Extended indication

Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have rec

Therapeutic value

No judgement

Total cost

32,670,000.00

Registration phase

Clinical trials

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.

Proprietary name

Enhertu

Manufacturer

Daiichi Sankyo

Mechanism of action

Antibody-drug conjugate

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Submission date

July 2020

Expected Registration

August 2021

Orphan drug

No

Registration phase

Clinical trials

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

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 11.1 month / months

Frequency of administration

1 times every 3 weeks

Dosage per administration

5,4 mg/kg

References
NCT03248492;NCT03523585; NCT03529110

Expected patient volume per year

Patient volume

< 242

Market share is generally not included unless otherwise stated.

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 comments
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

135,000.00

References
https://www.fiercepharma.com/special-report/1-enhertu
Additional comments
Op basis van de Amerikaanse verwachte prijs: €13,300 per maand. Uitgaande van 11,1 maanden zou dat neerkomen op €147,630, en zo'n 135.000.

Potential total cost per year

Total cost

32,670,000.00

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. Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer.

References
fabrikant

Other information

There is currently no futher information available.