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 judgement 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 2020 Expected Registration 2021 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 judgement This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen fase 3 data beschikbaar, maar op basis van eerdere studies is de verwachting van experts dat het middel toxisch zal zijn. 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 Expertopinie Additional remarks Pembrolizumab als monotherapie in de eerste lijn bij een PD-L1-expressie van >1% zal naar verwachting slechts bij uitzondering bij een klein patiëntaantal worden ingezet. Expected cost per patient per year Cost € 42,000.00 - 84,000.00 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 De behandelkosten per jaar zullen afhangen van de studieresultaten (gemiddelde dosering/behandelduur). AIP Bavencio 20mg/ml voor flacon 10 ml : €924,26 excl BTW (april 2019). Uitgaande van een behandeling van 6-12 maanden zullen de kosten respectievelijk €42.053,89 en €84.107,66 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 Nierkanker, maagkanker, blaaskanker References Clinicaltrials.gov Additional remarks Naar verwachting zal avelumab zich uitbreiden naar alle indicaties waar anti-PD1 en anti-PD-L1 zullen worden toegepast. Other information Additional remarks