Andexanet alfa is indicated 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.
|NCPE Assessment Process||Complete|
|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 check 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.