Cadonilimab Medicine 06 June 2023 Extended indication In patients with relapsed or metastatic cervical cancer (r/m CC) who have progressed on or after platinum-based chemotherapy. Therapeutic value No estimate possible yet Total cost € 24,345,600.00 Registration phase Clinical trials Product Active substance Cadonilimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Cervical cancer Extended indication In patients with relapsed or metastatic cervical cancer (r/m CC) who have progressed on or after platinum-based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Akeso Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: PD-1/CTLA-4 bi-specific antibody. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks In de Verenigde Staten bij de FDA aangemerkt als versnelde beoordeling. In China midden 2022 al goedgekeurd. Therapeutic value Current treatment options Bevacizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er loopt een RCT fase 3 studie. Het zal nog enige tijd duren voordat de resultaten bekend zijn. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References NCT05063916, NCT04982237, NCT05235516 Additional remarks Expected patient volume per year Patient volume < 951 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2021 (1); Additional remarks In 2021 waren er 951 patiënten bekend met een cervixcarcinoom. Expected cost per patient per year Cost € < 25,600.00 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 BaiPharm (1) Additional remarks Cadonilimab is beschikbaar in China voor een prijs van ¥13.220 (€1.710) voor een flacon van 125mg en wordt geschat op een jaarlijkse prijs van ¥198.000 (omgerekend ongeveer €25.600) per patiënt per jaar (1). Potential total cost per year Total cost € 24,345,600.00 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 Fase 3: Gastric cancer; Liver cancer; Oesophageal cancer References AdisInsight Additional remarks Other information Additional remarks