| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Gemtuzumab ozogamicin |
| Brand | Mylotarg® |
| Indication | For combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive AML, except acute promyelocytic leukaemia. |
| Assessment Process | |
| Rapid review commissioned | 21/06/2018 |
| Rapid review completed | 17/07/2018 |
| Rapid review outcome | A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of gemtuzumab ozogamicin compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 31/07/2018 |
| Pre-submission consultation with Applicant | 03/09/2018 |
| Full submission received from Applicant | 15/11/2018 |
| Preliminary review sent to Applicant | 06/03/2019 |
| NCPE assessment re-commenced | 01/04/2019 |
| Factual accuracy sent to Applicant | 04/06/2019 |
| NCPE assessment re-commenced | 17/06/2019 |
| NCPE assessment completed | 04/07/2019 |
| NCPE assessment outcome | The NCPE recommends that gemtuzumab ozogamicin (Mylotarg®) 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.
The HSE has approved reimbursement following confidential price negotiations; November 2020
