ANAHEIM, CA — A cost analysis from the COMPASS trial suggests that low-dose rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) on top of low-dose aspirin for secondary prevention lowers costs, accounting for both CV events and related procedures, compared with aspirin alone in patients with CAD or peripheral artery disease (PAD)[1].
Costs were lowest in patients with PAD or with extensive atherosclerosis as opposed to CAD alone. Much of the cost offset came from averted strokes and PAD-related events, rather than from prevention of MI or other cardiac events, reported Dr Andre Lamy (McMaster University, Hamilton, ON) here at the American Heart Association 2017 Scientific Sessions.
“I think this study at least provides the first insights,” Dr David J Cohen (Beth Israel Deaconess Medical Center, Boston, MA) told theheart.org | Medscape Cardiology, “that even though there are some complications—there is bleeding—the balance of events strongly favors rivaroxaban on the economic side” as well as the clinical side.
“Based on the COMPASS results, for patients with established CAD or PAD, addition of low-dose rivaroxaban to low-dose aspirin appears to provide meaningful cost offsets—particularly for patients with PAD or extensive atherosclerosis,” said Cohen, who was the assigned discussant following Lamy’s presentation.
The study showed that “anybody with PAD, economically speaking, will benefit more than those with CAD only,” Lamy agreed to theheart.org | Medscape Cardiology.
Costs Important: High Demand, Proprietary Drug
COMPASS randomized 27,395 patients with stable atherosclerotic vascular disease 1:1:1 to 2.5-mg twice-daily rivaroxaban plus 100-mg daily aspirin, 5-mg twice-daily rivaroxaban, or 100-mg daily aspirin. Most of the patients (91%) had CAD, 27% had PAD, 62% had a history of MI, and 4% had a previous stroke.
As previously reported, the trial was stopped at 23 months due to superiority of rivaroxaban plus aspirin vs aspirin alone for the primary composite outcome of cardiovascular death, stroke, or MI (HR 0.76, 95% CI 0.66–0.86, P<0.001), although there was more major bleeding with the combined therapy.
“The benefits are very striking: mortality reduction, reduction in stroke—two of the most serious events that we have—and reductions in PAD-related events,” Cohen said. “So the question of the economic costs becomes very important, because lots of people would like to be able to provide this.”
The cost analysis is also important because rivaroxaban is a branded drug; also, the size of the potential target population (stable CAD or PAD) is enormous in most Western societies; treatment duration is likely to be lifetime; and this type of analysis can clarify the trade-off between risks and benefits, he added.
Lamy and colleagues assigned costs for cardiovascular events and procedures, and they compared these costs in patients who received rivaroxaban plus aspirin vs patients who received aspirin alone.
Patients who received rivaroxaban and aspirin had lower rates of stroke, MI, severe limb ischemia, resuscitated cardiac arrest, venous thromboembolism, and angina. However, they also had higher rates of heart failure, cardiac arrhythmia, syncope, transient ischemic attack (TIA), and bleeding requiring an ER visit or hospitalization.
The cost savings amounted to $4.2 million, largely driven by a reduction in strokes. All costs in the analysis were in US dollars.
Those who received both antiplatelets also had fewer peripheral angioplasties, PCI, limb amputations, vascular surgery, and coronary angiography, but also more CABG, pacemaker/ICD implantations, and carotid angioplasty, Lamy reported, for a $2.0 million cost saving.
Overall, costs for CV events and procedures were $6.2 million less for the 9152 patients who received low-dose rivaroxaban plus aspirin vs the 9126 patients who received low-dose aspirin in COMPASS over a mean of 23 months.
For individuals, the overall mean cost for CV events and procedures was $682 lower per patient per 23 months for those who received the low-dose rivaroxaban plus aspirin. In patients with CAD alone, those were $360 lower per patient; they were reduced by about $1670 per patient with either CAD plus PAD or extensive atherosclerotic disease.
Higher Overall US Costs, Some Savings in Canada
Cohen estimated that in the US, the cost of 2.5-mg twice daily rivaroxaban would be half that of a 10-mg pill: about $7 a day, $200 a month, and more than $2400 a year.
Costs based on CV events and procedures were reduced by $357 per patient per year, given the per-patient reduction of $682 per 24 months per patient receiving both antiplatelets found by Lamy and colleagues.
The addition of $2400 per year for rivaroxaban would therefore result in a total cost of $2043 more per patient per year, according to Cohen.
He estimated that in Canada, 2.5-mg twice daily rivaroxaban would cost the same as a dose of 10, 15, or 20 mg: about $836 a year. Therefore, if CV events and procedures cost $357 less per year per patient receiving combined therapy, costs would be $479 more per patient per year, overall.
In the subgroup of patients with CAD only, these total costs would be $648 more per patient per year. But in patients with PAD, these total costs would only be $102 more per patient per year. In the subgroup with atherosclerotic disease in two or more vascular beds, there would be a cost saving.
“So it appears we may have a dominant therapy that improves outcomes and reduces costs,” Cohen said. “The ultimate value of this therapy,” he noted, “will depend on drug cost as well as the durability of benefit beyond the 2-year trial observation period.”
COMPASS was funded by Bayer. The authors report no relevant financial relationships.
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