Mitomycine extended release Medicine 03 December 2024 Extended indication Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC). Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Mitomycine extended release Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC). Current proprietary name Already available biosimilars / generics Proprietary name VesiGel Manufacturer Urogen Portfolio holder Mechanism of action Other, see general comments Route of administration Intravesical Therapeutical formulation Gel Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks VesiGel (UGN-102) is een formulering van mitomycine op basis van een hydrogel met langdurige afgifte. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De ontwikkeling lijkt te zijn gestopt. Het staat niet meer in de pijplijn van UroGen Pharma vermeld en het lijkt te zijn vervangen door UGN-103. Therapeutic value Current treatment options Conventioneel mitomycine Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De ATLAS-studie (UGN-102 voor de behandeling van laaggradig intermediair-risico niet-spierinvasief blaascarcinoom versus onmiddellijke transurethrale resectie) is voortijdig gestaakt vanwege verandering development strategie van de firma. De resultaten van de fase 3 ENVISION trial zijn nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References NCT04688931 (ATLAS); NCT05243550 (ENVISION). Additional remarks Expected patient volume per year Patient volume < 3,723 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2024 (1). Additional remarks In 2023 waren er 3.723 patiënten met niet-invasieve blaaskanker (NMIBC) (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks