By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

How to Get Hemgenix (Etranacogene Dezaparvovec) Covered by Humana in North Carolina: Prior Authorization Guide and Appeals Process

Answer Box: Getting Hemgenix Covered by Humana in North Carolina

Hemgenix (etranacogene dezaparvovec) requires prior authorization from Humana for adults with moderate to severe hemophilia B. The fastest path to approval involves three key steps: (1) Have your hematologist submit a comprehensive PA request with Factor IX levels ≤2%, bleeding history, and current prophylaxis documentation; (2) Include required baseline testing (AAV5 neutralizing antibodies, liver function) and confirm you're not on immunosuppressive therapy; (3) If denied, you have 60 days to appeal through federal Medicare processes (not North Carolina's Smart NC program). Contact Humana Clinical Pharmacy Review at 1-800-555-2546 to start your coverage determination request.

Table of Contents

Plan Types & Coverage Implications

Humana offers several Medicare plan types in North Carolina, each with different coverage rules for Hemgenix:

Medicare Advantage (Part C): Most common Humana option in North Carolina. Hemgenix would be covered under the medical benefit (Part B) since it's an infusion therapy administered in specialized centers. Prior authorization is required regardless of your specific Medicare Advantage plan.

Medicare Part D: Standalone prescription drug plans don't typically cover Hemgenix since it's administered as an infusion therapy rather than a self-administered medication.

Important: Medicare Advantage members cannot use North Carolina's Smart NC external review program. You must follow federal Medicare appeals processes described below.

Formulary Status & Tier Placement

Based on available information, Hemgenix requires prior authorization across Humana's Medicare plans. Given its $3.5 million list price and specialized administration requirements, it's subject to stringent utilization management.

Coverage Determination Process:

  • Contact Humana Clinical Pharmacy Review at 1-800-555-2546
  • Submit coverage determination request with complete clinical documentation
  • Standard timeline: 30 days for non-urgent requests
  • Expedited timeline: 72 hours for urgent medical situations

Prior Authorization Requirements

Patient Eligibility Criteria

To qualify for Hemgenix coverage through Humana, you must meet these clinical requirements:

Diagnosis Requirements:

  • Confirmed moderately severe to severe hemophilia B
  • Factor IX activity level ≤2% of normal
  • Age 18 years or older
  • Biologically male or male assigned at birth

Clinical Indication (one required):

  • Currently using Factor IX prophylaxis therapy, OR
  • Current life-threatening hemorrhage, OR
  • History of life-threatening hemorrhage

Safety Requirements:

  • Screened for acute infection prior to administration
  • Not currently receiving immunosuppressive therapy
  • No prior gene therapy for hemophilia B
  • AAV5 neutralizing antibody titer within acceptable range

Required Documentation

Your hematologist must provide comprehensive documentation including:

Laboratory Results:

  • Factor IX activity level (must be ≤2%)
  • AAV5 neutralizing antibody titer
  • Complete blood count within past 6 months
  • Liver function tests (baseline)
  • Inhibitor testing via Bethesda assay (negative, within 30 days)

Clinical History:

  • Detailed bleeding episode records
  • Emergency department visits for bleeding events
  • Current prophylaxis regimen and effectiveness
  • Prior factor treatments and outcomes
  • Quality of life assessments

Specialty Pharmacy Network

Hemgenix distribution is managed through Humana's CenterWell Specialty Pharmacy network. Given the specialized nature of gene therapy administration, you'll need to work with approved infusion centers.

Key Contacts:

  • CenterWell Specialty Pharmacy: 844-486-2668 (TTY: 711)
  • Hours: Monday–Friday 8 a.m.–8 p.m., Saturday 8 a.m.–6 p.m. Central time
  • Services: Prior authorization coordination, specialty drug access, clinical support
Note: Gene therapies like Hemgenix have restricted distribution networks. Your provider will help identify approved administration facilities in North Carolina.

Cost-Share Considerations

Given Hemgenix's high cost, understanding your potential out-of-pocket expenses is crucial:

Medicare Part B Coverage: As an infusion therapy, Hemgenix falls under Part B medical benefits rather than Part D prescription coverage. This typically means:

  • 20% coinsurance after meeting your Part B deductible
  • Potential catastrophic coverage protections
  • Supplemental insurance may help with cost-sharing

Financial Assistance: Contact CSL Behring's patient support program for potential assistance with cost-sharing obligations. Many gene therapy manufacturers offer comprehensive support programs for eligible patients.

Submission Process

Step-by-Step Approval Process

1. Pre-Authorization Consultation (Provider)

  • Hematologist reviews clinical criteria
  • Confirms patient meets eligibility requirements
  • Gathers required documentation
  • Timeline: 1-2 weeks

2. Prior Authorization Submission (Provider)

  • Submit PA request via Humana provider portal
  • Include all required clinical documentation
  • Provide medical necessity justification
  • Timeline: Same day submission

3. Humana Review Process

  • Clinical review by Humana medical team
  • Potential peer-to-peer consultation
  • Coverage determination issued
  • Timeline: 30 days standard, 72 hours expedited

4. Approval and Coordination (If approved)

  • CenterWell Specialty Pharmacy coordination
  • Infusion center scheduling
  • Patient education and consent
  • Timeline: 1-2 weeks

Appeals Process for North Carolina

If Humana denies your Hemgenix prior authorization, you have specific appeal rights under federal Medicare regulations:

Level 1: Redetermination (Initial Appeal)

  • Deadline: 60 days from denial notice
  • Timeline: 30 days for Humana decision (7 days starting 2026)
  • Expedited option: 72 hours if medically urgent
  • Submission: Humana member portal or mail to address on denial letter

Level 2: Independent Review Entity (IRE)

  • Automatic: Forwarded by Humana if Level 1 denied
  • Timeline: 30 days for decision
  • Process: Independent third-party review

Federal External Review (MAXIMUS)

For urgent situations requiring expedited external review:

  • Timeline: 72 hours or less for urgent cases
  • Standard review: 45 days maximum
  • Cost: Free to members
  • Deadline: Within 4 months of denial notice
  • Binding decision: Humana must accept reviewer's determination
Critical: North Carolina's Smart NC program does NOT apply to Medicare Advantage plans. You must use federal Medicare appeals processes.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Insufficient bleeding history Provide detailed bleeding diary, emergency records, and quality of life assessments
Missing baseline labs Submit complete Factor IX levels, AAV5 antibodies, and liver function tests
Alternative therapy not tried Document current prophylaxis regimen and clinical justification for gene therapy
Inadequate medical necessity Include hematologist's comprehensive letter with guideline references
Missing safety screening Provide infection screening results and confirm no immunosuppressive therapy

Clinician Corner: Medical Necessity Letter Essentials

Your hematologist's letter should include:

  • Diagnosis confirmation: Specific Factor IX level and hemophilia B severity
  • Current treatment: Prophylaxis regimen, effectiveness, and limitations
  • Clinical rationale: Why gene therapy is appropriate now
  • Safety considerations: Baseline testing results and monitoring plan
  • Guideline support: References to FDA labeling and treatment guidelines

FAQ

How long does Humana prior authorization take for Hemgenix? Standard PA decisions take up to 30 days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Hemgenix is not on Humana's formulary? As an infusion therapy, Hemgenix is covered under Part B medical benefits rather than Part D formulary. Prior authorization is still required.

Can I request an expedited appeal if denied? Yes, if you have an urgent medical condition. Your provider must certify that delays would seriously jeopardize your health.

Does step therapy apply to gene therapy? Humana may require documentation that standard Factor IX prophylaxis was tried first, unless contraindicated or ineffective.

What happens if I move from North Carolina during treatment? Coordinate with CenterWell Specialty Pharmacy to ensure continuity of care and network provider access in your new location.

Who can help me navigate the appeals process? Contact Humana member services at the number on your ID card, or work with your hematologist's office for clinical appeals support.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like gene therapies. Our platform helps patients and providers build evidence-backed appeals that address specific payer requirements and denial reasons. If you're facing challenges with prior authorization or appeals for Hemgenix, Counterforce Health can help streamline the process with targeted, policy-specific documentation.

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 personalized guidance. Coverage policies and requirements may change; verify current information with Humana directly.

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