Letermovir Medicine 07 December 2022 Extended indication Letermovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Letermovir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Letermovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients Current proprietary name Already available biosimilars / generics Proprietary name Prevymis Manufacturer MSD Portfolio holder MSD Mechanism of action Virus inhibitor Route of administration Intravenous Therapeutical formulation Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options valganciclovir Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Letermovir heeft een gunstig bijwerkingenprofiel in vergelijking met valganciclovir. Letermovir geeft wel wat interacties maar is niet nefrotoxisch en niet beenmerg toxisch de verwachting is dan ook dat letermovir de voorkeur gaat hebben. Duration of treatment Frequency of administration 1 times a day Dosage per administration 240 mg - 480 mg References NCT03443869 Additional remarks 480mg (or 240 mg when co-administered with cyclosporin A) Huidige behandeloptie wordt ingezet binnen 10 dagen na niertransplantatie tot aan 200 dagen na transplantatie, letermovir zal naar verwachting vergelijkbaar ingezet worden. Wel geldt dat als het in combinatie met cylclosporine wordt gegeven dat de dosering gehalveerd kan worden. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nierstichting Additional remarks In 2019 vonden er 951 niertransplantaties plaats. Expected cost per patient per year Cost References medicijnkosten.nl, GIP-databank Additional remarks Prevymis tablet filmomhuld 240mg Letermovir €163,50 per stuk inclusief BTW Prevymis tablet filmomhuld 480mg Letermovir €327 per stuk inclusief BTW. De prijs per patiënt per jaar voor de huidig geregistreerde indicatie betreft in 2021 €19.525. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Zie andere indicatie op de Horizonscan Geneesmiddelen References Additional remarks Other information Additional remarks