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Niraparib (tosylate monohydrate)

Medicine

Extended indication Zejula is geïndiceerd als monotherapie voor de onderhoudsbehandeling van volwassen patiënten met platinagevoelige, gerecidiveerde, hooggradige sereuze
Therapeutic value No judgement
Total cost € 15,660,000.00
Registration phase Unknown

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
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

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

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
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.

Expected cost per patient per year

Cost € 50,000.00 - 70,000.00

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.
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 € 15,660,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information