Durvalumab Medicine 08 June 2021 Extended indication Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Therapeutic value Possibly no place in the treatment regimen Total cost € 40,751,640.00 Registration phase Registered Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date April 2022 Expected Registration December 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2022. Registratie in december 2022. Therapeutic value Current treatment options Chemotherapie Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten uit de TOPAZ-1 studie zijn bekend. De hazard ratio voor overall survival was 0,80 (95% confidence interval [CI], 0.66 to 0.97; P=0.021). Er wordt op basis van dit resultaat niet aan de paskwil-criteria voldaan. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1500mg References NCT03875235 (TOPAZ-1). Additional remarks Behandelduur tot progressie. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna om de 4 weken. Expected patient volume per year Patient volume < 389 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks In 2021 waren er ongeveer 976 patiënten in Nederland gediagnosticeerd met een cholangiocarcinoom. Hiervan zijn er 389 patiënten met een stadium 4 carcinoom. Expected cost per patient per year Cost € 104,760.00 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 De fabrikant geeft aan dat de prijs nog niet bekend is. Inschatting: De dosis durvalumab is 1.500mg. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna 1x per 4 weken. Prijs per toediening is dan 3x€2.328=€6.984. Aantal toedieningen 8+7*€6.984=€104.760 per jaar. Potential total cost per year Total cost € 40,751,640.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks