1651 – Integrated, closed-system, extracorporeal photopheresis systems for the treatment of chronic graft-versus-host disease

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THERAKOS CELLEX extracorporeal photopheresis (ECP) is a leukapheresis-based, immunomodulatory therapy in which a patient’s leukocytes are collected and treated ex vivo with methoxsalen and UVA light and then returned to the patient (Photopheresis is also performed with open systems, also known as two-step methods, which are characterised by different devices for cell separation and drug photo activation). In these systems the combination of the device for separation and the device for photoactivation has not been approved for use together or specifically approved for Photopheresis. The two-step approach also increases the potential risk of patient reinfusion error, infection and cross-contamination. Open systems are only recommended for use in centres that have approval for handling blood components separately. Integrated, closed ECP systems complete the processes of cell separation, photo activation of methoxsalen, and reinfusion of the treated cells back into the patient within an automated and fully integrated process. All components of the treatment are validated for use together.

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Chronic graft vs host disease (cGVHD) can occur in patients undergoing allogeneic transplant procedures. This event originates from donated bone marrow or peripheral blood stem cells that view the recipient’s body as foreign, before mounting an attack against the host’s body cells. cGVHD can appear immediately or any time after a patient’s allogenic transplant. Despite prophylactic immunosuppression, there is an increased risk of developing the disease from HSCT. This may contribute to 17-20% of transplant-related deaths regardless of donor-relatedness.

The mainstay of treatment for cGVHD is systemic steroid therapy, however, the most effective approach to steroid-refractory/intolerant/dependent GVHD remains controversial. ECP is recommended by international guidelines and consensus documents for steroid-refractory and dependent cGVHD patients. This application focuses on the use of integrated, closed-system ECP in conjunction with methoxsalen for the treatment of cGVHD after HSCT in adults.

This application follows MSAC’s (and subsequently PBAC’s) recommendation at the April 2020 meeting for a MBS listing of ECP for the treatment of chronic T-cell lymphoma.

• PASC meeting: 10 December 2020
• ESC meeting: 10 to 11 June 2021
• MSAC meeting: 29 to 30 July 2021