Extended indication Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Can
Therapeutic value No judgement
Total cost 6,435,000.00
Registration phase Clinical trials

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA).
Proprietary name Lynparza
Manufacturer AstraZeneca
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date October 2021
Expected Registration 2022
Registration phase Clinical trials
Additional remarks Fabrikant verwacht indiening in de 2e helft van 2021.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 2 times a day
References NCT02032823 (OLYMPIA)

Expected patient volume per year

Patient volume

< 99

Market share is generally not included unless otherwise stated.

References IKNL 2016; Pakketadvies palbociclib (Ibrance®)
Additional remarks Invasief mammacarcinoom HER2 negatief kwam in 2016 bij Stadium II in 747 patiënten en bij Stadium III bij 239 patiënten voor. In totaal zouden dit 986 patiënten zijn. 5%-10% van borstkankers wordt veroorzaakt door BRCA mutaties. Dit zou betekenen dat er uiteindelijk maximaal 99 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost 65,000.00
References G-standaard
Additional remarks Indien de maximale behandelduur 24 maanden is 300 mg 2 maal daags. De kosten van 1 tablet zijn €44,46. Voor de behandeling van een jaar betekent dit €64.911,60.

Potential total cost per year

Total cost

6,435,000.00

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.