Original Title: Alternativer for plasma for transfusjon til pasienter

Authors' objectives: Plasma transfusion is used to stop or prevent bleeding. Currently, all plasma used for transfusion at Norwegian hospitals (50,000 units per year) is the plasma product Octaplas®. Each unit (200 mL) contains a mix of plasmas from around 1,000 donors, and is treated chemically using solvent-detergent to eliminate virus, bacteria and parasites (pathogens). Several alternative plasma products are available on the market, and there are concerns about the costs of purchasing Octaplas® and whether these costs are too high compared with other plasma products. Alternatives to Octaplas® may be based on plasma from only one or several donors and/or other methods of eliminating pathogens (pathogen inactivation. This is the background for the commission by the “Bestillerforum RHF” to the Norwegian Knowledge Centre for the Health Services to conduct a health technology assessment (HTA), which has compared the various alternatives for generation of plasma for transfusion purposes in terms of clinical effectiveness, safety and costs.

Authors' results and conclusions: RESULTS: Main results are the following: Clinical effectiveness According to available documentation, it is not possible determine whether there are differences in terms of clinical effectiveness between the different plasma alternatives assessed. Safety Based on registry data, it seems that the various types of plasma routinely used in various European countries are safe in terms of adverse events. Patogen inactivated plasma appears to be the safest alternative. There might be some indications that certain methods of pathogen inactivation may lead to more allergies than others, but the evidence is both sparse and partly inadequate. Costs Fresh frozen and quarantined plasma have the lowest costs among the alternatives evaluated. Pathogen inactivated plasma produced in-house represents the middle level of costs while purchase of Octaplas® incurs the highest costs. An important assumption in our analysis is that plasma, which is not used for transfusion, can be sold at the market price. CONCLUSION: According to available documentation, it is not possible determine whether there are differences in terms of clinical effectiveness between the different plasma alternatives assessed. With regard to safety issues, the documentation is both sparse and of inadequate. It seems that the various types of plasma overall are safe in terms of adverse events, and that patogen-inactivated plasmas are safer than non-pathogen-inactivacted plasmas. There might be some indications that certain methods of pathogen inactivation may lead to more allergies than others, but no conclusions can be drawn based on the insufficient evidence material. Fresh frozen and quarantined plasma entail the lowest costs, plasma produced by pathogen inactivation technologies is on the middle cost level and purchase of Octaplas® incurs the highest costs.

Authors' methods: Clinical effectiveness. To assess clinical effectiveness and safety we have followed the methods and work processes described in the handbook issued by the Norwegian Knowledge Centre for the Health Services (NOKC). June 2014 we searched for systematic reviews, but we did not find any of high enough quality we could communicate. Therefore, we performed a literature search for prospective controlled trials, that had compared Octaplas® or SD-plasma variants with the alternatives Intercept, Mirasol, Methylene blue, quarantine plasma, fresh frozen plasma and freeze-dried plasma. The search strategy was developed based on our predefined inclusion criteria, and the literature search was carried out in all relevant and available databases. For assessing the quality of the evidence we have used the GRADE tool. Safety. We pursued various options for assessing safety. In addition to looking at adverse events reported in the studies included to assess clinical effectiveness, we repeated the search conducted to assess clinical effectiveness, but excluded any study design filters. Moreover, we searched for data on adverse events related to plasma transfusions from registry data (hemovigilance reports). Costs. After a search and review of existing literature on economic evaluations of plasma products, we performed an economic evaluation from a societal perspective. Because the results of the clinical-effectiveness analysis revealed no differences in effects, we conducted a cost analysis which compares seven plasma products. We included Octaplas®, Intercept, Mirasol, Methylene blue, quarantined plasma, fresh frozen plasma and freeze-dried plasma. Freeze-dried plasma was not examined in detail since this alternative entails very high investment- and production costs. Probabilities and costs for side effects are presented separately because of high uncertainty surrounding the probabilities for side effects and incomplete information about all of the alternatives under consideration. We analysed three production strategies for coverage of the demand for plasma for transfusion in Norway. The strategies include central production at one hospital, regional production at four regional health authorities (RHF) and production at 19 health authorities. The time perspective is three years. The first year is presented separately due to investment costs. In a sensitivity analysis we have doubled the work time to investigate its impact on costs.

Project Status: Completed

Year Published: 2015

URL for published report: https://www.fhi.no/en/publ/2015/alternatives-of-plasma-for-transfusion-to-patients/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Pubmed ID: 28510408

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo