Consequently, patients who have a baseline LDL-C level 220 mg/dL ( 5.7 mmol/L) and an on-treatment LDL-C level 130 mg/dL ( 3.4 mmol/L) despite maximally tolerated statin and ezetimibe therapy may be considered for treatment with a PCSK9 inhibitor after a clini- cian patient discussion of the net benefits versus the costs of such therapy. 6. The cost-effectiveness of PCSK9 inhibitors for primary prevention among patients with LDL-C levels >190 mg/dL ( 4.9 mmol/L), or with FH, has not been evaluated extensively, and their clinical effectiveness in reducing ASCVD events in these patients has also not been established. The 2 published cost-effectiveness models for pri- mary prevention (see Online Data Supplements 44 and 45 and Section 7.) report very different results, with one suggesting an incremental cost- effectiveness ratio of $503000 per QALY added, and the other reporting $75000 per QALY added. Because of the lack of consistent evidence, the use of PCSK9 inhibitors has uncertain value for the primary prevention of ASCVD in patients with severe hypercholesterolemia. 4.3. Diabetes Mellitus in Adults Recommendations for Patients With Diabetes Mellitus Referenced studies that support recommendations are summarized in Online Data Supplements 11 and 12. 