Assessment of clinical and economic impact of rivaroxaban plus aspirin vs. aspirin alone as a secondary prophylaxis in patients with chronic and symptomatic peripheral arterial disease in the United States

Abstract

Aim

The objective in this study was to assess the clinical and economic implications of the inclusion of rivaroxaban as a secondary prophylaxis in patients with chronic or symptomatic peripheral artery disease (PAD) in the United States (US).

Methods

A cost-consequence model was adapted to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from multiple sources: efficacy and safety of rivaroxaban + aspirin vs. aspirin alone were abstracted from COMPASS and VOYAGER randomized clinical trials; the prevalence of chronic and symptomatic PAD and incidence rates of clinical events (major adverse cardiac events [MACE], major adverse limb events [MALE], and major bleeding), were abstracted from the analysis of claims data; healthcare costs of clinical events and wholesale acquisition costs for rivaroxaban were abstracted from the literature and Red Book, respectively (2022 USD). One-way sensitivity analyses and subgroup analyses were also conducted.

Results

Over one year, with a 5% uptake of rivaroxaban, the model estimated rivaroxaban + aspirin to reduce 21 MACE/MALE events in the PAD patient population. The reduction in these clinical events offsets the increased risk of major bleeding (16 additional events), demonstrating a positive health benefit of the rivaroxaban addition. These benefits led to a $0.27 incremental cost per member per month (PMPM) to a US plan. The major driver of the incremental cost was the cost of rivaroxaban. In a subgroup of patients with the presence of any high-risk factor (heart failure, diabetes, renal insufficiency, or history of vascular disease affecting two or more vascular beds), the incremental PMPM cost was $0.13.

Conclusions

Rivaroxaban + aspirin was found to provide positive net clinical benefit on the annual number of MACE/MALE avoided, with a modest increase in the PMPM cost.

Keywords:

• Aspirin
• peripheral artery disease
• cost-consequence analysis
• real-world evidence
• rivaroxaban
• major adverse cardiac events
• major adverse limb events

JEL Classification Codes:

• I10
• I1
• I
• I12
• D61
• D

Declaration of funding

Funding for this study was provided by Janssen Scientific Affairs.

Declaration of financial/other interests

AS, FD, and SS are employees of Evidera, a consulting company, which received funding from Janssen Scientific Affairs to conduct the study. AK and VA are employees of Janssen Scientific Affairs and hold Johnson and Johnson stock options. The authors report no other conflicts of interest in this work.

Author contributions

All authors contributed to the study design, drafting, or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Data availability statement

The source data for this study is available online with the exception of data obtained from the Optum^® Clinformatics^® Data Mart. Restrictions apply to the Optum data, which were licensed by Janssen for this study. The Optum database can be licensed for a fee (https://www.optum.com/business/life-sciences/real-world-data/claims-data.html).

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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