The assessment report may be commented until 15 January 2016. In such a case, the probable budget impact (additional cost) would be approximately EUR 100,000–170,000 per year.īased on this assessment, the use of idarucizumab as indicated seems reasonable with the price estimated by marketing authorisation holder. Fimea estimates that approximately 100 patients would receive idarucizumab in Finland each year.
In such a case, the additional cost of idarucizumab treatment per patient would be approximately EUR 1,000–1,700 compared to treatment without idarucizumab. In a budget impact assessment, idarucizumab treatment was considered to reduce the need for blood products, particularly for coagulation factor products. The research data available to date on the adverse effects of idarucizumab treatment suggests minor adverse reactions, but the risk of hypersensitivity reactions to the drug cannot be excluded.Īt the price reported by the marketing authorisation holder for the purposes of this assessment, the estimated cost of idarucizumab treatment per patient is EUR 2,500. According to a clinical assessment, in 92 per cent of patients who underwent urgent surgery, haemostasis was normal during the procedure, and mildly or moderately abnormal in 8 per cent. Laboratory test results based on a phase III prospective cohort study (RE-VERSE AD) indicate that idarucizumab reverses the anticoagulant effect of dabigatran in all patients within minutes of idarucizumab infusion. The European Commission granted a marketing authorisation for idarucizumab on 1 December 2015. Idarucizumab is intended for patients treated with dabigatran, for the rapid reversal of its anticoagulant effect in cases of uncontrolled or life-threatening bleeding, or if an urgent surgical intervention is necessary.
This assessment is part of the rapid assessment process currently being developed for hospital-only medicinal products. An assessment report on the use of idarucizumab to reverse the anticoagulation effect of dabigatran has been published following Fimea's assessment of pharmacotherapies.
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