Extended indication Castration resistant prostate cancer in combination with prednisone
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Niraparib / abiraterone
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Castration resistant prostate cancer in combination with prednisone
Manufacturer Janssen
Mechanism of action Other
Route of administration Oral
Budgetting framework Intermural (MSZ)
Additional comments Mechanism of action = PARP inhibitor + CYP17 inhibitor. Therapeutic formulation: tablets or capsules

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Janssen: expected registration Q2 2023

Therapeutic value

Current treatment options ADT, abiraterone/prednisone, docetaxel, enzalutamide
Therapeutic value No estimate possible yet
Substantiation Resultaten uit de (MAGNITUDE) studie worden later in 2022 verwacht. De Propel studie van concurrent olaparib is gepubliceerd, deze resultaten waren positief. Toepassing in de 1e lijn zal er komen, de vraag is welke PARP-remmer het meest effectief zal zijn.
Frequency of administration 1 times a day
Dosage per administration 200 mg niraparib + 1000 mg abiraterone + 10 mg prednisone
References clinicaltrials.gov. Trial NCT03748641

Expected patient volume per year

Patient volume

< 3,000

Market share is generally not included unless otherwise stated.

References NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom
Additional comments Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Het gaat hierbij om zo’n 2.400-3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten met CRPC uitzaaiingen hebben is de verwachting bijna de gehele groep mCRPC patiënten betreft.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments Niraparib kost €191,58 per 200mg. Abiraterone kost €104,20 per 1.000mg. Prednison kost €0,18 per10mg. Dit op basis van lijstprijzen (exclusief BTW). De kosten voor deze combinatietherapie zijn nog niet bekend.

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

Indication extension Yes
Indication extensions mHSPC
References clinicaltrials.gov
Additional comments extended indication falls outside Horizonscan window

Other information

There is currently no futher information available.