National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Andexanet alfa (Ondexxya®). HTA ID: 20014

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*.

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.