Niraparib (Zejula®) for 1L maintenance OVCA. HTA ID: 21004

Assessment Status NCPE Assessment Process Complete
HTA ID 21004
Drug Niraparib
Brand Zejula®
Indication Is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Assessment Process
Rapid review commissioned 22/02/2021
Rapid review completed 26/03/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of niraparib (Zejula®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/03/2021
Pre-submission consultation with Applicant 01/06/2021
Full submission received from Applicant 18/10/2021
Preliminary review sent to Applicant 14/06/2022
NCPE assessment re-commenced 28/07/2022
Factual accuracy sent to Applicant 31/08/2022
NCPE assessment re-commenced 07/09/2022
NCPE assessment completed 26/09/2022
NCPE assessment outcome The NCPE recommends that niraparib (Zejula®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English 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 April 2023.