Zanidatamab Medicine 03 December 2024 Extended indication Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2). Therapeutic value No estimate possible yet Total cost € 11,580,000.00 Registration phase Registered Product Active substance Zanidatamab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2). Current proprietary name Already available biosimilars / generics Proprietary name Ziihera Manufacturer Jazz Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Concentrate for solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Zanidatamab is een bispecifiek antilichaam met affiniteit voor twee epitopen van HER2. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2024 Expected Registration June 2025 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in april 2025. Therapeutic value Current treatment options nivolumab, pembrolizumab, trastuzumab, pertuzumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 5.1 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 20mg/kg References NCT04466891 (HERIZON-BTC-01); Harding et al. Lancet Oncol. 2023; Fabrikant Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2024 (1). Ostwal et al. JCO. 2023 (2). Additional remarks In 2022 werden er 273 mensen met galwegkanker (proximaal, distaal en overig) gediagnosticeerd, stadium 3 en 4 (1). HER2 over expressie wordt gezien bij 4 tot 16% van alle galwegkankers (2). Het patiëntvolume zal kleiner zijn in verband met de positie in de tweedelijn. Expected cost per patient per year Cost € < 115,800.00 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 Fabrikant Additional remarks Een flacon met 300mg zanidatamab zal maximaal €1.740 kosten. Op basis van de aanbevolen dosering van 20mg/kg, een tweewekelijkse toediening en een behandelduur van 5,1 maanden (mediaan) kost een behandeling voor een patiënt van 80kg €115.755 per patiënt per jaar (6x€1.740x365,24/14x5,1/12). Potential total cost per year Total cost € 11,580,000.00 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