Olaparib

Extended indication	In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Olaparib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Ovarian cancer
Extended indication	In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
Proprietary name	Lynparza
Manufacturer	AstraZeneca
Portfolio holder	AstraZeneca
Mechanism of action	PARP inhibitor
Therapeutical formulation	Coated tablet
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	2024
Expected Registration	2025
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	De verwachting is dat deze indicatie in de eerste helft van 2024 wordt ingediend.

Therapeutic value

Therapeutic value	No estimate possible yet
Additional remarks	NCT03737643

Expected patient volume per year

Patient volume	< 100 Market share is generally not included unless otherwise stated.
References	NKR2021 (1) Heitz F, Ataseven B, Staniczok C, Denkert C, Rhiem K, Hahnen E, Heikaus S, Moubarak M, Welz J, Dagres T, Vrentas V, Bommert M, Schneider S, Concin N, Harter P. Implementing HRD Testing in Routine Clinical Practice on Patients with Primary High-Grade Advanced Ovarian Cancer. Cancers (Basel). 2023 Jan 29;15(3):818. doi: 10.3390/cancers15030818. PMID: 36765776; PMCID: PMC9913091 (2)
Additional remarks	In 2021 waren er 1.130 diagnoses epitheliaal ovariumcarcinoom, 142 diagnoses extraovarieel ovariumcarcinoom en 69 diagnoses tubacarcinoom. In totaal zijn dit 1.341 patiënten. Hiervan heeft 47% stadium III (630) en 26% stadium IV (348), wat samen 978 patiënten betreft. Ongeveer 20% van deze patiënten heeft geen tumor BRCA1/2 mutatie (non-tBRCAm) (2). Op basis van de studie, betreft het alleen HRD+ patiënten. De inschatting van het patiënt volume is minder dan 100.

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References

NKR2021 (1) Heitz F, Ataseven B, Staniczok C, Denkert C, Rhiem K, Hahnen E, Heikaus S, Moubarak M, Welz J, Dagres T, Vrentas V, Bommert M, Schneider S, Concin N, Harter P. Implementing HRD Testing in Routine Clinical Practice on Patients with Primary High-Grade Advanced Ovarian Cancer. Cancers (Basel). 2023 Jan 29;15(3):818. doi: 10.3390/cancers15030818. PMID: 36765776; PMCID: PMC9913091 (2)

Additional remarks

In 2021 waren er 1.130 diagnoses epitheliaal ovariumcarcinoom, 142 diagnoses extraovarieel ovariumcarcinoom en 69 diagnoses tubacarcinoom. In totaal zijn dit 1.341 patiënten. Hiervan heeft 47% stadium III (630) en 26% stadium IV (348), wat samen 978 patiënten betreft. Ongeveer 20% van deze patiënten heeft geen tumor BRCA1/2 mutatie (non-tBRCAm) (2). Op basis van de studie, betreft het alleen HRD+ patiënten. De inschatting van het patiënt volume is minder dan 100.

Expected cost per patient per year

References	G-Standaard
Additional remarks	€2.490,00 per verpakking van 56 tabletten.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.