Enzalutamide

Active substance Enzalutamide
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication De behandeling van volwassen mannen met niet-gemetastaseerd hoog risico-CRPC (castratieresistent prostaatcarcinoom).

Product

Proprietary name Xtandi
Manufacturer Astellas
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 May 2018
Expected Registration November 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie september 2018. Geregistreerd in oktober 2018.

Therapeutic value

Current treatment options BSC, apalutamide
Therapeutic value No judgement
Duration of treatment Median 18.4 month / months
Frequency of administration 1 times a day
Dosage per administration 160 mg
References NCT02003924; Hussain et al. N Engl J Med 2018; 378:2465-2474.

Expected patient volume per year

Patient volume

53

Market share is generally not included unless otherwise stated.

References NKR; Kanker.nl; Fabrikant.
Additional comments In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Enzalutamide zal binnen deze indicatie moeten moeten concurreren met apalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53).

Expected cost per patient per year

Cost 40,000.00
References Fabrikant; G-standaard; SmPC.
Additional comments Minimale kosten indien patiënt slechts 1 verpakking van €3.080 euro per verpakking verbruikt omdat medicatie na 1 maand wordt gediscontinueerd. De mediane behandelduur is 18,4 maanden. Uitgaande van het verbruik van 1 verpakking per 28 dagen komt dit uit op 20 verpakkingen en dus €61.600 per patiënt per behandeling. Voor een jaar behandeling komt dit neer op 13 verpakkingen en dus €40.040

Potential total cost per year

Total cost

2,120,000

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Metastatic Hormone-sensitive Prostate Cancer.
References NCT02677896.

Other information

There is currently no futher information available.