Atezolizumab Medicine 12 June 2019 Extended indication Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Therapeutic value Possible added value Total cost € 3,000,000.00 Registration phase Registered Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 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 January 2020 Expected Registration November 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2020. Therapeutic value Current treatment options Chemotherapie en best ondersteunde zorg. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In de fase III studie IMbrave150 werden statistisch significante waarden voor progressievrije survival (PFS) en overall overleving (OS) gevonden. Er wordt verwacht dat op basis van de resultaten deze behandeling mogelijk standaardzorg zal worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.200 mg References Fabrikant; NCT03434379. Additional remarks Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 158 patiënten met HCC stadium 4. De werkgroep verwacht dat hier van 50-100 patiënten voor deze behandeling in aanmerking komen. 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 die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2020). Potential total cost per year Total cost € 3,000,000.00 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 Zie indicatie uitbreidingen in de Horizonscan op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker en borstkanker. References Fabrikant en Horizonscan Additional remarks Other information Additional remarks