Pembrolizumab/hyaluronidase Medicine 03 December 2024 Extended indication Pembrolizumab/hyaluronidase in combination with platinum doublet chemotherapy for first line treatment of non-small cell lung cancer metastatic in adults and elderly Therapeutic value No estimate possible yet Total cost € 427,500,000.00 Registration phase Clinical trials Product Active substance Pembrolizumab/hyaluronidase Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Pembrolizumab/hyaluronidase in combination with platinum doublet chemotherapy for first line treatment of non-small cell lung cancer metastatic in adults and elderly Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Subcutaneous Therapeutical formulation Injection 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 December 2024 Expected Registration August 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Op basis van een primary completion datum in september 2024, kan een indieningsdatum in december 2024 en een verwachte registratie in augustus 2025 geschat worden. Therapeutic value Current treatment options Pembrolizumab IV Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Pembrolizumab in combinatie met hyaluronidase zorgt ervoor dat het subcutaan toegediend kan worden bij de patiënt. Er loopt op dit moment een studie (KEYNOTE-D77) waarin de effectiviteit van de intraveneuze variant en de subcutane variant vergeleken worden. Duration of treatment Frequency of administration Dosage per administration References NCT05722015 (KEYNOTE-D77) Additional remarks Expected patient volume per year Patient volume < 4,750 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1). Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Indien alle patiënten die op dit moment intraveneus pembrolizumab ontvangen overstappen op de subcutane variant komen er maximaal 4.750 patiënten in aanmerking. 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 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 maal 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 € 427,500,000.00 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