A health economic analysis of the use of rhBMP-2 in Gustilo–Anderson grade III open tibial fractures for the UK, Germany, and France Volker Alt a, *, Simon T. Donell b , Amit Chhabra c , Anthony Bentley d , Alexander Eicher a , Reinhard Schnettler a a Department of Trauma Surgery Giessen University Hospital Giessen-Marburg, Site Giessen, Rudolf-Buchheim-Str. 7, 35385 Giessen, Germany b Faculty of Health, University of East Anglia, Norwich NR4 7SY, UK c Medtronic Sa `rl, Tolochenaz, Switzerland d Abacus International, Bicester, UK Introduction Open tibial fractures still lead to a high number of complica- tions, such as delayed fracture healing, non-union and infec- tion. 3,5,11,19 . It is these complications that have an important financial impact on health care systems. The Bone Morphogenetic Protein Evaluation Group in Surgery for Tibial Trauma ‘‘BESTT’’- Study 7 showed that the addition of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) led to significant reduction in secondary interventions for delayed fracture healing, signifi- cantly faster fracture healing in open tibial fractures, and significant reduction of infection rates in grade III open tibial fractures, when compared to intramedullary nailing and routine soft-tissue management alone. The use of rhBMP-2 (InductOs 1 , Wyeth, Maidenhead, UK) in open tibial fractures has gained regulatory approval in Europe 2003, however, routine use has not occurred. The price of one rhBMP-2 kit is s2238 (£1790) in the UK, s2970 in Germany, and s2950 in France. Currently, there is no reimbursement for the use of rhBMP-2 by most European health care systems except in France, Germany and the UK. This is a great barrier for its routine clinical use. There are two theoretical reasons for refusing payment for a new type of treatment. Either there is no proof of clinical benefit for the patient or the price of the therapy seems to be ‘‘unjustifiably high’’. The clinical advantage of using rhBMP-2 in open tibial fractures has been clearly shown. 7 Therefore it is most likely that European health care payers are reluctant to reimburse rhBMP-2 therapy due to its ‘‘high price’’. Injury, Int. J. Care Injured 40 (2009) 1269–1275 ARTICLE INFO Article history: Accepted 9 February 2009 Keywords: Bone Morphogenetic Protein (BMP) Health economics Tibial fracture ABSTRACT The purpose of this study was to determine the cost savings from a societal perspective for recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III A and B open tibial fractures treated with a locked intramedullary nail and soft-tissue management in the UK, Germany, and France. Health care system costs (direct health care costs) and costs for productivity losses (indirect health care costs) were calculated using the raw data from the Bone Morphogenetic Protein Evaluation Group in Surgery for Tibial Trauma ‘‘BESTT study’’. Return-to-work time for estimation of productivity losses was assumed to correspond with the time of fracture healing. For calculation of secondary interventions costs and productivity losses the respective 2007/2008 national tariffs for surgical procedures and average national wages for the UK, Germany, and France were used. For a 1 year perspective, overall treatment costs per patient after the initial surgery of the control vs. the rhBMP-2 group were s44,757 vs. s36,847 for the UK, s50,197 vs. s40,927 for Germany and s48,766 vs. s39,474 for France in favour of rhBMP-2 with overall savings overall savings per case of rhBMP-2 treatment of s7911 for the UK, s9270 for Germany, and s9291 for France which was mainly due to reduced productivity losses by significant faster fracture healing in the rhBMP-2 group (p = 0.01). These savings largely offset the upfront price of rhBMP-2 of s2266 (£1790) in the UK, s2970 in Germany, and s2950 in France. Total net savings can be estimated to be s9.6 million for the UK, s14.5 million for Germany, and s11.4 million for France. The results depend on the methodology used particularly for calculation of productivity losses and return-to- work time which was assumed to correspond with fracture healing time. In summary, despite the apparent high direct cost of rhBMP-2 in grade III A and B open tibial fractures, at a national level there are net cost savings from a societal perspective for all three countries. ß 2009 Elsevier Ltd. All rights reserved. * Corresponding author. Tel.: +49 641 99 44 601; fax: +49 641 99 44 666. E-mail address: volker.alt@chiru.med.uni-giessen.de (V. Alt). Contents lists available at ScienceDirect Injury journal homepage: www.elsevier.com/locate/injury 0020–1383/$ – see front matter ß 2009 Elsevier Ltd. All rights reserved. doi:10.1016/j.injury.2009.02.007