Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Lovotibeglogene autotemcel (Lyfgenia) may be approved when
ALL
of the following criteria are met:
-
The individual is greater than or equal to 12 and less than or equal to 50 years of age;
and
-
The individual has a diagnosis of sickle cell disease (SCD), with either βS/βS or βS/β0 or βS/β+ genotype;
and
-
The individual has experienced at least four (4) sickle cell-related VOCs or priapism within past 24 months that required pain medications or RBC transfusion at a medical facility while on hydroxyurea at the maximum (35 mg/kg/day) or maximally tolerated dose (mild myelosuppression is expected), as evidenced by paid claims or pharmacy printouts;
and
-
The individual does not have human immunodeficiency virus type 1 or 2 (HIV-1 and HIV-2), hepatitis B virus (HBV), or hepatitis C (HCV);
and
-
The individual does not have Inadequate bone marrow function, as defined by an absolute neutrophil count of less than 1000/µL (less than 500/µL for individuals on hydroxyurea treatment) or a platelet count less than 100,000/µL;
and
-
The individual must not be a recipient of a previous allogeneic transplant or gene therapy;
and
- The individual must not have more than two (2) α-globin gene deletions (−α3.7/−α3.7).
Note:
The safety and effectiveness of repeat administration of lovotibeglogene autotemcel (Lyfgenia) has not been evaluated. Therefore, coverage will be limited to once per lifetime.
The use of lovotibeglogene autotemcel (Lyfgenia) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
