Trastuzumab deruxtecan

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.
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 twee derde van de patiënten in aanmerking. Potentieel kan de hele groep die negatief is in aanmerking komen, indien er niet op getest wordt (2).

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 twee derde 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.

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.