Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Lovotibeglogene autotemcel (Lyfgenia) may be approved when ALL of the following criteria are met:
- Individual is at least 12 years of age; and
- Provider has considered use of prophylaxis therapy for seizures prior to initiating myeloablative conditioning; and
- Individual will be monitored for hematologic malignancies periodically after treatment; and
- Must not be administered concurrently with live vaccines while immunosuppressed; and
- Individual does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40; and
- Individual is HIV negative as confirmed by a negative HIV test prior to mobilization ( Note: Individuals who have received Lyfgenia are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV. Therefore, individuals who have received Lyfgenia should not be screened for HIV infection using a PCR-based assay.) ; and
- Individual will not receive therapy concomitantly with any of the following:
- Hydroxyurea for at least two (2) months prior to mobilization and until all cycles of apheresis are completed (Note: If hydroxyurea is administered between mobilization and conditioning, discontinue two (2) days prior to initiation of conditioning) ; and
- Myelosuppressive iron chelators (e.g., deferiprone, etc.) for seven (7) days prior to mobilization, conditioning, and six (6) months post-treatment; and
- Disease-modifying agents (e.g., L-glutamine, vexelotor, crizanlizumab) for at least two (2) months prior to mobilization; and
- Prophylactic HIV anti-retroviral therapy (Note: Individuals receiving prophylactic ART should stop therapy for at least one (1) month prior to mobilization and until all cycles of apheresis are completed) ; and
- Mobilization of stem cells using granulocyte-colony stimulating factor (G-CSF); and
- Erythropoietin for at least two (2) months prior to mobilization; and
- Individual has not received other gene therapy [e.g., exagamglogene autotemcel (Casgevy) † ]; and
- Individual is a candidate for autologous hematopoietic stem cell transplant (HSCT); and
- The individual has a confirmed diagnosis of sickle-cell disease with one of the following genotypes βS/βS or βS/β0 or βS/β+ (Note: Additional genotypes will be considered on a case-by-case basis based on disease severity) as determined by one of the following:
- Identification of significant quantities of HbS with or without an additional abnormal β-globin chain variant by hemoglobin assay; or
- Identification of biallelic HBB pathogenic variants where at least one allele is the p.Glu6Val pathogenic variant on molecular genetic testing; and
- The individual does NOT have disease with more than two (2) α-globin gene deletions; and
- The individual experienced at least two (2) vaso-occlusive events/crises (VOE/VOC)* in the previous 12 months while adhering to the above therapy (Note: Patients experiencing four events/crises in the previous 24 months will also have met this requirement).
*VOE/VOC is defined as an event requiring a visit to a medical facility for evaluation which results in a diagnosis of such being documented due to one (or more) of the following: acute pain, acute chestsyndrome, acute splenic sequestration, acute hepatic sequestration, priapism lasting greater than two (2) hours AND necessitating subsequent interventions such as opioid pain management, non-steroidal anti-inflammatory drugs, RBC transfusion, etc.
† Requests for subsequent use of lovotibeglogene after receipt of exagamglogene autotemcel will be evaluated on a case-by-case basis
Length of Approval: 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.
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