Darunavir / cobicistat Medicine 03 December 2024 Extended indication Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25kg). Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Darunavir / cobicistat Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25kg). 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 ATMP No Submission date June 2024 Expected Registration July 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2025. Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation In Nederland wordt monotherapie in deze setting doorgaans niet gegeven. Duration of treatment Frequency of administration 1 times a day Dosage per administration Darunavir 675 mg/cobicistat 150 mg once daily References NCT02016924; Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Er worden niet meer dan vijf patiënten ingeschat die voor deze indicatieuitbreiding in aanmerking komen. Expected cost per patient per year Cost € 4,600.00 - 4,700.00 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 stuks apothekers inkoopprijs €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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks