|Assessment Status||Assessment Process Complete|
|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.|
|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.*|
*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.