https://orcid.org/0000-0002-4218-2637
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Abstract
Aim
To conduct a cost-effectiveness analysis (CEA) on the use of andexanet alfa for the treatment of factor Xa inhibitor-related intracranial hemorrhage (ICH) from the US third-party payer and societal perspectives.
Methods
CEA compared andexanet alfa to prothrombin complex concentrate for the treatment of patients receiving factor Xa inhibitors admitted to hospital inpatient care with an ICH. The model comprised two linked phases. Phase 1 utilized a decision tree to model the acute treatment phase (admission of a patient with ICH into intensive care for the first 30 days). Phase 2 modeled long-term costs and outcomes using three linked Markov models comprising the six health states defined by the modified Rankin score.
Results
The analysis showed that the strategy of using andexanet alfa for the treatment of factor Xa inhibitor-related ICH is cost-effective, with incremental cost-effectiveness per quality-adjusted life-year gained of $35,872 from a third-party payer perspective and $40,997 from a societal perspective over 20 years.
Limitations
(1) Absence of head-to-head trials comparing therapies included in the economic model, (2) lack of comparative long-term data on treatment efficacy, and (3) bias resulting from the study designs of published literature.
Conclusion
Given these results, the use of andexanet alfa for the reversal of anticoagulation in patients with factor Xa inhibitor-related ICH may improve quality of life and is likely to be cost-effective in a US context.
Transparency
Declaration of funding
This study was supported by Portola Pharmaceuticals, Inc., now Alexion, AstraZeneca Rare Disease.
Declaration of financial/other interests
JF reports no conflicts of interest. JNG has received research funding from Portola Pharmaceuticals, Octapharma Biopharmaceuticals, and Pfizer Pharmaceuticals; and has received consulting fees from Portola Pharmaceuticals, CSL Behring, and Philips Healthcare. BL is employed by Alexion Pharmaceuticals. ACB was formerly employed by Alexion Pharmaceuticals. RSB and FA are employed by Maple Health Group, which received funding from Portola Pharmaceuticals, now Alexion Pharmaceuticals, to perform this study. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
Study concept and design: JF, JNG, BL, ACB, RSB, FA. Analysis: RSB, FA. Interpretation: JF, JNG, BL, ACB, RSB, FA. Manuscript drafting: RSB, FA. All authors were responsible for revising and critically appraising the manuscript for intellectual content and approved the final submission. All authors agree to be responsible for all aspects of the work.
Acknowledgements
The authors would like to thank Ishveen Chopra, Ph.D., for medical writing and editorial assistance during the development of the manuscript. Alexion, AstraZeneca Rare Disease (the sponsor) funded the medical writing and editorial assistance and provided a formal review of the publication. Authors retain control and final authority of publication content and decisions, including the choice of journal.
Data availability statement
Alexion will consider requests for disclosure of clinical study participant-level data provided that participant privacy is assured through methods like data de-identification, pseudonymization, or anonymization (as required by applicable law), and if such disclosure was included in the relevant study informed consent form or similar documentation. Qualified academic investigators may request participant-level clinical data and supporting documents (statistical analysis plan and protocol) pertaining to Alexion-sponsored studies. Further details regarding data availability and instructions for requesting information are available in the Alexion Clinical Trials Disclosure and Transparency Policy at https://alexion.com/our-research/research-and-development. Link to Data Request Form (https://alexion.com/contact-alexion/medical-information).
Previous presentations
These data were submitted for presentation at the American Society of Health-System Pharmacists Mid-year 2020 virtual conference.
