Trastuzumab deruxtecan Medicine 08 December 2020 Extended indication Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane 2L. Therapeutic value No judgement yet Total cost € 31,350,000.00 Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane 2L. Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer Daiichi Sankyo Portfolio holder 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 Unknown Submission date October 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant verwacht indiening in 2e helft 2021 en registratie in 2022. Therapeutic value Current treatment options Trastuzumab-emtansine Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de DESTINY-Breast03 studie nog. Duration of treatment Average 10 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References DESTINY-Breast03 (NCT03529110) Additional remarks Dit betreft dezelfde populatie als geneesmiddel 1 (op basis van DB-01/DB-02), maar dan in een lijn eerder. Deze indicatie zal naar verwachting gebruik in de derde lijn sterk doen afnemen. Expected patient volume per year Patient volume < 285 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2016; record Trastuzumab emtansine; GIPdatabank. Additional remarks Patiënten die nu in de tweede lijn trastuzumab emtansine ontvangen zullen in aanmerking komen. Dit waren in totaal 285 patiënten in 2019. Een gedeelte hiervan komt mogelijk in aanmerking voor behandeling met trastuzumab deruxtecan. Expected cost per patient per year Cost € 110,000.00 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 https://www.fiercepharma.com/special-report/1-enhertu Additional remarks Op basis van de Amerikaanse verwachte prijs: $13,300 per maand. Uitgaande van 10 maanden zou dat neerkomen op $133,000, en zo'n €110.000. De prijs in Nederland is nog niet bepaald. Potential total cost per year Total cost € 31,350,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer. Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690). References Fabrikant Additional remarks Other information Additional remarks