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Apalutamide

Erleada

Extended indication Gemetastaseerde hormoon-gevoelige, hoog-volume prostaat carcinoom.
Therapeutic value No judgement
Total cost 6,720,000.00
Registration phase Clinical trials

Product

Active substance Apalutamide
Domain Oncology and Hematology
Main indication Prostate cancer
Extended indication Gemetastaseerde hormoon-gevoelige, hoog-volume prostaat carcinoom.
Proprietary name Erleada
Manufacturer Janssen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Androgeen receptor inhibitor.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date February 2019
Expected Registration April 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 240 mg
References Fabrikant; NCT02489318

Expected patient volume per year

Patient volume

< 192

Market share is generally not included unless otherwise stated.
References NKR; Kanker.nl
Additional remarks 2302 diagnoses prostaatkanker stadium 4 in 2016. Ongeveer 25% van deze groep patiënten is hormoongevoelig (n=575). Gezien de concurrentie binnen deze indicatie wordt uitgegaan van maximaal 1/3 marktaandeel (n=192).

Expected cost per patient per year

Cost 30,000.00 - 40,000.00
References Medicijnkosten.nl
Additional remarks Moet concurreren met enzolutamide en darolutamide dus de prijs zal vergelijkbaar zijn.

Potential total cost per year

Total cost

6,720,000.00

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

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.