Olaparib Medicine 10 December 2019 Extended indication Maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy with bevacizumab Therapeutic value No judgement Total cost € 40,625,000.00 Registration phase Clinical trials Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Ovarian cancer Extended indication Maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy with bevacizumab 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 Combinatie van een PARP-remmer met VEGF-remmer. 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 Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 24 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References NCT02477644 Additional remarks Expected patient volume per year Patient volume < 625 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie Additional remarks In 2018 waren er 1.155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extra-ovarieel ovariumcarcinoom en 61 diagnoses tubacarcinoom. In totaal zijn dit 1.342 patiënten. Hiervan heeft 47% stadium III (631) en 26% stadium IV (349), wat samen 980 patiënten betreft. Van deze groep hebben 735 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Van deze groep hebben 625 patiënten (85%) een complete of gedeeltelijke respons. Van deze groep valt mogelijk nog een klein aantal patiënten af vanwege toxiciteit of fragiliteit. 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 G-standaard Additional remarks Maximale behandelduur is 24 maand 300 mg 2dd ( €64.740 per jaar) in combinatie met bevacizumab. Potential total cost per year Total cost € 40,625,000.00 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 Momenteel in fase 3: Non-small cell lung cancer; Pancreatic cancer; Prostate cancer; Squamous cell cancer References Clinicaltrials.gov Additional remarks Other information Additional remarks