Extended indication Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT.
Therapeutic value Possible added value
Total cost 17,500,000.00
Registration phase Registration application pending

Product

Active substance Darolutamide
Domain Oncology
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 comments Androgreenreceptor blokker.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration November 2022
Orphan drug No
Registration phase Registration application pending
Additional comments De indicatie-uitbreiding is in maart 2022 ingediend bij de EMA. De fabrikant verwacht registratie in het vierde kwartaal van 2022.

Therapeutic value

Current treatment options Docetaxel met ADT of tweede generatie anti-androgeen (abiraterone, enzalutamide, apalutamide) met ADT.
Therapeutic value Possible added value
Substantiation De fase 3 ARASENS studie heeft zijn primaire eindpunt gehaald. De overall survival (OS) nam significant toe vergeleken met docetaxel en ADT.
Duration of treatment Median 41 month / months
Frequency of administration 2 times a day
Dosage per administration 600 mg
References ARASENS (NCT02799602); https://pubmed.ncbi.nlm.nih.gov/35179323/

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

References NKR en ARCHES
Additional comments 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 G-standaard, november 2021
Additional comments 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.