Lenacapavir Medicine 03 December 2024 Extended indication Lenacapavir monotherapy for prophylactic treatment of HIV infection in adolescents over 16 years of age, adults and elderly Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Lenacapavir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Lenacapavir monotherapy for prophylactic treatment of HIV infection in adolescents over 16 years of age, adults and elderly Current proprietary name Already available biosimilars / generics Proprietary name Sunlenca Manufacturer Gilead Portfolio holder Mechanism of action Virus inhibitor Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Long acting, capsid protein inhibitor. Als tablet voor orale toediening en als injectie voor subcutane toediening. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2024 Expected Registration October 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum gebaseerd op de primary completion datum van PURPOSE-1 fase 3-trial (september 2024). De verwachte registratie is ingeschat op basis van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. Therapeutic value Current treatment options Andere HIV PrEP Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 6 months Dosage per administration References NCT04994509 (PURPOSE-1); NCT04925752 (PURPOSE-2) Additional remarks 600mg oral loading dose on days 1 and 2 with 927mg subcutaneous dose on day 1. Then subcutaneous dose every 6 months. 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 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