Zynteglo (betibeglogene autotemcel) — Medica

Initial criteria

• Patient will undergo mobilization, apheresis, and myeloablative conditioning; AND
• A granulocyte-colony stimulating factor product and a hematopoietic stem cell mobilizer will be utilized for mobilization; AND
• Busulfan will be used for myeloablative conditioning; AND
• Total hemoglobin level is ≥ 11.0 g/dL prior to mobilization AND prior to myeloablative conditioning; AND
• Patient screening is negative for human immunodeficiency virus‑1 and ‑2, hepatitis B virus, hepatitis C virus, and human T‑lymphotropic virus‑1 and ‑2 [documentation required]; AND
• For a patient of reproductive potential: if female, a negative serum pregnancy test will be confirmed prior to mobilization and re‑confirmed prior to myeloablative conditioning AND will use an effective method of contraception from the start of mobilization through at least 6 months after Zynteglo administration; OR if male, will use an effective method of contraception from the start of mobilization through at least 6 months after Zynteglo administration; AND
• Medication is prescribed by a hematologist or a stem cell transplant specialist; AND
• Current patient body weight obtained within 30 days [documentation required]; AND
• Patient has not received a prior hematopoietic stem cell transplantation; AND
• Patient has not received prior gene therapy; AND
• Not used concurrently with Reblozyl (luspatercept‑aamt)

Approval duration

one lifetime dose