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, and 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 steroid dependent, intolerant or resistant chronic graft versus host disease (cGvHD) 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 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, found here, states:
The PBAC recommended the Section 100 (Highly Specialised Drugs Program – Public and Private Hospital) Authority Required (STREAMLINED) listing for 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. The PBAC was satisfied that ECP involving methoxsalen provides, for some patients, a significant improvement in efficacy over current standard of care. The PBAC noted that MSAC accepted that ECP had likely superior clinical effectiveness and non-inferior safety compared with current standard of care. Further, the PBAC noted that MSAC advised that ECP plus methoxsalen has acceptable cost-effectiveness in the treatment of cGVHD compared with current standard of care for the proposed patient population.
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; and for palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that is unresponsive to other forms of treatment.
"Treatment for patients with cGvHD who do not respond to steroids has long been a challenge, and as a pharmaceutical company focused on improving outcomes for underserved patients with severe and critical conditions, we strive to provide treatment options that address unmet medical needs," said Maro Williams, Ph.D., Country Medical Director, International Medical Affairs at Mallinckrodt. "The positive reimbursement recommendation is an important step to help ensure that UVADEX with the THERAKOS ECP system is broadly available to patients who may benefit from this treatment."
In July 2020, UVADEX also received recommendations from both the MSAC and the PBAC to be listed on the PBS in Australia for the treatment of cutaneous T-cell lymphoma in adults.
"The PBAC assessment supports THERAKOS ECP with UVADEX as a cost-effective option for the treatment of patients with cGvHD in Australia, compared to other standard-of-care therapies," said Xavier Dubois, General Manager Australia and New Zealand, Terumo Blood and Cell Technologies. "This important milestone underscores the value of this treatment option for patients who are unresponsive to other forms of treatment."
About Chronic Graft Versus Host Disease (cGvHD)
Graft versus host-disease is a common complication of hematopoietic stem cell transplantation resulting in significant morbidity and mortality.2 It can be classified as acute or chronic based on the clinical presentation and the time of occurrence after the transplantation. Signs and symptoms of cGvHD nearly always occur within the first year post transplantation, but can occasionally happen several years later.3 In cGvHD, the skin is the most frequently affected organ wi...
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