Extracorporeal Photopheresis for Second-Line Treatment of Chronic Graft-versus-Host Diseases: Results from a Health Technology Assessment in Italy

Abstract

To develop a comparative, cost-effectiveness, and budget impact analysis of Therakos online extracorporeal photopheresis (ECP) compared with the main alternatives used for the treatment of steroid-refractory/resistant chronic graft-versus-host disease (cGvHD) in Italy. Methods: The current therapeutic pathway was identified by searching medical databases and from the results of a survey of practice in Italian clinical reference centers. A systematic review was performed to evaluate the efficacy and safety of second-line alternatives. Budget impact and cost-effectiveness analyses were performed from the Italian National Health Service perspective over a 7-year time horizon through the adaption of a Markov model. The following health states were considered: complete and partial response, stable disease, and progression. A discount rate of 3% was applied to costs and outcomes. Results: The most common alternatives used in Italy for the management of steroid-refractory/resistant cGvHD were ECP, mycophenolate, pentostatin, and imatinib. The literature review highlighted that complete and partial responses are higher with ECP than with the alternatives while serious adverse events are less common. The economic analysis showed that Therakos online ECP represents the dominating alternative, in that it delivers greater benefit at a lower cost. In fact, according to the alternatives considered, cost saving ranged from €3237.09 to €19,903.51 per patient with 0.04 to 0.21 quality-adjusted life-year gained. Conclusions: Therakos online ECP should be considered an effective, safe, and cost-effective alternative in steroid-refractory/ resistant cGvHD. There is inequality in access, and a dedicated reimbursement tariff, however, should be introduced to overcome these barriers.

A transition from using multi‐step procedures to a fully integrated system for performing extracorporeal photopheresis: A comparison of costs and efficiencies

“…The results of this study reflect the findings of similar studies conducted at different institutions comparing the CELLEX ® fully integrated system and multi‐step procedures used for ECP . One study reported a reduction in overall procedural times from 221 min to 145 min, while another reported a reduction from 435 min to 125 min .…”

“…The results of this study reflect the findings of similar studies conducted at different institutions comparing the CELLEX ® fully integrated system and multi-step procedures used for ECP. 12,20,21 One study reported a reduction in overall procedural times from 221 min to 145 min, while another reported a reduction from 435 min to 125 min. 12,21 The CELLEX ® treatment time observed (120 min) was also similar to those recorded by a number of other units across the world (range: 91-135 min).…”

“…TDABC provides a more comprehensive understanding of resource usage and its associated costs, while measuring processes and encouraging quality improvement . A number of studies have investigated differences in procedure times and costs associated with the Therakos ® CELLEX ® fully integrated ECP system and other main alternatives, and have suggested advantages for the integrated system …”

“…18,19 A number of studies have investigated differences in procedure times and costs associated with the Therakos ® CEL-LEX ® fully integrated ECP system and other main alternatives, and have suggested advantages for the integrated system. 12,20,21 The Hemobiotherapy Department at Piti e Salpêtrière Hospital in Paris, France, has focused on the mobilization and collection of hematopoietic stem cells (HSC) for allogeneic and autologous HSC transplantation (HSCT) since 1989. The department has been performing ECP procedures for patients presenting with GvHD after HSCT and patients with CTCL since November 2011, and for lung transplant patients since June 2013.…”

An automated mini buffy coat preparation method for use in mini extracorporeal photopheresis treatment of graft‐vs‐host‐disease in a low body weight pediatric patient

“…It is well known that the treatment of GVHD complications results in the high expenses, and one of the obstacles to ECP treatment is the substantial cost associated with this long‐term therapy . The cost of blood processing on the Sepax separator is equal to that of a conventional “off line” ECP apheresis procedure.…”