Pembrolizumab Medicine 08 December 2020 Extended indication Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Therapeutic value No estimate possible yet Total cost € 48,600,000.00 Registration phase Registered Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. 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 July 2021 Expected Registration January 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in december 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Resultaten van de 30-maanden follow-up van de KEYNOTE-564: Er werd een voordeel in ziekte vrije overleving (DFS) behaald met pembrolizumab (HR 0.63, 95% CI 0.50−0.80; nominal P < 0.0001) onder verschillende subgroepen. De DFS rate op 24 maanden was 78,3% met pembrolizumab versus 67,3% met placebo. De verwachting is dat er zal worden voldaan aan de PASKWIL-criteria. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References SMPC Keytruda, NCT03142334. Additional remarks Bij monotherapie eenmaal in de 6 weken 400mg mogelijk; tot maximaal 1 jaar behandeling. Expected patient volume per year Patient volume < 540 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL(1); Additional remarks Op basis van de inclusiecriteria van de Keynote-564 zijn de specifieke aantallen bij IKNL opgevraagd. Er komen op basis van deze data jaarlijks maximaal 540 patiënten voor deze behandeling 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 AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Uitgaande van een behandeling van 1 maal 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 € 48,600,000.00 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