HEMLIBRA (emicizumab), haemostatic
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.
Improvement in actual benefit