Trastuzumab pamirtecan Medicine 03 June 2025 Extended indication Trastuzumab pamirtecan (Db-1303/bnt323) monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve. Therapeutic value No estimate possible yet Total cost € 46,002,000.00 Registration phase Clinical trials Product Active substance Trastuzumab pamirtecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Trastuzumab pamirtecan (Db-1303/bnt323) monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biontech Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: topoisomerase 1 inhibitor-gebaseerd antilichaam‑geneesmiddelconjugaat (ADC) Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date August 2026 Expected Registration September 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 8mg/kg References NCT06018337 Additional remarks 8mg/kg intraveneuze dosis op dag een van elke cyclus, elke drie weken. Expected patient volume per year Patient volume < 1,353 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); bcrf.org 2025 (2) Additional remarks In 2022 kregen 2.504 mensen de diagnose invasief mammacarcinoom (stadium 3 en 4) (1). Hiervan is 54% HER2-low (IHC 2+/ISH- or IHC 1+ (ISH- or untested)) (n=1353). Het aantal patiënten dat in aanmerking komt voor dit middel zal lager zijn, omdat het een behandeling in de derdelijn betreft. Expected cost per patient per year Cost € 34,000.00 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 Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (L01FD - HER2 remmers) geneesmiddelen in Nederland. Potential total cost per year Total cost € 46,002,000.00 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