Authors' objectives: The terms of reference of this HTA are to: (a) describe the epidemiology of vCJD in Ireland (b) examine the current risk of contracting vCJD from a blood transfusion in Ireland (c) examine the current controls and practices in place to prevent the transmission of vCJD via transfusion (d) examine the current evidence of efficacy and safety for prion-removing filters (e) examine the costs and cost-effectiveness associated with the implementation of prion filtration of red cell concentrates in the Irish Blood Transfusion Service (f) advise on other issues which may need to be considered prior to the introduction of such a policy (g) advise on the appropriateness of using prion filters in sub-groups of the transfused population only, and the potential costs associated with this.

Authors' recommendations: This HTA has reviewed the evidence regarding prion filtration of red cell concentrates (RCC). Current evidence suggests that the filters are safe and will remove almost all residual risk of vCJD transmission with the caveat that 1 in 10,000 infectious particles may pass through the filter. Furthermore, the residual risk of vCJD transmission through transfusion of platelets (which cannot be prion filtered) will remain. There is substantial uncertainty around a number of the key factors that impact on the risk of transmission of vCJD. As it is not possible to screen for vCJD infection, the prevalence of subclinical vCJD in Ireland is unknown introducing marked uncertainty into estimates of the risk of transfusion-transmitted vCJD. As the economic model includes assumptions about factors such as the prevalence of subclinical vCJD, the results are therefore subject to uncertainty. In Ireland the risk of acquiring vCJD from RCC transfusion in the absence of prion filtration is low. It is estimated that two people (range: 0-8) will die from clinical vCJD as a result of an exposure to infected blood in Ireland during the next 10 years. Due to filter-induced reductions in haemoglobin, introduction of universal prion filtration may necessitate changes in the specifications for filtered RCC units and an additional transfusion burden for transfusion-dependent patients. It is predicted that the prion filtration of all RCCs will initially cost €11 million per annum and, over a 10-year time period, will prevent two deaths from vCJD and result in 19.4 discounted life years gained. The incremental cost-effectiveness ratio (ICER) of prion filtration is €2.6 million per life year gained. Introduction of prion filtration for selected patient sub-groups results in lower ICERs, but also a much lower probability of any life years gained. As a comparison, population-based colorectal cancer screening had an estimated ICER of €1,696 per quality-adjusted life year (QALY) compared to a policy of no screening. This screening was estimated to cost €15 million per annum at full implementation, averting 160 cases of colorectal cancer and 270 deaths from the disease in year 10 of the screening programme.(29;35) Introduction of prion filtration for either all transfusion recipients or for limited sub-groups was found to be not cost-effective by traditional standards of costeffectiveness. However, other blood safety interventions considered not cost-effective by traditional standards have been implemented previously, for example, NAT testing for HIV, Hepatitis B and Hepatitis C. Introducing limited prion filtration for selected patient sub-groups may involve additional logistical issues associated with product distribution and supply. Failure to introduce prion filtration may be associated with a risk of liability in the case of vCJD transmission from RCC. The cost of universal prion filtration is substantial, with estimated initial costs of €11 million per annum. This financial cost of further minimising what is at most likely to be a low risk is high compared to the likely benefits. In the context of a finite healthcare budget, consideration must be given to the existing technologies and services that may need to be displaced should a decision be made to introduce prion filtration at a cost of up to €11 million per annum.

Project Status: Completed

Year Published: 2011

URL for published report: http://www.hiqa.ie/healthcare/health-technology-assessment/assessments/prion-filtration

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Ireland

Organisation Name: Health Information and Quality Authority (HIQA)

Contact Address: Health Information and Quality Authority, George's Court, George's Lane,Smithfield, Dublin 7. PH : + 353 (01) 814 7464

Contact Name: info@hiqa.ie

Contact Email: info@hiqa.ie

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