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

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime

• Diagnosis of sickle cell disease (SCD)
AND
• Submission of medical records (e.g., chart notes) confirming patient has on of the following genotypes as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2] :
• βS/βS
• βS/β0
• 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
• Submission of medical records (e.g., chart notes) confirming patient has less than or equal to two α-globin gene deletions as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
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
• 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
AND
• Prescribed by one of the following at a SCD treatment center with expertise in gene therapy and with shared decision-making regarding treatment risks:
• Hematologist/oncologist
• Specialist with expertise in the diagnosis and management of sickle cell disease

P & T Revisions

2026-05-28, 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

• 2026-05-28: 2026 Annual Review. Updated genetic testing criteria to require submission of medical records with standard verbiage. Removed requirement to test for HBV,HVC and HIV prior to cell collection. Combined prescriber requirement criterion and treatment center criterion into one criterion with addition of shared decision making. Formatting updates.
• 2025-01-29: 2025 Annual Review. Background updates only.
• 2024-02-15: New Program

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