Apalutamide

Active substance
Apalutamide
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Prostate cancer
Extended indication
Gemetastaseerde hormoon-gevoelige, hoog-volume prostaatcarcinoom.

1. Product

Proprietary name
Erleada
Manufacturer
Janssen
Mechanism of action
Antiandrogen
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Androgeen receptor inhibitor.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2019
Expected Registration
May 2020
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Fabrikant verwacht registratie in Q2 2020

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
240 mg
References
Fabrikant; NCT02489318

4. Expected patient volume per year

Patient volume

< 192

Market share is generally not included unless otherwise stated.

References
NKR; Kanker.nl
Additional comments
2.302 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).

5. Expected cost per patient per year

Cost
44,000
References
Prestatie- en tariefbeschikking add-ongeneesmiddelen
Additional comments
Erleada tablet filmomhuld 60mg, 112 stuks kost €3.357,20. Bij een behandelduur van een jaar 240 mg per dag komt dit totaal neer op €43.763,50

6. Potential total cost per year

Total cost

8,448,000

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.

7. Off label use

Off label use
No

8. Indication extension

Indication extension
Yes
References
clinicaltrials.gov
Additional comments
Geen fase III studies voor andere indicaties dan in de horizonscan. In de horizonscan: Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met abiraterone & niet-gemetastaseerde castratie resistente prostaat carcinoom.

9. Other information

There is currently no futher information available.