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 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.

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.