Atezolizumab Medicine 12 June 2019 Extended indication Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy for the neoadjuvant treatment of adult patients with locally advanced or early Triple Negative Breast Cancer (TNBC). Therapeutic value No estimate possible yet Total cost € 40,000,000.00 Registration phase Registration application pending Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy for the neoadjuvant treatment of adult patients with locally advanced or early Triple Negative Breast Cancer (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 December 2020 Expected Registration October 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie - trastuzumab - pertuzumab Therapeutic value No estimate possible 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, IMpassion031 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 2018: 1.735 diagnoses mammacarcinoom HR-, HER-. Hiervan betreft het 549 patiënten in stadium 1, 812 patiënten in stadium 2, 252 patiënten in stadium 3 en 122 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 per patiënt per jaar 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 2023). 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 Zie indicatieuitbreidingen in de Horizonscan Geneesmiddelen op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker, nierkanker en borstkanker. References Horizonscan Geneesmiddelen Additional remarks Other information Additional remarks