PREVYMIS (letermovir), antiviral
Reason for request
High clinical benefit and minor clinical improvement in the prevention of CMV reactivation and CMV disease after allogeneic haematopoietic stem cell transplantation
PREVYMIS has MA for the prevention of cytomegalovirus (CMV) reactivation and CMV disease in adult CMV-seropositive allogeneic haematopoietic stem cell transplantation (HSCT) recipients [R+].
It has demonstrated its efficacy, particularly in terms of the reduction of pre-emptive treatment initiation, with no blood toxicity.
Its clinical impact on mortality, the incidence of CMV disease or the onset of graft-versus-host disease (GvHD) has yet to be demonstrated.
Improvement in actual benefit