Cosibelimab Medicine 03 June 2025 Extended indication Cosibelimab monotherapy for first line treatment of metastatic or locally advanced cutaneous squamous cell carcinoma in adults and elderly who are not eligible for curative surgery or radiation. Therapeutic value No estimate possible yet Total cost € 4,897,000.00 Registration phase Clinical trials Product Active substance Cosibelimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Cosibelimab monotherapy for first line treatment of metastatic or locally advanced cutaneous squamous cell carcinoma in adults and elderly who are not eligible for curative surgery or radiation. Current proprietary name Already available biosimilars / generics Proprietary name Unloxcyt Manufacturer Checkpoint Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Checkpoint Therapeutics. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Cemiplimab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog niets te zeggen over de effectiviteit ten opzichte van cemiplimab. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.200mg References NCT03212404 (CK-301-101) Additional remarks De aanbevolen dosering van Unloxcyt is 1.200mg als intraveneuze infusie gedurende 60 minuten, elke drie weken. Expected patient volume per year Patient volume < 118 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2022 waren er 118 gebruikers van cemiplimab voor dezelfde indicatie. Expected cost per patient per year Cost € < 41,500.00 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 GIPdatabank Additional remarks Vergoeding per gebruiker cemiplimab in 2022: €41.485 Potential total cost per year Total cost € 4,897,000.00 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