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

OBJECTIVES: 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.

Is the Use of BIMA in CABG Sub-Optimal? A Review of the Current Clinical and Economic Evidence Including Innovative Approaches to the Management of Mediastinitis.

Bilateral internal mammary artery (BIMA) in coronary artery bypass grafting (CABG) has traditionally been limited. This review looks at the recent outcome data on BIMA in CABG focusing on the management of risk factors for mediastinitis, one of the potential barriers for more extensive BIMA utilization. A combination of pre-, intra- and postoperative strategies are essential to reduce mediastinitis. Limited data indicate that the incidence of mediastinitis can be reduced using closed incision negative-pressure wound therapy as a part of these strategies with the possibility of offering patients best treatment options by extending BIMA to those with a higher risk of mediastinitis. Recent economic data imply that the technology may challenge the current low uptake of BIMA by reducing the short-term cost differentials between single internal mammary artery and BIMA. Given that most published randomized controlled trials and meta-analyses of observational long-term outcome data favor BIMA, if short-term complications of BIMA including mediastinitis can be controlled adequately, there may be opportunities for more extensive use of BIMA leading to improved long-term outcomes. An ongoing study looking at BIMA in high-risk patients may provide evidence to support the hypothesis that mediastinitis should not be a factor in limiting the use of BIMA in CABG.