By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

How to Get Hemgenix (Etranacogene Dezaparvovec) Covered by Cigna in Pennsylvania: Complete Appeals Guide and Timeline

Answer Box: Getting Hemgenix Covered by Cigna in Pennsylvania

Hemgenix (etranacogene dezaparvovec) requires prior authorization from Cigna with strict clinical criteria. You must have hemophilia B, be on Factor IX prophylaxis or have serious bleeding history, test negative for inhibitors, and have no prior gene therapy. If denied, Pennsylvania's new external review process has overturned 50% of denials in 2024. First step: Have your hemophilia specialist gather all required documentation and submit the prior authorization through Cigna's provider portal within 30 days of prescription.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Yes, mandatory for all Hemgenix coverage Cigna policy IP-0535 Cigna Coverage Policy
Formulary Status Covered but subject to PA and exclusions Express Scripts formulary Express Scripts 2025 Exclusions
Site of Care Restriction Specialized gene therapy centers only FDA labeling requirements Hemgenix.com Patient Services
Lifetime Limit One dose per patient maximum Cigna policy IP-0535 Cigna Coverage Policy
Appeal Deadline (Internal) 180 days from denial Cigna member materials Cigna Appeals Process
External Review (PA) 4 months after final denial PA Insurance Department PA External Review

Step-by-Step: Fastest Path to Approval

1. Confirm Specialist Credentials

Who: Patient/family
Action: Ensure your prescribing physician is a hemophilia specialist
Timeline: Before prescription
Source: Cigna requires hemophilia specialist prescriber

2. Gather Required Documentation

Who: Healthcare team
Documents needed:

  • Hemophilia B diagnosis with Factor IX deficiency confirmation
  • Current weight (within 30 days)
  • Factor IX inhibitor test results (must be negative)
  • Proof of current Factor IX prophylaxis OR serious bleeding history
  • Recent liver and kidney function tests
  • Confirmation of no prior gene therapy

3. Submit Prior Authorization

Who: Prescribing physician
Method: Cigna provider portal or fax
Timeline: Within 30 days of prescription
Expected response: 72 hours for standard review, 24 hours for expedited

4. If Approved: Coordinate Treatment

Who: Treatment center coordinator
Action: Schedule infusion at approved gene therapy center
Timeline: Per center availability

5. If Denied: Request Peer-to-Peer Review

Who: Prescribing physician
Action: Call Cigna medical director for clinical discussion
Timeline: Within 7 days of denial for best results

6. File Internal Appeal

Who: Patient or physician
Method: Written appeal with additional evidence
Timeline: Within 180 days of denial
Source: Cigna Appeals Guidelines

7. Pennsylvania External Review (if needed)

Who: Patient
Method: PA Insurance Department portal
Timeline: Within 4 months of final internal denial
Success rate: ~50% overturn rate in 2024
Source: PA External Review Success

Understanding Cigna's Prior Authorization Requirements

Cigna's coverage policy for Hemgenix (policy IP-0535) requires meeting specific clinical criteria. As of June 2024, the requirements have become more stringent, eliminating some previous approval pathways.

Must Meet ALL of These Criteria:

Clinical Requirements:

  • Adult patient with hemophilia B (congenital Factor IX deficiency)
  • Currently using Factor IX prophylaxis therapy OR has current/historical life-threatening hemorrhage OR repeated serious spontaneous bleeding episodes
  • Negative Factor IX inhibitor titer (recent testing required)
  • No history of prior gene therapy for hemophilia B (including Hemgenix or Beqvez)
  • No current advanced liver impairment or uncontrolled HIV infection

Administrative Requirements:

  • Prescription by hemophilia specialist physician
  • Current body weight documented (within 30 days)
  • Adequate hepatic function (liver enzymes) and renal function documented
  • Treatment at specialized gene therapy center
Clinician Corner: The June 2024 policy update removed the option to approve patients solely based on "2+ months of Factor IX prophylaxis." Now, stronger clinical justification is required, emphasizing bleeding history or life-threatening episodes.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide detailed bleeding history and failed prophylaxis documentation Hemophilia Treatment Center records, emergency department visits, hospitalizations
"Experimental/investigational" Submit FDA approval documentation and clinical guidelines FDA Hemgenix approval letter, treatment center protocols
"Alternative therapy available" Document prophylaxis failures, breakthrough bleeds, or contraindications Detailed treatment history, adverse event reports, quality of life impact
"Insufficient documentation" Resubmit with complete clinical package All lab results, specialist consultation notes, imaging studies
"Plan exclusion" Request formulary exception with medical necessity letter Comprehensive clinical rationale, peer-reviewed literature

Appeals Process: Your Pennsylvania Rights

Pennsylvania residents have enhanced appeal rights thanks to the state's new external review program launched in January 2024.

Internal Appeals with Cigna

First Level Internal Appeal:

  • Timeline: Must file within 180 days of denial
  • Decision timeframe: 30 days for standard, 72 hours for expedited
  • Who can file: Patient, authorized representative, or prescribing physician

Second Level Internal Appeal:

  • Available if first level is denied
  • Same timeline and decision requirements
  • Must exhaust before external review

Pennsylvania External Review Process

After exhausting Cigna's internal appeals, Pennsylvania residents can access the state's Independent External Review program.

Key Advantages:

  • 50% success rate in overturning denials during 2024
  • Independent medical reviewers (not employed by Cigna)
  • Binding decision—if approved, Cigna must provide coverage
  • State oversight ensures fair process

How to File:

  1. Obtain "Final Adverse Benefit Determination" letter from Cigna
  2. Submit request within 4 months via PA Insurance Department portal
  3. Include all denial letters, medical records, and physician statements
  4. Decision within 45 days (72 hours for expedited)

Contact Information:

  • PA Insurance Department Consumer Services: 1-877-881-6388
  • Online portal: pa.gov (search "external review")
From Our Advocates: We've seen several Pennsylvania patients successfully overturn Cigna denials for expensive specialty drugs through the state's external review process. The key was submitting comprehensive clinical documentation, including peer-reviewed studies supporting the treatment and detailed records of failed alternatives. While outcomes vary by case, the independent medical review often provides a fresh perspective that internal appeals may miss.

Cost Considerations and Financial Assistance

Understanding the Financial Impact

Hemgenix carries a list price of approximately $3.5 million per dose. For Pennsylvania marketplace and most employer plans, the Affordable Care Act prohibits annual and lifetime benefit maximums, meaning no dollar caps apply to essential health benefits like gene therapy.

Cigna's Embarc Benefit Protection

Cigna offers Embarc Benefit Protection for eligible employer plans, which can help mitigate the high upfront costs of gene therapies like Hemgenix. This program may reduce financial barriers to coverage.

Patient Assistance Options

CSL Behring Support Programs:

  • Hemgenix Connect patient support program
  • Commercial insurance copay assistance (up to annual limits)
  • Not available for Medicare/Medicaid patients
  • Application required: Hemgenix Connect enrollment

Foundation Support:

  • National Hemophilia Foundation financial assistance
  • Patient Advocate Foundation copay relief
  • HealthWell Foundation (when funds available)

At Counterforce Health, we help patients navigate these complex coverage challenges by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific basis for rejection, and drafts point-by-point rebuttals aligned to each payer's own rules—exactly what's needed for high-stakes therapies like Hemgenix.

Scripts for Key Conversations

Calling Cigna Customer Service

"Hi, I'm calling about prior authorization status for Hemgenix, spelled H-E-M-G-E-N-I-X, for my hemophilia B. My member ID is [number]. Can you tell me if the prior auth was submitted, what the status is, and if any additional information is needed? I also need to confirm this will be covered under my medical benefit, not pharmacy benefit."

Requesting Peer-to-Peer Review (for physicians)

"I'm requesting a peer-to-peer review for my patient's Hemgenix prior authorization denial. This is a one-time gene therapy for severe hemophilia B, and my patient meets all clinical criteria in your policy IP-0535. The patient has documented breakthrough bleeding despite prophylaxis and meets the medical necessity requirements. When can we schedule the peer-to-peer discussion?"

Pharmacy Coordination

"I need to confirm Hemgenix administration logistics. This is a gene therapy that must be given at a specialized center, not a regular pharmacy. Can you help me identify in-network gene therapy centers in Pennsylvania and confirm the prior authorization covers the administration procedure codes?"

When to Escalate to State Regulators

Contact the Pennsylvania Insurance Department if you experience:

  • Cigna fails to respond within required timeframes
  • Inappropriate denial reasons (e.g., calling FDA-approved therapy "experimental")
  • Procedural violations during appeals process
  • Discrimination based on disability or medical condition

Pennsylvania Insurance Department:

  • Consumer Services: 1-877-881-6388
  • Online complaint portal: pa.gov
  • External review assistance available

FAQ

How long does Cigna prior authorization take for Hemgenix in Pennsylvania?

Standard prior authorization decisions are made within 72 hours of receiving complete documentation. Expedited reviews (for urgent medical situations) are decided within 24 hours.

What if Hemgenix is excluded from my Cigna formulary?

Request a formulary exception by having your physician submit a medical necessity letter explaining why Hemgenix is clinically superior to covered alternatives. Include documentation of failed prophylaxis or contraindications to other treatments.

Can I get an expedited appeal if my condition is urgent?

Yes, if there's risk to your health or ability to regain function, you can request expedited review. Both internal appeals and Pennsylvania's external review offer expedited pathways with faster decision timelines.

Does Pennsylvania's external review cost anything?

No, the external review process through the Pennsylvania Insurance Department is free to consumers. The state covers the cost of independent medical review.

What happens if I paid out-of-pocket during the appeal?

If your appeal is successful, Cigna must provide retroactive coverage and reimburse you for covered out-of-pocket costs incurred during the appeal process.

How do I find a qualified gene therapy center in Pennsylvania?

Contact Hemgenix Connect for a list of certified treatment centers. Major academic medical centers like Penn Medicine and UPMC typically have gene therapy capabilities.

What if my employer plan has different rules than standard Cigna policies?

Self-funded employer plans may have different coverage rules. Request a copy of your Summary Plan Description (SPD) and contact your HR benefits administrator to understand plan-specific coverage criteria.

Can I appeal if I'm denied due to cost concerns?

Yes, cost alone cannot be the basis for denying medically necessary treatment. If cost is cited as a factor, emphasize the one-time nature of gene therapy versus lifetime costs of prophylaxis, and reference Cigna's Embarc Benefit Protection program.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may vary by plan and change over time. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized assistance with complex coverage challenges, Counterforce Health provides specialized support in turning insurance denials into successful appeals through evidence-backed advocacy.

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