Extended indication

Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Can

Therapeutic value

No estimate possible yet

Total cost

15,383,907.00

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

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening in de tweede helft van 2021.

Therapeutic value

Therapeutic value

No estimate possible yet

Frequency of administration

2 times a day

Dosage per administration

300 mg

References
NCT02032823 (OLYMPIA)

Expected patient volume per year

Patient volume

158 - 316

Market share is generally not included unless otherwise stated.

References
IKNL 2018; Pakketadvies palbociclib (Ibrance®)
Additional comments
Invasief mammacarcinoom HER2 negatief kwam in 2018 bij 16.312 patiënten voor. Hiervan bevond 46% zich in stadium II of III. IKNL data geeft aan dat er 6.863 patiënten HER2 plus TNBC zijn. 5%-10% van borstkankers wordt veroorzaakt door BRCA mutaties. Dit zou betekenen dat er uiteindelijk 158-316 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost

64,911.00

References
G-standaard
Additional comments
Behandelduur is tot aan progressie of maximaal 12 maanden; 300mg 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

15,383,907.00

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

Treatment in combination with abiraterone acetate in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) mCRPC (first-line setting). (PROPEL).

Other information

There is currently no futher information available.