Rucaparib Medicine 12 June 2019 Extended indication Extension of Indication as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Therapeutic value No judgement Total cost € 3,880,000.00 Registration phase Registered and not reimbursed Product Active substance Rucaparib Domain Oncology and Hematology 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 recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to 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 Unknown Submission date 2018 Expected Registration January 2019 Orphan drug Yes Registration phase Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Positieve opinie december 2018. Geregistreerd in januari 2019. Therapeutic value Current treatment options Olaparib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 81 - 113 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 1155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extra-ovarieel ovariumcarcinoom en 61 diagnoses tubacarcinoom. In totaal zijn dit 1342 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. Op basis van literatuurstudies en inschattingen van experts wordt het aantal patiënten dat een kiembaan of somatische mutatie heeft in BRCA ingeschat tussen de 13-18%. Dit zou betekenen dat 81-113 patiënten mogelijk in aanmerking komen voor deze behandeling. Van deze groep valt mogelijk nog een klein aantal patiënten af vanwege toxiciteit of fragiliteit. Expected cost per patient per year Cost € 30,000.00 - 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 Additional remarks Op basis van de inschatting van olaparib is de inschatting dat het zo'n 30.000 - 50.000 euro zal gaan kosten. Prijzen rucaparib tabletten inmiddels ook bekend: tablet 300MG is € 68,03 (i.v.t. 2 tabletten olaparib 150MG: € 96,94). Potential total cost per year Total cost € 3,880,000.00 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 BRCA1/2-mutated metastatic castration resistant prostate cancer - second-line therapy or greater, as monotherapy References SPS Additional remarks Other information Additional remarks