Atezolizumab Medicine 09 January 2018 Extended indication Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Therapeutic value No judgement Total cost € 4,480,000.00 Registration phase Registered and reimbursed Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. 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 October 2018 Expected Registration August 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2019. Geregistreerd in augustus 2019. Therapeutic value Current treatment options Chemotherapie en in de toekomst ook immuuntherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 26.5 week / weeks Frequency of administration 1 times every 2 weeks Dosage per administration 840 mg References Fabrikant;Schmid et al. 2018. Additional remarks Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer, NEJM. Expected patient volume per year Patient volume 90 - 134 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Incidentie stadium IV borstkanker is ongeveer 6% van het totaal. Waarvan ongeveer 10%-15% TNBC. NKR 2016: 134 diagnoses mammacarcinoom HR-, HER-, stadium 4. 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 Fabrikant Additional remarks Mediane behandelduur met atezolizumab in klinische studie was 26,5 weken. Dit betreft 13 toedieningen van 840 mg atezolizumab wat resulteert in een kleine €40.000 per patiënt, aangegeven range €30.000 - €50.000 per patiënt per jaar. 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 € 4,480,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere fase 3 studies. References clinicaltrials.gov en zie huidige Horizonscan. Additional remarks Other information Additional remarks