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Author's reply: Solvent–detergent‐treated plasma: clinical evidence prior to economics

The recent review of the pharmaco-economics of blood transfusion safety [1] was thorough in its identification of published material on this subject, but failed to identify methodological inadequacies in some of the studies reviewed, in particular, those concerning solvent–detergent (SD)-treated fresh-frozen plasma (SD-FFP). All health economic studies evaluating SD-FFP, which were discussed by van Hulst et al. [2,3], were, in our opinion, significantly flawed, as they took no account of non-infective events, which occur much more frequently than infective ones. We are currently re-evaluating the cost-effectiveness of SD-FFP relative to untreated FFP, bearing in mind the impact of non-infective complications as well as rare infective diseases. The most important of these non-infective conditions (from the perspective of cost-effectiveness analysis) is transfusion-related acute lung injury (TRALI). This has an incidence of one in every 2000–5000 plasma-containing units transfused and an acute mortality of 5–14% [4,5]. Unlike FFP, SD-FFP does not appear to cause TRALI: no SD-FFPrelated cases have been reported in the literature, to date. Even at a very simple level it is clear that TRALI would be an important driver of cost-effectiveness. If we take the incidence of TRALI to be 1/3500 and the associated mortality rate to be 10%, then we would expect to see one death from TRALI among 35 000 transfused units. In the UK, Octaplas® costs around £26/unit more than FFP, so it would cost £910 000 to prevent one death. For a hypothetical patient with a remaining life expectancy of 20 years, this would equate to £45 500 per life-year saved. This is substantially lower than the estimates reported in previous studies and would have greatly affected the conclusions of van Hulst et al. If all 375 000 FFP units used in the UK each year [6] were replaced with SD-FFP, the net incremental cost would be less than £10 million/year, but would prevent around 11 deaths caused by TRALI. Recent personal injury awards for events such as hepatitis C infection have been greater than £1 million per person. If the increasing trend towards litigation continues amongst the UK public, it is clear that SD-FFP could very easily save money, as well as lives. We suspect that the continued use of an agent that is probably killing 11 people per year in the UK alone is likely to raise significant medico-legal issues – especially when alternative technologies are available, including SD-FFP, which, by our calculations, is cost-effective. We recognize that this simple estimation fails to address issues such as the cost of treating TRALI, the impact of infective events, other preventative strategies and discounting: a more detailed analysis is currently underway.