Lenacapavir Medicine 03 December 2024 Extended indication The full indication for Yeytuo solution for injection is: Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). The full indication for Yeytuo film-coated tablets is: Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg for: oral loading, oral bridging. Therapeutic value Possible added value for a subgroup Total cost Registration phase Registered Product Active substance Lenacapavir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication The full indication for Yeytuo solution for injection is: Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). The full indication for Yeytuo film-coated tablets is: Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg for: oral loading, oral bridging. Current proprietary name Already available biosimilars / generics Proprietary name Yeytuo Manufacturer Gilead Portfolio holder Mechanism of action Virus inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Langwerkende capside-eiwitremmer. Als tablet voor orale toediening en als injectie voor subcutane toediening. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New therapeutical formulation ATMP No Submission date February 2025 Expected Registration August 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juli 2025. Therapeutic value Current treatment options Andere HIV PrEP Therapeutic value Possible added value for a subgroup This assessment does not indicate any potential inclusion in the package. Substantiation Langwerkende therapie wordt steeds breder toegepast en dit product zal slechts twee keer per jaar worden toegediend. Voor patiënten die in aanmerking komen, biedt dit een aantrekkelijke en praktische benadering. Het voorziet duidelijk in een meerwaarde voor een selecte groep. Vanwege de hoge kosten zal het naar verwachting niet in Nederland vergoed worden. Duration of treatment Frequency of administration 1 times every 6 months Dosage per administration References NCT04994509 (PURPOSE-1); NCT04925752 (PURPOSE-2) Additional remarks 600mg orale oplaaddosis op dag een en twee met 927mg subcutane dosis op dag een. Daarna subcutane dosis iedere zes maanden. Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks De verwachting is dat niet meer dan tien mensen in Nederland Yeytuo gaan gebruiken. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks