Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use

Abstract

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.

Figure 1

Octaplas^® manufacturing process. FFP: fresh-frozen plasma; TNBP: tri(n-butyl) phosphate; PrP: prion protein.

Figure 2

Schematic representation of two different kits for Theraflex^® MB-Plasma system for leucodepleted plasma (on the left side of the figure) and for non-leucodepleted plasma (on the right side of the figure). MB: methylene blue. Source: modified from reference .

Figure 3

Study selection process for clinical efficacy domain.

Figure 4

Study selection process for safety domain.

Figure 5

Study selection process for economic domain.

Figure 6

Study selection process for organisational domain.

Figure 7

Transfusion Chain: differences between PI methods. PI: plasma inactivatioon.