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.