Background and Importance The drug Andexanet Alfa (AA), an anti-haemorrhagic antidote capable of rapidly reversing the effect of factor Xa inhibitor DOACS (Apixaban, Rivaroxaban), was recently introduced on the market. The 4-factor prothrombin complex (CPP4), already in use at our centre, also has the same indication.

Aim and Objectives In collaboration with a haematologist and a cardiologist-anaesthetist, an HTA analysis was conducted with the aim of evaluating the real need for the inclusion of AA within the Hospital Therapeutic Handbook (HTH) and its use in cardiac surgery emergency situations and cardiovascular emergency.

Material and Methods A brief review of the literature currently available on various search engines (PubMed, clinicaltrials.gov) was conducted by the hospital pharmacy, looking in particular for comparison studies between AA and CPP4. In parallel, a search was conducted for poison control centres (PCC) and hospital centres close to the facility that had the drug available, an economic evaluation and an analysis of the Summary of Product Characteristics (SmPC).

Results From the retrospective studies analysed (eight, of which only three meta-analyses), data were collected and summarised in terms of efficacy/haemostasis rate (AA: 77.88% vs CPP4: 76.47%, average data) and safety/incidence of post-treatment thromboembolic events (AA: 10.47% vs CPP4: 5.98% average figure).

From the parallel research, the following results emerged: availability of the antidote (one PCC and two hospital centres); treatment costs (AA: Euro 52,666.52 vs CPP4: Euro 3795.90); reimbursement (non-reimbursable drug); AA preparation/infusion times (approximately 2h 30).

Conclusion and Relevance The analysed studies, subject to bias due to the variability of the analysed sample, were mainly focused on intracranial haemorrhage events and not on cardiac surgical complications. From these, it also emerged that AA promotes a refractoriness to the anticoagulant effect of unfractionated heparin, making the use of AA incompatible in patient candidates for a cardiac surgical procedure that requires pre-heparinisation.

Therefore, by virtue of the poor and unfavourable quality of the trials and the unfavourable cost-effectiveness and risk-benefit ratios, it was not considered necessary to introduce the drug within the HTH.

References and/or Acknowledgements Web reference (https://pubmed.ncbi.nlm.nih.gov)

Digital Object Identifier (DOI):

1) https://doi.org/10.1016/j.jacc.2021.04.061;

2) https://doi.org/10.1016/j.ajem.2022.02.029;

3) https://doi.org/10.1177/10760296211039020;

4) DOI: 10.1097/CCM.0000000000005059;

5) https://doi.org/10.1182/hematology.2019000074;

6) DOI: 10.7759/cureus.20632;

7) https://doi.org/10.1002/rth2.12518;

8) DOI: 10.1213/XAA.000000000000163;

9) https://doi.org/10.1007/s12028-022-01573-5;

10) DOI: 10.1213/XAA.0000000000001636

Conflict of Interest No conflict of interest.