Avelumab Medicine 10 June 2020 Extended indication First line treatment of locally advanced or metastatic urothelial carcinoma (UC). Therapeutic value No judgement Total cost € 11,025,000.00 Registration phase Clinical trials Product Active substance Avelumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication First line treatment of locally advanced or metastatic urothelial carcinoma (UC). 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 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 Chemotherapie en in de toekomst immuuntherapie. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Studie heeft primair eindpunt (OS) behaald. Duration of treatment Frequency of administration Dosage per administration 800 mg References NCT02603432 Additional remarks Flat dosing Expected patient volume per year Patient volume 150 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pembrolizumab urotheelcarcinoom record; NKR Additional remarks Naar verwachting zal het patiëntvolume in lijn zijn met andere PD-1/PD-L1 remmers. Stadium 3 en 4 urotheelcarcinoom betrof in 2015, 1.018 patiënten. De verwachting is dat zo'n 20% hiervan de behandeling gaat krijgen. 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 In lijn met andere PD-1/PD-L1 remmers en indicaties voor avelumab. De behandelkosten per jaar zullen afhangen van de studieresultaten (gemiddelde dosering/behandelduur). AIP Bavencio 20mg/ml voor flacon 10 ml : €924,26 exclusief 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 € 11,025,000.00 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 Verschillende lopende fase 3 studies References adisinsight Additional remarks Other information Additional remarks