Avelumab Medicine 10 December 2019 Extended indication First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Avelumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer. Current proprietary name Already available biosimilars / generics Proprietary name Bavencio Manufacturer Merck/Pfizer Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antilichaam tegen PD-L1. Betreft een samenwerking tussen Merck en Pfizer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Pembrolizumab + chemotherapie, atezoluzimab + chemotherapie & nivolumab + ipilimumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen fase 3 data beschikbaar. Voor deze indicatie zijn er al veel geneesmiddelen op de markt, er wordt hierdoor veel concurrentie verwacht. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 10 mg/kg References NCT02576574. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, Expertopinie. Additional remarks In 2018 waren er 10.190 diagnoses NSCLC in Nederland. Dit betrof 1.724 stadium I, 921 stadium II, 2.452 stadium III (waarvan zo'n 55% stadium IIIa en zo'n 45% stadium IIIb), 5.062 stadium IV en 31 onbekend. De indicatie betreft patiënten met NSCLC stadium IV. Avelumab als monotherapie in de eerste lijn bij een PD-L1-expressie van >1% zal naar verwachting slechts bij uitzondering bij een klein patiëntenaantal worden ingezet. Expected cost per patient per year Cost € 46,674.00 - 93,349.00 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 Fabrikant; Z-index mei 2021 Additional remarks De behandelkosten per jaar zullen afhangen van de studieresultaten (gemiddelde dosering/behandelduur). AIP Bavencio 20mg/ml voor flacon 10ml: €894,52 (mei 2021). Uitgaande van een behandeling van 6-12 maanden zullen de kosten respectievelijk €46.674,78 en €93.349,35 bedragen. Potential total cost per year Total cost 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 Blaaskanker, nierkanker References Clinicaltrials.gov. Additional remarks Other information Additional remarks