Pembrolizumab Medicine 09 January 2018 Extended indication Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Therapeutic value Possibly no place in the treatment regimen Total cost € 31,950,000.00 Registration phase Registered and reimbursed Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. 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 Anti-PD-1 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration October 2021 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in het laatste kwartaal van 2021. Positieve CHMP-opinie (september 2021). Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Patiënten met een CPS score van 10 of meer hadden in de klinische studie een mediane progressie-vrije overleving van 9,7 maanden met pembrolizumab chemotherapie ten opzichte van 5,6 maanden met placebo-chemotherapie (hazard ratio [HR] voor progressie of overlijden is 0,65]). De verwachting is dat de PASKWILL criteria hierdoor gehaald zullen worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References SmPC; Keynote 355 Additional remarks -bij mono en combinatie therapie eenmaal in de 6 weken 400mg mogelijk; -tot maximaal 2 jaar behandeling. Expected patient volume per year Patient volume 355 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018 Additional remarks In 2018 waren er 355 diagnoses mammacarcinoom HR-, HER-, stadium 4. Rekening houdend met de brede inclusie van patiënten in de klinische studie zal het patiëntvolume mogelijk nog iets hoger uit kunnen vallen. 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; fabrikant Additional remarks AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml flacon 4ml (oplossing). Uitgaande van een behandeling van 1 x 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 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. Potential total cost per year Total cost € 31,950,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, et cetera.) References Fabrikant Additional remarks Other information Additional remarks