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Cost-Effectiveness of PCSK9 Inhibitor Therapy in HeFH or ASCVD
Study Questions:
What is the cost-effectiveness of PCSK9 inhibitors and potential effect on US health care spending on the Food and Drug Administration–approved indications including heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD)?
Methods:
The Cardiovascular Disease Policy Model included the entire population of US adults aged 35-94 years in 2015, and followed them over their lifetime (until death or survival to 95 years of age). The model incorporated 2015 annual PCSK9 inhibitor costs of $14,350 (based on mean wholesale acquisition costs of evolocumab and alirocumab) and adopted a health-system perspective.
Results:
Adding PCSK9 inhibitors to statins in HeFH was estimated to prevent 316,300 major adverse cardiac events (MACE) at a cost of $503,000 per quality-adjusted life-year (QALY) gained compared with adding ezetimibe to statins. In ASCVD, adding PCSK9 inhibitors to statins was estimated to prevent 4.3 million MACE compared with adding ezetimibe at $414,000 per QALY. Reducing drug costs to ≤$4,536 per year per patient would be needed for PCSK9 inhibitors to be cost-effective at <$100,000 per QALY. At 2015 prices, PCSK9 inhibitor use in all eligible patients was estimated to reduce CV care costs by $29 billion over 5 years, but drug costs increased by an estimated $592 billion (a 38% increase over 2015 prescription drug expenditures).
Conclusions:
Assuming 2015 prices, PCSK9 inhibitor use in patients with HeFH or ASCVD did not meet generally acceptable incremental cost-effectiveness thresholds and was estimated to increase US health care costs substantially. Reducing annual drug prices from >$14,000 to $4,536 would be necessary to meet a $100,000 per QALY threshold.
Perspective:
Each of the available PCSK9 inhibitors reduces the low-density lipoprotein cholesterol (LDL-C) by about 60% regardless of statin therapy. Accurate cost/benefit analysis of therapy superimposed on maximal tolerated dosing of statins or alone in statin-intolerant patients awaits the results of the 5-year outcome data. And it may well vary by baseline LDL-C. Importantly, this analysis did not consider the evidence that CV event rates in HeFH patients who have lifelong exposure to very high LDL-C levels are three- to four-fold that of adults patients with equivalent LDL-C >190 mg/dl. The eventual cost/benefit will depend on additional value over statins in HeFH and high- and intermediate-risk individuals.
Keywords: Atherosclerosis, Cardiovascular Diseases, Cholesterol, LDL, Cost-Benefit Analysis, Drug Costs, Dyslipidemias, Health Care Costs, Health Expenditures, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hyperlipoproteinemia Type II, Primary Prevention, Proprotein Convertases, Quality-Adjusted Life Years
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