CASGEVY (exagamglogene autotemcel)

CASGEVY (exagamglogene autotemcel)

Length of Authorization: 12 months

Criteria to Approve

• Patient is ≥ 12 years of age; AND
• Diagnosis of Sickle Cell Disease (SCD) with confirmatory genetic testing; AND
• Prior use, failure, intolerance, or patient/family refusal of hydroxyurea (per health care 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
• Patient has experienced two or more documented Vaso-Occlusive Crises (VOCs) per year int eh previous twenty-four (24) months, based on provider attestation; OR
• Patient currently receiving chronic transfusion therapy for recurrent VOCs (based on provider attestation).

CASGEVY | FDA

CASGEVY PA SUBMISSION GUIDELINES