Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication Treatment of adult patients with HER2-positive breast cancer (IHC3+ or ISH+) who have residual invasive disease after neoadjuvant HER2 targeted treatment. Therapeutic value No estimate possible yet Total cost € 43,250,000.00 Registration phase Registration application pending Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Treatment of adult patients with HER2-positive breast cancer (IHC3+ or ISH+) who have residual invasive disease after neoadjuvant HER2 targeted treatment. 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 February 2026 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded Additional remarks Fabrikant verwacht registratie in het vierde kwartaal van 2026. 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. TDM-1 heeft per augustus 2024 goedkeuring CieBOM. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References Additional remarks NCT04622319 (DESTINY-Breast05); FDA prescribing information. Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Record trastuzumab emtansine Additional remarks Er zijn 2.060 HER2+ patiënten met mammacarcinoom (zo'n 12% van alle patiënten met mammacarcinoom), 50 tot 60% behandeld middels een systemische therapie, van deze ongeveer 1.000 patiënten komt dan een subgroep (personen met een ziekteresidu) in aanmerking voor deze behandeling. Inschatting: maximaal zo'n 50%, dit betreft dus zo'n 500 patiënten. 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 TTrastuzumab-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 € 43,250,000.00 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