Version 2

Rucaparib

Medicine

Extended indication Monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelia
Therapeutic value No judgement
Total cost € 5,220,000.00
Registration phase Registered

Product

Active substance Rucaparib
Domain Oncology and Hematology
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 Unknown
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
ATMP Unknown
Submission date December 2016
Expected Registration May 2018
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie maart 2018

Therapeutic value

Current treatment options Olaparib
Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume < 87

Market share is generally not included unless otherwise stated.
References NKR, CieBOM
Additional remarks In 2016 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4, hiervan heeft de helft waarschijnlijk een BRCA mutatie. Dat betekent maximaal 174 patiënten. Realistisch (gezien concurentie en 2L,3L behandeling) zal maar de helft hiervan voor het middel in aanmerking komen.

Expected cost per patient per year

Cost € 60,000.00

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 Schatting o.b.v. olaparib (capsule van 50 mg €11,78)

Potential total cost per year

Total cost € 5,220,000.00

Off label use

Off label use Unknown

Indication extension

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

Other information