Niraparib / abiraterone Medicine 07 December 2021 Extended indication Castration resistant prostate cancer in combination with prednisone Therapeutic value No estimate possible yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Janssen Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Mechanism of action = PARP inhibitor + CYP17 inhibitor. Therapeutic formulation: tablets or capsules Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Janssen: expected registration Q2 2023 Therapeutic value Current treatment options ADT, abiraterone/prednisone, docetaxel, enzalutamide Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration 1 times a day Dosage per administration 200 mg niraparib + 1000 mg abiraterone + 10 mg prednisone References clinicaltrials.gov. Trial NCT03748641 Additional remarks Expected patient volume per year Patient volume < 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom Additional remarks 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 Cost References medicijnkosten.nl Additional remarks 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions mHSPC References clinicaltrials.gov Additional remarks extended indication falls outside Horizonscan window Other information Additional remarks