Olaparib

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).

Product

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

Duration of treatment

Not found

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

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.