Enzalutamide

Active substance
Enzalutamide
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Prostate cancer
Extended indication
Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy.

1. Product

Proprietary name
Xtandi
Manufacturer
Astellas
Mechanism of action
Antiandrogen
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Anti-androgeen, remmer van de androgeenreceptorsignalering.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2019
Expected Registration
October 2020
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Fabrikant verwacht registratie in oktober 2020.

3. Therapeutic value

Current treatment options
BSC, docetaxel + prednison, abirateron + prednison
Therapeutic value
No judgement
Duration of treatment
Median 12.8 month / months
Frequency of administration
1 times a day
Dosage per administration
160 mg
References
NCT02677896; Armstrong AJ et al., 2019 J Clin Oncol. 2019 Nov 10;37(32):2974-2986

4. Expected patient volume per year

Patient volume

< 192

Market share is generally not included unless otherwise stated.

References
NKR
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
40,000
References
Fabrikant; G-standaard; SmPC.
Additional comments
Uitgaande van het verbruik van 1 verpakking per 28 dagen en een behandeling van >12 maanden komt dit dit neer op 13 verpakkingen voor een jaar en dus €40.040.

6. Potential total cost per year

Total cost

7,680,000

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
Yes

8. Indication extension

Indication extension
Yes
Indication extensions
Niet gemetastaseerde castratieresistente prostaatkanker (nmCRPC); nmHSPC
References
NCT02003924; NCT02319837

9. Other information

There is currently no futher information available.