Trastuzumab deruxtecan Medicine 04 June 2024 Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Tumour agnostic medication Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor 2 (HER2)-directed antibody-drug conjugate approved in HER2-expressing breast and gastric cancers and HER2-mutant non-small-cell lung cancer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Aan de hand van de resultaten is het nog onduidelijk of aan de PASKWIL-criteria worden voldaan. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References NCT04482309 (DESTINY-PanTumor02) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Bryant et al. JAMA Oncology. 2025 Additional remarks Ongeveer 3% van alle solide tumoren zijn van het type HER2+ (IHC3+). 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 CBS; fabrikant Additional remarks Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs bedraagt €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 €1.243). De kosten per maand zijn dan €7.200 ((365/12)*(4.972/21)). 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