Pembrolizumab Medicine 05 December 2023 Extended indication Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive therapy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive 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 October 2023 Expected Registration August 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemoradiatie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Stadium IB2-IVa krijgt CRT; een (klein) deel zal contra-indicaties hebben, maar merendeel krijgt CRT. ESMO 2023 LBA toont positieve PFS data (mediaan in beide armen nog niet bereikt) met een HR 0,7. Duration of treatment Frequency of administration Dosage per administration References Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) ClinicalTrials.gov ID NCT04221945; Study Completion (Estimated) 2024-12-07; expertopinie Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL; expert Additional remarks CRT is vrijwel altijd de eerste behandeling van locally advanced ziekte. Incidentie rond de 500 op basis van IKNL data per subgroep. Expected cost per patient per year Cost References G-standaard Additional remarks AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). 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 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