Atezolizumab Medicine 10 December 2019 Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC. 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 IMpower110. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2019 Expected Registration April 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Complexe behandeling. Gaat de concurrentie aan met pembro+chemo in de eerste lijn. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT02409342. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2018 waren er 5.062 patiënten met NSCLC stadium IV. De inschatting is dat onder andere vanwege de complexe behandeling er slechts weinig patiënten voor deze behandeling in aanmerking zullen 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 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 Fabrikant en Horizonscan Geneesmiddelen Additional remarks Other information Additional remarks