Extended indication Ovarian cancer; BRCA-mutated or with BRCA-like mutation, platinum-sensitive, 2L of 3L.
Therapeutic value No judgement
Total cost 7,830,000.00

Product

Active substance Rucaparib
Domain Oncology and Hematology
Main indication Ovarian cancer
Extended indication Ovarian cancer; BRCA-mutated or with BRCA-like mutation, platinum-sensitive, 2L of 3L.
Proprietary name Rubraca
Manufacturer Clovis
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2016
Expected Registration February 2018
Orphan drug Yes

Therapeutic value

Current treatment options Olaparib
Therapeutic value No judgement

Expected patient volume per year

Patient volume

87 - 174

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 het middel ontvangen.

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)

Potential total cost per year

Total cost

7,830,000.00

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 third-line therapy (phIII); Pancreatic cancers (phII).

Other information

There is currently no futher information available.