Olaparib Medicine 09 January 2018 Extended indication Extension of indication to include the use of Lynparza tablets as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent. Therapeutic value No judgement Total cost € 4,000,000.00 Registration phase Registration application pending Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Extension of indication to include the use of Lynparza tablets as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent. 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 Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q4 2020. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 7.4 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References NCT02987543; fabrikant Additional remarks Expected patient volume per year Patient volume 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Na et al. Eur Urol. 2017 May;71(5):740-747; Kirby et al. Int J Clin Pract. 2011 Nov;65(11):1180-92 Additional remarks NKR 2015: 2.568 gevallen van prostaatkanker, stadia 3 en 4. Ongeveer 6% van prostaattumoren heeft een mutatie in BRCA of ATM (154). 10-20% van de prostaatkankerpatiënten ontwikkelt CRPC (15-30). Het gaat echter niet om een 1e lijns behandeling. Om die reden zal het aantal patiënten dat in aanmerking komt voor dit middel naar schatting eerder rond de 100 patiënten per jaar liggen. 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 150 mg is €44,46 per tablet. Bij een dosering van 300 mg 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 € 4,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Colorectal cancer; Non-small cell lung cancer; Squamous cell cancer References adisinsight Additional remarks Lopende fase 3 studies. Other information Additional remarks