Crovalimab Medicine 04 June 2026 Extended indication Crovalimab is Indicated for Adult and Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS). Therapeutic value Total cost Registration phase Clinical trials Product Active substance Crovalimab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Crovalimab is Indicated for Adult and Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS). Current proprietary name Already available biosimilars / generics Proprietary name Piasky Manufacturer Roche Portfolio holder Roche Mechanism of action Complement inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Complement C5-remmer. De eerste behandeling van piasky is intraveneus. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration August 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Eculizumab Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04958265; NCT04861259 Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies ravulizumab (Ultomiris®) Zorginstituut Nederland Additional remarks Atypisch hemolytisch uremisch syndroom (aHUS) is een zeer zeldzame ziekte. In Nederland wordt de diagnose ongeveer 15 tot 20 keer per jaar gesteld (ongeveer vijf kinderen en tien tot vijftien volwassenen) en naar schatting rond de 100 mensen leven met aHUS in Nederland. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks In Nederland is de verwachte vial prijs €8.896 voor een 340mg flacon (exclusief BTW). Totale jaarkosten zijn afhankelijk van het behandelschema en dosering. 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