title: Extracorporeal Photopheresis for Second-Line Treatment of Chronic Graft-versus-Host Diseases: Results from a Health Technology Assessment in Italy.
abstract: OBJECTIVE
  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.
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy. Electronic address: chiara.dewaure@rm.unicatt.it.
authors.forename: Chiara
authors.initials: C
authors.lastname: de Waure
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy; School of Economics and Management, LIUC University, Castellanza (VA), Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Capri
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Maria Assunta
authors.initials: MA
authors.lastname: Veneziano
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Maria Lucia
authors.initials: ML
authors.lastname: Specchia
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Cadeddu
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Nardo
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Ferriero
authors.affiliation: Therakos, Inc., West Chester, PA, USA.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gennari
authors.affiliation: Therakos, Inc., West Chester, PA, USA.
authors.forename: Colette
authors.initials: C
authors.lastname: Hamilton
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Agostino
authors.initials: A
authors.lastname: Mancuso
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Quaranta
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Raponi
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Valerio
authors.affiliation: Faculty of Medicine, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Gensini
authors.affiliation: Section of Hygiene, Institute of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Ricciardi
mesh_terms: D002908:Chronic Disease; D003362:Cost-Benefit Analysis / Q000379:methods / Q000592:standards; D005260:Female; D006086:Graft vs Host Disease / Q000191:economics / Q000453:epidemiology* / Q000628:therapy*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D017893:Photopheresis / Q000191:economics / Q000379:methods* / Q000592:standards; D013673:Technology Assessment, Biomedical / Q000379:methods* / Q000592:standards; D016896:Treatment Outcome
keywords: Markov model; cost-effectiveness analysis; economic evaluation; graft-versus-host disease; photopheresis; technology assessment