ODYSSEY OUTCOMES: Alirocumab Cost-effective at $6000 a Year

Marlene Busko

November 11, 2018

CHICAGO — Treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab (Praluent, Sanofi/Regeneron) is cost-effective at $6319 a year when the willingness-to-pay threshold is the generally accepted $100,000 per quality-adjusted life-year (QALY), new research reports.  

Deepak L. Bhatt, MD, MPH, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, presented these cost-effectiveness findings for alirocumab, based on data from the ODYSSEY OUTCOMES trial, here at the American Heart Association (AHA) 2018 Scientific Sessions

As previously reported, results from ODYSSEY OUTCOMES were presented at American College of Cardiology (ACC) 2018 Annual Scientific Session in March and the study was published November 7 in the New England Journal of Medicine.

Strengths of the current cost analysis include that it used actual trial data as opposed to modeling estimates, Bhatt pointed out to theheart.org | Medscape Cardiology.

"My hope is that this analysis might move the needle and provide evidence for what the cost should be, as opposed to just pricing drugs based on what the market might tolerate," he said. Research should "see what the value is, and that's what the price should be — not higher."

Currently, pricing of the two PCSK9 inhibitors approved by the US Food and Drug Administration  — alirocumab and evolocumab (Repatha, Amgen) — is far from transparent, he noted.

As reported previously on October 24, Amgen lowered the list price of evolocumab by 60%, from more than $14,000 a year to $5850 a year. 

Alirocumab currently costs between $4500 to $8000 per year, but the actual price is "very opaque" because of hidden rebates, Bhatt noted.

"You don't actually know what the price is when you are walking into that pharmacy," he said. The pharmacy benefits manager knows the rebate that has been negotiated with the company, but physicians and patients don't have access to this information, he noted.

"PCSK9 prices are not transparent and are usually negotiated in private between the drug company and the payors, and that information is often not available to the public," the paper's assigned discussant, Andrew E. Moran, MD, Columbia University Medical Center, New York City, echoed in a comment to theheart.org | Medscape Cardiology.

On the one hand, PCSK9 inhibitors are "very promising agents," Moran stressed and are "some of the most innovative breakthrough cardiovascular prevention agents that have come around since the statins came on the scene." However, he said, "there have been big problems with the price of the drugs that has made it hard for the patients who are eligible for them to obtain them."

On the bright side, "the pricing is in flux, but it seems that both companies are converging on a similar price that's closer to about $5000 or $6000, which is also the value-based price" that was found in this analysis by Bhatt and colleagues. "But certainly those prices remain high and lower prices would help deliver this effective therapy to more patients" said Moran.

What Price Is Right?

ODYSSEY OUTCOMES enrolled nearly 19,000 patients who had acute coronary syndrome (ACS) in the past 1 to 12 months and had low-density lipoprotein cholesterol (LDL-C) levels of 70 mg/dL or higher despite receiving high-intensity or maximum tolerated doses of atorvastatin or rosuvastatin, Bhatt said, reviewing the trial on which this cost analysis is based.

At 2.8 years, the primary outcome of major adverse cardiovascular events (MACE), defined as coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina necessitating hospitalization, was 15% lower in the patients treated with alirocumab than in those receiving placebo (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.78 - 0.93; P < .001).

The secondary outcome of all-cause death was also 15% lower in the alirocumab group than in the placebo group (HR, 0.85; 95% CI, 0.73 - 0.98).

Among patients with a baseline LDL-C level of 100 mg/dL or greater, the risk for MACE was even lower with alirocumab than with placebo (HR, 0.76; 95% CI, 0.65 - 0.87), as was the risk for all-cause death (HR, 0.71; 95% CI, 0.56 - 0.90).

The cost analysis found that overall, alirocumab was cost-effective at $6319 at a threshold of $100,000 per QALY. But in patients with baseline LDL-C of 100 mg/dL or greater, alirocumab was cost-effective at an even higher price of $13,400 a year at this willingness-to-pay threshold.

Thus, "based on both absolute clinical benefit and cost-effectiveness, alirocumab may offer good value in patients with a history of ACS and LDL-C ≥100 mg/dL despite maximally tolerated statin therapy," Bhatt and colleagues summarize.

These cost-effectiveness findings, said Moran, are higher than results based on the same trial that were calculated by the Institute for Clinical and Economic Review (ICER).

Those authors report that in patients with a recent ACS, alirocumab was cost-effective at a price of $2300 to 3400 per year in patients with LDL-C  of 70 mg/dL or greater despite intensive statin therapy, and at a price of $4500 to 8000 per year in patients with LDL cholesterol of 100 mg/dL or greater.

The current analysis is preliminary, and it's still necessary to wait for the full report in a peer-reviewed publication, Moran said. This study also did not evaluate any added benefit of LDL-C lowering in patients with diabetes, or any detrimental effect on quality of life in patients who do not like to inject themselves with a drug every 2 weeks.

Bhatt discloses that he receives research grants from Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Sanofi Aventis, Eisai, Roche, Pfizer, Ethicon, Medtronic, Forest Laboratories, Lilly, Ironwood, and Ischemix and is a consultant for Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, and Sanofi Aventis. Moran has no relevant financial disclosures.  

American Heart Association (AHA) Scientific Sessions 2018.  LBS.01, Abstract 19490. Presented November 10, 2018.

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