Olaparib

Active substance
Olaparib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Ovarian cancer
Extended indication
Extension of indication to include the use of Lynparza tablets in combination with bevacizumab for the 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.

1. Product

Proprietary name
Lynparza
Manufacturer
AstraZeneca
Mechanism of action
PARP inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Combinatie van een PARP-remmer met VEGF-remmer.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
December 2019
Expected Registration
November 2020
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Fabrikant verwacht de registratie in Q4 2020.

3. Therapeutic value

Current treatment options
Chemotherapie
Therapeutic value
No judgement
Duration of treatment
Median 17.3 month / months
Frequency of administration
2 times a day
Dosage per administration
300 mg
References
PAOLA-1: NCT02477644; Ray-Coquard et al. N Engl J Med 2019; 381:2416-2428
Additional comments
Toepasssing bevacicumab 1L heeft een negatief CieBOM advies.

4. Expected patient volume per year

References
NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie
Additional comments
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. Aangezien bevacizumab in de eerstelijnsbehandeling ovariumcarcinoom in Nederland geen standaardpraktijk is, zal de combinatie beva-olaparib in principe geen toepassing gaan vinden in Nederland.

5. Expected cost per patient per year

Cost
65,000
References
G-standaard
Additional comments
Maximale behandelduur is 24 maanden 300 mg 2 maal daags. De kosten van 1 tablet zijn €44,46. Voor de behandeling van een jaar betekent dit €64.911,60. Hier komt bevacizumab nog bij.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Momenteel in fase 3: Non-small cell lung cancer; Pancreatic cancer; Squamous cell cancer
References
Clinicaltrials.gov

9. Other information

There is currently no futher information available.