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Olaparib

Lynparza

Extended indication Maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial
Therapeutic value No judgement
Total cost 40,625,000.00
Registration phase Clinical trials

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Ovarian cancer
Extended indication Maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy with bevacizumab
Proprietary name Lynparza
Manufacturer AstraZeneca
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Combinatie van een PARP-remmer met VEGF-remmer.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2019
Expected Registration November 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No judgement
Duration of treatment Average 24 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References NCT02477644

Expected patient volume per year

Patient volume

< 625

Market share is generally not included unless otherwise stated.
References NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie
Additional remarks In 2018 waren er 1.155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extra-ovarieel ovariumcarcinoom en 61 diagnoses tubacarcinoom. In totaal zijn dit 1.342 patiënten. Hiervan heeft 47% stadium III (631) en 26% stadium IV (349), wat samen 980 patiënten betreft. Van deze groep hebben 735 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Van deze groep hebben 625 patiënten (85%) een complete of gedeeltelijke respons. Van deze groep valt mogelijk nog een klein aantal patiënten af vanwege toxiciteit of fragiliteit.

Expected cost per patient per year

Cost 65,000.00
References G-standaard
Additional remarks Maximale behandelduur is 24 maand 300 mg 2dd ( €64.740 per jaar) in combinatie met bevacizumab.

Potential total cost per year

Total cost

40,625,000.00

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 Momenteel in fase 3: Non-small cell lung cancer; Pancreatic cancer; Prostate cancer; Squamous cell cancer
References Clinicaltrials.gov

Other information

There is currently no futher information available.