Cemiplimab Medicine 03 June 2025 Extended indication Cemiplimab monotherapy for adjuvant treatment of high-risk Cutaneous squamous cell carcinoma in adults and elderly who have completed surgery and post-operative RT radiation therapy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Cemiplimab Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Cemiplimab monotherapy for adjuvant treatment of high-risk Cutaneous squamous cell carcinoma in adults and elderly who have completed surgery and post-operative RT radiation therapy. Current proprietary name Already available biosimilars / generics Proprietary name LIBTAYO Manufacturer Regeneron 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 Unknown Particularity Unknown ATMP No Submission date April 2025 Expected Registration February 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03969004 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Gemiddelde prijs per 1 flacon LIBTAYO, 7 ml CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE 50 mg/ml € 5.918,82. 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