Extended indication

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline B

Therapeutic value

No judgement

Total cost

1,602,240.00

Registration phase

Registered and reimbursed

Product

Active substance

Olaparib

Domain

Oncology and Hematology

Reason of inclusion

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.

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

July 2020

Orphan drug

No

Registration phase

Registered and reimbursed

Additional comments
Positieve CHMP-opinie in juni 2020.

Therapeutic value

Current treatment options

Chemotherapie

Therapeutic value

No judgement

Substantiation

Resultaten POLO trial in NEJM 2019 gepubliceerd; tonen effect op PFS, (nog) geen effect op OS voor zeer kleine groep patiënten; wel proof-of-principle studie. Gezien positieve CHMP opinie ligt het dossier bij de cieBOM.

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 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.

Expected cost per patient per year

Cost

40,056.00

References
fabrikant; z-index
Additional comments
Prijs per maand is (4*€44,46*365,25)/12) = €5.413 * 7,4 = € 40.056.

Potential total cost per year

Total cost

1,602,240.00

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

Colorectal cancer; Non-small cell lung cancer; Squamous cell cancer.

References
adisinsight
Additional comments
Fase 3 studies

Other information

There is currently no futher information available.