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

February 2023

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.