If the annual cost of the PCSK9 inhibitors were to remain at $14,000–14,600, then specialty pharmaceutical pricing models previously reserved for drugs which benefitted limited patient populations will collide with prospective treatment cohorts in the tens of millions of patients at high risk for CVD, when using PCSK9 inhibitors as an adjunct to diet-maximally tolerated cholesterol lowering therapy in heterozygous (HeFH) or homozygous (HoFH) familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease (CVD). This evidence concerns the gene PCSK9 and familial hypercholesterolemia.