Paclitaxel/hyaluronzuur Medicine 04 December 2025 Extended indication Paclitaxel/hyaluronic acid monotherapy for second line treatment of persistent or recurrent BCG-unresponsive carcinoma in situ of the bladder in adults and elderly with or without Ta-T1 papillary disease. Therapeutic value No estimate possible yet Total cost € 109,375,000.00 Registration phase Clinical trials Product Active substance Paclitaxel/hyaluronzuur Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Paclitaxel/hyaluronic acid monotherapy for second line treatment of persistent or recurrent BCG-unresponsive carcinoma in situ of the bladder in adults and elderly with or without Ta-T1 papillary disease. Current proprietary name Already available biosimilars / generics Proprietary name ONCOFID-P-B Manufacturer Fidia Farmaceutici Portfolio holder Fidia Farmaceutici Mechanism of action Route of administration Intravesical Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Radicale cystectomie, chemohyperthermie (HIVEC®) als blaas sparend alternatief, off-label intravesicale chemotherapie (gemcitabine/docetaxel), en in studieverband of beperkt off-label immunotherapie zoals pembrolizumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie loopt nog. Duration of treatment Average 12 week / weeks Frequency of administration 1 times a week Dosage per administration References NCT05024773 Additional remarks Expected patient volume per year Patient volume 450 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Babjuk et al. 2024 (1); NKR 2023 (2); Kamat et al. 2014 (3) Additional remarks Jaarlijks krijgen ongeveer 6.500 mensen in Nederland blaaskanker, waarvan circa 5.000 patiënten een niet-spierinvasieve vorm (NMIBC) hebben (IKNL, 2023). Van deze groep worden ongeveer 1.500 tot 2.000 patiënten behandeld met BCG vanwege hooggradige Ta/T1-laesies of carcinoma in situ (CIS) (1,2). Naar schatting wordt 30 tot 40% BCG-ongevoelig, wat neerkomt op 450 tot 800 patiënten per jaar (3). Expected cost per patient per year Cost € 150,000.00 - 200,000.00 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 Drugs.com Additional remarks Er is nog geen marktprijs beschikbaar. Een vergelijkbare behandeling nadofaragene firadenovec (Adstiladrin) kost in de Verenigde Staten ongeveer €200.000 per jaar. Schatting paclitaxel/hyaluronic acid: €150.000 tot €200.000 per jaar. Potential total cost per year Total cost € 109,375,000.00 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