| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22001 |
| Drug | Venetoclax |
| Brand | Venclyxto® |
| Indication | In combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 05/01/2022 |
| Rapid review completed | 01/02/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with a hypomethylating agent compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 23/02/2022 |
| Pre-submission consultation with Applicant | 05/07/2022 |
| Full submission received from Applicant | 13/10/2022 |
| Preliminary review sent to Applicant | 25/04/2023 |
| NCPE assessment re-commenced | 25/05/2023 |
| Factual accuracy sent to Applicant | 26/07/2023 |
| NCPE assessment re-commenced | 03/08/2023 |
| NCPE assessment completed | 26/09/2023 |
| NCPE assessment outcome | The NCPE recommends that venetoclax 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.
