Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication Trastuzumab deruxtecan (Enhertu) with or without pertuzumab compared to standard of care in patients with HER2-positive metastatic breast cancer (DB09). Therapeutic value No estimate possible yet Total cost € 64,875,000.00 Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Trastuzumab deruxtecan (Enhertu) with or without pertuzumab compared to standard of care in patients with HER2-positive metastatic breast cancer (DB09). Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Fabrikant verwacht registratie in het derde kwartaal van 2026. Therapeutic value Current treatment options Trastuzumab/pertuzumab combinatie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References NCT04784715 (DESTINY-Breast09); FDA prescribing information Additional remarks Expected patient volume per year Patient volume < 750 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2021 waren er ongeveer 750 gebruikers van een trastuzumab/pertuzumab combinatie voor gemetastaseerd HER2+ borstkanker. De studie vergelijkt echter de combinatie met monotherapie trastuzumab deruxtecan. Vandaar is de situatie niet helemaal vergelijkbaar. Expected cost per patient per year Cost € < 86,500.00 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; CBS Additional remarks Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs bedraag €1.243 per flacon. De aanbevolen dosering is 5,4mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 72kg bedragen de kosten van trastuzumab-deruxtecan €4.972 per behandelcyclus (vier flacons van €1.243). De kosten per maand zijn dan €7.208 ((365,25/12)*(4.972/21)). De kosten per patiënt per jaar zijn dan €86.496 Potential total cost per year Total cost € 64,875,000.00 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