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Olaparib

Lynparza

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 comments 
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 comments 
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 comments 
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.