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Rucaparib

Rubraca

Extended indication Extension of indication to include maintenance treatment of adult patients with advanced (FIGO Stage
Therapeutic value No estimate possible yet
Total cost 31,800,000.00
Registration phase Registration application pending

Product

Active substance Rucaparib
Domain Oncology
Reason of inclusion Indication extension
Main indication Ovarian cancer
Extended indication Extension of indication to include maintenance treatment of adult patients with advanced (FIGO Stages III and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to 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 July 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Niraparib
Therapeutic value No estimate possible yet
Substantiation Vergelijkbaar met niraparib maar er is geen head-to-head studie beschikbaar.
Frequency of administration 2 times a day
Dosage per administration 600 mg
References NCT03522246

Expected patient volume per year

Patient volume

< 636

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 2020 waren er 1183 diagnoses epitheliaal ovariumcarcinoom, 127 diagnoses extra-ovarieel ovariumcarcinoom en 56 diagnoses tubacarcinoom. In totaal zijn dit 1366 patiënten. Hiervan heeft 47% stadium III (642) en 26% stadium IV (355), wat samen 997 patiënten betreft. Van deze groep hebben 748 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Van deze groep hebben 636 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 600 mg gedurende een jaar komen de kosten uit op ongeveer €50.000.

Potential total cost per year

Total cost

31,800,000.00

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.