Reason for request

Inclusion

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

Substantial

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Insufficient

Clinical Added Value

important

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Not applicable

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