Pembrolizumab Medicine 09 January 2018 Extended indication Locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma - second- and subsequent-line. Therapeutic value No judgement Total cost € 53,100,000.00 Registration phase Unknown Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Main indication Stomach cancer Extended indication Locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma - second- and subsequent-line. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder Mechanism of action Unknown 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 Unknown Submission date Expected Registration October 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 574 - 1,550 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2014/2015 waren er gemiddeld 1550 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom. Ongeveer een derde van deze patiënten werd niet behandeld in de 1e lijn. Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37%. 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 Medicijnkosten.nl Additional remarks €3.355,96 per injectieflacon van 4 ml, 25 mg/ml. Potential total cost per year Total cost € 53,100,000.00 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