HEMGENIX

HEMGENIX Connect Patient Guide: How to Get HEMGENIX at Low or No Cost

About HEMGENIX

HEMGENIX (etranacogene dezaparvovec-drlb) is a one-time gene therapy for adults with hemophilia B (congenital Factor IX deficiency). Unlike traditional factor replacement therapies that require ongoing infusions, HEMGENIX is administered as a single intravenous infusion designed to provide long-term improvement in Factor IX activity and bleeding control.

HEMGENIX is indicated for adults with hemophilia B who:

• Currently use Factor IX prophylaxis therapy, or
• Have current or historical life-threatening bleeding, or
• Have repeated, serious spontaneous bleeding episodes

Who Qualifies for HEMGENIX Connect Financial Assistance

CSL Behring offers HEMGENIX Connect, a comprehensive support program that includes financial assistance for eligible patients. While specific income thresholds are not publicly detailed, the program is designed to help patients access this therapy regardless of financial circumstances.

Eligible commercially insured patients may pay as little as $0 per month on their prescription through the copay assistance program.

Medical Eligibility Requirements

Before receiving HEMGENIX, you must meet specific medical criteria:

1. Factor IX Inhibitor Testing: You will be tested for Factor IX inhibitors to determine if HEMGENIX is appropriate for you
2. Retest Protocol: If your initial test is positive, a retest will be performed 2 weeks later
3. Contraindication: If both tests are positive for Factor IX inhibitors, your doctor will not administer HEMGENIX
4. Post-Administration Monitoring: After receiving HEMGENIX, you may undergo additional testing to confirm effectiveness

Insurance Requirements

HEMGENIX Connect works with both commercially insured and uninsured patients. The program can:

• Review your insurance coverage and explain your benefits
• Investigate coverage for treatment
• Help determine your eligibility for financial assistance programs
• Assist with benefits investigation and claims processing

Enrollment in HEMGENIX Connect is not required to receive your prescription, but you must be enrolled to be eligible for financial assistance programs.

How to Apply for HEMGENIX Connect

Step 1: Work with Your Healthcare Provider

Your doctor will complete the HEMGENIX Patient Start Form, which initiates the enrollment process. Your provider should include their Tax ID and NPI numbers to facilitate the benefits investigation process.

Step 2: Enroll in HEMGENIX Connect

Contact HEMGENIX Connect at 1-833-436-0021 or visit Hemgenix.com to enroll. You can also authorize your provider to initiate enrollment on your behalf.

Step 3: Provide Consent and Information

You will be asked to provide consent for CSL Behring to:

• Review your insurance and health information
• Evaluate your eligibility for financial assistance programs
• Enroll you in available patient services
• Contact you about your treatment and support services

Step 4: Benefits Investigation

CSL Behring's case managers will investigate your insurance coverage and determine your eligibility for copay assistance or other financial programs.

Step 5: Receive Your Therapy

Once approved, CSL Behring will work with you and your healthcare provider to schedule your HEMGENIX administration at an appropriate treatment center.

Financial Assistance Programs Available

Copaytion Program

CSL Behring's Copaytion program may cover eligible out-of-pocket copay expenses for HEMGENIX, helping reduce your financial burden.

CSL Behring Assurance Program

If you experience a lapse in third-party or private health insurance, the CSL Behring Assurance Program can help you continue your vital treatments.

Timeline and Delivery

While specific processing timelines are not publicly detailed, CSL Behring's case managers work to expedite the process. Important Note: CSL Behring is currently experiencing a temporary global stockout of HEMGENIX that may result in treatment delays. Contact HEMGENIX Connect for current availability information.

HEMGENIX is administered as a single intravenous infusion at a designated treatment center. Administration day and location are captured during the product ordering process.

What If Your Application Is Denied

If you are denied financial assistance, contact HEMGENIX Connect at 1-833-436-0021 to:

• Understand the reason for denial
• Discuss alternative payment options
• Explore other CSL Behring support programs
• Appeal the decision if circumstances have changed

Additional Support Resources

Patient Advocate Program

HEMGENIX offers a Patient Advocate Program where you can connect with other patients and caregivers to discuss their experiences with HEMGENIX and receive peer support.

Reporting Side Effects

If you experience any side effects, report them to:

• FDA MedWatch: 1-800-FDA-1088 or www.fda.gov/medwatch
• CSL Behring Pharmacovigilance: 1-866-915-6958

Important Disclaimer

This guide provides general information about HEMGENIX Connect and CSL Behring's financial assistance programs. Program details, eligibility requirements, and benefits may change. For the most current and complete information, contact HEMGENIX Connect at 1-833-436-0021 or visit Hemgenix.com. Always consult with your healthcare provider about whether HEMGENIX is appropriate for your specific medical situation. Please see the full prescribing information for HEMGENIX for complete safety and efficacy information.