Darolutamide

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.
Therapeutic value	No judgement
Total cost	1,855,000.00
Registration phase	Registered

Product

Active substance	Darolutamide
Domain	Oncology and Hematology
Reason of inclusion	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.
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)
Submission date	March 2019
Expected Registration	March 2020
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP-opinie in januari 2020

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 remarks	Studieresultaten van de ARASENS studie verwacht in Q4/2020.

Expected patient volume per year

Patient volume	53 Market share is generally not included unless otherwise stated.
References	NKR; Kanker.nl; Fabrikant
Additional remarks	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).

Patient volume

53

Market share is generally not included unless otherwise stated.

References

NKR; Kanker.nl; Fabrikant

Additional remarks

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).

Expected cost per patient per year

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

Potential total cost per year

Total cost	1,855,000.00 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.

Total cost

1,855,000.00

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

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

Other information

There is currently no futher information available.