1676 – Amendments to eligibility criteria for tisagenlecleucel for treatment of relapsed or refractory diffuse large B-cell lymphoma – amend clinical criteria for patients with Transformed Follicular Lymphoma (TFL) and propose inclusion of patients with grade 3B follicular lymphoma (3B FL)

Page last updated: 29 September 2021

Application Detail

Description of Medical Service

Tisagenlecleucel 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.

Description of Medical Condition

Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive and common subtype of Non-Hodgkin Lymphoma (NHL).

Reason for Application

Minor changes to the MSAC eligibility criteria are requested:
- to allow TFL patients who have undergone prior autologous stem cell transplant (ASCT) to access tisagenlecleucel, without the requirement for additional systemic therapy post-ASCT; and
- that grade 3B FL patients be considered as DLBCL in the eligibility criteria due to the similarity of grade 3B FL to DLBCL in terms of presentation, behaviour and outcomes.

Medical Service Type

Hybrid health technology

Previous Application Number/s

1519, 1519.1

Associated Documentation

Application Form

Not applicable

Consultation Survey

Feedback and comments are welcome at any stage during the MSAC process. Please provide comments on Application 1676 via a maximum of two A4 pages to  HTA@health.gov.au (making sure that you type the application number at the start of your comments and in the subject heading of your email).

Public Summary Document

Public Summary Document (PDF 495 KB)
Public Summary Document (Word 153 KB)

Meetings for this Application


Expedited – Bypassing PASC


Expedited – Bypassing ESC


29-30 July 2021