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HEMLIBRA (emicizumab), haemostatic

HAEMATOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 06 2019

Reason for request


High clinical benefit for the prophylaxis of bleeding episodes in congenital haemophilia A with high-titer anti-factor VIII inhibitor and significant clinical added value overFEIBA and NOVOSEVEN


Insufficient clinical benefit to justify its reimbursement for the prophylaxis of bleeding episodes in congenital haemophilia A without high-titer anti-factor VIII inhibitor


  • HEMLIBRA has been granted a marketing authorisation for the prevention of bleeding episodes in patients with haemophilia A who have developed an anti-factor VIII inhibitor.

  • This monoclonal antibody mimics FVIII activity. It is administered via a once-weekly subcutaneous (SC) injection.

  • The clinical data, even though the level of evidence is sub-optimal, suggest that the efficacy of HEMLIBRA is greater than prophylaxis with bypassing agents (FEIBA and NOVOSEVEN). It is expected to offer a major quality of life benefit for patients by comparison to these treatments.

  • The SPC must be consulted for the interpretation of coagulation tests (interference with HEMLIBRA) and in the event of concomitant administration of a bypassing agent (interaction with FEIBA), considering the risks of thrombotic microangiopathy and thromboembolic events. 


Clinical Benefit




Clinical Added Value



Not applicable