Extended indication Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer.
Therapeutic value Possible added value
Total cost 15,383,907.00
Registration phase Registration application pending

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.
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 August 2022
Orphan drug No
Registration phase Registration application pending
Additional comments Fabrikant verwacht indiening in de tweede helft van 2021.

Therapeutic value

Therapeutic value Possible added value
Substantiation De resultaten van de studie zijn inmiddels bekend en gepubliceerd. Mediane follow-up van 2,5 jaar, de 3-jaars invasieve ziekte vrije overleving was 85,9% in de olaparib groep en 77,1% in de placebo groep. De hazard ratio voor invasieve ziekte of sterfte, 0,58. De verwachting is dat het de PAKSWILL-criteria zal halen.
Duration of treatment Median 350 day / days
Frequency of administration 2 times a day
Dosage per administration 300 mg
References NCT02032823 (OLYMPIA) https://www.nejm.org/doi/full/10.1056/NEJMoa2105215

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, 42%. Daarnaast wordt 5%-10% van de borstkankers 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.