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Trastuzumab deruxtecan

Enhertu

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 remarks 
EMA registratie in januari 2021. Dit middel is 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 remarks 
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 derde kwartaal van 2023 verwacht.

Expected patient volume per year

Patient volume

100 - 200

Market share is generally not included unless otherwise stated.
References 
NKR 2018
Additional remarks 
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 remarks 
Op basis van de Amerikaanse verwachte prijs: $13,300 per maand. Uitgaande van 10 maanden zou dat neerkomen op $133,000 dus ongeveer €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). Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).
References 
fabrikant

Other information

There is currently no futher information available.