| Assessment Status | Assessment process complete |
| HTA ID | 18056 |
| Drug | Enzalutamide |
| Brand | Xtandi® |
| Indication | For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). |
| Assessment Process | |
| Rapid review commissioned | 18/12/2018 |
| Rapid review completed | 06/02/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of enzalutamide in combination with ADT compared with the current standard of care |
| Full pharmacoeconomic assessment commissioned by HSE | 13/02/2019 |
| Pre-submission consultation with Applicant | 11/06/2019 |
| Full submission received from Applicant | 30/04/2021 |
| Preliminary review sent to Applicant | 14/12/2021 |
| NCPE assessment re-commenced | 25/01/2022 |
| Factual accuracy sent to Applicant | 08/04/2022 |
| NCPE assessment re-commenced | 21/04/2022 |
| NCPE assessment completed | 24/05/2022 |
| NCPE assessment outcome | Following assessment of the company submission, the NCPE recommend that enzalutamide (Xtandi®) 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 201
