| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Inotuzumab ozogamicin |
| Brand | Besponsa® |
| Indication | As monotherapy for the treatment of adults with relapsed or refractory (R/R) CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). |
| Assessment Process | |
| Rapid review commissioned | 03/07/2017 |
| Rapid review completed | 08/09/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 11/09/2017 |
| Pre-submission consultation with Applicant | 02/10/2017 |
| Full submission received from Applicant | 08/03/2018 |
| Preliminary review sent to Applicant | 13/07/2018 |
| NCPE assessment re-commenced | 02/08/2018 |
| Factual accuracy sent to Applicant | 31/08/2018 |
| NCPE assessment re-commenced | 07/09/2018 |
| NCPE assessment completed | 14/09/2018 |
| NCPE assessment outcome | The NCPE recommends that inotuzumab should be considered for reimbursement if 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.
The HSE has approved reimbursement following confidential price negotiations; May 2019
