Niraparib

Extended indication	Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Niraparib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Prostate cancer
Extended indication	Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer
Proprietary name	Zejula
Manufacturer	Janssen
Mechanism of action	PARP inhibitor
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)

Registration

Type of trajectory	Normal trajectory
ATMP	No
Submission date	2024
Expected Registration	2025
Registration phase	Clinical trials
Additional remarks	NCT03748641

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Mediane rPFS in de BRCA1/2 subgroep was significant langer in de niraparib + AAP groep vergeleken met de placebo + AAP groep (16,6 versus 10,9 maanden; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001). Er wordt verwacht dat niraparib niet bij de gehele HHR populatie ingezet zal gaan worden, maar enkel bij patiënten met de BRCA1/2 mutatie.
References	NCT03748641

Expected patient volume per year

Patient volume	< 220 Market share is generally not included unless otherwise stated.
References	(1) IKNL 2022; (2) https://iknl.nl/kankersoorten/prostaatkanker/registratie/incidentie
Additional remarks	In 2022 waren er 12.400 patiënten met prostaatkanker (1). 3.598 (2). Het betreft hier 2.197 patiënten die zich in stadium 4 bevonden. Daarvan heeft ongeveer 10% een BRCA1/2 mutatie.

Patient volume

< 220

Market share is generally not included unless otherwise stated.

References

(1) IKNL 2022; (2) https://iknl.nl/kankersoorten/prostaatkanker/registratie/incidentie

Additional remarks

In 2022 waren er 12.400 patiënten met prostaatkanker (1). 3.598 (2). Het betreft hier 2.197 patiënten die zich in stadium 4 bevonden. Daarvan heeft ongeveer 10% een BRCA1/2 mutatie.

Expected cost per patient per year

References	G-standaard
Additional remarks	Een capsule van 100mg kost €111,45

Potential total cost per year

There is currently nothing known about the possible total cost.

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.