Enfortumab vedotin Medicine 06 June 2023 Extended indication Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Enfortumab vedotin Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name PADCEV Manufacturer Astellas Portfolio holder Astellas Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2024 Expected Registration September 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juli 2024 en EC decision in augustus 2024. Deze indicatieuitbreiding voldoet aan het sluiscriterium van >€20.000.000 per jaar. Therapeutic value Current treatment options Platinum-based chemotherapy and/or checkpoint inhibitor (PDL-1 positive) Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Het geneesmiddel is geregistreerd voor patiënten in de tweede lijn. OS: (median, 31.5 months versus 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). Voldoet daarmee aan PASKWIL-criteria. Duration of treatment Frequency of administration 2 times every 3 weeks Dosage per administration References NCT04223856 (EV-302); Powles et al. N Engl J Med. 2024. Additional remarks Expected patient volume per year Patient volume < 713 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Additional remarks In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom. In totaal 1.213 patiënten. In dat jaar zijn 713 patiënten behandeld met chemotherapie. (1) Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Padcev infusiepoeder flacon 20mg enfortumab vedotine Astellas Pharma €707,05 per stuk (inclusief BTW) Padcev infusiepoeder flacon 30mg enfortumab vedotine Astellas Pharma €1.060,57 per stuk (inclusief BTW) Potential total cost per year Total cost 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 MIBC References fabrikant Additional remarks Other information Additional remarks