Letermovir Medicine 03 December 2024 Extended indication Letermovir monotherapy for the prophylactic treatment of reactivation of cytomegalovirus infection in neonates, infants, toddlers, children and adolescents at risk of developing CMV infection following allogeneic hematopoietic stem cell transplantation. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Letermovir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Letermovir monotherapy for the prophylactic treatment of reactivation of cytomegalovirus infection in neonates, infants, toddlers, children and adolescents at risk of developing CMV infection following allogeneic hematopoietic 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 ATMP No Submission date April 2024 Expected Registration April 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Letermovir heeft relatief weinig bijwerkingen en werkt goed als profylaxe tegen CMV. Indicatieuitbreiding bij kinderen is nuttig. Doelgroep is klein: allo-HSCT. Zou off-label ingezet kunnen worden bij SOT (bij volwassenen is het ook geregistreerd voor high risk NTX). Duration of treatment Frequency of administration Dosage per administration References NCT03940586 (MK-8228-030) Additional remarks Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EBMT database Additional remarks Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks