Zynteglo

Indicated For

Transfusion-dependent beta-thalassemia

About This Medication

# My Bluebird Support Patient Guide: How to Get Zynteglo at Low or No Cost ## About This Program My Bluebird Support is Bluebird Bio, Inc.'s patient assistance program designed to help eligible patients access Zynteglo (betibeglogene autotemcel), a groundbreaking gene therapy treatment. This guide explains how the program works and what you need to know to get started. ## What Is Zynteglo? Zynteglo is an FDA-approved gene therapy indicated for treating **β-thalassemia major** in adults and pediatric patients (ages 4 and older) who require regular red blood cell transfusions. This innovative treatment works by helping your body produce healthy red blood cells, thereby reducing or eliminating the need for blood transfusions. Zynteglo is an autologous hematopoietic stem cell-based gene therapy. It adds functional copies of a modified beta globulin gene into your own stem cells through a specialized process. After infusion, these modified cells engraft in your bone marrow and differentiate to produce red blood cells containing biologically active beta globulin. ## Who Qualifies for My Bluebird Support? To be eligible for assistance through My Bluebird Support, you must meet the following criteria: - **Age requirement**: Be 4 years of age or older - **Diagnosis**: Have a confirmed diagnosis of β-thalassemia major - **Transfusion history**: Have received at least 100 mL/kg of body weight of packed red blood cells per year in the previous 2 years - **Provider requirement**: Be prescribed by or in consultation with a hematologist - **Treatment eligibility**: Be eligible to undergo hematopoietic stem cell transplant (HSCT) and have not had prior treatment with HSCT or Zynteglo - **Health status**: Not have certain contraindications, including renal impairment (creatinine clearance ≤ 70 mL/min/1.73 m²) - **Dosing requirement**: Receive a dose within the recommended range of a minimum of 5.0 × 10⁶ CD34+ cells/kg ## Income Eligibility My Bluebird Support does not have published income thresholds. Eligibility is primarily based on medical necessity and clinical criteria rather than financial need. However, the program is designed to assist patients who may face financial barriers to accessing this treatment. Contact the program directly to discuss your specific financial situation. ## Insurance Requirements Zynteglo is typically covered by insurance plans when medical necessity criteria are met. My Bluebird Support can work with your insurance to facilitate coverage. The program accepts patients with: - Commercial insurance - Medicare - Medicaid - Medicare-Medicaid Plans (MMP) - Uninsured patients If you have insurance, the program will work with your plan first. If you are uninsured or underinsured, My Bluebird Support may be able to assist with costs. ## How to Apply My Bluebird Support accepts applications through **multiple methods**. Here's what you need to do: ### Step 1: Gather Required Information Before applying, have the following ready: - Your medical records and diagnosis documentation - Proof of transfusion history (medical records showing transfusions in the previous 2 years) - Current insurance information (if applicable) - Your hematologist's contact information ### Step 2: Contact the Program Reach out to My Bluebird Support through the available application methods. Your healthcare provider can also initiate the application process on your behalf. ### Step 3: Submit Your Application Complete the application form and submit all required medical documentation. Your hematologist may need to provide clinical information supporting your eligibility. ### Step 4: Verification The program will verify your identity and medical information. Your healthcare provider may be contacted to confirm clinical details. ### Step 5: Approval and Next Steps Once approved, you will receive authorization for treatment. Your care team will coordinate with a Qualified Treatment Center for administration. ## Timeline and Delivery **Processing Time**: While specific processing timelines are not published, most patient assistance programs process applications within 5-10 business days once all documentation is received. **Delivery and Administration**: Zynteglo is **administered at a Qualified Treatment Center** by trained medical professionals. This is not a medication you take at home. The treatment involves: - A single intravenous infusion administered over less than 30 minutes - Administration of a dose containing a minimum of 5.0 × 10⁶ CD34+ cells/kg - Lifelong monitoring for hematological malignancies following treatment ## Important Coverage Details - **One-time treatment**: My Bluebird Support covers one treatment course (one dose of Zynteglo) and cannot be renewed - **No reauthorization required**: Once approved and administered, you will not need to reauthorize this treatment - **Lifetime monitoring**: You will receive periodic lifelong monitoring for hematological malignancies as part of your treatment protocol ## What If Your Application Is Denied? If your application is denied, you have several options: 1. **Request reconsideration**: Ask the program to review your application if you believe new information supports your eligibility 2. **Work with your healthcare provider**: Your hematologist may be able to provide additional clinical documentation 3. **Appeal process**: Ask about the program's formal appeal process 4. **Insurance appeal**: If you have insurance, work with your insurance company to appeal a coverage denial 5. **Alternative resources**: Discuss other treatment options with your hematologist ## Biosimilar Alternatives There are currently no biosimilar alternatives to Zynteglo. This is a unique gene therapy with no equivalent treatments available. ## Important Reminders - Zynteglo is indicated for one-time, single-dose intravenous use only - You must be eligible for hematopoietic stem cell transplant to receive this treatment - Lifelong monitoring is required following treatment - Your hematologist must be involved in your care throughout the process ## Disclaimer This guide provides general information about My Bluebird Support and Zynteglo. It is not a substitute for professional medical advice. Program details, eligibility criteria, and coverage policies may change. For the most current and accurate information, contact My Bluebird Support directly or speak with your healthcare provider. Always consult with your hematologist about whether Zynteglo is appropriate for your specific medical situation.

Program information last verified: March 30, 2026