Durvalumab Medicine 03 June 2025 Extended indication Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN). Therapeutic value No estimate possible yet Total cost € 2,500,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2026 Expected Registration November 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Fabrikant verwacht registratie in de tweede helft van 2027 Therapeutic value Current treatment options Definitieve chemoradiatietherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog geen data beschikbaar. Duration of treatment Frequency of administration Dosage per administration References Additional remarks NCT04550260 (KUNLUN) Expected patient volume per year Patient volume 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2021; 2: Epidemiology of Esophageal Squamous Cell Carcinoma. Christian C. Abnet.; Treatment patterns and survival in advanced unresectable esophageal squamous cell cancer: A population‐based study; 3: Expert opinie; Additional remarks In 2021 zijn in Nederland 1.787 patiënten met stadium 3 en 4 slokdarmkanker gediagnosticeerd (1). In ongeveer 25 tot 30% van de gevallen zal het een plaveisel carcinoom betreffen (2). Dit betekent 447 tot 536 patiënten. Als we uitgaan van de groep die 'definitive chemoradiation' ontvangt zullen er ongeveer 50 patiënten per jaar in aanmerking komen (3). Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Additional remarks Afhankelijk van de studieresultaten wordt er verwacht dat de kosten van deze behandeling in lijn liggen met andere PD-(L)1 remmers Potential total cost per year Total cost € 2,500,000.00 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