Darunavir / Cobicistat Medicine 03 December 2024 Extended indication Darunavir/cobicistat monotherapy for treatment of HIV-1 infection in children over 6 years of age weighing at least 25 kg. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Darunavir / Cobicistat Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Darunavir/cobicistat monotherapy for treatment of HIV-1 infection in children over 6 years of age weighing at least 25 kg. Current proprietary name Already available biosimilars / generics Proprietary name Rezolsta Manufacturer Janssen Portfolio holder Janssen Mechanism of action Virus inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Darunavir is een proteaseremmer. Cobicistat versterkt de werking van darunavir doordat het de tijd dat darunavir in het lichaam werkzaam is, verlengt. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2024 Expected Registration April 2025 Orphan drug No Registration phase Registration application pending Reimbursement 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 Duration of treatment Frequency of administration Dosage per administration References NCT02016924 Additional remarks darunavir 675 mg/cobicistat 150 mg once daily Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 4,692.00 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 G- standaard en SmPC Additional remarks Het gaat om een nieuwe dosering en tablet. Het is wel mogelijk een inschatting te maken op huidige dosering: Rezolsta tablet filmomhuld 800/150mg 30 stk AIP €385,68 exclusief BTW. Dosering is 1 tablet per dag. 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