Durvalumab Medicine 08 June 2021 Extended indication Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced or metastatic biliary tract cancer (BTC). Therapeutic value No estimate possible yet Total cost € 25,980,480.00 Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced 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 February 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in het tweede kwartaal van 2022 en registratie in het tweede kwartaal van 2023. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten van de TOPAZ-1 studie bekend. 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 < 248 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er zijn ongeveer 700 patiënten in Nederland gediagnosticeerd met een cholangiocarcinoom. Hiervan zijn er 248 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 (3 x €2.328)=€6.984. Aantal toedieningen 8 + 7 * €6.984 = €104.760 per jaar. Potential total cost per year Total cost € 25,980,480.00 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