Extended indication

Patients With HER2-Expressing Solid Tumors.

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Trastuzumab Deruxtecan

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Tumour agnostic medication

Extended indication

Patients With HER2-Expressing Solid Tumors.

Proprietary name

Enhertu

Manufacturer

AstraZeneca

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional remarks
Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor 2 (HER2)-directed antibody-drug conjugate approved in HER2-expressing breast and gastric cancers and HER2-mutant non-small-cell lung cancer.

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

2024

Expected Registration

2025

Registration phase

Clinical trials

Therapeutic value

Therapeutic value

No estimate possible yet

Frequency of administration

1 times every 3 weeks

Dosage per administration

5.4 mg/kg

References
NCT04482309

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

125,143.00

References
CBS; fabrikant
Additional remarks
Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs (AIP) bedraag €1.800 per flacon. De aanbevolen dosering is 5,4mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 72kg bedragen de kosten van trastuzumab-deruxtecan €7.200 per behandelcyclus (4 flacons van €1.800). De kosten per maand zijn dan €10.428,57 ((365/12)*(7.200/21)). De kosten per patiënt per jaar zijn dan €125.143.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.