PREVYMIS (letermovir), antiviral
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Sep 11 2018
Reason for request
Inclusion
High clinical benefit and minor clinical improvement in the prevention of CMV reactivation and CMV disease after allogeneic haematopoietic stem cell transplantation
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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+].
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It has demonstrated its efficacy, particularly in terms of the reduction of pre-emptive treatment initiation, with no blood toxicity.
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Its clinical impact on mortality, the incidence of CMV disease or the onset of graft-versus-host disease (GvHD) has yet to be demonstrated.
Clinical Benefit
Substantial |
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Clinical Added Value
minor |
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