Oportuzumab monatox Medicine 12 June 2019 Extended indication Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG Therapeutic value No estimate possible yet Total cost € 246,000,000.00 Registration phase Registration application pending Product Active substance Oportuzumab monatox Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG Current proprietary name Already available biosimilars / generics Proprietary name Vicinium Manufacturer Sesen Bio Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravesical Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Protein synthesis inhibitors. Ook bekend als VB4-845. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2021 Expected Registration April 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPS UK"Mar 21 · Sesen Bio has submitted its Marketing Authorization Application to the EMA for Vicineum for the treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer". Therapeutic value Current treatment options Blaasspoeling BCG Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Zal in de toekomst ook concurrentie krijgen van immuuntherapie. Duration of treatment Frequency of administration Dosage per administration 30 mg References NCT02449239; NCT03258593 Additional remarks De inductietherapie bestaat uit 30 mg Vicinium tweemaal per week gedurende 6 weken gevolgd door eenmaal per week gedurende 6 weken. De onderhoudstherapie bestaat uit 30 mg Vicinium eenmaal per twee weken gedurende 104 weken. Expected patient volume per year Patient volume < 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; expertopinie Additional remarks Totaal aantal patiënten met invasief blaaskanker: 3.337. De inschatting is dat hiervan ongeveer 1.500 patiënten gediagnosticeerd worden met hooggradig niet-spierinvasief blaascarcinoom (HG-NMIBC). Een deel hiervan krijgt BCG spoeling na een transurethrale resectie van de blaas. Nadere toelichting schatting 1.500 patiënten: In de afgelopen jaren kregen zo’n 700 patiënten met een in situ of T1 tumor een BCG-spoeling en zo'n 850 patiënten met een hooggradige tumor. Expected cost per patient per year Cost € < 164,000.00 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 https://www.thepharmaletter.com/article/icer-recommends-top-price-of-200-000-per-year-for-new-bladder-cancer-drugs Additional remarks ICER heeft berekend dat er maximaal $200.000 per jaar voor oportuzumab monatox gerekend zou moeten worden op basis van de mogelijke gezondheidswinst- prijsverhouding. Potential total cost per year Total cost € 246,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Phase II/III Head and neck cancer References adisinsight Additional remarks Other information Additional remarks