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Idarucizumab for Reversing Anticoagulation in Adults Treated with Dabigatran: A Review of the Clinical Effectiveness, Cost-effectiveness, and Guidelines

Last updated: January 31, 2017
Project Number: RD0035-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Peer-reviewed summary with critical appraisal
Result type: Report

Question

  1. What is the comparative effectiveness and safety of idarucizumab versus standard supportive care for reversing the anticoagulation state in adults treated with dabigatran requiring surgery/ urgent procedures or having life-threatening or uncontrolled bleeding?
  2. What is the cost-effectiveness of idarucizumab versus standard supportive care, for reversing the anticoagulation state in adults treated with dabigatran requiring surgery/ urgent procedures or having life-threatening or uncontrolled bleeding?
  3. What are the guidelines with respect to the use of idarucizumab for reversing the effect of dabigatran in the hospital setting?

Key Message

No comparative clinical evidence or economic studies were identified in this review. In one phase III, single-arm, prospective, cohort study, idarucizumab exhibited high efficacy in reversing the effects of dabigatran as demonstrated by the dilute-thrombin-time and ecarin clotting-time. Lack of comparative evidence and the use of surrogate outcomes pose a challenge to further generalizability. Two guidelines strongly recommend idarucizumab use as indicated, assigning higher value on the seriousness of the clinical presentation and the potential to prevent further deterioration than on the quality of the supporting evidence, which they deemed as moderate-quality evidence.