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Circulation. 2019;139:e1082–e1143. DOI: 10.1161/CIR.0000000000000625 June 18/25, 2019 e1121 CLINICAL STATEMENTS AND GUIDELINES

­implementation should be analyzed in advance, and implementation strategies should be tailored to the setting and target audience. Multiple strategies may be needed to effectively implement guidelinesS6-5,S6-6 (Table S7 in the Web Supplement). 3.	Patients who participate in shared decision-making may have better health outcomes, better healthcare experiences, and lower costs.S6-7,S6-8 During the clinician–patient risk discussion with shared decision-making, the patient participates with the clinician in deciding lifestyle modifications, medication treatment, and goals of therapy. The clinician should explain the patient’s risk of clinical ASCVD and how the treatment recommendations reduce ASCVD risk. The patient should verbalize values, attitudes, abilities, concerns, and personal goals for making lifestyle changes and taking medications, including concerns about cost.S6-22 The clinician may use a checklist to facilitate shared decision-making with the patient (Table S8 in the Web Supplement).

The clinician should use tools and techniques to support shared decision-making.S6-7,S6-22–S6-26 Decision aids may allow the patient to be more knowledgeable, have better risk perception, and have a clearer understanding of their values.S6-8,S6-27 Question prompt lists may increase knowledge by including questions about the purpose or goal of treatment, the risk with and without treatment, how the medication should be taken, potential side effects and how to manage them, when to notify the office, and monitoring and follow-up. Motivational interviewingS6-28 and decision coaching may also promote patient knowledge and satisfaction.

7 COST AND VALUE CONSIDERATIONS

7.1 Economic Value Considerations: PCSK9 Inhibitors

ACC/AHA clinical guidelines now recognize the importance of considering economic value in making recommendations, in accordance with the principles established by an expert group.S7.1-1 PCSK9 inhibitors further reduce LDL-C when combined with other LDL-lowering drugs, and they reduced composite cardiovascular events in 2 RCTs of high-risk, secondaryprevention patients with clinical ASCVD.S7.1-2 The costeffectiveness and economic value of PCSK9 inhibitors have been assessed by using simulation models (Online Data Supplements 47 and 48); the published models are based on different sets of assumptions. Compared with statin therapy for secondary prevention, PCSK9 inhibitors have incremental cost-effectiveness ratiosS7.1-3 from $141 700 to $450 000 per quality-adjusted lifeyear (QALY) added, at mid-2018 list prices. None of the published models report “good value” (<$50 000 per QALY added; Table 12), and virtually all indicate “low value” (≥$150 000 per QALY added). All models projected mortality benefit by assuming that mortality rate reductions either parallel LDL-C loweringS7.1-4 or parallel RRRs for nonfatal ASCVD events.

All models project higher lifetime cost from use of PCSK9 inhibitors because the cost will exceed any savings from prevention of cardiovascular events. To be cost-effective by conventional standards, the cost of PCSK9 inhibitors will have to be reduced on the order of 70% to 85% in the United States.S7.1-3 At any given price, the economic value of PCSK9 inhibitors will be improved by restricting their use to patients at very high-risk of ASCVD events, as recommended in the present guidelines. The inverse relationship between improved survival and the incremental cost-effectiveness ratio (Figure 3) indicates that the economic value of PCSK9 inhibitors will be improved by selecting higher-risk patients. One simulation model suggested that restricting the use of PCSK9 inhibitor therapy to patients with baseline LDL-C levels ≥119 mg/dL (≥3 mmol/L), instead of ≥70 mg/dL (≥1.8 mmol/L), would improve their cost-effectiveness to $150 000 per QALY added, instead of $268 000.S7.1-5 Another study projected a similar improvement in economic value.S7.1-6 Thus, raising the threshold for LDL-C on maximal statin therapy to initiate a PCSK9 inhibitor should improve its cost-effectiveness (Figure 3). Only 2 economic models have specifically examined the value provided by PCSK9 inhibitors for primary prevention in patients with heterozygous FH (Online Data Supplement 45). One modelS7.1-7 found low value when PCSK9 inhibitors were used for FH ($503 000 per QALY added), whereas the second modelS7.1-8 reported intermediate value (incremental cost-effectiveness ratio of $75 900 per QALY added). Consequently, the value of PCSK9 inhibitor therapy in FH is uncertain.

Table 12.  Proposed Integration of Level of Value Into Clinical Guideline Recommendations*

Level of Value High value: Better outcomes at lower cost or ICER <$50 000 per QALY gained Intermediate value: $50 000 to <$150 000 per QALY gained Low value: ≥$150 000 per QALY gained Uncertain value: Value examined, but data are insufficient to draw a conclusion because of absence of studies, low-quality studies, conflicting studies, or prior studies that are no longer relevant Not assessed: Value not assessed by the writing committee Proposed abbreviations for each value recommendation:Level of value: H to indicate high value; I, intermediate value; L, low value; U, uncertain value; and NA, value not assessed. *Dollar amounts used in this table are based on US GDP data from 2012 and were obtained from WHO-CHOICE Cost-Effectiveness Thresholds.S7.1-9 Reproduced from Anderson et al.S7.1-1 GDP indicates gross domestic product; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-years; and WHO-CHOICE, World Health Organization Choosing Interventions that are Cost-Effective.

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