Darolutamide (Nubeqa®). HTA ID: 20022
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.