Background

Lovotibeglogene autotemcel (Lyfgenia™) is a genetically modified autologous CD34+ cell enriched population that contains human hematopoietic stem and progenitor cells edited ex vivo by BB305 LVV encoding the βA-T87Q-globin gene. This modified β-globin gene is designed to correct the β/α-globin imbalance in erythroid cells of individuals with sickle cell disease. Lovotibeglogene autotemcel (Lyfgenia) adds functional copies of βA-T87Q-globin gene, thereby addressing the underlying genetic cause of sickle cell disease.

Policy

Lovotibeglogene autotemcel is considered medically necessary for individuals when ALL the following are met:

• Submission of medical records (e.g., chart notes) documenting confirmed diagnosis of sickle cell disease with ONE of the following genotypes:
  • βS/βS
  • βS/β0
  • βS/β+

NOTE: Additional genotypes will be considered on an individual consideration (IC) basis based on disease severity.

• Age 12 years or older
• Prescriber is a specialist at a qualified treatment center for Lyfgenia
• Patient does not have a contraindication to the prescribed medication
• Patient does not have clinically suitable, known and available 10/10 human leukocyte antigen matched sibling donor willing to participate in an allogenic hematopoietic stem cell transplant
• Patient must not have received prior treatment with any gene therapy for sickle cell disease or an allogenic hematopoietic stem cell transplant
• Submission of medical records (e.g., chart notes) documenting patient has history of intolerance or failure of hydroxyurea treatment OR patient use of hydroxyurea is contraindicated
• Submission of medical records (e.g., chart notes) documenting prior to treatment, patient experienced at least 4 (four) severe vaso-occlusive crises in the past 24 months OR is currently receiving chronic red blood cell (RBC) transfusion therapy for the prevention of severe vaso-occlusive episodes

NOTE: Severe VOC is defined as an occurrence of at least one of the following events requiring an evaluation at a medical facility with no medically determined cause other than vaso-occlusion requiring administration of pain medications such as opioids or intravenous (IV) non-steroidal anti-inflammatory drugs (NSAIDs) or RBC transfusions:

• Acute pain
• Acute chest syndrome
• Acute hepatic sequestration
• Priapism > 2 hours
• Splenic sequestration

• Patient has a negative serologic test for HIV infection

References

1. Kanter J, Walters MC, Krishnamurti L et al. Biologic and clinical efficacy of lentiglobin for sickle cell disease. NEJM. 2022;386:617-28.
2. Clinical PharmacologyTM Compendium. 2023. Tampa FL: Gold Standard, Inc. Lovotibeglogene autotemcel.
3. Micromedex DrugDex Compendium®. 2023. Lovotibeglogene autotemcel.
4. Lyfgenia^® (lovotibeglogene autotemcel) suspension, for intravenous infusion [package insert]. Bluebird bio, Inc. Somerville, MA. Revised 12/2023.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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