Extended indication Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresecta
Therapeutic value No estimate possible yet
Total cost 16,500,000.00
Registration phase Clinical trials

Product

Active substance Trastuzumab deruxtecan
Domain Oncology and Hematology
Reason of inclusion Indication extension
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.
Proprietary name Enhertu
Manufacturer AstraZeneca
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments 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
Substantiation Op dit moment loopt de DESTINY-Breast03 studie nog.
Duration of treatment Average month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 5,4mg/kg
References DESTINY-Breast03 (NCT03529110)
Additional comments 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.

References NKR 2018
Additional comments 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 110,000.00
References https://www.fiercepharma.com/special-report/1-enhertu
Additional comments 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

16,500,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension 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

Other information

There is currently no futher information available.