1587 – YESCARTA™ (axicabtagene ciloleucel [KTE-C19]) for the treatment of refractory or relapsed CD19-positive lymphoma

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status -
  • Type -
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome -

Application details

Reason for application

New non-MBS item.

Service or technology in this application

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 service

Axicabtagene ciloleucel is a Chimeric Antigen Receptor T-cell (CAR-T) therapy which can help patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), and Follicular Lymphoma (FL).

Axicabtagene ciloleucel is a CD19-directed genetically modified autologous T-cell immunotherapy. To prepare axicabtagene ciloleucel, patient’s own T-cells are harvested via a standard leukapheresis procedure and genetically modified ex-vivo by retroviral transduction to express a Chimeric Antigen Receptor (CAR). The anti-CD19 CAR-positive viable T-cells are then expanded and infused back into the patient, where they can recognise and eliminate CD19 expressing target cells.

Type: Hybrid health technology

Medical condition this application addresses

Non-Hodgkin Lymphoma (NHL) comprises a heterogeneous group of cancers originating primarily in B lymphocytes (and, to a lesser extent in T lymphocytes, and natural killer cells). The prognosis depends on the histologic type, stage, and treatment, along with other factors including the patient’s age and general health, whether there are certain changes in the genes, the amount of Lactate Dehydrogenase (LDH) in the blood, and whether the lymphoma has been newly diagnosed or has recurred.

Aggressive subtypes of B-cell NHL include DLBCL, PMBCL, and FL that has transformed histologically to DLBCL and also referred to as Transformed Follicular Lymphoma (TFL).

Application documents

Application form

Consultation survey

Public summary document

Final stakeholder meeting outcome statement

We aim to provide documents in an accessible format. If you're having problems using a document with your accessibility tools, please contact us for help.

Meetings to consider this application

  • PASC meeting: -
  • ESC meeting: 10 to 11 October 2019
  • MSAC meeting: 
    • 28 to 29 November 2019
    • 16 January 2020

MSAC stakeholder meeting

MSAC stakeholder meeting for CAR-T cell therapy for relapsed or refractory Diffuse Large B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma and Follicular Lymphoma

The Medical Services Advisory Committee (MSAC) will hold a stakeholder meeting on 12 November 2019 on CAR-T cell therapy for relapsed or refractory Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), and Follicular Lymphoma (FL).

The purpose of the meeting is to allow MSAC to seek advice on patient eligibility for treatment and other aspects of patient management, in light of the recent MSAC consideration of Kymriah® (tisagenlecleucel, sponsored by Novartis Australia) and the future MSAC consideration of Yescarta® (axicabtagene ciloleucel, sponsored by Gilead Sciences).

MSAC has invited treating clinicians, consumers, and representatives of Novartis and Gilead and the Commonwealth and State/Territory health departments to attend the meeting.