Atezolizumab Medicine 10 December 2019 Extended indication 1L advanced or mTNBC +cobimetinib+(nab)paclitaxel Therapeutic value No estimate possible yet Total cost € 5,360,000.00 Registration phase No registration expected Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication 1L advanced or mTNBC +cobimetinib+(nab)paclitaxel 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks COLET(WO29479) Registratie zal niet plaatsvinden op basis van deze studie die de volgende conclusie heeft in de publicatie. Cobimetinib added to paclitaxel did not lead to a statistically significant increase in PFS or ORR, although a nonsignificant trend toward a numerical increase was observed. https://pubmed.ncbi.nlm.nih.gov/33539944/ 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 Betreft een competitief veld, meerwaarde cobimetinib onduidelijk, de studie zal dit uit moeten wijzen. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 840 mg References NCT02322814 Additional remarks Expected patient volume per year Patient volume < 134 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR. 2016 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. patiënten in stadium 4 komen in aanmerking voor deze behandeling. 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 € 5,360,000.00 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 indicatie-uitbreidingen in de Horizonscan Geneesmiddelen op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker en borstkanker References Additional remarks Other information Additional remarks