Atezolizumab Medicine 12 June 2018 Extended indication For the 1L treatment of patients with metastatic, squamous NSCLC in combination with chemotherapy Therapeutic value No judgement Total cost € 36,350,000.00 Registration phase Clinical trials Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication For the 1L treatment of patients with metastatic, squamous NSCLC in combination with chemotherapy Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Mechanism of action Unknown 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 Indication extension ATMP Unknown Submission date September 2018 Expected Registration February 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Sluis-product, financieel arrangement van toepassing. Therapeutic value Current treatment options Chemotherapie/Pembrolizumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References Fabrikant; NCT02367794 Additional remarks Expected patient volume per year Patient volume < 727 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab Additional remarks Aantal patiënten met plaveiselcel NSCLC is 1731, aantal patiënten met als eerstelijnsbehandeling chemotherapie: 727. 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 Medicijnkosten.nl Additional remarks Dit is enkel voor Atezolizumab Potential total cost per year Total cost € 36,350,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Diverse indicaties References clinicaltrials.gov Additional remarks Other information Additional remarks