Teprasiran Medicine 13 December 2018 Extended indication Renal transplant, prevention of delayed graft function in recipients of a deceased older donor kidney Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Teprasiran Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Renal transplant, prevention of delayed graft function in recipients of a deceased older donor kidney Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Quark Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks QPI1002 is een siRNA oligonucleotide gericht tegen p53. Novartis heeft de rechten voor de commercialisatie. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion date van de ReGIFT studie is in juni 2019. Therapeutic value Current treatment options Verschillende immunosuppressiva (o.a. antilichamen zoals basiliximab en antithymocyte immunoglobulin, calcineurin inhibitors zoals ciclosporin of tacrolimus, azathioprine, mycophenolate mofetil en corticosteroïden zoals prednisolone of methylprednisolone). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT02610296 Additional remarks Expected patient volume per year Patient volume 90 - 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nierstichting.nl; quarkpharma Additional remarks In 2017 vonden er 425 niertransplantaties plaats met een nier van een overleden donor. Volgens de fabrikant komt delayed graft function voor bij 21-35% van de gevallen. Voor Nederland zou dit dan bij 89-149 patiënten voorkomen. Het aantal patiënten wat daadwerkelijk in aanmerking komt is afhankelijk van de therapeutische waarde en de plaats in de behandelrichtlijn. 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 Yes Indication extensions Acute kidney injury, fase II References clinicaltrials.gov; quarkpharma.com Additional remarks Other information Additional remarks