Fostemsavir Medicine 12 June 2018 Extended indication HIV/aids in heavily treatment experienced patients. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Fostemsavir Domain Infectious diseases Reason of inclusion Main indication Viral infections other Extended indication HIV/aids in heavily treatment experienced patients. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Viivhealthcare Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Scrip pipeline watch 3 nov 2017: BRIGHTE trail, positive results in heavily pretreated patients. Antiretroviral designed to prevent HIV attachment to and entry into CD4+ T cells, first-in-class. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Middel zal naar verwachting ingezet als laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt. Duration of treatment Frequency of administration 2 times a day Dosage per administration 600 mg References clinicaltrials.gov, NCT02362503 Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De werkgroep schat dat er maximaal 500 patiënten in aanmerking zullen komen voor dit middel. Dit gegeven dat het middel wordt ingezet als laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt. 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