Pembrolizumab Medicine 08 December 2020 Extended indication Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1. Therapeutic value Possible added value Total cost € 6,750,000.00 Registration phase Registered and reimbursed Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer 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 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 Unknown Submission date October 2021 Expected Registration April 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks EMA registratie april 2022. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 KEYNOTE-826 trial, waarin KEYTRUDA plus chemotherapie met of zonder bevacizumab (the KEYTRUDA regimen) gegeven werd is een statistisch significant resultaat op overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) en progressie-vrije survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) behaald ten opzichte van chemotherapie met of zonder bevacizumab. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References SMPC Keytruda, NCT03635567. Additional remarks - Bij mono therapie 1x in de 6 weken 400mg mogelijk; - tot maximaal 2 jaar behandeling. Expected patient volume per year Patient volume 70 - 80 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References DGOG Additional remarks Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor deze behandeling. Deze inschatting is gedaan op basis van huidige getallen van bevacizumab bij cervixcarcinoom. 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 1x 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 € 6,750,000.00 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 Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen. References Fabrikant. Additional remarks Other information Additional remarks