Pembrolizumab Medicine 07 December 2022 Extended indication Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Therapeutic value No estimate possible yet Total cost € 19,440,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder MSD Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid 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 February 2023 Expected Registration August 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve opinie in juli 2023 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 1 times every 3 weeks Dosage per administration 200 mg References NCT03615326 Additional remarks Expected patient volume per year Patient volume 173 - 259 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1) IKNL 2021 2) expert opinie op basis van literatuur 3) declaratiedat en expertopinie Additional remarks 622 cardiacarcinoom en 1.109 maagcarcinoom onafhankelijk van het stadium (1). 10 tot 15% van alle maagkanker HER2 is positief (2). Gegeven de gebruikersaantallen bij trastuzumab is de inschatting dat er maximaal 150 tot 200 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € < 90,000.00 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 AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Uitgaande van een behandeling van 1maal per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. Potential total cost per year Total cost € 19,440,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks