Atezolizumab Medicine 04 June 2024 Extended indication Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy. Therapeutic value No estimate possible yet Total cost € 81,250,000.00 Registration phase Registered Product Active substance Atezolizumab Domain Oncology 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 advanced NSCLC who are ineligible for platinum-based therapy. Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Roche 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 Particularity ATMP No Submission date September 2023 Expected Registration August 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Out of the sluice Additional remarks Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Zie publicatie in de Staatscourant van 6 november 2023. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03191786 Additional remarks Expected patient volume per year Patient volume 750 - 2,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021; expertopinie Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Ongeveer 50% van de patiënten in Nederland heeft een ECOG PS 2-3 of heeft co morbiditeit. Indien atezolizumab alleen ingezet gaat worden bij PDL1 hoger dan 50% zou het om ongeveer 30% van deze patiënten gaan (750 per jaar). Indien het ook gegeven zal worden bij een lagere PDL1, worden er 2.500 patiënten verwacht. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Op basis van lijstprijs per vial (1.200mg atezolizumab) van €4.145, Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Potential total cost per year Total cost € 81,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks