Extended indication

Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresecta

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

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

Daiichi Sankyo

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

Submission date

October 2021

Expected Registration

2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
De fabrikant verwacht indiening in 2e helft 2021 en registratie in 2022.

Therapeutic value

Current treatment options

Trastuzumab-emtansine

Therapeutic value

No judgement yet

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 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

< 285

Market share is generally not included unless otherwise stated.

References
NKR 2016; record Trastuzumab emtansine; GIPdatabank.
Additional comments
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

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

31,350,000.00

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.