Gemcitabine Medicine 05 December 2023 Extended indication Intra-arterial Gemcitabine for the treatment of locally advanced pancreatic adenocarcinoma which is unresectable in combination with Nab-paclitaxel following radiotherapy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Gemcitabine Domain Oncology Reason of inclusion New medicine (specialité) Main indication Pancreatic cancer Extended indication Intra-arterial Gemcitabine for the treatment of locally advanced pancreatic adenocarcinoma which is unresectable in combination with Nab-paclitaxel following radiotherapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Renovorx Portfolio holder Mechanism of action Unknown Route of administration Intra-arterial Therapeutical formulation Unknown 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 2024 Expected Registration 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studieopzet is heel anders dan de praktijk en behandelrichtlijn in Nederland op dit moment. Data worden nog afgewacht. Duration of treatment Average 4 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 1,000 mg/m2 References NCT03257033 Additional remarks IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks. Expected patient volume per year Patient volume 503 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) IKNL 2021; (2) https://iknl.nl/kankersoorten/hpb-tumoren/registratie/incidentie Additional remarks In 2021 waren er in totaal 2.922 patiënten met een pancreascarcinoom, waarvan ongeveer 530 patiënten met stadium 3 (1). De meest voorkomende vorm is het van het type adenocarcinoom (95%) (2). Voor deze behandeling zullen circa 503 patiënten in aanmerking komen. Expected cost per patient per year Cost References Drugs.com Additional remarks De kosten in de Verenigde Staten voor de intraveneuze oplossing van gemcitabine (38 mg/ml) bedragen ongeveer $ 15 voor 5,26 milliliter. De prijs in de Verenigde Staten liggen doorgaans hoger dan in Nederland. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks