Pembrolizumab Medicine 07 December 2022 Extended indication Extension of indication to include in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Therapeutic value No estimate possible yet Total cost € 24,750,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Extension of indication to include in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. 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 March 2023 Expected Registration November 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Registratie per 24 november 2023. Positieve CHMP-opinie oktober 2023 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de studie is enkel meerwaarde voor subgroep met CPS>10 gevonden. In the PD-L1 CPS ≥10 population, median OS was 15.7 mo (95% CI 13.8-19.3) with pembro + chemo vs 11.8 mo (95% CI 10.3-12.7) with placebo + chemo (HR 0.65, 95% CI 0.53-0.79; P< 0.0001). In the PD-L1 CPS ≥1 population, median OS was 13.0 mo (95% CI 11.6-14.2) for pembro + chemo vs 11.4 mo (95% CI 10.5-12.0) for placebo + chemo (HR 0.74, 95% CI 0.65-0.84; P< 0.0001 Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References NCT03675737 Additional remarks Expected patient volume per year Patient volume 260 - 290 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; (record avelumab, Zolbetuximab) Additional remarks Het aantal patiënten dat eerste lijns systemische therapie heeft gehad voor onresectable locally advanced of gemetastaseerd voor adenocarcinoom van de maag of gastro-oesofageale overgang lag tussen 2015 en 2017 tussen de 330 en 350 patiënten per jaar. Vaak worden geneesmiddelen die initieel zijn goedgekeurd voor deze groep ook ingezet voor patiënten met adenocarcinoom van de slokdarm. Dit zou betekenen dat er in totaal ongeveer 260 tot 290 patiënten per jaar in aanmerking 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 1 maal 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 € 24,750,000.00 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 zie alle uitbreidingen op de website van Horizonscan Geneesmiddelen References Additional remarks Other information Additional remarks