Atezolizumab Medicine 12 June 2019 Extended indication Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC. Therapeutic value Possible added value Total cost € 22,200,000.00 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 nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC. 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 Inhalation gas 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 IMpower130. Positieve CHMP-opinie juli 2019. Therapeutic value Current treatment options Chemotherapie en immuuntherapie Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Verbeterde OS en PFS gepubliceerd door Cappuzzo et al. 2018 in Annals of Oncology Duration of treatment Median 7 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 1.200 mg References Fabrikant; Cappuzzo et al. 2018. Additional remarks Expected patient volume per year Patient volume 222 - 888 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab; American Cancer Society Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom (2.115). Hiervan ontvangt 60% een eerstelijnsbehandeling (1.269) waarvan 70% chemotherapie (888). De verwachting is dat dit aantal patiënten gedeeld zal moeten worden met nivolumab en pembrolizumab in de eerste lijn. Gezien de overige behandelopties met immuuntherapie is de verwachting dat het in de praktijk niet in de eerste lijn zal worden opgenomen maar in lijn 2 of 3. Expected cost per patient per year Cost € 30,000.00 - 50,000.00 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, G-standaard. Additional remarks Gebaseerd op de mediane PFS van 10 toedieningen en een lijstprijs van atezolizumab van €4.145 per 1.200 mg. 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 € 22,200,000.00 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 vele indicaties / lopende fase III studies References fabrikant en horizonscan Additional remarks Other information Additional remarks