Sugemalimab Medicine 04 June 2024 Extended indication Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma. Therapeutic value No estimate possible yet Total cost € 24,600,000.00 Registration phase Clinical trials Product Active substance Sugemalimab Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer CStone Portfolio holder 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 Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Pdl-1 remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.200mg References NCT04187352 Additional remarks Expected patient volume per year Patient volume 447 - 536 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021; Epidemiology of Esophageal Squamous Cell Carcinoma. Christian C. Abnet.; Additional remarks In 2021 zijn in Nederland 1.787 patiënten met stadium 3 en 4 slokdarmkanker gediagnosticeerd. In ongeveer 25 tot 30% van de gevallen zal het een plaveisel carcinoom betreffen. 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-L1 remmers. Potential total cost per year Total cost € 24,600,000.00 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