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.