Enzalutamide

Extended indication	Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy.
Therapeutic value	No judgement
Total cost	4,128,000.00
Registration phase	Clinical trials

Product

Active substance	Enzalutamide
Domain	Oncology and Hematology
Main indication	Prostate cancer
Extended indication	Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy.
Proprietary name	Xtandi
Manufacturer	Astellas
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)
Additional remarks	Anti-androgeen, remmer van de androgeenreceptorsignalering.

Registration

Registration route	Centralised (EMA)
Particularity	Indication extension
Submission date	2020
Expected Registration	April 2021
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No judgement
Frequency of administration	1 times a day
Dosage per administration	160 mg
References	NCT02677896
Additional remarks	Studieresultaten verwacht in Q4/2020.

Expected patient volume per year

Patient volume	< 192 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	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).

Patient volume

< 192

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

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	3,000.00 - 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.

Potential total cost per year

Total cost	4,128,000.00 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

4,128,000.00

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

Off label use	Yes

Indication extension

Indication extension	Yes
Indication extensions	Niet gemetastaseerde castratieresistente prostaatkanker (M0CRPC).
References	NCT02003924

Other information

There is currently no futher information available.