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Trastuzumab deruxtecan

Enhertu

Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive
Therapeutic value No estimate possible yet
Total cost 2,400,210.00
Registration phase Registered

Product

Active substance Trastuzumab deruxtecan
Domain Oncology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Proprietary name Enhertu
Manufacturer 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 October 2021
Expected Registration December 2022
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie november 2022. Registratie december 2022. Dit geneesmiddel is in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation In de DESTINY-Gastric02 werd een respons percentage van 38% gevonden. Enhertu is per december 2022 geregistreerd op basis van de DESTINY-Gastric01 en DESTINY-Gastric02 studies.
Frequency of administration 1 times every 3 weeks
Dosage per administration 6,4mg/kg

Expected patient volume per year

Patient volume

40 - 50

Market share is generally not included unless otherwise stated.
References (1) GIPdatabank (2) expertopinie (3) CieBOM advies Trastuzumab-deruxtecan bij het gevorderd HER2-positief adenocarcinoom van de maag of gastro-oesofageale overgang 08-2024 (4) expert opinie.
Additional remarks Uitgaande van 360 patiënten die nu met ramucirumab worden behandeld (1), heeft 20% een HER2+ expressie (2). Uitgaande van het CieBOM advies met inzet in de derde lijn (3) is de verwachting van de werkgroep dat 40-50 patiënten in aanmerking voor Enhertu (4).

Expected cost per patient per year

Cost 53,338.00
References CBS; fabrikant
Additional remarks Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs (AIP) bedraag €1.600 per flacon. De aanbevolen dosering is 6,4 mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 78kg bedragen de kosten van trastuzumab-deruxtecan €8.000 per behandelcyclus (5 flacons van €1.600). De kosten per maand zijn dan €11.595 (365,25/12)*(8.000/21)). De mediane behandelduur is 4,6 maanden; De kosten per patiënt per jaar zijn dan €53.338.

Potential total cost per year

Total cost

2,400,210.00

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

Indication extension Yes
Indication extensions Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies (2L) (NCT03529110). Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer. Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).

Other information

There is currently no futher information available.