The analysis presented at the American Heart Association looks strictly at healthcare costs, but a broader cost-effectiveness study is planned that will consider drug costs as well as effect on patient quality of life.
Giving patients with stable cardiovascular (CV) disease the combination of rivaroxaban and aspirin that was proven effective in the COMPASS trial cuts overall direct healthcare costs, according to an analysis presented Tuesday at the 2017 American Heart Association Scientific Sessions.
The analysis,1 presented by Andre Lamy, MD, MHSc, FRSC, a cardiac surgeon of the Population Health Research Institute in Hamilton, Ontario, was drawn from data gathered during the COMPASS trial, which in August showed that giving patients with CV disease 2.5 mg of rivaroxaban twice a day and a 100 mg of aspirin reduced CV events 24% and increased survival 18%, compared with 100 mg of aspirin alone.
More results from the trial, published in Lancet and released this weekend, showed that patients in the trial with stable coronary artery disease saw death rates reduced by 23%.2 A subanalysis of patients with peripheral artery disease (PAD) found a whopping 70% reduction in major amputations, which is a risk for people with this condition.3
Lamy’s focus was translating the reductions in events and procedures—fewer strokes, heart attacks, incidents of venous thromboembolism and amputations, and less vascular surgery—into reduced costs. That had to be balanced against a few added costs, particularly where bleeding occurred. To gauge costs, Lamy said, a diagnosis-related group (DRG) approach was used.
Overall, Lamy said, use of the rivaroxaban and aspirin combination versus aspirin across the study population resulted in $4,180,325 in savings from fewer events, along with $1,963,984 in savings from fewer procedures—for a total savings of $6,144,309 over the 23-month follow-up time of the study. Calculated on a savings per participant basis, that saved $682 per person. (Results for the analysis were gathered from 4 countries—the United States, France, Canada, and Germany—and all costs were converted to US dollars.)
Some limitations were acknowledged. “We can only show the cost impact,” he said. And the analysis only looks at direct costs, not indirect costs, which he presumed to be substantial.
Lamy said the cost offsets for patients with coronary artery disease and PAD were particularly meaningful, given the high risk of these patients and the high costs of those diseases. In an interview with The American Journal of Managed Care®, he noted the savings were twice the average—about $1200 to $1300. A discussant, David J. Cohen, MD, MSc, of Beth Israel Deaconess Medical Center in Boston, Massachusetts, agreed with Lamy on this point—but he diverged elsewhere.
While Cohen agreed that the cost of this combination therapy is an unknown, some assumptions can be made—it will be a branded drug, he said. And based on that, Cohen ran some numbers that did not show the drug being cost-effective.
But Lamy hasn’t done a cost-effectiveness analysis yet. In an interview with he said that will come later, assuming approvals happen and prices are set. Such an analysis would also include a thorough analysis of the value of the drug on patients’ quality of life, especially in its ability to eliminate strokes. Lamy cited research of patients who say they fear strokes “almost worse than death,” because of their debilitating effects.
"Stroke has a huge impact on quality of life. For these patients, the quality of life goes down dramatically," he said in the interview. "We’re collecting these quality of life (data); the event rate is fairly small, only about 5%, so that means that 95% of the people don’t have any events. ... We expect to see a difference in quality of life overall between the 2 medications."
Lamy said calculating the cost impact is just the first step. "What we don’t have so far is the quality of life and also how many life-years saved. It’s a long process—you need to be able to model to study that, to determine how many lives will be saved with rivaroxaban vs aspirin when you do a lifetime analysis. We’re working on that. It will probably take another 4-6 months before we can publish that."
Bayer, which funded COMPASS, has filed with European regulators to market the rivaroxaban-aspirin combo and a filing with FDA is expected this year. Lamy said he expects the combination to be available some time in the next year in North America.