乌鸦传媒

Staying on ticagrelor (Brilinta) in the long run is of middling value to many patients when compared with aspirin, according to an economic substudy of the PEGASUS-TIMI 54 trial.

Hospitalization costs were similar between patients that got ticagrelor and their peers on aspirin ($2,262 versus $2,333, P=0.54), but with the daily cost of ticagrelor being $10.52 -- for the FDA-approved dose of 60 mg twice daily, without discounts or rebates -- total costs after 33 months of treatment were more than 4 times higher with the former ($10,016 versus $2,333, P<0.001).

Over a lifetime, ticagrelor was associated with quality-adjusted 0.078 more life years over aspirin at a cost of $7,435 extra, yielding an incremental cost-effectiveness ratio (ICER) of (QALY) gained, suggested the study published in the August 1 issue of the Journal of the American College of Cardiology by Elizabeth A. Magnuson, ScD, of Saint Luke's Mid America Heart Institute in Kansas City, Mo., and colleagues.

"The results of our patient-level economic study, therefore, suggest that ticagrelor + low-dose aspirin provides intermediate value relative to aspirin alone for patients who are >1 year post-MI," the researchers wrote.

Ticagrelor would have better value if its cost dropped down to $5.62 per day; the ICER would be $50,000/QALY gained.

Even so, several subgroups derived relatively good value with ticagrelor costing $10.52, namely patients with:

• More than one prior MI (ICER $69,537/QALY gained)
• Multivessel disease (ICER $66,386/QALY gained)
• Diabetes (ICER $50,325/QALY gained)
• Renal dysfunction (ICER $52,492/QALY gained)
• Age under 75 years (ICER $44,779/QALY gained)
• Peripheral artery disease (ICER $13,427/QALY gained)

The PEGASUS-TIMI trial randomized 21,162 patients with MIs in the last 3 years to aspirin alone; lower-dose ticagrelor (60 mg) and aspirin; or high-dose ticagrelor (90 mg) and aspirin. Only the patients who got 60-mg ticagrelor (n=7,045) or placebo (n=7,067) were included in Magnuson's economic substudy.

Data showed that the two groups had well-balanced baseline characteristics (mean age 66 years, 76% men).

"The projected QALY gains with ticagrelor in our analysis were largely driven by a trend toward reduced mortality (specifically, a reduction in cardiovascular death and null effect on non-cardiovascular death) observed in the PEGASUS-TIMI 54 trial," according to the study authors.

"By contrast, in the DAPT (Dual Antiplatelet Therapy) trial, treatment with prolonged clopidogrel or prasugrel was associated with increased non-cardiovascular and all-cause mortality, suggesting that the results from the PEGASUS-TIMI 54 trial may not extend to other P2Y12 inhibitors."

Another caveat is the trial's exclusion of patients at high bleeding risk or low ischemic event risk. Moreover, no information was collected on outpatient care nor its costs.

"Because the ICER involves a tradeoff between dollars spent and health benefits gained, the ranges of benefit reflect the current willingness of society to pay for a specific benefit, and therefore, they are a matter of public policy rather than a scientifically based assessment of true cost-effectiveness," commented Eliano P. Navarese, MD, PhD, of Inova Heart and Vascular Institute in Falls Church, Va., and Jan G.P. Tijssen, PhD, of Academic Medical Center in the Netherlands.

What Navarese and Tijssen could conclude from the study, they wrote in an accompanying editorial, is that "from a cost-effective perspective, it appears reasonable to continue ticagrelor beyond 1 year in the patients with only the highest ischemic risk."

"It is our opinion that future studies should be directed to the generation of personalized medicine models that ultimately integrate the demographic characteristics, biological data, and genomic information of patients. These models should target antiplatelet therapy with the potential to usher in a new era of individualized treatment strategies that maximize the clinical efficacy while minimizing bleeding complications and associated costs."