Andexanet alfa (Ondexxya®). HTA ID: 20014

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*.

Technical Summary

Plain English Summary

* 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.