Olaparib

Active substance
Olaparib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Pancreatic cancer
Extended indication
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

1. Product

Proprietary name
Lynparza
Manufacturer
AstraZeneca
Mechanism of action
PARP inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2019
Expected Registration
August 2020
Orphan drug
No
Registration phase
Positive CHMP opinion
Additional comments
Positieve CHMP-opinie in juni 2020.

3. 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

4. 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 comments
NKR 2016: 1.432 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben (72). Vrijwel iedereen komt uiteindelijk in een gemetastaseerd stadium maar niet iedereen wordt behandeld, inschatting van de werkgroep: 30-50 patiënten per jaar. Het is de vraag of er een richtlijn zal komen betreffende het screenen op een BRCA mutatie.

5. Expected cost per patient per year

Cost
40,000
References
G-standaard
Additional comments
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 (7,4x30,4x4x€44,46).

6. Potential total cost per year

Total cost

1,600,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Colorectal cancer; Non-small cell lung cancer; Squamous cell cancer
References
adisinsight
Additional comments
Fase 3 studies

9. Other information

There is currently no futher information available.