Olaparib

Extended indication	Metastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on first line platinum based chemotherapy.
Therapeutic value	No judgement
Total cost	2,047,500.00
Registration phase	Clinical trials

Product

Active substance	Olaparib
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Pancreatic cancer
Extended indication	Metastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on first line platinum based chemotherapy.
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	2019
Expected Registration	2020
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	POLO trial

Therapeutic value

Current treatment options	Concurrentie van alle parp-remmers.
Therapeutic value	No judgement
Frequency of administration	2 times a day
Dosage per administration	300 mg
References	POLO trial: NCT02184195
Additional remarks	De behandelduur is nog niet bekend.

Expected patient volume per year

Patient volume	19 - 65 Market share is generally not included unless otherwise stated.
References	Fabrikant; NKR; Examining the Relationship Between BRCA and Pancreatic Cancer, curetoday.com
Additional remarks	NKR 2015: 1301 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben. Fabrikant geeft een realistisch patientvolume aan van 19.

Patient volume

19 - 65

Market share is generally not included unless otherwise stated.

References

Fabrikant; NKR; Examining the Relationship Between BRCA and Pancreatic Cancer, curetoday.com

Additional remarks

NKR 2015: 1301 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben. Fabrikant geeft een realistisch patientvolume aan van 19.

Expected cost per patient per year

Cost	32,500.00 - 65,000.00
References	G-standaard / Medicijnkosten.nl
Additional remarks	De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij een dosering van 300 mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64,911,60 (3654€44,46). Onbekend is echter wat de behandelduur is. Bij een behandelduur van 6-12 manden is de prijsrange €32.500-€65.000

Potential total cost per year

Total cost	2,047,500.00 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.

Total cost

2,047,500.00

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	Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer
References	NCT02477644

Other information

There is currently no futher information available.