Trastuzumab deruxtecan Medicine 03 June 2025 Extended indication first-line treatment in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DL04). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication first-line treatment in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DL04). Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks EMA verwacht registratie in de tweede helft van 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Wordt onderzocht in NCT05048797 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 bedraagt €1.243 per flacon (exclusief 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 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