LYFGENIA (lovotibeglogene autotemcel)

LYFGENIA (lovotibeglogene autotemcel)

Lenth of Authorization: 12 months

Criteria to Approve

• Patient is ≥ 12 years of age at the expected time of admission; AND
• Diagnosis of Sickle Cell Disease (SCD) with confirmatory genetic testing; AND
• Prior use, failure, intolerance, or patient/family refusal of hydroxyurea (per health professional judgement) at any point in the past; AND
• Patient is clinically stable and fit for transplantation; AND
• Prescribed by or in consultation with a board-certified hematologist with SCD expertise; AND
• Eligible Beneficiary's Treatment Center has a Sickle Cell Center; AND
• Patient currently receiving chronic transfusion therapy for recurrent Vaso-Occlusive Events (VOEs); OR
• Patient has experienced four (4) or more VOEs in the previous twenty-four (24) months as determined by the eligible beneficiary's treating clinician.

LYFGENIA | FDA

LYFGENIA PA SUBMISSION GUIDELINES