Economic and outcomes consequences of TachoSil®: a systematic review

Abstract

Giorgio L Colombo,1,2 Daria Bettoni,3 Sergio Di Matteo,2 Camilla Grumi,3 Cinzia Molon,4 Daniela Spinelli,5 Gaetano Mauro,6 Alessia Tarozzo,4 Giacomo M Bruno2 1Department of Drug Sciences, University of Pavia, Pavia, Italy; 2Studi Analisi Valutazioni Economiche (SAVE), Milan, Italy; 3Hospital Pharmacy, Spedali Civili Brescia, Brescia, Italy; 4Città della Salute e della Scienza di Torino, Presidio Molinette, Turin, Italy; 5Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; 6Scuola di Specializzazione in Farmacia Ospedaliera, Università La Sapienza, Roma, Italy Background: TachoSil® is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient. This review systematically analyses the international scientific literature relating to the use of TachoSil in hemostasis and as a surgical sealant, from the point of view of its economic impact. Methods: We carried out a systematic review of the PubMed literature up to November 2013. Based on the selection criteria, papers were grouped according to the following outcomes: reduction of time to hemostasis; decrease in length of hospital stay; and decrease in postoperative complications. Results: Twenty-four scientific papers were screened, 13 (54%) of which were randomized controlled trials and included a total of 2,116 patients, 1,055 of whom were treated with TachoSil. In the clinical studies carried out in patients undergoing hepatic, cardiac, or renal surgery, the time to hemostasis obtained with TachoSil was lower (1–4 minutes) than the time measured with other techniques and hemostatic drugs, with statistically significant differences. Moreover, in 13 of 15 studies, TachoSil showed a statistically significant reduction in postoperative complications in comparison with the standard surgical procedure. The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01–3.58 days versus standard techniques, with a statistically significant difference in favor of TachoSil in eight of 15 studies. Conclusion: This analysis shows that TachoSil has a role as a supportive treatment in surgery to improve hemostasis and promote tissue sealing when standard techniques are insufficient, with a consequent decrease in postoperative complications and hospital costs. Keywords: TachoSil®, systematic review, economic evaluation, cost analysis, outcomes research