Q2041 Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Name of the Procedure:

Axicabtagene ciloleucel (Yescarta) Technical Term: Autologous Anti-CD19 CAR T-Cell Therapy (HCPCS code Q2041)

Summary

Axicabtagene ciloleucel is a treatment involving the modification of a patient's own T-cells to fight certain types of blood cancers. This therapy includes collecting T-cells, modifying them in a lab to better target cancer cells, and then reinfusing them into the patient.

Purpose

Axicabtagene ciloleucel is designed to treat relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The treatment aims to improve survival rates and achieve cancer remission.

Indications

• Relapsed or refractory large B-cell lymphoma
• Diffuse large B-cell lymphoma (DLBCL) that has not responded to other treatments
• Patients who have undergone at least two prior systemic treatment regimens

Preparation

• Pre-treatment assessment includes blood tests, imaging tests, and a thorough medical evaluation.
• Patients may need to undergo leukapheresis (a procedure to collect T-cells from the blood).
• Patients may be required to stop certain medications and may need to fast before the procedure.

Procedure Description

1. Leukapheresis: Blood is drawn from the patient, and T-cells are separated and collected.
2. T-cell Engineering: T-cells are sent to a lab where they are modified to express a Chimeric Antigen Receptor (CAR) targeting CD19 protein on cancer cells.
3. Cell Expansion: The engineered T-cells are multiplied to create enough cells for treatment.
4. Chemotherapy Preparation: A short course of chemotherapy may be given to prepare the body.
5. Cell Infusion: The modified T-cells are infused back into the patient through an IV.
   • Tools: Leukapheresis machine, specialized lab equipment for genetic modification.
   • Anesthesia: Usually not required, but sedation may be used during leukapheresis.

Duration

The leukapheresis process takes about 2-4 hours. The entire procedure from cell collection to infusion can take several weeks.

Setting

• Leukapheresis is performed in a hospital or specialized clinic.
• T-cell infusion is typically done in a hospital, often requiring inpatient monitoring.

Personnel

• Hematologists/Oncologists
• Nurses
• Transfusion Medicine Specialists
• Lab Technicians

Risks and Complications

• Cytokine release syndrome (CRS)
• Neurological toxicities
• Infection
• Anemia and other blood-related issues
• Management involves close monitoring and medications to counteract severe reactions.

Benefits

• Potential for cancer remission
• Improved survival rates for patients with refractory lymphoma
• Benefits may start to appear within weeks of infusion.

Recovery

• Close monitoring in a hospital for at least a week post-infusion.
• Outpatient follow-up to monitor for delayed side effects.
• Recovery time varies; patients might experience fatigue, infection risk, and need ongoing support.

Alternatives

• Additional rounds of chemotherapy
• Radiation therapy
• Bone marrow or stem cell transplant
• Immunotherapy
• Each alternative has varying success rates and risks; choice depends on individual patient factors.

Patient Experience

• Leukapheresis might cause mild discomfort or fatigue.
• During infusion, some may experience fever, chills, or other mild symptoms.
• Post-procedure, patients often need support to manage fatigue, potential side effects, and emotional stress.