Atezolizumab Medicine 13 December 2018 Extended indication Extensive-stage small-cell lung cancer, first-line treatment in combination with carboplatin and etoposide. Independent of PD-L1 expression. Therapeutic value Possible added value Total cost € 18,000,000.00 Registration phase Registration application pending Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extensive-stage small-cell lung cancer, first-line treatment in combination with carboplatin and etoposide. Independent of PD-L1 expression. 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 Unknown ATMP Unknown Submission date August 2018 Expected Registration September 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Atezolizumab intravenous infusion will be administered at a dose of 1.200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward). 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 €30.000,00 per patiënt, aangegeven range: €20.000,00 - €40.000,00 p.p.p.j.. 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 Additional remarks Other information Additional remarks