| Assessment Status | Company no longer intend to submit a full HTA dossier |
| HTA ID | 23012 |
| Drug | Acalabrutinib |
| Brand | Calquence® |
| Indication | Indicated as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The Applicant is seeking reimbursement in a subgroup of the licensed population: as monotherapy for previously untreated CLL without 17P deletion or TP53 mutation, in adult patients unsuitable for chemoimmunotherapy and venetoclax in combination with obinutuzumab. |
| Assessment Process | |
| Rapid review commissioned | 24/02/2023 |
| Rapid review completed | 31/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of acalabrutinib for this subgroup of the licensed population compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 25/04/2023 |
| Pre-submission consultation with Applicant | 20/02/2024 |
The company has not submitted a HTA dossier to the NCPE; therefore the cost-effectiveness of the technology could not be proven.
