Latest analysis of evolocumab suggests the drug is—finally—affordable

An updated cost-effectiveness analysis of evolocumab suggests that while treatment with the PCSK9 inhibitor may always be somewhat costly, it remains effective in hard-to-treat patients and its reduced list price meets cost-effectiveness thresholds across a range of CV events in patients with very-high-risk atherosclerotic CVD (ASCVD).

Since evolocumab—sold by Amgen as Repatha—was first approved by the FDA nearly four years ago, the cholesterol-lowering drug has made headlines for its high price point. Even after 2017’s FOURIER study proved just how effective PCSK9 inhibitors could be in managing stubborn hyperlipidemia, subsequent analyses suggested evolocumab’s $14,000-per-year price tag made the drug inaccessible to the average patient.

An August 2017 report in JAMA Cardiology found Amgen would need to cut the price of evolocumab by at least one-third, from $14,253 to $9,669, to meet widely accepted cost-effectiveness standards for treating patients with ASCVD. Another study followed that October, calling for a more dramatic 62% cut to make evolocumab affordable.

Amgen settled for something in the middle, announcing on Oct. 24 of last year it would be reducing the sticker price of Repatha to $5,850 per year. The company said at the time it believed the price cut would improve accessibility to the drug and lower patient copays, especially for Medicare beneficiaries.

In the newest analysis of evolocumab data, published June 5 in JAMA Cardiology, Gregg C. Fonarow, MD, and colleagues studied the efficacy of the lower-priced Repatha in very-high-risk ASCVD patients who either received evolocumab with their standard therapy or underwent standard therapy alone. Unlike previous studies, Fonarow et al.’s work considered high-risk ASCVD as defined by the updated 2018 ACC/AHA cholesterol management guideline.

The authors reported evolocumab was indeed linked to increased costs in their study—but it was also tied to improved outcomes when added to a patient’s standard background therapy, which could include maximally tolerated statin therapy with or without ezetimibe. Incremental costs varied across the range of CV risk within the ASCVD population, from $22,228 for a baseline CV event rate of 6.4 events per 100 patient-years to $3,411 for a baseline CV event rate of 12.3 events per 100 patient-years.

Incremental quality-adjusted life years (QALYs) gained ranged from 0.39 to 0.44, respectively, translating to incremental cost-effectiveness ratios (ICERs) ranging from $56,655 to $7,667 per QALY gained, respectively.

“As noted in the 2018 ACC/AHA guideline, at any given price, the value of PCSK9 inhibitors will be improved by selecting patients at higher risk for the occurrence of CV events,” Fonarow, of the University of California, Los Angeles Medical Center, and colleagues wrote in JAMA. “At its new annual list price of $5,850, the addition of evolocumab to standard background therapy in patients with very-high-risk ASCVD yields ICERs that meet currently accepted cost-effectiveness thresholds and are consistent with providing high-value care.”

The authors said their analysis might be useful for policymakers and healthcare providers who are working toward the best use of PCSK9 inhibitors in clinical practice. They wrote the 2018 ACC/AHA guideline questioned the value of PCSK9 inhibitors—probably because that guideline considered mid-2018 prices, before the cut—but a more recent statement from the National Lipid Association recommended the drugs for certain patient groups, like extremely- and very-high-risk ASCVD patients.

“The reduction in list price improved the cost-effectiveness for patients with ASCVD before characterizing patients at very high risk, for whom baseline CV event rates would be higher,” the researchers wrote. “Despite the improvement in value at the new current list price, a comprehensive disease management approach including a heart-healthy lifestyle across the life course and adherence to standard background therapy, as per current guidelines, should be applied.”