Pembrolizumab Medicine 13 December 2018 Extended indication Treatment of recurrent locally advanced or metastatic oesophageal cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have received prior systemic therapy. Therapeutic value No judgement yet Total cost € 11,250,000.00 Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Treatment of recurrent locally advanced or metastatic oesophageal cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have received prior systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD 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 Anti-PD-1 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2019 Expected Registration August 2019 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Mogelijk met een PD-L1 expressie marker. Therapeutic value Current treatment options Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References SmPC Additional remarks Expected patient volume per year Patient volume 200 - 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, expertopinie. Additional remarks Aantal patiënten met slokdarmkanker stadium II/III/IV betrof 1.596. Gezien het een 2L behandeling voor patiënten met een plaveiselcelcarcinoom betreft schatting patiëntvolume: 200-250 patiënten voor deze indicatie. Mocht het in de toekomst breder ingezet gaat worden (in combinatie met brachytherapie), dan zal het patiëntaantal groter worden. 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 G-Standaard Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost € 11,250,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, etc.) References Fabrikant Additional remarks Other information Additional remarks