By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

Getting Hemgenix (etranacogene dezaparvovec) Approved by UnitedHealthcare in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: How to Get Hemgenix Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Hemgenix (etranacogene dezaparvovec) with strict clinical criteria: 50+ Factor IX exposure days, no inhibitors, adult status, and normal liver function. Step 1: Submit PA through the UnitedHealthcare Provider Portal with comprehensive documentation from a hemophilia treatment center. Step 2: If denied, file internal appeal within 180 days. Step 3: Request Virginia external review within 120 days of final denial through the State Corporation Commission Bureau of Insurance. Standard reviews take 45 days; expedited reviews 72 hours.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Documentation
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Virginia
  6. Long-Term Monitoring Requirements
  7. Costs & Financial Assistance
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find Documentation Source
Prior Authorization Required before coverage UnitedHealthcare Provider Portal UHC Policy
Age Restriction Adults only (≥18 years) FDA prescribing information FDA Label
Factor IX Exposure Minimum 50+ documented exposure days Treatment records from hemophilia center UHC Gene Therapy Policy
Inhibitor Status No current inhibitors (<0.6 Bethesda units) Recent inhibitor screen results UHC Policy
Liver Function Normal ALT, AST, bilirubin levels Laboratory results within 30 days FDA Label
Specialist Care Must be prescribed by hemophilia treatment center CDC-listed treatment center verification UHC Policy

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility (Patient/Clinic - Day 1)

  • Verify adult hemophilia B diagnosis with Factor IX levels ≤2%
  • Document 50+ exposure days to Factor IX products
  • Obtain recent inhibitor screen showing <0.6 Bethesda units
  • Complete baseline liver function tests (ALT, AST, bilirubin)

2. Gather Clinical Documentation (Clinic - Days 2-7)

  • Medical necessity letter from hemophilia specialist
  • Complete treatment history including prior therapies and outcomes
  • Bleeding episode logs and current prophylaxis regimen
  • Laboratory results and genetic confirmation

3. Submit Prior Authorization (Clinic - Day 8)

  • File through UnitedHealthcare Provider Portal
  • Include all required clinical documentation
  • Request expedited review if medically urgent (72-hour decision)
  • Standard review timeline: 15 business days

4. Monitor PA Status (Patient/Clinic - Days 9-23)

  • Check portal daily for status updates
  • Respond immediately to requests for additional information
  • Prepare for potential peer-to-peer review if requested

5. If Approved: Coordinate Treatment (Clinic - Days 24+)

  • Schedule infusion at qualified treatment center
  • Arrange post-treatment monitoring plan
  • Confirm insurance authorization details with pharmacy

6. If Denied: File Internal Appeal (Patient/Clinic - Within 180 days)

  • Submit appeal through UnitedHealthcare within 180 days of denial
  • Include updated clinical documentation and peer-reviewed evidence
  • Request expedited appeal if treatment delay poses health risks

7. External Review if Needed (Patient - Within 120 days of final denial)

  • File Form 216-A with Virginia Bureau of Insurance
  • Include all appeal documentation and physician certification
  • Decision within 45 days (72 hours if expedited)

Required Documentation

Medical Necessity Letter Checklist

Your hemophilia specialist should include:

  • Diagnosis confirmation: Severe/moderate hemophilia B with Factor IX levels ≤2%
  • Treatment history: Detailed record of 50+ exposure days to Factor IX concentrates
  • Clinical rationale: Why gene therapy is medically necessary vs. continued prophylaxis
  • Contraindications: Documentation of any issues with current treatment
  • Monitoring plan: Post-infusion surveillance protocol including liver function tests
  • Guideline support: Reference to FDA prescribing information and hemophilia treatment guidelines
Clinician Corner: Evidence Standards

UnitedHealthcare requires comprehensive documentation aligned with FDA labeling. Include baseline Factor IX activity levels, inhibitor testing results, and documentation from a CDC-recognized hemophilia treatment center. Reference the World Federation of Hemophilia guidelines for additional clinical support when drafting medical necessity letters.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient exposure days Document all Factor IX treatments Complete infusion logs, pharmacy records
Missing inhibitor testing Provide recent results Lab report showing <0.6 Bethesda units
Not prescribed by qualified center Confirm specialist credentials CDC hemophilia center directory verification
Experimental/investigational Challenge with FDA approval FDA approval letter and prescribing information
Alternative therapy required Document failure/contraindications Treatment history showing inadequate response

Appeals Process in Virginia

Internal Appeals with UnitedHealthcare

  • Timeline: 180 days from denial notice to file
  • Submission: Via provider portal, fax, or mail
  • Decision time: 30-60 days standard; 72 hours expedited
  • Required: Updated clinical documentation, peer-reviewed literature

Virginia External Review Process

After exhausting internal appeals, Virginia residents can request independent review through the State Corporation Commission Bureau of Insurance.

Key Details:

  • Deadline: 120 days from UnitedHealthcare's final denial
  • Form: Form 216-A External Review Request
  • Cost: Free to patients
  • Decision timeline: 45 days standard; 72 hours expedited
  • Contact: Virginia Bureau of Insurance at 1-877-310-6560

Expedited Review Criteria:

  • Physician certifies delay could seriously jeopardize health
  • Treatment is time-sensitive for optimal outcomes
  • Standard timeline could result in irreversible harm
From Our Advocates

We've seen Virginia external reviews succeed when patients include comprehensive specialist documentation and clear evidence that gene therapy meets FDA-approved criteria. The independent medical reviewers often overturn denials when the clinical case is well-documented, even for high-cost treatments like Hemgenix.

Long-Term Monitoring Requirements

UnitedHealthcare requires ongoing clinical surveillance after Hemgenix infusion:

Required Laboratory Monitoring

  • Factor IX activity levels: Weekly for first 3 months, then biannually
  • Liver function tests: Weekly for 3 months, then as clinically indicated
  • Inhibitor screening: If breakthrough bleeding occurs
  • Hepatocellular carcinoma surveillance: Annual ultrasound and AFP for high-risk patients (5 years minimum)

Documentation Requirements

  • Periodic outcomes reports to UnitedHealthcare
  • Bleeding episode logs and Factor IX usage records
  • Specialist follow-up notes confirming treatment effectiveness
  • Adverse event reporting per FDA requirements

Note: Since Hemgenix is a one-time treatment, annual reauthorization for additional doses is not required.

Costs & Financial Assistance

Manufacturer Support Programs

  • CSL Behring Patient Assistance: Coverage support and copay assistance programs
  • Hemgenix Access Program: Prior authorization support and appeals assistance
  • Contact: Visit Hemgenix.com for current program details

Additional Resources

  • National Hemophilia Foundation: Financial assistance and advocacy support
  • Virginia Medicaid: May provide coverage for eligible patients
  • Patient Advocate Foundation: Insurance navigation and appeals assistance

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex treatments like gene therapy. Our platform helps patients and clinicians navigate UnitedHealthcare's specific requirements and Virginia's external review process.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Hemgenix? Standard review takes 15 business days. Expedited review (when medically urgent) is completed within 72 hours. Submit through the UnitedHealthcare Provider Portal for fastest processing.

What if Hemgenix isn't on my formulary? Hemgenix requires prior authorization regardless of formulary status. UnitedHealthcare evaluates coverage based on medical necessity criteria rather than formulary placement for gene therapies.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health. Expedited external reviews in Virginia are decided within 72 hours.

Does step therapy apply to Hemgenix? UnitedHealthcare typically requires documentation of current or prior Factor IX prophylaxis, but formal step therapy protocols are less common for gene therapies given their unique mechanism.

What happens if my appeal is denied? After exhausting UnitedHealthcare's internal appeals, you can request Virginia external review within 120 days. The independent medical review is binding on UnitedHealthcare if they overturn the denial.

How much does Hemgenix cost without insurance? The list price is approximately $3.5 million per dose. Insurance coverage is essential, making the prior authorization and appeals process critical for access.

Can I get a second opinion during the appeals process? Yes, additional specialist opinions can strengthen your appeal. Include any new clinical assessments or treatment recommendations in your appeal documentation.

What if I have coverage through an employer plan? Self-funded employer plans may opt into Virginia's external review process. If not, federal external review through HHS may be available. The Virginia Bureau of Insurance can help determine which process applies.

Sources & Further Reading

For personalized assistance with UnitedHealthcare appeals and Virginia's external review process, Counterforce Health provides specialized support for complex prior authorization cases.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage policies and requirements may change; verify current information through official sources.

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