Trastuzumab deruxtecan Medicine 10 June 2020 Extended indication Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies. Therapeutic value No judgement Total cost € 26,620,000.00 Registration phase Registration application pending Product Active substance Trastuzumab deruxtecan Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies. 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 Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration February 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in februari 2021. Therapeutic value Current treatment options No standard of care: lapatinib + chemo or trastuzumab +/- pertuzumab +/- chemo or hormone therapy or T-DM1. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment is er een vergelijkende studie ten opzichte van T-DM1 ( NCT03529110). Resultaten zullen bekend zijn in 2022. Duration of treatment Median 10 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 5,4 mg/kg References NCT03248492;NCT03523585; NCT03529110 Additional remarks Gemiddelde behandelduur is op basis van fase 2 studie. Fase 3 is nog lopend. De huidige registratie aanvraag is gebaseerd op fase 2 onderzoek (DB-01). EMA update op basis van fase 3 3L wordt in het vierde kwartaal van 2022 verwacht. Expected patient volume per year Patient volume < 242 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer Sara M. Tolaney. Journal of Clinical Oncology 2019 37:22, 1868-1875; vektis. Additional remarks De verwachting is dat indien trastuzumab deruxtecan effectiever blijkt te zijn dan T-DM1 de patiëntpopulatie zal overstappen. Op dit moment zijn er 242 patiënten welke T-DM1 ontvangen voor de huidige indicatie. 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 € 26,620,000.00 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-positive breast cancer who have received one or more prior anti-HER2 therapies (2L) (NCT03529110). 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