Lyfgenia (lovotibeglogene autotemcel) — Medica
Sickle cell disease
Initial criteria
- Patient is age ≥ 12 years
- Patient has not received a gene therapy for sickle cell disease in the past [verification in claims history required]; if no claim for Lyfgenia or Casgevy (exagamglogene autotemcel intravenous infusion) is present (or if claims history is not available), the prescribing physician confirms that the patient has not previously received Lyfgenia or Casgevy
- According to the prescribing physician, a hematopoietic stem cell transplantation is appropriate for the patient
- Patient meets ONE of the following: (i) Patient does not have a Human Leukocyte Antigen (HLA)-matched donor OR (ii) Patient has an HLA-matched donor, but the individual is not able or is not willing to donate
- Genetic testing [documentation required] indicates ONE of the following sickle cell disease genotypes: βS/βS, βS/β0, or βS/β+
Approval duration
1 year (one-time per lifetime single dose)