Avelumab Medicine 09 January 2018 Extended indication Treatment of locally advanced unresectable, metastatic or recurrent non-small cell lung cancer (NSCLC) after prior chemotherapy in adults, 2L. Therapeutic value No judgement Total cost € 76,500,000.00 Registration phase Unknown Product Active substance Avelumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Treatment of locally advanced unresectable, metastatic or recurrent non-small cell lung cancer (NSCLC) after prior chemotherapy in adults, 2L. 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 Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration March 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Nivolumab, Pembrolizumab, Atezolizumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a month Dosage per administration 200 mg References Additional remarks Toediningsfrequentie: 1 maal per 2 weken Expected patient volume per year Patient volume 765 - 2,295 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies Pembrolizumab Additional remarks Patiëntvolume is vergelijkbaar met Pembrolizumab/Nivolumab voor deze indicatie. Beoordeling Zorginstituut Pembrolizumab: Max. patiëntvolume: 1.230-2.295; Realistisch patiëntvolume: 410-765 (1/3 van max. volume). Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 € 76,500,000.00 Total cost for sluice Additional remarks Off label use Off label use No 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