Atezolizumab Medicine 12 June 2019 Extended indication Extension of indication to include, in combination with platinum-based chemotherapy, first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) for Tecentriq. Therapeutic value Possibly no place in the treatment regimen Total cost € 20,000,000.00 Registration phase No registration expected Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Extension of indication to include, in combination with platinum-based chemotherapy, first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) for Tecentriq. 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 March 2020 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Voor alle indicaties van atezolizumab geldt een financieel arrangement (tot en met eind 2023). De EMA geeft aan dat de registratie teruggetrokken is doordat er geen positieve benefit-risk balance op te maken was uit de data. Therapeutic value Current treatment options Chemotherapie en in de toekomst ook immuuntherapie. Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 studie genaamd IMvigor130 werd een statistisch significant verschil gevonden voor de progressievrije overleving (PFS) ten opzichte van enkel chemotherapie. Voor de overall overleving (OS) werd geen statistisch significant verschil gevonden, (HR)=0.82. Mogelijk zullen hierdoor de PASKWIL-criteria niet gehaald worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.200 mg References NCT02807636 Additional remarks Expected patient volume per year Patient volume 400 - 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In totaal zijn er 3.337 patiënten met UC in 2016: 1.110 stadium 1, 622 stadium 2, 339 stadium 3, 636 stadium 4. Vergelijkbare groep patiënten zal in aanmerking komen als voor durvalumab (ongeveer 400-600 patiënten). 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 Additional remarks Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk €30.000-€50.000 per patiënt per jaar kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement (tot en met eind 2023). Potential total cost per year Total cost € 20,000,000.00 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 Vele indicaties / lopende fase 3 studies References Fabrikant en Horizonscan Geneesmiddelen Additional remarks Other information Additional remarks