Olaparib Medicine 10 December 2019 Extended indication Lynparza in combination with bevacizumab is indicated for the 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. Therapeutic value No judgement Total cost Registration phase Registered and not reimbursed Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Ovarian cancer Extended indication Lynparza in combination with bevacizumab is indicated for the 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. 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 Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2020. Aanspraak status ZN: Nee (december 2020) 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 Median 17.3 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References PAOLA-1: NCT02477644; Ray-Coquard et al. N Engl J Med 2019; 381:2416-2428 Additional remarks Toepasssing bevacicumab 1L heeft een negatief cieBOM advies. Expected patient volume per year Patient volume 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; Konstantinopoulos et al. 2015, DOI: 10.1158/2159-8290.CD-15-0714; expertopinie. Additional remarks In 2018 waren er 1.155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extraovarieel 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. Hiervan is naar verwachting 50% HDR positief (313). Aangezien bevacizumab in de eerstelijnsbehandeling ovariumcarcinoom in Nederland geen standaardpraktijk is, zal de combinatie beva-olaparib in principe geen toepassing gaan vinden in Nederland. 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 maanden 300 mg 2 maal daags. De kosten van 1 tablet zijn €44,46. Voor de behandeling van een jaar betekent dit €64.911,60. Hier komt bevacizumab nog bij. 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 Yes Indication extensions Momenteel in fase 3: Non-small cell lung cancer; Pancreatic cancer; Squamous cell cancer. References Clinicaltrials.gov Additional remarks Other information Additional remarks