| Assessment Status | Awaiting full HTA submission from Applicant |
| 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 pharmacoeconomic assessment commissioned by HSE | 31/07/2025 |
| Pre-submission consultation with Applicant | 11/09/2025 |
*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.