Extended indication Metastatic breast cancer with gBRCA1/2 mutations - monotherapy in patients who have previously recei
Therapeutic value No judgement
Total cost 3,412,500.00
Registration phase Registration application pending

Product

Active substance Olaparib
Domain Oncology and Hematology
Main indication Breast cancer
Extended indication Metastatic breast cancer with gBRCA1/2 mutations - monotherapy in patients who have previously received treatment with anthracycline and taxane and are suitable for single-agent chemotherapy.
Proprietary name Lynparza
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks PARP inhibitor

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date April 2018
Expected Registration December 2018
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Concurrentie van alle parp-remmers.
Therapeutic value No judgement
Duration of treatment Median 8 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References Robson, M. et al. N. Engl. J. Med. 2017 377, 523–533.
Additional remarks Mediane behandelduur is 8,2 maanden.

Expected patient volume per year

Patient volume

40 - 155

Market share is generally not included unless otherwise stated.

References Fabrikant: berekeningen op basis van Kankerzorginbeeld 2014, IKNL, OlympiAD publicatie.

Expected cost per patient per year

Cost 35,000.00
References Fabrikant
Additional remarks €11,78 voor 50mg capsule.

Potential total cost per year

Total cost

3,412,500.00

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.