Pharmacy Prior Authorization Criteria

Lyfgenia (lovotibeglogene autotemcel)

Indications for Prior Authorization

Lyfgenia (lovotibeglogene autotemcel)

• For diagnosis of 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.

Criteria

Lyfgenia

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

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime*

• Diagnosis of sickle cell disease (SCD)
AND
• Patient has genotype βS/βS, βS/β0, or βS/β+ [2]
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)
AND
• 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
• Patient will receive both of the following:
• Full myeloablative conditioning with busulfan prior to treatment with Lyfgenia
AND
• 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

P & T Revisions

2025-01-29, 2024-02-15

References

1. Lyfgenia Prescribing Information. Bluebird Bio, Inc. Somerville, MA. December 2023.
2. Exa-Cel and Lovo-Cel: Final Policy Recommendations Policy Recommendations, August 2023. https://icer.org/wp-content/uploads/2023/08/ICER_Sickle-Cell-Disease_Final-Policy-Recommendations.pdf. Accessed January 29, 2025

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Revision History

• 2025-01-29: 2025 Annual Review. Background updates only.
• 2024-02-15: New Program

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