Extended indication Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline B
Therapeutic value Possible added value
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. Registratie in juli 2020. Aanspraakstatus ZN JA

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value Possible added value
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. Positief CieBOM advies in sept 2020.
Duration of treatment Median 7.4 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References POLO trial: NCT02184195 https://www.nvmo.org/bom/onderhoudsbehandeling-met-olaparib-bij-gemetastaseerd-pancreascarcinoom/?meta

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 - Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) -Treatment in combination with abiraterone acetate in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) mCRPC (first-line setting). (PROPEL)
References adisinsight
Additional comments Fase 3 studies

Other information

There is currently no futher information available.