Atezolizumab Medicine 06 June 2023 Extended indication Atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC). Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registration application pending Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC). 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 Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date November 2022 Expected Registration January 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Aangezien dit een tweedelijns registratie is en in de eerstelijn al intraveneus pdl-1 remmer pembrolizumab gegeven wordt is de verwachting dat dit nauwelijks tot niet ingezet zal worden (1). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1875mg References fabrikant; NCT03735121 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie(1) Additional remarks Aangezien dit een tweedelijns registratie is en in de eerstelijn al intraveneus pdl-1 remmer pembrolizumab gegeven wordt is de verwachting dat dit nauwelijks tot niet ingezet zal worden (1). 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 2023). Het is niet bekend of deze nieuwe formulering ook een andere prijs zal hebben. 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 Verschillende indicaties in ontwikkeling References Product Development Portfolio Additional remarks Other information Additional remarks