Expand all sections

Apalutamide

Erleada

Extended indication Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met Abiraterone.
Therapeutic value No judgement
Total cost 28,840,000.00
Registration phase Clinical trials

Product

Active substance Apalutamide
Domain Oncology and Hematology
Main indication Prostate cancer
Extended indication Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met Abiraterone.
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 April 2019
Expected Registration February 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 NCT02257736

Expected patient volume per year

Patient volume

< 824

Market share is generally not included unless otherwise stated.
References NKR; GIPdatabank
Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2015. 75% van deze patiënten ontwikkelt CRCP (n=1.727). In 2015 werden 1.648 patiënten voor deze indicatie behandeld met enzalutamide. Apalutamide zal op termijn maximaal 50% marktaandeel bereiken (n=824).

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

28,840,000.00

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.