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.

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.

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.

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

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).

Expected cost per patient per year

Cost 40,000.00
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.

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.

Off label use

Off label use Yes

Indication extension

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

Other information

There is currently no futher information available.