Atezolizumab Medicine 13 December 2018 Extended indication Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Therapeutic value Possible added value Total cost € 18,000,000.00 Registration phase Registered and reimbursed Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 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 An engineered anti-PD-L1 antibody Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2018 Expected Registration September 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Deze potentiele indicatie-uitbreiding is gebaseerd op de klinische studie IMpower133. Positieve CHMP-opinie juli 2019. Therapeutic value Current treatment options Chemotherapie en in de toekomst ook immuuntherapie Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Fabrikant: op basis van verbeterde PFS en OS Duration of treatment Median 4.7 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT02763579; Fabrikant; Horn et al. 2018. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer, NEJM Additional remarks Een dosis van 1.200 mg atezolizumab wordt intraveneuze toegediend op dag 1 van iedere 21-daagse cyclus. Expected patient volume per year Patient volume 500 - 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2017, expertopinie. Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Inschatting patientvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling. Expected cost per patient per year Cost € 20,000.00 - 40,000.00 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 Fabrikant. Additional remarks Mediane behandelduur met atezolizumab in klinische studie bedroeg 4,7 maanden. Dit betreft 7 toedieingen van 1.200mg atezolizumab, wat resulteert in een kleine €30.000 per patiënt, aangegeven range: €20.000 - €40.000 per patiënt per jaar. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis. Potential total cost per year Total cost € 18,000,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Er zijn vele indicatie-uitbreidingen in ontwikkeling, momenteel heeft roche 19 fase III studies in hun pijplijn. References Roche pipeline, zie ook huidige Horizonscan. Additional remarks Other information Additional remarks