Expand all sections

Rucaparib

Rubraca

Extended indication Extension of indication as monotherapy for the maintenance treatment of adult patients with advanced
Therapeutic value No estimate possible yet
Total cost 31,250,000.00
Registration phase Positive CHMP opinion

Product

Active substance Rucaparib
Domain Oncology
Reason of inclusion Indication extension
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.
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
ATMP No
Submission date September 2022
Expected Registration December 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie oktober 2023

Therapeutic value

Current treatment options Niraparib, olaparib.
Therapeutic value No estimate possible yet
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).
Frequency of administration 2 times a day
Dosage per administration 600 mg
References NCT03522246

Expected patient volume per year

Patient volume

< 625

Market share is generally not included unless otherwise stated.
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
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

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.