Enzalutamide

Extended indication	De behandeling van volwassen mannen met niet-gemetastaseerd hoog risico-CRPC (castratieresistent prostaatcarcinoom).
Therapeutic value	No judgement
Total cost	2,120,000.00
Registration phase	Registered and reimbursed

Product

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).
Proprietary name	Xtandi
Manufacturer	Astellas
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	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 remarks	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 remarks	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).

Patient volume

53

Market share is generally not included unless otherwise stated.

References

NKR; Kanker.nl; Fabrikant.

Additional remarks

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 remarks	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	2,120,000.00 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.

Total cost

2,120,000.00

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

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.