Darolutamide

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.

Product

Proprietary name Nubeqa
Manufacturer Bayer
Mechanism of action Antiandrogen
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)
Additional comments Androgreenreceptor blokker.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2021
Expected Registration August 2022
Orphan drug No
Registration phase Clinical trials
Additional comments 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 judgement
Duration of treatment Not found
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 Bron: NKR en ARCHES
Additional comments Totaal aantal nieuwe prostaatkankerpatienten per jaar is meer dan 12000. Patienten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8226 in totaal. Maximaal 20% gaat het om gemetastaseerde hormoon gevoelige prostaatkanker (n = 1645). Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaatkankerpatienten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patienten zich melden. Uiteindelijke inschatting: max 500 patienten die reeel gezien in aanmerking zullen komen.

Expected cost per patient per year

Cost 30,000.00 - 40,000.00
References Medicijnkosten.nl
Additional comments Moet concurreren met enzalutamide en apalutamide dus de prijs zal vergelijkbaar zijn.

Potential total cost per year

Total cost

17,500,000

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.