Application Detail

Description of Medical Service

Axicabtagene ciloleucel is a CAR T-cell therapy that is produced using a patient’s own T-cells (another form of immune cell), making the product unique to each patient. For CAR-T therapy, a patient’s T-cells are collected and genetically modified in a lab to express an anti-CD19 chimeric antigen receptor (CAR) that targets the lymphoma B-cells. The modified T-cells are multiplied and then infused back into the patient where they target and kill the cancerous lymphoma B-cells, thereby treating the lymphoma.

CAR-T cell therapies are a relatively new type of treatment that are used when patients with some types of cancers (currently blood cancers such as large B-cell lymphoma), don’t respond to (refractory), or relapse (come back) after, other types of treatment, such as chemotherapy. Second-line therapy means that axicabtagene ciloleucel would be a second choice after another therapy, likely chemoimmunotherapy.

Description of Medical Condition

Large B-cell lymphoma is a type of blood cancer that arises from lymphocytes (a type of white blood cell), which are part of the body’s immune system. Large B-cell lymphoma is a form of non-Hodgkin’s lymphoma, and patients typically present with swelling of the lymph nodes or disease in other parts of the body such as the stomach, bowel, skin and lungs, which can cause swelling and discomfort. In addition, patients can have fever, night sweats and unexplained weight loss.

Reason for Application

Highly Specialised Therapy - National Health Reform Agreement

Medical Service Type

Therapeutic technology

Previous Application Number/s

1722

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 201 KB)
Application Summary (Word 33 KB)

PICO Set (PDF 242 KB)
PICO Set (Word 98 KB)

Consultation Survey

Consultation Survey (PDF 165 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Not applicable

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 16 February 2024 for it to be considered by MSAC at its April 2024 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

-

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

Expedited - bypassed PASC

ESC

15-16 February 2024

MSAC

4-5 April 2024