Extended indication Lynparza in combination with bevacizumab is indicated for the maintenance treatment of adult patient
Therapeutic value No estimate possible yet
Registration phase Registered and not reimbursed

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Ovarian cancer
Extended indication Lynparza in combination with bevacizumab is indicated 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.
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.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2019
Expected Registration November 2020
Orphan drug No
Registration phase Registered and not reimbursed
Additional comments Positieve CHMP-opinie in september 2020. Aanspraak status ZN: Nee (april 2020)

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No estimate possible yet
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.

Expected patient volume per year

References NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; Konstantinopoulos et al. 2015, DOI: 10.1158/2159-8290.CD-15-0714; expertopinie.
Additional comments In 2018 waren er 1.155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extraovarieel 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. Hiervan is naar verwachting 50% HDR positief (313). Aangezien bevacizumab in de eerstelijnsbehandeling ovariumcarcinoom in Nederland geen standaardpraktijk is, zal de combinatie beva-olaparib in principe geen toepassing gaan vinden in Nederland.

Expected cost per patient per year

Cost 65,000.00
References G-standaard
Additional comments Maximale behandelduur is 24 maanden 300mg 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.

Potential total cost per year

There is currently nothing known about the possible total cost.

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 Clinicaltrials.gov

Other information

There is currently no futher information available.