Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DB05). Therapeutic value No estimate possible yet Total cost € 43,248,000.00 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 (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DB05). 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 Unknown ATMP No Submission date 2026 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q4 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 5,4 mg/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 € 86,496.00 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 (AIP) 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 (4 flacons van €1243). 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 € 43,248,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks