Extended indication Monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutat
Therapeutic value No judgement
Total cost 2,940,000.00
Registration phase Registered

Product

Active substance Rucaparib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Ovarian cancer
Extended indication Monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy (2L / 3L).
Proprietary name Rubraca
Manufacturer Clovis
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2016
Expected Registration May 2018
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie maart 2018. Geregistreerd in mei 2018.

Therapeutic value

Current treatment options Olaparib
Therapeutic value No judgement

Expected patient volume per year

Patient volume

41 - 57

Market share is generally not included unless otherwise stated.

References NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie; CieBOM
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% wat 81-113 patiënten betreft. Realistisch (gezien concurentie en 2L,3L behandeling) zal maar de helft hiervan voor het middel in aanmerking komen. In dit geval zullen hier 41-57 patiënten voor in aanmerking komen.

Expected cost per patient per year

Cost 60,000.00
References Medicijnkosten.nl
Additional remarks Schatting o.b.v. olaparib (capsule van 50 mg €11,78). 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

2,940,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Ovarian cancer; advanced BRCA-mutated - maintenance therapy following response to thirdline therapy (phIII); Pancreatic cancers (phII).

Other information

There is currently no futher information available.