Darolutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
|NCPE Assessment Process||Complete|
|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 the 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 check sent to Applicant||20/08/2021|
|NCPE assessment re-commenced||26/08/2021|
|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.