Darolutamide

Active substance
Darolutamide
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Prostate cancer
Extended indication
Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

1. 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.

2. Registration

Registration route
Centralised (EMA)
Submission date
March 2019
Expected Registration
March 2020
Orphan drug
No
Registration phase
Registered
Additional comments
Positieve CHMP-opinie in januari 2020

3. Therapeutic value

Current treatment options
Enzalutamide en apalutamide zijn geregistreerd voor deze indicatie.
Therapeutic value
No judgement
Substantiation
Metastasevrije overleving was significant langer in vergelijking met placebo. De verwachting is dat de therapeutische waarde vergelijkbaar is met met enzalutamide en apalutamide.
Duration of treatment
Median 14.8 month / months
Frequency of administration
2 times a day
Dosage per administration
600 mg
References
NCT02200614; Fizazi et al. N Engl J Med. 2019 Mar 28;380(13):1235-1246
Additional comments
Studieresultaten van de ARASENS studie verwacht in Q4/2020.

4. Expected patient volume per year

Patient volume

53

Market share is generally not included unless otherwise stated.

References
NKR; Kanker.nl; Fabrikant
Additional comments
In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Darolutamide zal binnen deze indicatie moeten moeten concurreren met apalutamide en enzalutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53).

5. Expected cost per patient per year

Cost
30,000 - 40,000
References
Medicijnkosten.nl
Additional comments
Moet concurreren met enzolutamide en apalutamide dus de prijs zal vergelijkbaar zijn.

6. Potential total cost per year

Total cost

1,855,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Metastatic castration sensitive cancer.
References
NCT02799602
Additional comments
Deze indicatieuitbreiding wordt pas na 2023 verwacht.

9. Other information

There is currently no futher information available.