July 13,2020

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, and Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, the exclusive distributor of the Therakos extracorporeal photopheresis (ECP) platform in Australia, announced today that both the Medical Services Advisory Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee (PBAC) recently recommended that UVADEX^? (methoxsalen) for extracorporeal administration with the THERAKOS^? CELLEX^? Photopheresis System be listed on the Pharmaceutical Benefits Scheme (PBS) in Australia for the treatment of cutaneous T-cell lymphoma (CTCL) in adults.

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 three comparators. The role of both committees is to advise the Australian Minister for Health to help inform Australian Government decisions about public funding.¹ The full assessment report related to the MSAC recommendation can be found in the published public summary document. The PBAC recommendation can be found here.

UVADEX is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the treatment of steroid–refractory and steroid–intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation; and for palliative treatment of the skin manifestations of CTCL that is unresponsive to other forms of treatment.

"CTCL is a rare condition with high unmet patient needs. These positive reimbursement recommendations are an important step to help ensure that UVADEX with the THERAKOS ECP system is broadly available to patients who may benefit from this treatment," said Hugh O'Neill, Executive Vice President and Chief Commercial and Operations Officer at Mallinckrodt. "We are now working with the Australian government to finalize a public funding agreement in the coming months."

Data on the cost-effectiveness of ECP to treat CTCL was recently presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting, Virtual ISPOR 2020. Results demonstrated that ECP displaced expensive pharmaceutical therapies and was associated with a higher quality of life compared with comparator treatments.² 

"The MSAC and PBAC assessments are supported by data which demonstrate that THERAKOS ECP with UVADEX is a cost-effective option for the treatment of patients with CTCL in Australia, compared to other standard-of-care therapies,"² Julia Wenner, Ph.D., General Manager Australia, Terumo BCT Australia. "This important milestone underscores the value of this treatment option for patients with complex conditions who are unresponsive to other forms of treatment."