LYFGENIA (lovotibeglogene autotemcel)

LYFGENIA (lovotibeglogene autotemcel)

Medical Administration – intravenous

Diagnosis considered for coverage:

Sickle Cell Disease: Indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. Limitations of Use: Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. Lyfgenia has not been studied in patients with more than two α-globin gene deletions.

Coverage Criteria:

For diagnosis of sickle cell disease (SCD):

• Diagnosis of sickle cell disease (SCD), AND
• Patient has genotype βS/βS, βS/β0, or βS/β+, AND
• Patient is 12 years of age or older, AND
• Provider attests that patient is clinically stable and eligible to undergo hematopoietic stem cell transplant (HSCT), AND
• Patient has a history of at least 4 vaso-occlusive events (VOEs) in the past 24 months defined by one of following scenarios:
  • an episode of acute pain with no medically determined cause other than vaso-occlusion, lasting more than 2 hours 
  • acute chest syndrome (ACS) 
  • acute hepatic sequestration 
  • acute splenic sequestration 
  • VOE requiring a hospitalization or multiple visits to an emergency department/urgent care over 72 hours and receiving intravenous medications at each visit 
  • priapism requiring any level of medical attention, AND
• Patient does not have more than two α-globin gene deletions, AND
• Patient has obtained a negative test result for all of the following prior to cell collection:
  • Hepatitis B virus (HBV) 
  • Hepatitis C virus (HCV) 
  • Human immunodeficiency virus (HIV) 
• Patient is able to provide an adequate number of cells to meet the minimum recommended dose of 3 x 10^6 CD34+ cells/kg, AND
  • Full myeloablative conditioning with busulfan prior to treatment with Lyfgenia
  • Anti-seizure prophylaxis with agents other than phenytoin prior to initiating busulfan conditioning, AND
• Prescriber attests that patient will discontinue disease modifying therapies for sickle cell disease (e.g., hydroxyurea, crizanlizumab, voxelotor) 8 weeks before the planned start of mobilization and conditioning, AND
• Prescribed by a provider at a SCD treatment center with expertise in gene therapy, AND
• Prescribed by one of the following:
  • Hematologist/oncologist 
  • Specialist with expertise in the diagnosis and management of sickle cell disease, AND 
• Both of the following:
  • Patient has never received any previous sickle cell gene therapy treatment in their lifetime (i.e., Casgevy, Lyfgenia) 
  • Patient has never received prior allogeneic transplant

Coverage Duration: 

• Initial: 1 Time Authorization in Lifetime

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Per prescribing information, Lyfgenia is for one-time, single dose intravenous use only.

Policy Updates:

• 6/1/2024 (policy effective date)- New Lyfgenia Criteria (P&T 5/20/2024) (P&T Meeting May)

References:

1. Lyfgenia Prescribing Information. Bluebird Bio, Inc. Somerville, MA. December 2023. 
2. Exa-Cel and Lovo-Cel: Final Policy Recommendations Policy Recommendations. https://icer.org/wp-content/uploads/2023/08/ICER_Sickle-Cell-Disease_Final-Policy-Recommendations.pdf