Talazoparib Medicine 07 December 2022 Extended indication Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. Therapeutic value Possible added value Total cost Registration phase Positive CHMP opinion Product Active substance Talazoparib Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. Current proprietary name Already available biosimilars / generics Proprietary name Talzenna Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date February 2023 Expected Registration January 2024 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in januari 2024 Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Mediane behandelduur in de talazoparib/enzalutamide-arm was 19,8 maanden voor talazoparib en 22,2 maanden voor enzalutamide. Mediane behandelduur in de placebo/enzalutamide-arm was 16,1 maanden voor placebo en 16,6 maanden voor enzalutamide. Duration of treatment Average 0 Not found Frequency of administration Dosage per administration Starting dose talazoparib 0,5MG per day with enzalutimide 160MG per day References Agarwal et al (2023): Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial, https://doi.org/10.1016/ S0140-6736(23)01055-3 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 Taxe november 2023 Additional remarks De lijstprijs van Talzenna 0,25mg (x30) = €1.778,57 (exclusief BTW). Een behandeling van 0,5mg per dag zou neerkomen op €118,57 per dag. Behandelduur voor prostaatkanker is op dit moment nog niet bekend. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks