Hematology - Casgevy™
EVICORE-EMBARC-8103815A
The policy covers one-time (per‑lifetime) Casgevy (exagamglogene autotemcel) IV gene therapy for sickle cell disease in patients ≥12 years with recurrent VOCs and specifically excludes prior HSCT or prior gene‑therapy recipients, those with active infections, advanced liver disease, severe cerebral vasculopathy (e.g., untreated Moyamoya), prior/current malignancy or significant immunodeficiency, and indications not listed (beta‑thalassemia review excluded). Approval requires documentation of eligible genotypes (βS/βS, βS/β0, or βS/β+ or Medical Director review), ≥4 severe VOCs in 2 years despite ≥1 pharmacologic therapy, negative HIV/HBV/HCV/HTLV screening, planned mobilization/apheresis with a mobilizer and busulfan myeloablative conditioning, contraception, weight within 30 days, discontinuation of disease‑modifying therapy ≥2 months and iron chelation ≥7 days, hematologist/transplant prescriber, and verification of a minimum dose of 3×10^6 CD34+ cells/kg (approval issued as a single dose with up to 1 year to prepare).