Xevinapant Medicine 05 December 2023 Extended indication Xevinapant in combination with platinum-based chemoradiotherapy is indicated for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Xevinapant Domain Oncology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Xevinapant in combination with platinum-based chemoradiotherapy is indicated for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Merck Portfolio holder Merck Mechanism of action Other Route of administration Oral Therapeutical formulation Liquid Budgetting framework Intermural (MSZ) Centre of expertise Hoofd-hals oncologische expertisecentra Additional remarks Previously known as Debio 1143. Inhibitor of apoptosis proteins (IAP) inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Geen registratie verwacht Therapeutic value Current treatment options Chemoradiotherapie (CRT) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eerdere resultaten uit de fase II studie toonden aan dat xevinapant toegevoegd aan standard-of-care CRT een statistisch significant resultaat geven. Indien dezelfde resultaten uit de fase 3 studie komen is er waarschijnlijk een meerwaarde. Duration of treatment Maximal 21 day / days Frequency of administration 6 times a year Dosage per administration 200 mg oraal eenmaal daags van dag 1 t/m 14 van een 21-daagse behandelcyclus gedurende zes cycli, gelijktijdig bij start van op cisplatine gebaseerde chemoradiotherapie (CRT) References NCT04459715 Additional remarks Totale behandelduur 126 dagen, waarvan 84 dagen met toediening werkzame stof. Expected patient volume per year Patient volume < 1,755 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021(1); Additional remarks Hoofd-hals tumoren, stadium 3 en 4, respectievelijk 548 en 1.207. In totaal betekent dit dat er 1.755 patiënten in aanmerking komen. Het gedeelte patiënten dat enkel met chemotherapie behandeld wordt zal ook in aanmerking komen voor xevinapant. 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