Tislelizumab Medicine 07 June 2022 Extended indication 2L ESCC (esophageal squamous-cell carcinoma) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tislelizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication 2L ESCC (esophageal squamous-cell carcinoma) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Novartis 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 Unknown ATMP No Submission date March 2022 Expected Registration May 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options OVerige PD/PDL-1 remmers Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase III (RATIONALE 302) vergelijkt chemotherapie met tislelizumab. Dit zorgde voor een significante verbetering van de mediane overall survival (8.6 maanden versus 6.3 maanden; HR = 0.70; P = .0001). Het is onduidelijk of deze resultaten voldoende zijn voor uiteindelijke goedkeuring. Duration of treatment Frequency of administration Dosage per administration References Ajani J, El Hajbi F, Cunningham D, et al: Randomized phase III study of second-line tislelizumab vs chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2018 Additional remarks Aantal patiënten met slokdarmcarcinoom stadium I, II, III was in 2018 2.116. 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 No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks