pharmacy with complete HSCT documentation, 2) If denied, file internal appeal within 12 months electronically via UHC Provider Portal, 3) Request Texas external review within 120 days if internal appeal fails. Start PA requests 3-4 weeks before treatment needed. Appeals in Texas have binding external review through independent organizations.

Table of Contents

Plan Types & Coverage Implications

UnitedHealthcare offers several plan types in Texas, each with different referral and network requirements:

Commercial Plans (HMO/PPO/EPO): Most require prior authorization for Defitelio through OptumRx. PPO plans typically allow direct access to transplant specialists, while HMO plans may require referrals.

Medicare Advantage: Subject to UnitedHealthcare's Medicare Part D formulary with PA requirements. The 2025 $2,000 out-of-pocket cap applies to specialty drugs like Defitelio.

Medicaid Plans (UnitedHealthcare Community Plan): Follow Texas Medicaid guidelines with additional UHC utilization management. As of August 2025, all appeals must be submitted electronically.

Note: ERISA self-funded employer plans follow federal appeal rules, not Texas state regulations.

Formulary Status & Tier Placement

Coverage Status: Defitelio is listed as covered on OptumRx's 2024 and 2025 formularies with the following restrictions:

Requirement Status Details
Prior Authorization Required (PA) Must obtain approval before dispensing
Extended Days Supply Not Available (NDS) Limited to standard 30-day supply
Step Therapy Not Required No alternative therapies must be tried first
Specialty Pharmacy Required Must use Optum Specialty Pharmacy or approved network

Alternative Agents: No FDA-approved alternatives exist for hepatic VOD/SOS, which is why step therapy doesn't apply to Defitelio.

Prior Authorization Requirements

Medical Necessity Criteria for UnitedHealthcare approval include:

  1. Confirmed diagnosis of hepatic VOD/SOS (ICD-10: K76.5) following HSCT
  2. Organ dysfunction (renal and/or pulmonary) documented
  3. Post-transplant setting with appropriate clinical context
  4. FDA-approved dosing plan (6.25 mg/kg IV every 6 hours, up to 60 days)

Required Documentation:

  • HSCT records and transplant center notes
  • Laboratory values showing organ dysfunction
  • Clinical rationale for medical necessity
  • Proposed treatment duration and monitoring plan

Submission Process: Prior authorization requests must be submitted through the UnitedHealthcare Provider Portal or OptumRx specialty pharmacy network.

Specialty Pharmacy Network

Mandatory Network Use: Defitelio must be dispensed through UnitedHealthcare's specialty pharmacy network, primarily Optum Specialty Pharmacy.

Setup Process:

  1. Provider submits PA through specialty pharmacy
  2. Patient enrollment in Optum Specialty Pharmacy program
  3. Coordination with transplant center for delivery and administration
  4. Clinical monitoring and refill coordination

Key Advantage: Specialty pharmacies handle PA submissions and appeals coordination, reducing administrative burden on transplant teams.

Cost-Share Dynamics

Medicare Advantage Plans: Subject to the 2025 $2,000 out-of-pocket maximum for specialty drugs, though Defitelio is typically administered in hospital settings under medical benefits.

Commercial Plans: Cost-sharing varies by plan design. Hospital-administered Defitelio may be covered under medical benefits rather than pharmacy benefits, affecting deductible and coinsurance calculations.

Important: This information is educational only. Consult your specific plan documents for exact cost-sharing details.

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Transplant Team)
    • HSCT records, lab values, clinical notes
    • Timeline: 1-2 days
  2. Submit PA Request (Provider)
    • Use UnitedHealthcare Provider Portal or contact Optum Specialty Pharmacy
    • Timeline: Same day submission possible
  3. Initial Review (UnitedHealthcare)
    • Standard review: 72 hours
    • Expedited review: 24 hours if delay would harm patient health
  4. Specialty Pharmacy Setup (If Approved)
    • Patient enrollment and delivery coordination
    • Timeline: 1-2 business days
  5. Peer-to-Peer Review (If Initial Denial)
    • Request within 24 hours of denial notice
    • Direct discussion between transplant physician and UHC medical director
  6. Treatment Initiation
    • Hospital administration with specialty pharmacy coordination
    • Ongoing monitoring and refill management

Appeals Process in Texas

Texas provides robust appeal rights for UnitedHealthcare denials:

Internal Appeals

Deadlines: 12 months from initial denial date for both reconsideration and formal internal appeal.

Electronic Submission Required: As of August 2025, all UnitedHealthcare Community Plan appeals in Texas must be submitted electronically through the Provider Portal.

Timeline: UnitedHealthcare has 30 days for standard internal appeal decisions.

External Review (Texas-Specific)

Eligibility: Available for medical necessity denials after internal appeal exhaustion.

Deadline: 120 days (4 months) from final internal denial.

Timeline:

  • Standard: 20 days for decision
  • Expedited: 72 hours for urgent cases

Process: Request through Texas Department of Insurance using their Independent Review Organization (IRO) system. The IRO's decision is binding on UnitedHealthcare.

Contact: Texas Department of Insurance IRO line: 1-866-554-4926

Tip: Texas external review is particularly valuable for specialty drugs like Defitelio, as independent medical experts review the clinical necessity outside of insurance company influence.

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient documentation Submit complete HSCT records, lab values, and clinical rationale
Not medically necessary Provide peer-reviewed evidence of VOD/SOS diagnosis and organ dysfunction
Site of care issues Clarify hospital-based administration requirement
Dosing concerns Reference FDA labeling for approved dosing regimen
Missing specialty pharmacy Coordinate with Optum Specialty Pharmacy for proper routing

Cost Assistance Programs

JazzCares Patient Assistance Program: Jazz Pharmaceuticals offers financial assistance for eligible patients. Contact: 1-844-527-7225 or visit the Jazz Pharmaceuticals website.

Hospital Financial Assistance: Many Texas transplant centers have financial counselors who can help navigate insurance appeals and identify additional assistance programs.

State Resources: Texas residents can contact the Office of Public Insurance Counsel (OPIC) at 1-877-611-6742 for appeals guidance.

From Our Advocates

We've seen families successfully overturn Defitelio denials by ensuring the transplant team includes detailed organ dysfunction labs and clear documentation of the post-HSCT timeline. The key is showing not just the VOD/SOS diagnosis, but the specific renal or pulmonary complications that make Defitelio medically necessary under FDA criteria.

FAQ

Q: How long does UnitedHealthcare PA take for Defitelio in Texas? A: Standard review is 72 hours; expedited review is 24 hours if delay would seriously harm patient health.

Q: Does step therapy apply to Defitelio? A: No. UnitedHealthcare does not require trying alternative therapies first because no other FDA-approved treatments exist for hepatic VOD/SOS.

Q: Can I request expedited appeals in Texas? A: Yes, both internal appeals and external review can be expedited if delays would jeopardize patient health.

Q: What if my employer plan denies Defitelio? A: ERISA self-funded plans follow federal appeal rules, not Texas state regulations. You'll use the federal external review process instead of Texas IRO.

Q: Is Defitelio covered under medical or pharmacy benefits? A: Typically under medical benefits when administered in hospital settings, though this varies by plan design.

Q: What happens if external review overturns the denial? A: UnitedHealthcare must comply with the IRO decision and provide coverage. The decision is binding.

Counterforce Health helps patients and clinicians navigate complex insurance appeals for specialty drugs like Defitelio. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer requirements. By identifying specific denial reasons and crafting point-by-point rebuttals with the right clinical documentation, we help turn insurance denials into approvals. Visit www.counterforcehealth.org to learn how we can support your appeal process.

For additional appeals support, Counterforce Health specializes in turning insurance denials into targeted appeals using payer-specific workflows and evidence-based documentation strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult your healthcare provider and insurance plan documents for specific coverage details. Appeal rights and processes may vary by plan type and may change over time.

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