Avelumab Medicine 10 June 2020 Extended indication Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum-based induction chemotherapy. Therapeutic value No judgement Total cost € 8,054,900.00 Registration phase Registration application pending Product Active substance Avelumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum-based induction chemotherapy. 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 June 2020 Expected Registration February 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q1 2021. Therapeutic value Current treatment options "- Platinum-gebaseerde chemotherapie - Pembrolizumab voor patiënten die eerder platinum bevattende chemotherapie hebben ondergaan, óf die niet in aanmerking komen voor cisplatine bevattende chemotherapie én bij wie de tumoren een PD-L1-expressie vertonen met een 'combined positive score' (CPS) ≥ 10." 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 Median 24.9 week / weeks Frequency of administration 1 times every 2 weeks 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 € 46,028.00 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; Powels et al. 2020 NEJM Javelin Bladder 100 (DOI: 10.1056/NEJMoa2002788); z-index november 2020" Additional remarks De kosten van een verpakking van 200 mg Bavencio bedragen €924.26 (z-index nov 2020). Het bij EMA ingediende label voor 1LM UC gaat uit van 800mg flat dosing iedere 2 weken toegediend. Uitgaande van een mediane behandelduur voor avelumab in 1LM UC van 24,9 weken (Powles et al. 2020) zullen de kosten €46.028,15 bedragen. Potential total cost per year Total cost € 8,054,900.00 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 Longkanker, nierkanker References Fabrikant Additional remarks Other information Additional remarks