State and School Employees' Health Insurance Plan - Gene Therapy for Treatment of Sickle Cell Disease

POLICY NUMBER

S.5.01.607

Casgevy (exagamglogene autotemcel)

Lyfgenia (lovotibeglogene autotemcel)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Sickle cell disease (SCD) is a group of inherited red blood cell disorders. Red blood cells contain hemoglobin, a protein that carries oxygen. Healthy red blood cells are round, and they move through small blood vessels to carry oxygen to all parts of the body.

In someone who has SCD, the hemoglobin is abnormal, which causes the red blood cells to become hard and sticky and look like a C-shaped farm tool called a sickle. The sickle cells die early, which causes a constant shortage of red blood cells. Also, when they travel through small blood vessels, sickle cells get stuck and clog the blood flow. This can cause pain and other serious complications, such as infection, acute chest syndrome, and stroke.

Casgevy (exagamglogene autotemcel) is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 12 years and older with:

• sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and with

• transfusion-dependent β-thalassemia (TDT).

Lyfgenia (lovotibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.

POLICY

Gene therapy, including but not limited to Casgevy (exagamglogene autotemcel) and Lyfgenia (lovotibeglogene autotemcel), is considered not medically necessary for the treatment of sickle cell disease as there is insufficient evidence of greater clinical benefit when compared to other available treatment options covered by the Plan.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

01/15/2025: New policy added.

09/01/2025: Code Reference section updated to add HCPCS codes J3392 and J3394.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description and policy section updated with minor changes. Sources updated.

SOURCE(S)

1. Casgevy prescribing information. Vertex Pharmaceuticals Incorporated. August 2025. Last accessed October 2025.

2. Centers for Disease Control and Prevention. (2025 Feb 21). About sickle cell disease.

   https://www.cdc.gov/sickle-cell/about/index.html . Last accessed October 2025.

3. Lyfgenia prescribing information. Bluebird bio, Inc. January 2024. Last accessed October 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.