| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23072 |
| Drug | Zanubrutinib |
| Brand | Brukinsa® |
| Indication | Zanubrutinib monotherapy is indicated for adult patients with relapsed/refractory marginal zone lymphoma with at least one prior anti-CD20-based therapy. |
| Assessment Process | |
| Rapid review commissioned | 01/12/2023 |
| Rapid review completed | 09/01/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of zanubrutinib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 31/01/2024 |
| Pre-submission consultation with Applicant | 12/03/2024 |
| Full submission received from Applicant | 20/08/2024 |
| Preliminary review sent to Applicant | 23/05/2025 |
| NCPE assessment re-commenced | 20/06/2025 |
| Follow-up to preliminary review sent to Applicant | 08/07/2025 |
| NCPE assessment re-commenced | 10/07/2025 |
| Factual accuracy sent to Applicant | 30/07/2025 |
| NCPE assessment re-commenced | 08/08/2025 |
| NCPE assessment completed | 03/09/2025 |
| NCPE assessment outcome | The NCPE recommends that zanubrutinib 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.