|Assessment Status||Assessment process complete|
|Indication||For the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.|
|Rapid review commissioned||27/04/2020|
|Rapid review completed||25/05/2020|
|Rapid review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of darolutamide compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||27/05/2020|
|Pre-submission consultation with Applicant||14/07/2020|
|Full submission received from Applicant||10/12/2020|
|Preliminary review sent to Applicant||28/05/2021|
|NCPE assessment re-commenced||25/06/2021|
|Factual accuracy sent to applicant||20/08/2021|
|NCPE assessment completed||10/09/2021|
|NCPE assessment outcome||The NCPE recommend that darolutamide (Nubeqa®) 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 2022.