Heart of Health Policy | PINNACLE Registry Research Suggests a Need to Address PCSK9 Inhibitor Pricing

With the number of U.S. adults eligible for PCSK9 inhibitors ranging from 700,000 to approximately 10 million, reducing PCSK9 inhibitor prices to meet cost-effectiveness thresholds may need to be considered, say researchers involved in a newly released study using data from ACC’s PINNACLE Registry.

The study, published in American Heart Journal, comprised 252,956 patients ages 18-75 years with available LDL-C data who had prior acute coronary syndrome, coronary or other arterial revascularization, cerebrovascular accident, transient ischemic attack or peripheral arterial disease. Researchers assessed the impact of LDL-C and statin intensities on the proportion of patients who might be eligible for PCSK9 inhibitor therapy. Eligibility was defined using a range of LDL-C thresholds (≥70 mg/dL or ≥160 mg/dL) and statin dosing at high intensity, moderate intensity or any intensity.

Of the study population, 23.3 percent of patients were taking a high-intensity statin, 27.7 percent were taking a moderate-intensity statin and 60.6 percent were taking any statin. Among patients on a high-intensity statin, the proportion of patients potentially eligible for PCSK9 inhibitor therapy significantly increased from 1.9 percent with the threshold of ≥160 mg/dL to 23.3 percent with the threshold of ≥70 mg/dL. For those receiving moderate-intensity statins, PCSK9 inhibitor eligibility went up from 1.7 percent with the higher LDL-C threshold to 27.7 percent with the lower threshold. Similarly, for patients receiving any statin, PCSK9 inhibitor eligibility increased from 4.3 percent to 60.6 percent.

Along with addressing the substantial cost implications associated with PCSK9 inhibitor therapy, researchers also recommended encouraging lifestyle changes, titrating statin therapy, increasing statin compliance, and targeting a subset of high-risk patients based on clinical factors that include high LDL-C as a means of reducing the need for PCSK9 inhibitor therapy.

The ACC has been focused over the last year on addressing the administrative burden associated with pre-authorization of PCSK9 drugs. A PCSK9 Prior Authorization Reporting Tool (PART) is available on ACC.org/PARTool to help with tracking of PCSK9-related denials. The College is also working closely with payers and industry to look at ways of reducing this burden. In addition, the College’s Advocacy leaders and staff continue to look at the broader issue of drug pricing and patient access to appropriate treatments as a priority topic.

Learn more about ACC’s Advocacy efforts at ACC.org/Advocacy. The PINNACLE Registry research was conducted as part of ACC’s Research to Practice initiative, which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC’s NCDR clinical registries.

Clinical Topics: Acute Coronary Syndromes, Dyslipidemia, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Nonstatins, Novel Agents, Statins

Keywords: ACC Publications, Cardiology Magazine, Health Policy, Ischemic Attack, Transient, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Peripheral Arterial Disease, Acute Coronary Syndrome, Cost-Benefit Analysis, Stroke, Registries, PINNACLE Registry, Research, Life Style


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