| Assessment Status | Assessment process complete |
| HTA ID | 20046 |
| Drug | Venetoclax in combination with obinutuzumab |
| Brand | Venclyxto® / Gazyvaro® |
| Indication | For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. |
| Assessment Process | |
| Rapid review commissioned | 07/10/2020 |
| Rapid review completed | 22/10/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with obinutuzumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/10/2010 |
| Pre-submission consultation with Applicant | 30/11/2020 |
| Full submission received from Applicant | 05/02/2021 |
| Preliminary review sent to Applicant | 31/05/2021 |
| NCPE assessment re-commenced | 30/06/2021 |
| Factual accuracy sent to Applicant | 27/07/2021 |
| NCPE assessment re-commenced | 04/08/2021 |
| NCPE assessment completed | 17/08/2021 |
| NCPE assessment outcome | The NCPE recommends that venetoclax in combination with obinutuzumab be considered for reimbursement.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medicinal Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations March 2022.
