Avelumab Medicine 09 January 2018 Extended indication Bavencio is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met gemetastaseerd merkelcelcarcinoom (MCC). Therapeutic value Possible added value Total cost € 2,130,000.00 Registration phase Unknown Product Active substance Avelumab Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Bavencio is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met gemetastaseerd merkelcelcarcinoom (MCC). Current proprietary name Already available biosimilars / generics Proprietary name Bavencio Manufacturer Merck Portfolio holder Mechanism of action Unknown 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 November 2016 Expected Registration September 2017 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Geregistreerd in september 2017. Therapeutic value Current treatment options 2L is meestal in studieverband. 1L is meestal cisplatine/etoposide Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Alleen behandeling in academisch centrum. Duration of treatment Average 16 week / weeks Frequency of administration 2 times a month Dosage per administration 10 mg/kg References EPAR Additional remarks Gemiddelde behandelduur: 15,72 weken; administered intravenously over 60 minutes every 2 weeks Expected patient volume per year Patient volume 25 - 116 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Incidentie 0,19 - 0,82/100.000. In Nederland tussen 32-139. NKR voor 2016 was 116 patiënten. Beroepsgroep schat: 25 patiënten. Expected cost per patient per year Cost € 20,000.00 - 40,000.00 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 Medicijnkosten.nl Additional remarks €979,72 per 20 mg/ml voor 10 ml flacon. Potential total cost per year Total cost € 2,130,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Fabrikant geeft aan in H1 2019 indicatie-uitbreiding te verwachten voor: Treatment of adult patients with gastric cancer, 3L (GC); Treatment of adult patients with ovarian cancer (OC). 2L/1L. In de toekomst ook voor: Treatment of adult patients with renal cell carcinoma (RCC) 1L. References Additional remarks Other information Additional remarks