By Counterforce Health Team in Orfadin (nitisinone) —

How to Get Orfadin (nitisinone) Covered by UnitedHealthcare in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Orfadin Approved by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Orfadin (nitisinone) but does not require step therapy since it's the only FDA-approved treatment for hereditary tyrosinemia type 1 (HT-1). To get approval in Virginia: (1) Gather complete HT-1 diagnosis documentation including elevated succinylacetone levels and FAH gene testing, (2) Submit PA request through UnitedHealthcare Provider Portal with medical necessity letter, and (3) If denied, file internal appeal within 65 days, then Virginia external review using Form 216-A within 120 days. Success rate for well-documented appeals is approximately 82%.

Start today: Contact your metabolic specialist to compile all HT-1 diagnostic records and treatment history.

Table of Contents

Understanding Orfadin Coverage Requirements

Orfadin (nitisinone) is the only FDA-approved medication for hereditary tyrosinemia type 1, manufactured by Sobi. UnitedHealthcare covers Orfadin through OptumRx but requires prior authorization for all strength formulations.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans UnitedHealthcare PA Requirements
Step Therapy Not applicable (only FDA-approved option) OptumRx formulary documents
Diagnosis Code ICD-10: E70.21 (Tyrosinemia, type I) Medical records
Formulary Tier Varies by plan (typically specialty tier) Member portal or EOB
Quantity Limits May apply by strength Plan-specific formulary

The key difference from other specialty medications is that step therapy requirements don't apply because there are no alternative FDA-approved treatments for HT-1.

Step-by-Step: Fastest Path to Approval

1. Confirm HT-1 Diagnosis Documentation

Who: Patient/caregiver and metabolic specialist
Timeline: 1-2 days
Required: Elevated succinylacetone levels (blood/urine), FAH gene testing results, baseline liver function tests

2. Gather Treatment History

Who: Healthcare team
Timeline: 2-3 days
Required: Previous therapies attempted, dietary management plan from registered dietitian, monitoring schedule

3. Submit Prior Authorization Request

Who: Prescribing physician
Timeline: Submit within 1 week of prescription
Method: UnitedHealthcare Provider Portal or OptumRx at 888-397-8129
Response time: 5-7 business days (standard), 24-72 hours (urgent)

4. Include Medical Necessity Letter

Who: Metabolic specialist
Required elements:

  • Confirmed HT-1 diagnosis with ICD-10 code E70.21
  • Elevated succinylacetone documentation
  • FAH gene mutation details
  • Dietary restriction plan
  • Expected clinical outcomes
  • FDA approval status confirmation

5. Track and Follow Up

Who: Patient/clinic staff
Timeline: Check status within 3-5 business days
Method: Provider portal or member services

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Insufficient HT-1 diagnosis Submit complete biochemical and genetic testing Succinylacetone levels, FAH gene analysis
Missing dietary management plan Include registered dietitian consultation Formal dietary restriction protocol
Lack of medical necessity justification Comprehensive prescriber letter FDA labeling, treatment guidelines, patient-specific rationale
Quantity limit exceeded Request exception with clinical justification Dosing rationale based on weight/BSA
Tip: UnitedHealthcare's automated approval system can process requests within 24 hours when all required documentation is complete and meets criteria.

Appeals Process in Virginia

If your initial prior authorization is denied, Virginia provides a structured appeals pathway with specific protections.

Internal Appeals with UnitedHealthcare

Timeline: 65 days from denial notice (as of January 2025)
Process: Two-step system - reconsideration, then formal appeal
Success rate: Approximately 82% when properly documented
Submit via: UnitedHealthcare Provider Portal or member services

Required for appeals:

  • Copy of original denial letter
  • All supporting medical records
  • Updated medical necessity letter addressing denial reasons
  • New clinical evidence if available

Peer-to-Peer Review

UnitedHealthcare often allows peer-to-peer consultations between your specialist and their medical director. Request this immediately upon receiving a denial - it can resolve issues before formal appeals.

Preparation for P2P calls:

  • Have all clinical notes readily available
  • Prepare responses to specific denial reasons
  • Reference FDA labeling and clinical guidelines
  • Document the call outcome in writing

Patient Assistance and Cost Support

Sobi offers comprehensive support through the Orfadin4U Patient Support Program, which can significantly reduce out-of-pocket costs even with UnitedHealthcare coverage.

Available Support Programs

  • Co-pay assistance as low as $0 for eligible patients
  • Insurance navigation and prior authorization support
  • Specialty pharmacy coordination
  • HT-1 community connections

Contact: (800) 496-6111 or visit Orfadin.com/support

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters and crafting evidence-backed rebuttals. Their platform helps patients and clinicians navigate complex prior authorization requirements for specialty medications like Orfadin, particularly when dealing with challenging payer policies.

Generic Nitisinone Options

As of November 2024, generic versions of nitisinone became available, which may impact coverage decisions and costs. Discuss with your specialist whether generic alternatives are appropriate for your specific situation.

When to Escalate: Virginia External Review

If UnitedHealthcare upholds their denial after internal appeals, Virginia law provides an independent external review process through the State Corporation Commission Bureau of Insurance.

Virginia External Review Process

Timeline: Must file within 120 days of final internal denial
Form: Complete Form 216-A (External Review Request)
Decision timeframe: 45 days (standard), 72 hours (expedited)
Cost: Free to patients

Submit to: State Corporation Commission
Bureau of Insurance – External Review
P.O. Box 1157
Richmond, VA 23218
Fax: 804-371-9915
Email: [email protected]

Required documents:

  • Completed Form 216-A
  • Copy of denial letters
  • Insurance card copy
  • Medical records release form
  • Supporting clinical documentation
Note: The external review decision is binding on both you and UnitedHealthcare. Virginia's process has helped many patients obtain coverage for necessary specialty medications.

For expedited reviews (when delay could seriously jeopardize health), your physician must complete Form 216-C certifying urgent need.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Orfadin in Virginia?
A: Standard reviews take 5-7 business days. Urgent requests with physician attestation are processed within 24-72 hours.

Q: What if Orfadin is not on my UnitedHealthcare formulary?
A: Even non-formulary medications can be covered through medical exception requests. The lack of FDA-approved alternatives strengthens your case.

Q: Can I request an expedited appeal if my child needs Orfadin urgently?
A: Yes. Both UnitedHealthcare and Virginia external review offer expedited processes when delays could harm health.

Q: Does step therapy apply if I've tried treatments outside Virginia?
A: Step therapy doesn't apply to Orfadin since it's the only FDA-approved HT-1 treatment. Previous treatment history from any state supports medical necessity.

Q: What happens if I miss the 120-day deadline for Virginia external review?
A: The deadline is strict, but contact the Bureau of Insurance immediately - they may provide guidance on exceptional circumstances.

Q: Are there income limits for Sobi's patient assistance programs?
A: Eligibility varies by program. Contact Orfadin4U at (800) 496-6111 to determine what assistance you qualify for.

Resources and Next Steps

Immediate Action Items

✓ Gather all HT-1 diagnostic records
✓ Confirm UnitedHealthcare plan details and formulary status
✓ Request medical necessity letter from metabolic specialist
✓ Apply for Sobi patient assistance programs
✓ Track all submission deadlines and appeal timelines

Key Contacts

  • UnitedHealthcare Provider Services: 888-397-8129
  • Orfadin4U Patient Support: (800) 496-6111
  • Virginia Bureau of Insurance: (877) 310-6560
  • Counterforce Health: Visit counterforcehealth.org for specialized appeals assistance

Official Forms and Documents

Getting Orfadin covered requires persistence and proper documentation, but Virginia's consumer protections and manufacturer support programs provide multiple pathways to access this life-saving medication. The combination of federal protections, state external review rights, and comprehensive patient assistance makes successful coverage highly achievable with the right approach.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan details and medical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For official Virginia insurance regulations and consumer rights, visit the State Corporation Commission Bureau of Insurance.

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