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 estimate possible yet Total cost 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 AstraZeneca 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 No Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant verwacht indiening in de tweede helft van 2021 en registratie in de tweede helft van 2022. Therapeutic value Current treatment options Trastuzumab-emtansine Therapeutic value No estimate possible 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 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 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018 Additional remarks Er waren 2.060 HER2+ patiënten met mammacarcinoom in 2018. Zo'n 200 patiënten betreft stadium 4 mammacarcinoom. Het gaat echter om een tweedelijns behandeling. Afhankelijk van de studieresultaten zal een subgroep van de patiënten die in de tweede lijn worden behandeld in aanmerking komen voor dit geneesmiddel. Inschatting 100-200 patiënten. Expected cost per patient per year Cost 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, dus ongeveer €110.000. De prijs in Nederland is nog niet bepaald. Potential total cost per year Total cost 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