Pembrolizumab Medicine 03 December 2024 Extended indication Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. Therapeutic value No estimate possible yet Total cost € 43,740,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for 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 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 April 2024 Expected Registration November 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2024 Therapeutic value Current treatment options Dostarlimab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dostarlimab wordt enkel ingezet bij MMR deficiënte patiënten. Pembrolizumab kan tevens voor patiënten met tumor proficiënte MMR ingezet worden. De onderlinge plaatsbepaling is echter nog onduidelijk. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References NCT03914612 (KEYNOTE-868/NRG-GY018); Eskander et al. NEJM. 2023. Additional remarks The administration of pembrolizumab was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks. Expected patient volume per year Patient volume < 486 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1). Additional remarks In 2022 waren er 2.181 patiënten met baarmoederlichaam kanker gediagnosticeerd, waarvan 486 in stadium 3 en 4 (1). Gezien het een eerstelijnsbehandeling is zal een deel van de patiënten hiervoor in aanmerking komen. 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 Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. Apothekersinkoopprijs per november 2017: €2.624,38 per injectieflacon 25mg/ml FL 4ml (oplossing). Uitgaande van een behandeling van een keer per drie weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Potential total cost per year Total cost € 43,740,000.00 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