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.