Zanubrutinib as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). The place in therapy for zanubrutinib, proposed by the Applicant, is narrower than the licensed population i.e. as monotherapy
- for patients with CLL, who are treatment naïve and have del(17p) and/or TP53 mutations or
- for patients that have relapsed and/or refractory disease
| Assessment Status | Rapid Review Complete |
| HTA ID | 23010 |
| Drug | Zanubrutinib |
| Brand | Brukinsa® |
| Indication | Zanubrutinib as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). The place in therapy for zanubrutinib, proposed by the Applicant, is narrower than the licensed population i.e. as monotherapy for patients with CLL, who are treatment naïve and have del(17p) and/or TP53 mutations or for patients that have relapsed and/or refractory disease |
| Assessment Process | |
| Rapid review commissioned | 20/02/2023 |
| Rapid review completed | 23/03/2023 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that zanubrutinib not be considered for reimbursement at the submitted price*. This recommendation is contingent on restriction of reimbursement to the proposed place in therapy which is narrower than the licensed indication |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations. September 2023
