Fostemsavir Medicine 12 June 2018 Extended indication HIV/aids in heavily treatment experienced patients. Therapeutic value No judgement Total cost € 108,000.00 Registration phase Registration application pending Product Active substance Fostemsavir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication HIV/aids in heavily treatment experienced patients. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer ViiV Portfolio holder Mechanism of action HIV inhibitor 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 Accelerated assessment Particularity Unknown ATMP Unknown Submission date February 2020 Expected Registration January 2021 Orphan drug No Registration phase Registration application pending 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 Dit middel zal naar verwachting worden ingezet als een 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 < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De schatting is dat er maximaal 10 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 € 9,600.00 - 12,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant Additional remarks In dezelfde orde grootte als huidige STRs die variëren tussen de €800-€1.000 per maand (gelijke kosten verwacht). De kosten bestaan grotendeels niet uit meerkosten maar uit vervanging van bestaande middelen. Potential total cost per year Total cost € 108,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References SPS Additional remarks Other information Additional remarks