Niraparib (tosylate monohydrate)

Extended indication	Zejula is geïndiceerd als monotherapie voor de onderhoudsbehandeling van volwassen patiënten met platinagevoelige, gerecidiveerde, hooggradige sereuze epitheliale eierstok-, eileider- of primaire peritoneumkanker, die (volledig of partieel) reageren op platina gebaseerde chemotherapie.
Therapeutic value	No judgement
Total cost	15,630,000.00

Product

Active substance	Niraparib (tosylate monohydrate)
Domain	Oncology and Hematology
Main indication	Ovarian cancer
Extended indication	Zejula is geïndiceerd als monotherapie voor de onderhoudsbehandeling van volwassen patiënten met platinagevoelige, gerecidiveerde, hooggradige sereuze epitheliale eierstok-, eileider- of primaire peritoneumkanker, die (volledig of partieel) reageren op platina gebaseerde chemotherapie.
Proprietary name	Zejula
Manufacturer	Tesaro
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	November 2016
Expected Registration	November 2017
Orphan drug	Yes
Additional remarks	Geregistreerd in november 2017.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Median 11 month / months

Expected patient volume per year

Patient volume	174 - 347 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	In 2016 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4. Realistisch (gezien concurentie en 2L,3L behandeling) zal maar de helft hiervan het middel ontvangen.

Patient volume

174 - 347

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

In 2016 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4. Realistisch (gezien concurentie en 2L,3L behandeling) zal maar de helft hiervan het middel ontvangen.

Expected cost per patient per year

Cost	50,000.00 - 70,000.00
References	GoodRx.com
Additional remarks	In de VS kost Niraparib $15.000 voor 90 capsules van 100mg. Schatting pppj is op basis van olaparib.

Potential total cost per year

Total cost	15,630,000.00 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

15,630,000.00

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.