Oscar Mesa, MD, MSC, Global Director, Health Economics, outcomes research and Market Access Critical care at Mallinckrodt. Speaks about Mallinckrodt and Terumo Blood and Cell Technologies Announce Positive Recommendations in Australia for Public Funding of UVADEX® (methoxsalen) for ECP Administration with the THERAKOS® CELLEX® Photopheresis System for Chronic Graft Versus Host Disease (cGvHD) in Adults.
Link to Article:
https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=28736
Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, and Terumo Blood and Cell Technologies, a global leader in blood component, therapeutic apheresis, and cellular technologies, as well as the exclusive distributor of the Therakos extracorporeal photopheresis (ECP) platform in Australia, announced today that the Medical Services Advisory Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee (PBAC
The MSAC accepted the claim of superiority for safety and non-inferiority for efficacy between ECP with UVADEX and comparators in this two-part evaluation. The PBAC supported the cost-effectiveness of UVADEX, the pharmaceutical component of the treatment system, and the MSAC accepted the claim of superiority for safety and non-inferiority for efficacy between ECP with UVADEX and comparators. Both committees’ mission is to provide advice to the Australian Minister for Health in order to assist the Australian Government in making public funding decisions. The public summary document contains the full assessment report connected to the MSAC recommendation.
The PBAC recommended that methoxsalen, delivered as part of an integrated, closed system ECP service for the treatment of patients with steroid-dependent, steroid intolerant, or steroid-refractory cGVHD, be listed under Section 100 (Highly Specialised Drugs Program – Public and Private Hospital) Authority Required (STREAMLINED). The PBAC was satisfied that ECP with methoxsalen provided a considerable improvement in efficacy above the current standard of therapy for some patients. MSAC agreed that ECP was likely superior, according to the PBAC.
When compared to the current standard of care, clinical efficacy and non-inferior safety are demonstrated. In addition, the PBAC highlighted that MSAC suggested that ECP plus methoxsalen had acceptable cost-effectiveness in the treatment of cGVHD for the proposed patient population when compared to the existing standard of care.
UVADEX is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the treatment of steroid-refractory and steroid-intolerant cGVHD in adults following allogeneic hematopoietic stem cell transplantation, as well as for palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that are unresponsive to other treatments.
UVADEX got recommendations to be listed on the PBS in Australia for the treatment of cutaneous T-cell lymphoma in adults from both the MSAC and the PBAC in July 2020.