Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metasta
Therapeutic value No estimate possible yet
Total cost 16,500,000.00
Registration phase Registered

Product

Active substance Trastuzumab deruxtecan
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens.
Proprietary name Enhertu
Manufacturer AstraZeneca
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
ATMP No
Submission date June 2020
Expected Registration January 2021
Orphan drug No
Registration phase Registered
Additional comments Fabrikant verwacht registratie in januari 2021. Dit middel voor deze indicatie in de sluis geplaatst.

Therapeutic value

Current treatment options No standard of care: lapatinib + chemo or trastuzumab +/- pertuzumab +/- chemo or hormone therapy or T-DM1.
Therapeutic value No estimate possible yet
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 comments 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

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 derdelijns behandeling. Afhankelijk van de studieresultaten zal een subgroep van de patiënten die in de derde 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-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

Other information

There is currently no futher information available.