Olaparib Medicine 08 June 2021 Extended indication Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. Therapeutic value No estimate possible yet Total cost € 195,000,000.00 Registration phase Registered Product Active substance Olaparib Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza Manufacturer AstraZeneca Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Tablet 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 January 2022 Expected Registration December 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie eind 2022. Olaparib is per 26 augustus 2022 breed uitgesloten van het basispakket voor nieuwe indicaties. (https://zoek.officielebekendmakingen.nl/stcrt-2022-22265.html). Positieve CHMP-opinie november 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit de interim resultaten van de studie (NCT03732820) bleek een significant effect op de rPFS (24,8 versus 16,6 maanden; hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54–0.81; P<0.0001). De resultaten lijken met name gedreven door HRR status. Duration of treatment Frequency of administration 2 times a day Dosage per administration 300 mg References NCT03732820, NCT03012321 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 tot 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 € < 65,000.00 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 Additional remarks Prijs per jaar is (4*€44,46*365) is zo'n €65.000. Echter, de behandelduur is nog niet bekend. Potential total cost per year Total cost € 195,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks