Olaparib

Extended indication	Extension of indication for the maintenance treatment of gBRCAm metastatic pancreatic cancer in adults whose disease has not progressed on first line platinum based chemotherapy.
Therapeutic value	No judgement
Total cost	1,600,000.00
Registration phase	Registration application pending

Product

Active substance	Olaparib
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Pancreatic cancer
Extended indication	Extension of indication for the maintenance treatment of gBRCAm metastatic pancreatic cancer 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	July 2019
Expected Registration	May 2020
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Fabrikant verwacht registratie in Q2 2020.

Therapeutic value

Current treatment options	Chemotherapie
Therapeutic value	No judgement
Duration of treatment	Not found
Frequency of administration	2 times a day
Dosage per administration	300 mg
References	POLO trial: NCT02184195

Expected patient volume per year

Patient volume	30 - 50 Market share is generally not included unless otherwise stated.
References	NKR; Examining the Relationship Between BRCA and Pancreatic Cancer, curetoday.com
Additional remarks	NKR 2016: 1.432 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben (72). Vrijwel iedereen wordt gemetastaseerd maar niet iedereen wordt behandeld, inschatting van de werkgroep: 30-50 patiënten per jaar

Patient volume

30 - 50

Market share is generally not included unless otherwise stated.

References

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

Additional remarks

NKR 2016: 1.432 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben (72). Vrijwel iedereen wordt gemetastaseerd maar niet iedereen wordt behandeld, inschatting van de werkgroep: 30-50 patiënten per jaar

Expected cost per patient per year

Cost	40,000.00
References	G-standaard
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 7,4 maanden is de totaalprijs €40,006,89 (7,430,44*€44,46).

Potential total cost per year

Total cost	1,600,000.00 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

1,600,000.00

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.