Exagamglogene autotemcel (Casgevy) - CAM 915HB
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
Casgevy (exagamglogene-autotemcel) for Sickle Cell Disease Criteria
Exagamglogene autotemcel is considered medically necessary for individuals when ALL of the following are met:
- Confirmatory genetic testing
- Age 12 years or older
- Prescriber is a specialist at a qualified treatment center for Casgevy
- Patient does not have a contraindication to the prescribed medication
- Patient has history of intolerance or failure of hydroxyurea treatment or patient use of hydroxyurea is contraindicated (per provider clinical judgement)
- Clinically stable and fit for transplantation
- Prior to treatment, provider attestation that patient has experienced at least two vaso-occlusive crises per year in the previous twenty-four (24) months, based on provider attestation.
Length of Authorization: |
One treatment course (12 months) |
Renewal Criteria: | Not applicable as no further authorizations will be provided |
Casgevy (exagamglogene-autotemcel) for Transfusion-Dependent B- Thalassemia Criteria
Exagamglogene autotemcel is considered medically necessary for Transfusion-Dependent β-Thalassemia when the following are met:
- Age 12 years or older with transfusion-dependent β-thalassemia
- Transfusion dependence is defined as a minimum of at least 100 mL/kg/year or 10 units/year of RBC transfusions in the most recent two years.
- Prescriber is a specialist at a qualified treatment center for Casgevy
- Patient does not have a contraindication to the prescribed medication
- Patient has not previously received gene therapy for the requested diagnosis.
- Patient has not previously received an allogeneic or autologous HSCT
Length of Authorization: |
One treatment course (12 months) |
Renewal Criteria: | Not applicable as no further authorizations will be provided |
References
- Casgevy™ (exagamglogene autotemcel) suspension, for intravenous infusion [package insert]. Vertex Pharmaceuticals, Inc. Boston, MA. Revised 12/2023.
- Clinical PharmacologyTM Compendium. 2023. Tampa FL: Gold Standard, Inc. Exagamglogene autotemcel.
- Micromedex DrugDex Compendium®. 2023. Exagamglogene autotemcel.
- Centers for Medicare & Medicaid Services (CMS). HCPCS quarterly update: January 2025. CMS website. Updated December 17, 2024. Accessed January 6, 2025.
Coding Section
Code |
Number |
Description |
HCPCS |
J3590 |
Unclassified biologics |
J3392 | Injection, exagamglogene autotemcel, per treatment (Effective January 1, 2025) |
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"
History From 2024 Forward
7/02/2025 | Interim review, updating criteria for sickle cell disease, adding criteria for thalassemia, updating coding section. |
06/01/2025 | Interim review, Clarifications to treatment course (12 months) and additional revisions as requested. |
04/01/2025 | interim review, Updated “patient experienced at least four vaso-occulisive crises” to at last two vaso-occlusive crises. |
02/21/2025 | Annual review, no changes to policy intent. |
11/01/2024 |
New Policy |