| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20014 |
| Drug | Andexanet alfa |
| Brand | Ondexxya® |
| Indication | For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. |
| Assessment Process | |
| Rapid review commissioned | 12/03/2020 |
| Rapid review completed | 23/04/2020 |
| Rapid review outcome | A full HTA is required to assess the clinical effectiveness and cost-effectiveness of andexanet alfa compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/04/2020 |
| Pre-submission consultation with Applicant | 26/01/2021 |
| Full submission received from Applicant | 26/10/2021 |
| Preliminary review sent to Applicant | 13/12/2021 |
| NCPE assessment re-commenced | 31/01/2022 |
| Factual accuracy sent to Applicant | 27/04/2022 |
| NCPE assessment re-commenced | 04/05/2022 |
| NCPE assessment completed | 27/05/2022 |
| NCPE assessment outcome | The NCPE recommends that andexanet alfa (Ondexxya®) 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 April 2023.
