Atezolizumab Medicine 06 June 2023 Extended indication Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck. Therapeutic value No estimate possible yet Total cost € 18,750,000.00 Registration phase Clinical trials Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck. 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 Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2023 Expected Registration June 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De klinische studie loopt nog. Behandeling is na (operatie) en/of chemoradiotherapie. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT03452137 Additional remarks Expected patient volume per year Patient volume < 375 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020(1); expertopinie(2); Additional remarks Er zijn in totaal 2.855 patiënten met SCC van het hoofd-halsgebied, 375 hiervan hebben stadium 3. Het is nog niet bekend of er ook een grens voor de PD-L1 expressie aangehouden zal worden. 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). Potential total cost per year Total cost € 18,750,000.00 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 Meerdere indicaties in ontwikkeling References Product Development Portfolio Additional remarks Other information Additional remarks