Alirocumab ‘Modestly’ Cost-effective at Lower List Price: ODYSSEY OUTCOMES

With its new, more consumer-friendly price, use of the PCSK9 inhibitor alirocumab (Praluent; Sanofi/Regeneron) in patients with acute coronary syndrome is a relatively cost-effective option for reducing the risks of major cardiovascular events, according to a new patient-level analysis from ODYSSEY OUTCOMES.

When priced at $5,850 per year, the new list price that had been reduced from an initial cost of more than $14,000, the overall incremental cost-effectiveness ratio (ICER) was $92,200 per quality-adjusted life-year (QALY) gained, which is deemed “intermediate” value according to benchmarks established by the American College of Cardiology/American Heart Association (ACC/AHA).

If alirocumab is only prescribed to patients with baseline LDL cholesterol levels ≥ 100 mg/dL, the cost is $41,800 per QALY gained, a much more favorable economic value, report investigators in their new paper published online ahead of the May 12, 2020, issue of the Journal of the American College of Cardiology.

“We showed, overall, that the drug is modestly cost-effective,” lead investigator Deepak Bhatt, MD (Brigham and Women’s Hospital, Boston, MA), told TCTMD. “I think many physicians have formed the opinion that these are super cost-ineffective drugs but I think at the current price for alirocumab, and I think the same applies for evolocumab (Repatha; Amgen) as well, although we didn’t specifically study that here, that it’s reasonably cost-effective, especially if you’re talking about folks with LDL cholesterol greater than or equal to 100 mg/dL.”

If the LDL cholesterol level is less than 100 mg/dL when initiating treatment, said Bhatt, the drug is still effective, but the absolute risk reductions are smaller and as such the drug is not considered cost-effective by the ACC/AHA benchmark. In those patients, the cost per QALY gained was $299,400. “If the LDL cholesterol is high, that’s where you get, literally, the most bang for you buck,” said Bhatt. “If the LDL is reasonably well controlled, yes, there’s some incremental clinical benefit for sure, but it doesn’t meet the current standards of what we’d consider to be cost-effective.”

In an editorial, William Weintraub, MD (MedStar Heart & Vascular Institute, Washington, DC), and William Boden, MD (VA New England Health Care System, Boston), write that the patient-level, cost-effectiveness analysis does provide more detailed, granular data on patients than is available in cost-effectiveness simulations but even these require considerable outside input and modeling, and these analyses can be complex. Still, the new analysis is a welcome addition as it provides insight into value and data showing that alirocumab appears favorable in those with LDL cholesterol levels ≥ 100 mg/dL, they write.        

A Little Easier to Prescribe Today

In ODYSSEY OUTCOMES, the large cardiovascular morbidity and mortality trial, the addition of alirocumab on top of a high-intensity statin in patients with a recent ACS and LDL cholesterol levels > 70 mg/dL reduced the risk of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization by 15% compared with placebo. All-cause mortality was also reduced by 15%. Based on the trial, the US Food and Drug Administration expanded the indication of alirocumab to include cardiovascular event reduction.

When the drugs cost more than $14,000 per year, the manufacturers were criticized for setting the price too high. Several cost-effectiveness analyses based on that initial price found them to be too expensive for widespread use. This led to difficulties in prescribing the drugs—onerous paperwork, mandatory specialist visits, and nonstandardized insurance requirements—and patients were often denied coverage from third-party payers.

With respect to prescribing alirocumab or evolocumab, Bhatt said the prior authorization process is easier today than it was in the past, especially since the cost of the drugs came down, but the perception among physicians hasn’t changed a great deal.

“Many were soured on these drugs with the initial expense to prescribe,” he said. “For the most part, third-party payers were just shutting us down. It has gotten a lot better. It’s not perfect by any means. There is still some resistance by payers, even in patients where they are at high risk and the right thing to do would be to allow the patient to receive the drug. Having said that, it’s not as bad as it used to be. Unfortunately, many physicians were burned and haven’t come back to try again.”