1748 – Review of Tisagenlecleucel for treatment of confirmed relapsed/refractory CD19-positive acute lymphoblastic leukaemia in children and young adults up to 25 years old

Page last updated: 02 November 2023

Application Detail

Description of Medical Service

Tisagenlecleucel (Kymriah®) is an autologous, murine anti-CD19 Chimeric Antigen Receptor T cell (CAR-T) therapeutic process, involving harvesting, modifying, expanding and re-infusing a patient's own immune T-cells, to target and destroy certain cancerous cells. This therapy is used when patients do not respond to other treatment, such as chemotherapy, or relapse.

Description of Medical Condition

Acute lymphoblastic leukaemia is the malignant proliferation of lymphoid progenitor cells in the bone marrow.

Reason for Application

Following consideration by MSAC at its November 2018 and March 2019 meetings, and an out-of-session meeting in April 2019, the committee supported funding of tisagenlecleucel (Kymriah®) for treatment of acute lymphoblastic leukaemia in paediatric and young adult patients (pALL) as a highly specialised therapy through the National Health Reform Agreement (NHRA). A condition of MSAC’s support was that a full review of the clinical effectiveness, cost-effectiveness and budget impact would be provided to MSAC by the applicant after a specified amount of time had passed from the therapy being made available. In addition to the submission from the applicant, the Department has also invited States and Territories, as suppliers and joint funders of the treatment to provide submissions to the review.

Further information about the NHRA is available at www.health.gov.au/our-work/2020-25-national-health-reform-agreement-nhra

Previous Application Number


Associated Documentation

Consultation Survey

MSAC values consultation input from individuals and organisations with an interest in an application that it is considering, including experience of the medical conditions, services or technologies being addressed by the application. Please send feedback on this application to commentsMSAC@health.gov.au

PASC Consultation
Bypassing PASC

MSAC Consultation
MSAC consultation input closed Friday, 9 June 2023.

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

Public Summary Document

Public Summary Document (PDF 1205 KB)
Public Summary Document (Word 741 KB)

Meetings for this Application


Bypassing PASC


8-9 June 2023


27-28 July 2023