Atezolizumab Medicine 12 June 2019 Extended indication Neoadjuvant treatment for patients with early TNBC Therapeutic value No judgement yet Total cost € 40,000,000.00 Registration phase Clinical trials Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Neoadjuvant treatment for patients with early TNBC Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche 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 An engineered anti-PD-L1 antibody Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2019 Expected Registration September 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie en in de toekomst ook immuuntherapie Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 840 mg References Fabrikant (De resultaten van de klinische studie zijn nog niet bekend) Additional remarks Expected patient volume per year Patient volume 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 1.687 diagnoses mammacarcinoom HR-, HER-. Hiervan betreft het 563 patiënten in stadium 1, 747 patiënten in stadium 2, 239 patiënten in stadium 3 en 134 patiënten in stadium 4. Een deel van de patiënten met stadium 2 komen in aanmerking voor deze behandeling en alle patiënten met stadium 3. Schatting: in totaal kunnen er zo'n 1.000 patiënten in aanmerking komen. Expected cost per patient per year Cost € 30,000.00 - 50,000.00 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 Additional remarks Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk 30.000 -50.000 euro p.p.p.j. kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis. Potential total cost per year Total cost € 40,000,000.00 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 vele indicaties / lopende fase III studies References fabrikant en Horizonscan Additional remarks Other information Additional remarks