Darolutamide

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.

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)

Submission date

March 2019

Expected Registration

March 2020

Orphan drug

No

Registration phase

Registered

Additional comments
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 comments
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 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).

Expected cost per patient per year

Cost

30,000.00 - 40,000.00

References
Medicijnkosten.nl
Additional comments
Moet concurreren met enzolutamide en apalutamide dus de prijs zal vergelijkbaar zijn.

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.

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 comments
Deze indicatieuitbreiding wordt pas na 2023 verwacht.

Other information

There is currently no futher information available.