Extended indication Tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients wit
Therapeutic value No estimate possible yet
Total cost 14,250,000.00
Registration phase Registered

Product

Active substance Tucatinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.
Manufacturer Seattle Genetics
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments ERBB 2 receptor antagonists.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2020
Expected Registration February 2021
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in december 2020. Dit middel voor deze indicatie in de sluis geplaatst.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment Average 7.3 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References Meerdere fase 2 studies (zie clinicaltrials.gov), zie onder andere NCT02614794, fase 3 studie nu ook gestart: NCT03975647.

Expected patient volume per year

Patient volume

100 - 200

Market share is generally not included unless otherwise stated.

References IKNL 2018
Additional comments Er waren 2.060 HER2+ patiënten met mammacarcinoom in 2018. Zo'n 200 patiënten betreft stadium 4 mammacarcinoom. Het gaat echter om een derdelijns behandeling. Afhankelijk van de studieresultaten zal een subgroep van de patiënten die in de derde lijn worden behandeld in aanmerking komen voor dit geneesmiddel. Inschatting 100-200 patiënten.

Expected cost per patient per year

Cost < 95,000.00
References https://pharmaphorum.com/news/fda-approves-seattle-genetics-advanced-breast-cancer-drug/
Additional comments Prijs in Nederland nog onbekend, wel is er al een Amerikaanse prijs bekend: "This is Seattle Genetics‘ first approval in breast cancer, and the drug will reportedly cost $18,500 for a 30-day supply with an average cost for a course at around $111,000 per patient". Omgerekend zou dit om zo'n €95.000 per patiënt per jaar gaan.

Potential total cost per year

Total cost

14,250,000.00

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 colorectaal carcinoom
References AdisInsight, clinicaltrials.gov

Other information

There is currently no futher information available.