Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DG04). Therapeutic value No estimate possible yet Total cost € 14,342,400.00 Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DG04). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks EMA wordt verwacht Q4 2025 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation T-DXd goedgekeurd als monotherapie voor patiënten met een gevorderd HER2-positief adenocarcinoom van eerdere behandeling met trastuzumab. Ook een positief BOM advies op basis van fase 2. HER2 positief in gemetastaseerde setting is circa 15 tot 25% Duration of treatment Frequency of administration Dosage per administration References https://pubmed.ncbi.nlm.nih.gov/31927675/. Na progressie onder herceptin komt deze groep in aanmerking voor T-DXd. Additional remarks Wordt onderzocht in NCT04704934 Expected patient volume per year Patient volume < 166 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); expertopinie (2) Additional remarks De incidentie van maagcarcinoom betrof 1.109 (1); 15 tot 20% zal in aanmerking komen. (2) Expected cost per patient per year Cost € < 86,400.00 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 Medicijnkosten.nl Additional remarks Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs (AIP) bedraagt €1.243 per flacon (excl. BTW). 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 €4.971 per behandelcyclus (4 flacons van €1.243). De kosten per maand zijn dan €7.200 ((365/12)*(4.971/21)). De kosten per patiënt per jaar zijn dan €86.400. Potential total cost per year Total cost € 14,342,400.00 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