Extended indication Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast
Therapeutic value No estimate possible yet
Total cost 176,639,344.50
Registration phase Clinical trials

Product

Active substance Trastuzumab deruxtecan
Domain Oncology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Proprietary name Enhertu
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options SoC chemotherapie
Therapeutic value No estimate possible yet
Substantiation De DESTINY-Breast06 studie loopt op dit moment nog.
Frequency of administration 1 times every 3 weeks
Dosage per administration 5,4mg/kg
References DESTINY-Breast06 (NCT04494425).

Expected patient volume per year

Patient volume

1,122 - 1,701

Market share is generally not included unless otherwise stated.

References NKR2021 (1); Expertopinie (2)
Additional remarks Invasief mammacarcinoom HER2-negatief kwam in 2021 bij 1.022 stadium-3 en 679 stadium-4 patiënten voor (1). Inclusiecriteria van de studie zijn als volgt omschreven: 'HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)'. Als er uitgegaan wordt dat ongeveer 25 tot 30% van de patiënten HER2-positief is, komt ongeveer 2/3 van de patiënten in aanmerking. Potentieel kan de hele groep die negatief is in aanmerking komen, indien er niet op getest wordt (2).

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) bedraagt €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 (vrouw) 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

Total cost

176,639,344.50

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.