Disclosures: The ODYSSEY OUTCOMES study was supported by Sanofi and Regeneron. Bhatt reports he has financial ties with numerous drug and device companies, including receiving research funding from Regeneron and Sanofi. Boden and Weintraub report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
June 26, 2020
2 min read
Save

Economic value of alirocumab good if LDL greater than 100 mg/dL

Disclosures: The ODYSSEY OUTCOMES study was supported by Sanofi and Regeneron. Bhatt reports he has financial ties with numerous drug and device companies, including receiving research funding from Regeneron and Sanofi. Boden and Weintraub report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Deepak L. Bhatt

In a cost-effectiveness model, the PCSK9 inhibitor alirocumab had good economic value at its present cost in patients with a baseline LDL greater than 100 mg/dL, though less value in patients with LDL less than 100 mg/dL.

ODYSSEY OUTCOMES patient data

In this study, Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, and colleagues developed a cost-effectiveness model with patient data from the ODYSSEY OUTCOMES trial (n = 18,924) to estimate outcomes and costs over a lifetime.

Cost with pills
Source: Adobe Stock.

As Healio previously reported, the ODYSSEY OUTCOMES trial found that reducing LDL to very low levels with alirocumab (Praluent, Sanofi/Regeneron) lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy.

In this study, researchers determined incremental cost per quality-adjusted life-year (QALY) when alirocumab was added compared with placebo. Clinical efficacy findings were used to stratify patients by baseline LDL of greater than or less than 100 mg/dL.

When an annual treatment cost of $5,850 — the current list price without discounts — was used, the mean overall incremental cost-effectiveness ratio for the overall population was $92,200 per QALY. The cost per QALY was $41,800 in patients with a baseline LDL greater than 100 mg/dL compared with $299,400 for those with baseline LDL less than 100 mg/dL.

Several sensitivity analyses determined that incremental cost-effectiveness ratios for patients with LDL greater than 100 mg/dL were below $100,000 per QALY.

“In the subgroup with LDL-C 100 mg/dL at baseline, in which alirocumab appeared to demonstrate good value, there is biological plausibility for its increased value for money,” Bhatt and colleagues wrote. “Baseline risk in these patients is generally higher than among patients with LDL-C < 100 mg/dL. At the same time, a higher LDL-C concentration at baseline is associated with a larger absolute decrease in LDL-C under treatment with alirocumab, yielding a greater effect on risk reduction. Together, these findings make the subgroup with baseline LDL-C 100 mg/dL clinically relevant and easily identified in routine clinical practice.”

Favorable cost effectiveness

William S. Weintraub
William E. Boden

In a related editorial, Cardiology Today Editorial Board Member William S. Weintraub, MD, director of outcomes research at the MedStar Heart & Vascular Institute, MedStar Washington Hospital Center, and William E. Boden, MD, FACC, FAHA, professor of medicine at the Boston University School of Medicine, lecturer in medicine at Harvard Medical School and physician research lead and scientific director of the Clinical Trials Network of the VA New England Healthcare System in Boston, wrote, “Accordingly, the study ... is a welcome addition to the literature, providing insight into value and providing evidence that the cost-effectiveness of alirocumab is favorable for LDL-C 100 mg/dL. Nonetheless, the process of evaluating the economic value as well as societal burden of PCSK9 inhibitors on overall health care expenditures remains a challenge to our analytic capabilities. Undoubtedly, we will learn more in the future as analyses like this continue to inform our treatment decisions and their potential cost consequences.”

PAGE BREAK

Reference: