| Assessment Status | 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.
