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CLINICAL STATEMENTS AND GUIDELINES

August 29, 2023 Circulation. 2023;148:e9–e119. DOI: 10.1161/CIR.0000000000001168

Virani et al 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Chronic Coronary Disease Guideline

absolute risk of future ASCVD events was significantly higher; therefore, the absolute risk reduction from the use of a PCSK9 monoclonal antibody was also much higher than the overall absolute risk reductions seen in the original trials.23,26,28,51,52 Although generally well tolerated, injection site reactions can occur, and long-term safety data are limited. Maximal LDL-C-lowering therapy should include maximally tolerated statin plus ezetimibe; however, ezetimibe may be insufficient when a ≥25% reduction in the LDL-C level is desired. Clinicians bypassing the addition of ezetimibe before adding a PCSK9 monoclonal antibody should recognize this may not be cost effective (Figure 8). 8 The US cost of PCSK9 monoclonal antibodies has

declined by 60% since their initial market entry (from approximately $14 000 per year to $5850 per year), which, all things being equal, has improved the cost-effectiveness of these drugs.12,20,21 At this price point, the cost-effectiveness of the agents in very high risk patients with CCD is uncertain, with some studies projecting low economic value12,20 and others suggesting intermediate to high economic value.30,31 This value statement should not be extrapolated to patients with CCD who are at low to moderate risk of adverse cardiovascular events, in whom PCSK9 inhibitor monoclonal antibodies are of low economic value. The cost-effectiveness

Figure 8. Lipid Management in Patients With CCD. Colors correspond to Class of Recommendation in Table 3. Very high-risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions (Table 10). *Only when ezetimibe and PCSK9 mAb are deemed insufficient or not tolerated should bempedoic acid or inclisiran (in place of PCSK9 mAb) be considered to further reduce LDL-C levels. The effect of bempedoic acid and inclisiran on MACE is being evaluated. LDL-C indicates low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; PCSK9 mAb, PCSK9 monoclonal antibody; RCT, randomized controlled trial; and TG, triglycerides. Adapted with permission from Grundy SM, et al.42 Copyright 2019 American Heart Association, Inc., and American College of Cardiology Foundation.

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