Rucaparib Medicine 07 December 2022 Extended indication Extension of indication as monotherapy 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. Therapeutic value No estimate possible yet Total cost € 31,250,000.00 Registration phase Registered and not reimbursed Product Active substance Rucaparib Domain Oncology Reason of inclusion Indication extension IND Main indication Ovarian cancer Extended indication Extension of indication as monotherapy 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. Current proprietary name Already available biosimilars / generics Proprietary name Rubraca Manufacturer Clovis Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2022 Expected Registration November 2023 Orphan drug No Registration phase Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Registratie november 2023 Therapeutic value Current treatment options Niraparib, olaparib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Vergelijkbaar met niraparib maar er is geen head-to-head studie beschikbaar. De mediane progressie vrije overleving (95% CI) was 28,7 maanden met rucaparib versus 11,3 maanden (9,1 tot 22,1) met placebo in de HRD populatie (log-rank P = .0004; hazard ratio [HR], 0,47; 95% CI, 0,31 tot 0,72). Duration of treatment Frequency of administration 2 times a day Dosage per administration 600 mg References NCT03522246 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 2021 waren er 1.130 diagnoses epitheliaal ovariumcarcinoom, 142 diagnoses extraovarieel ovariumcarcinoom en 69 diagnoses tubacarcinoom. In totaal zijn dit 1.341 patiënten. Hiervan heeft 47% stadium III (630) en 26% stadium IV (348), wat samen 978 patiënten betreft. Van deze groep hebben 735 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Daarvan hebben 625 patiënten (85%) een complete of gedeeltelijke respons. Van deze groep valt mogelijk nog een aantal patiënten af vanwege toxiciteit of fragiliteit. Expected cost per patient per year Cost € < 50,000.00 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 Medicijnkosten.nl Additional remarks Bij een behandeling van 2 maal per dag 600mg gedurende een jaar komen de kosten uit op ongeveer €50.000. Potential total cost per year Total cost € 31,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks