Add-On Colchicine Cost-Effective After MI

Low-dose colchicine lowered the risk of ischemic cardiovascular (CV) events after MI, and did so cost-effectively, according to results from the Canadian COLCOT trial.

The primary efficacy outcome — CV death (CVD), MI, stroke, resuscitated cardiac arrest, or urgent hospitalization for unstable angina leading to revascularization — occurred in 5.5% of the colchicine group versus 7.1% of the placebo group (HR 0.77, 95% CI 0.61-0.96, P=0.02), reported Michelle Samuel, PhD, of the Montreal Heart Institute, at the virtual American College of Cardiology (ACC) meeting.

As for cost, the addition of the anti-inflammatory agent to standard therapy post-MI reduced mean overall per-patient costs by 47% during the in-trial period ($265 vs $502 Canadian) and 69% in the lifetime period ($2,590 vs $8,239 with placebo), The cost advantages held up across multiple sensitivity analyses, according to the investigators.

Also, the average number of quality-adjusted life years (QALYs) gained was higher with colchicine during the trial (1.34 vs 1.30), and over the 20-year lifetime (11.68 vs 8.82), than with placebo, they reported.

“From the Canadian healthcare system perspective, the addition of low-dose colchicine to standard of care therapy after myocardial infarction is economically dominant,” Samuel said, adding that colchicine would maintain its economic dominance in the various models even if its current price in Canada of 26-cents/pill rose to $1.25/pill.

In the U.S., a single colchicine pill is priced at $4-$6, but Samuels’ group found that the treatment was still economically dominant, assuming the $50,000 threshold for QALYs. In the Medicare system, and over a 20-year lifetime, colchicine was economically dominant at $5 or less and cost-effective at $6, the authors reported.

“From the U.S. private insurance system perspective, low-dose colchicine post-myocardial infarction was economically dominant at $5 of less per pill for the in-trial period, and was economically dominant at $4-6 per pill for the lifetime period incremental cost-effectiveness ratio,” Samuel noted.

For COLCOT, the investigators randomized 4,745 patients (mean age 60.6; 19.2% women) in a dozen countries to colchicine (0.5 mg once daily) or placebo. Mean time of enrollment was 13.5 days post-MI, and 93% of participants had undergone percutaneous coronary intervention.

Secondary outcomes for the colchicine group versus placebo were:

• CVD: 0.8% vs 1.0% of the placebo group (P=nonsignificant)
• Stroke: 0.2% vs 0.8% of the placebo group (P<0.05)
• Urgent hospitalization for unstable angina leading to revascularization: 1.1% vs 2.1% (P<0.05)
• Infection: 2.2% vs 1.6% (P=0.15)
• Diarrhea: 9.7% vs 8.9% (P=0.35)

ACC panelist Paul Ridker, MD, of Brigham & Women’s Hospital and Harvard Medical School in Boston, said, “We talk a lot in the cardiovascular field about drugs that are effective and that we can afford to pay for, and these data are obviously exceptional in that regard. While we focus on residual cholesterol risk, I think we have all come to recognize that residual inflammatory risk is an other example of the very large part of the equation that we deal with.”

Ridker noted that reducing the inflammatory cascade had been shown possible with expensive monoclonal agents. “[Colchicine] is at the other end of the spectrum in terms of drug that are being re-purposed for atherosclerosis,” he said.

He noted that a political discussion could be had about the differences in colchicine’s price-tag in Canada versus the U.S.,”but even under that U.S. pricing, you have shown a dominant model for lifetime, and probably a dominant model for the hospitalization period with colchicine.”

“I am not a cost-effective expert, but I do know that being dominant means you are saving money,” Ridker pointed out.