Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication Extension of indication to include the indication first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab. Therapeutic value No estimate possible yet Total cost € 64,875,000.00 Registration phase Registration application pending Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include the indication first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab. 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 January 2026 Expected Registration August 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded Additional remarks 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 Uit een interimanalyse is een sterke progressie-vrije survival (PFS)-winst gebleken van 14 maanden (41 met trastuzumab deruxtecan en pertuzumab versus 27 maanden met een taxaan, trastuzumab en pertuzumab). De overall survival (OS) data is nog immatuur. De toxiciteit is vergelijkbaar, maar er is een extra risico op interstitiële longziekte (ILD). Mogelijk wordt dit de nieuwe eerstelijnsstandaard voor HER2+ gemetastaseerde borstkanker. Er moet echter nog gewacht worden op de volledige resultaten. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References NCT04784715 (DESTINY-Breast09); FDA prescribing information; Tolaney et al. NEJM. 2026; Expertopinie. 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 Declaratiedata 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