Trastuzumab deruxtecan Medicine 06 June 2023 Extended indication Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting. Therapeutic value No estimate possible yet Total cost € 176,701,916.00 Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting. 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 Injection / infusion solution 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 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options SoC chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De DESTINY-Breast06 studie loopt op dit moment nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References DESTINY-Breast06 (NCT04494425). Additional remarks Expected patient volume per year Patient volume 1,122 - 1,701 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Expertopinie (2) Additional remarks Invasief mammacarcinoom HER2-negatief kwam in 2021 bij 1.022 stadium-3 en 679 stadium-4 patiënten voor (1). Inclusiecriteria van de studie zijn als volgt omschreven: 'HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)'. Als er uitgegaan wordt dat ongeveer 25 tot 30% van de patiënten HER2-positief is, komt ongeveer twee derde van de patiënten in aanmerking. Potentieel kan de hele groep die negatief is in aanmerking komen, indien er niet op getest wordt (2). Expected cost per patient per year Cost € 125,143.00 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 (AIP) bedraagt €1.800 per flacon. De aanbevolen dosering is 5,4mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 72kg (vrouw) bedragen de kosten van trastuzumab-deruxtecan €7.200 per behandelcyclus (4 flacons van €1.800). De kosten per maand zijn dan €10.428,57 ((365/12)*(7.200/21)). De kosten per patiënt per jaar zijn dan €125.143. Potential total cost per year Total cost € 176,701,916.00 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