Description

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 if they meet criteria 1 through 10:

1. At least 12 years of age.
2. Documented diagnosis of sickle cell disease.
3. History of vaso-occlusive events.
4. Patients < 18 years of age only: lack of a willing, matched HLA-identical sibling hematopoietic cell donor.
5. No history of receiving allogenic hematopoietic stem cell transplant.
6. Does not have advanced liver disease.
7. Negative serologic test for HIV infection.
8. Does not have any of the following:
   1. Any prior or current malignancy (with the exception of adequately treated cone biopsied in situ carcinoma of cervix uteri and basal or squamous cell carcinoma of the skin) or myeloproliferative or significant immunodeficiency disorder.
   2. Immediate family member with a known suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary non-polyposis colorectal cancer syndrome, and familial adenomatous polyposis).
9. No active bacterial, fungal, parasitic, or viral infection, including active/uncontrolled HBV and HCV.
10. No history of receiving gene therapy or under consideration for treatment for another gene therapy for sickle cell disease.

Lovotibeglogene autotemcel is considered investigational when the above criteria are not met.

Lovotibeglogene autotemcel is considered investigational for all other indications.

Repeat treatment with lovotibeglogene autotemcel is considered investigational.

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, 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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