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Darolutamide

Nubeqa

Extended indication

Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT.
Therapeutic value

No estimate possible yet
Total cost

17,500,000.00
Registration phase

Clinical trials

Product

Active substance

Darolutamide
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT.
Proprietary name

Nubeqa
Manufacturer

Bayer
Mechanism of action

Antiandrogen
Route of administration

Oral
Therapeutical formulation

Film-coated tablet
Budgetting framework

Intermural (MSZ)
Additional remarks 
Androgreenreceptor blokker.

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

2022
Expected Registration

2023
Orphan drug

No
Registration phase

Clinical trials
Additional remarks 
De fabrikant verwacht indiening in het vierde kwartaal van 2021 en registratie in het derde kwartaal van 2022.

Therapeutic value

Current treatment options

Docetaxel met ADT of tweede generatie anti-androgeen (abiraterone, enzalutamide, apalutamide) met ADT.
Therapeutic value

No estimate possible yet
Frequency of administration

2 times a day
Dosage per administration

600 mg
References 
ARASENS (NCT02799602);

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
References 
NKR en ARCHES
Additional remarks 
Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaat kankerpatiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: maximaal 500 patiënten die reëel gezien in aanmerking zullen komen.

Expected cost per patient per year

Cost

30,000.00 - 40,000.00
References 
Z-Index, Taxe November 2021
Additional remarks 
Op basis van behandelduur van 12 maanden.

Potential total cost per year

Total cost

17,500,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.