Olaparib Medicine 07 June 2022 Extended indication treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Olaparib Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone 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 Unknown Submission date January 2022 Expected Registration December 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in 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 Duration of treatment Frequency of administration 2 times a day Dosage per administration Olaparib 300 mg for days 1-28 in 28 day cycles. References NCT03012321 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 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 8226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten). Expected cost per patient per year Cost € < 39,922.00 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 G-standaard, november 2021. Additional remarks Uitgaande van 12 maanden behandelduur. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks