Extended indication

Lynparza in combination with bevacizumab is indicated for the maintenance treatment of adult patient

Therapeutic value

No judgement

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 (december 2020)

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.

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 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.

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

Momenteel in fase 3: Non-small cell lung cancer; Pancreatic cancer; Squamous cell cancer.

References
Clinicaltrials.gov

Other information

There is currently no futher information available.