Niraparib (Zejula®) for recurrent OVCA maintenance treatment

Assessment Status Assessment Process Complete
Drug Niraparib
Brand Zejula®
Indication Is indicated as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Assessment Process
Rapid review commissioned 01/06/2018
Rapid review completed 21/06/2018
Rapid review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of niraparib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/06/2018
Pre-submission consultation with Applicant 14/08/2018
Full submission received from Applicant 09/01/2019
Preliminary review sent to Applicant 21/03/2019
NCPE assessment re-commenced 23/04/2019
Factual accuracy sent to Applicant 19/07/2019
NCPE assessment re-commenced 26/07/2019
NCPE assessment completed 14/08/2019
NCPE assessment outcome The NCPE recommends that niraparib (Zejula®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.*

Technical Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations March 2021.