Original Title: Avis : Évaluation des technologies de réduction des agents pathogènes Intercept et Mirasol C pour le traitement des produits sanguins labiles au Québec

Authors' objectives: The Institut national d'excellence en santé et en services sociaux (INESSS) was mandated by the Direction de la biovigilance et de la biologie médicale (DBBM) of the Ministère de la Santé et des Services sociaux (MSSS) to reassess the relevance of introducing Intercept and Mirasol pathogen reduction technologies (PRTs) for the treatment of labile blood products in Quebec. This is the second assessment of these technologies by INESSS following the recommendation in 2017 not to introduce the InterceptTM Blood System in the labile blood products’ production chain in Quebec.

Authors' results and conclusions: RESULTS (#1 SOCIO-CULTURAL DIMENSION): Héma-Québec deploys the preventive measures it deems necessary to ensure the safety of labile blood products distributed in Quebec. Similarly, the Canadian Blood Services (CBS) is implementing preventive measures for the other Canadian provinces and has gradually been rolling out PRTs since January 2022 for the treatment of platelet units in selected hospitals. Some countries that are socially and economically comparable to Canada have taken divergent positions on PRTs, with some being favourable, such as France and Switzerland, and others being unfavourable, such as England. Considering a partial or complete introduction in other countries and Canadian provinces and based on the precautionary principle, the Comité de biovigilance decided that it would be important to consider a strategic introduction of PRTs in order to prepare for the emergence of various pathogens in Quebec. However, the committee has specified that this technology should not replace current preventive measures and should apply only to a small percentage of labile blood products. (#2 POPULATION DIMENSION): In order to meet transfusion safety needs, the blood system in Quebec could benefit from better communication on transfusion complications, more preventive measures for noninfectious complications, alternative treatments to transfusions, and increased selfsufficiency in labile blood products. Since the risk of infectious complications associated with transfusions is currently considered low and acceptable by all stakeholders consulted, the main benefit of a PRT occurs during the hypothetical emergence of an UPA. (#3 CLINICAL DIMENSION): Intercept and Mirasol technologies have been shown to be effective on a wide range of viruses, bacteria, and protozoa in laboratory tests. However, the effectiveness of these two PRTs is limited against certain spores, biofilms, residual endotoxins, prions, multidrug-resistant Gram-negative bacteria, and non-enveloped viruses. In addition, there are concerns about the lack of efficacy of Mirasol™ technology against blood-borne viruses such as hepatitis B and cytomegalovirus (CMV). (#4 ORGANIZATIONAL DIMENSION): the introduction of these technologies would require changes in the production chain, such as the rapid treatment of collected blood products. According to HémaQuébec, the scale of these changes as well as the resources mobilized would be limited. CBS has made the decision to remove bacterial screening and irradiation from the production chain of products treated with Intercept™ in other Canadian provinces. However, in Quebec, the withdrawal of certain preventive measures that have shown their effectiveness in ensuring the safety of labile products is not unanimous and is not planned by Héma-Québec in the short term. (#5 ECONOMIC DIMENSION): A scientific literature update on economic efficiency identified one recently published study specifically assessing Intercept. According to this analysis, the use of a PRT would have an incremental cost-utility ratio (ICUR) of $9.3 million per QALY gained compared to current preventive measures. This ICUR could see a downturn in the event of the emergence of an UPA, decreasing to $8.6M or approximately $331K per QALY earned, depending on scenario analyses based on rates of infectious transmission of previous pathogens. The conclusions established in the 2017 assessment by INESSS remain unchanged. Uncertainty remains as to the system’s willingness to pay for a health intervention such as a PRT according to an insurance principle.

Authors' recommendations: Based on the knowledge mobilized for each dimension of value and considering the associated uncertainties, members of the Comité délibératif permanent - Remboursement et accès are unanimously of the opinion that the relevance of introducing pathogen reduction technologies in the production chain of labile blood products in Quebec is currently limited. REASONS FOR THE DECISION: •Members expressed concerns about the increase in the number of PRT-treated platelet transfusions per patient compared to untreated platelets. • The committee members believe that the residual risk of infection is low in Quebec given the highly effective measures currently in place, as demonstrated by the haemovigilance data. In addition, they point out that, to date, PRTs do not treat packed red blood cells, or whole blood that represent the majority of transfusions, thus limiting their potential benefits. The committee members believe that the residual risk of infection is low in Quebec given the highly effective measures currently in place, as demonstrated by the haemovigilance data. In addition, they point out that, to date, PRTs do not treat packed red blood cells, or whole blood that represent the majority of transfusions, thus limiting their potential benefits. Based on the information available to date and given the importance of the uncertainties raised about the added value of PRTs in the production chain of labile blood products in Quebec, INESSS considers that it would not be fair and equitable to implement such a technology.

Authors' methods: The assessment used an approach based on the overall value appraisal that the Institute advocates in its Statement of Principles and ethical fondations. A rapid review of the literature was carried out in order to mobilize evidence and reassess the relevance of introducing PRTs in the labile blood products’ production chain in Québec. PRT manufacturers were invited to transmit relevant information. Contextual and experiential data was collected from stakeholders through a meeting with Héma-Québec, an expert advisory committee, a focus group with representatives of patient organizations, and a citizen panel. A budget impact analysis (BIA) aiming to quantify the expected financial impact following the introduction of a PRT for the treatment of plasma and platelets was also conducted. The comprehensive scientific, contextual, and experiential data was interpreted using a multidimensional framework to guide certain consultation processes as well as the deliberation process for the development of recommendations by the "Comité délibératif permanent - Remboursement et accès".

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-des-technologies-de-reduction-des-agents-pathogenes-interceptmc-et-mirasolmc-pour-le-traitement-des-produits-sanguins-labiles-au-quebec.html

Year Published: 2023

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-des-technologies-de-reduction-des-agents-pathogenes-interceptmc-et-mirasolmc-pour-le-traitement-des-produits-sanguins-labiles-au-quebec.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)