Deucrictibant Medicine 04 December 2025 Extended indication Deucrictibant monotherapy for on-demand or prophylactic treatment of hereditary angioedema attack in adolescents, adults and elderly with hereditary angioedema type 1 or type 2. Therapeutic value No estimate possible yet Total cost € 33,672,000.00 Registration phase Clinical trials Product Active substance Deucrictibant Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Deucrictibant monotherapy for on-demand or prophylactic treatment of hereditary angioedema attack in adolescents, adults and elderly with hereditary angioedema type 1 or type 2. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pharvaris Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Pharvaris. Deucrictibant kent twee verschillende toedieningsvormen: een liquid capsule voor on demand therapie en een extended release tablet voor lange termijn profylaxe. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2026 Expected Registration December 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Acute behandeling: C1-esteraseremmer, plasma-derived (Berinert, Cinryze) en recombinant (Ruconest). Bradykinine B2-receptorantagonist (icatibant, Firazyr). Langetermijn/routineprofylaxe: C1-esteraseremmer (Cinryze). Kallikreïneremmer (lanadelumab [Takhzyro], berotralstat [Orladeyo]). Garadacimab is recent goedgekeurd. Pre-procedurele profylaxe: C1-esteraseremmer, plasma-derived (Berinert, Cinryze). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend van de fase 3 studies. Duration of treatment Frequency of administration Dosage per administration References NCT06669754 (CHAPTER-3); NCT06343779 (RAPIDe-3) Additional remarks Expected patient volume per year Patient volume < 230 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GVS advies berotralstat (Orladeyo®) voor hereditair angio-oedeem. Zorginstituut Nederland. 2025 (1); Expertopinie (2). Additional remarks 230 patiënten worden medicamenteus behandeld voor hereditair angio-oedeem, waarvan 64 routine profylaxe (1). De patiëntaantallen voor de indicatie profylaxe zullen rond de 50 liggen, maar er wordt een groter aantal vermoed voor de on-demand indicatie (100-230), afhankelijk van hoeveel patiënten tegen die tijd het nu nog niet geregistreerde medicijn sebetralstat (Ekterly) gebruiken (2). Expected cost per patient per year Cost € 146,400.00 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 GVS advies berotralstat (Orladeyo®) voor hereditair angio-oedeem. Zorginstituut Nederland. 2025. Additional remarks Mogelijk gelijk aan Orladeyo (€146.365). Potential total cost per year Total cost € 33,672,000.00 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