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

Page last updated: 27 November 2019

Announcement

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.

MSAC Stakeholder Meeting Outcome

Final Stakeholder Meeting Outcome Statement (PDF 585 KB)
Final Stakeholder Meeting Outcome Statement (Word 56 KB)

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 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.

Description of Medical Condition

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).

Reason for Application

New non-MBS item

Medical Service Type

Hybrid Health Technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1105 KB)
Application Form (Word 243 KB)

Consultation Survey

Consultation Survey (PDF 491 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

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ESC

10-11 October 2019

MSAC

28-29 November 2019