| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25040 |
| Drug | Acalabrutinib |
| Brand | Calquence® |
| Indication | Acalabrutinib is indicated in combination with venetoclax with or without obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| Assessment Process | |
| Rapid review commissioned | 30/06/2025 |
| Rapid review completed | 16/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of acalabrutinib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/07/2025 |
| Pre-submission consultation with Applicant | 11/09/2025 |
| Full submission received from Applicant | 14/01/2026 |
| Preliminary review sent to Applicant | 01/05/2026 |
| NCPE assessment re-commenced | 29/05/2026 |
| Factual accuracy sent to Applicant | 02/07/2026 |
| NCPE assessment re-commenced | 09/07/2026 |
| NCPE assessment completed | 24/07/2026 |
| NCPE assessment outcome | The NCPE recommends that acalabrutinib not be considered for reimbursement, for this indication unless cost-effectiveness can be improved relative to existing treatments.* The full licensed population is broader than the subpopulation used to inform the cost-effectiveness analysis. |
The Applicant is seeking reimbursement for a subpopulation of the licensed population, specifically for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia excluding those with del(17p)/TP53 mutation.
*Next steps: The NCPE Assessment Report and recommendation will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.