Background

Exagamglogene autotemcel (Casgevy™) is a genetically modified autologous CD34+ cell enriched population that contains human hematopoietic stem and progenitor cells edited ex vivo by CRISPR/Cas9 at the erythroid-specific enhancer region of the BCL11A gene.

Exagamglogene autotemcel (Casgevy) works by increasing the production of a special type of hemoglobin called fetal hemoglobin (HbF). Having more fetal hemoglobin increases hemoglobin levels in the body and improves the production and function of red blood cells.

Policy

Exagamglogene autotemcel is considered medically necessary for individuals if they meet criteria 1 through 9:

1. At least 12 years of age.
2. Documented diagnosis of sickle cell disease.
3. History of recurrent vaso-occlusive crises.
4. Patient does NOT have a known 10/10 human leukocyte antigen matched related donor willing to participate in an allogeneic HSCT. 
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. No active bacterial, fungal, parasitic, or viral infection, including active/uncontrolled HBV and HCV.
9. No history of receiving gene therapy or under consideration for treatment for another gene therapy for sickle cell disease.

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

Repeat treatment with exagamglogene autotemcel is considered investigational.

References

1. Casgevy™ (exagamglogene autotemcel) suspension, for intravenous infusion [package insert]. Vertex Pharmaceuticals, Inc. Boston, MA. Revised 12/2023.
2. Clinical PharmacologyTM Compendium. 2023. Tampa FL: Gold Standard, Inc. Exagamglogene autotemcel.
3. Micromedex DrugDex Compendium^®. 2023. Exagamglogene autotemcel.

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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