Letermovir Medicine 03 December 2024 Extended indication Letermovir monotherapy for prophylactic treatment of cytomegalovirus infection reactivation in newborns, infants and toddlers, children and adolescents who are at risk of developing CMV infection following an allogeneic haematopoietic stem cell transplantation Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Letermovir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Letermovir monotherapy for prophylactic treatment of cytomegalovirus infection reactivation in newborns, infants and toddlers, children and adolescents who are at risk of developing CMV infection following an allogeneic haematopoietic stem cell transplantation Current proprietary name Already available biosimilars / generics Proprietary name Prevymis Manufacturer MSD Portfolio holder Mechanism of action Virus inhibitor Route of administration Oral Therapeutical formulation Granulate Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date April 2024 Expected Registration April 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03940586 (MK-8228-030) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks