Olaparib Medicine 09 January 2018 Extended indication Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. (only BRCA mutations included in the indication). Therapeutic value Possible added value Total cost € 5,320,000.00 Registration phase Registered and reimbursed Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. (only BRCA mutations included in the indication). 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 December 2019 Expected Registration November 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2020. Geregistreerd in november 2020. Aanspraak Status ZN: Ja (april 2021). Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Profound studie is positief met aangetoonde OS voordeel (NEJM 2020; 382:2091-2102). Patiënten in Cohort A in de studie moeten BRCA1, BRCA2, of ATM mutatie hebben. Indicatie bevat alleen BRCA gemuteerde patiënten. Positief cieBOM advies in november 2020. Duration of treatment Median 7.4 month / months Frequency of administration 2 times a day Dosage per administration 300mg References NCT02987543; Fabrikant. Additional remarks Expected patient volume per year Patient volume 100 - 165 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom, DOI: 10.1056/NEJMoa1911440 doi: 10.1155/2020/4986365. eCollection 2020. 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), de inschatting is dat het in maximaal 10 % gaat om een mutatie in BRCA 1/2. De verwachting is echter dat het lager zal zijn, inschatting 100-165 patiënten. Expected cost per patient per year Cost € 40,000.00 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 G-standaard; fabrikant. Additional remarks De lijstprijs van een tablet 150mg is €44,46 per tablet. Bij een dosering van 300mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64.911,60 (365*4*€44,46). De mediane behandelduur is echter 7,4 maanden dus de kosten voor een behandeling zullen (€64.911,60/12)*7,4 = €40.029 bedragen. Potential total cost per year Total cost € 5,320,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions - Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) -Treatment in combination with abiraterone acetate in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) mCRPC (first-line setting). (PROPEL). References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks