Mallinckrodt Says Switzerland Okays ECP For Reimbursement

(RTTNews) - Mallinckrodt plc (MNK) said that Switzerland's Federal Department of Home Affairs or FDHA has approved reimbursement of Extracorporeal Photopheresis or ECP treatment for patients in Switzerland with Bronchiolitis Obliterans Syndrome or BOS following lung transplantation.

Mallinckrodt Pharmaceuticals provides ECP therapy through its THERAKOS therapeutic platforms, including the latest generation THERAKOS CELLEX Photopheresis System.

The FDHA's decision relates to the use of ECP in Switzerland as salvage therapy for patients with BOS already on augmented immunosuppression and macrolide antibiotics as immunomodulation. It represents the first approval of a Health Technology Appraisal for ECP in BOS by a national governmental regulatory agency.

The initial request for FDHA approval was submitted by the University Hospital of Zurich's Lung Transplant Program and supported by Mallinckrodt. It was followed in September 2015 by a Health Technology Appraisal that made a detailed evaluation of the scientific, health economics and value information on ECP in patients with BOS. The approval of reimbursement went into effect on 1 August 2016, and is subject to re-evaluation by the end of 2019, based on any new evidence generated at that point.