Sipavibart Medicine 03 December 2024 Extended indication Pre-exposure prophylaxis (prevention) of symptomatic COVID-19 in an immunocompromised patient population Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sipavibart Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Pre-exposure prophylaxis (prevention) of symptomatic COVID-19 in an immunocompromised patient population Current proprietary name Already available biosimilars / generics Proprietary name AZD3152 Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Antibody-drug conjugate Route of administration Intramuscular Therapeutical formulation Concentrate for solution for injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP No Submission date June 2024 Expected Registration 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Accelerated Assessment. Fabrikant verwacht registratie in het vierde kwartaal van 2024 of het eerste kwartaal van 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit is een langwerkende monoklonale neutraliserende antistof tegen SARS-CoV-2. Zolang het virus gevoelig is, werken deze middelen erg goed (zowel therapeutisch of profylactisch). Echter er is ondertussen resistentie ontstaan tegen alle SARS-CoV-2-neutraliserende monoklonale antistoffen. De vrees is dat er ook resistentie ontstaat tegen sipavibart, dit zet twijfels bij de meerwaarde van dit middel. De resistentie tegen neutraliserende mAbs bij SARS-CoV-2 kan ook heel goed zonder behandeling met mAbs (gezien onze eigen antistoffen op dezelfde manier werken). Dat maakt het probleem van resistentie veel groter dan bij andere antivirals (2). Duration of treatment Frequency of administration Dosage per administration References NCT05648110 (SUPERNOVA) (1); Expertopinie (2). Additional remarks Expected patient volume per year Patient volume 10 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Experopinine (1). Additional remarks De schatting is dat er tussen de 10 en de 100 patiënten in aanmerking komen voor dit middel, afhankelijk van de resistentie (1). 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