COST EFFECTIVENESS Health economic evaluation of PCSK9 Inhibition Alexander Dressel, Felix Fath und Burkhard Schmidt et al.* Decreasing LDL C is one of the few established and proven principles for prevention and treatment of atherosclerosis. Statins are the drugs of choice, with other options including ezetimibe and the since recently available monoclonal antibodies against PCSK9 (PCSK9I). The aim is to evaluate the cost effectiveness of PCSK9I on top of conventional lipid-lowering therapy. CONFERENCES Methods The incidence of fatal and non-fatal CHD events and cerebrovascular events as well as fatal neither CHD nor cerebrovascular events is modelled with the aid of the Markov Chain Monte Carlo (MCMC) method with 1,000 bootstrap iterations and an Alexander Dressel (dr.alexander.dressel@gmx.de) 1 , Felix Fath 2 , Burkhard Schmidt 3 , Nina Schmidt 1 , Tanja Grammer 4 , Marcus Kleber 5 1, 2, 6 , Winfried März (1) CaRe High Cascade Screening and Registry for High Cholesterol, D-A-CH-Gesellschaft Prävention von Herz-Kreislauf- Erkrankungen e.V., Mannheim; (2) SYNLAB Holding Germany GmbH, SYNLAB Academy, Mannheim; (3) University for International Management Heidelberg; (4) Mannheim Institute for Public Health, Mannheim Medical Faculty, University of Heidelberg; (5) Faculty Mannheim of Heidelberg University; (6) Medical University Graz annual period up to a maximal age of 99 completed years. The model is illustrated in Figure 1. Target Population: The target population is represented by 373 female and 1,157 male participants of the LURIC study with stable CAD [1]; the mean age of these female (resp. male) individuals is 66 (resp. 63.39) years with a standard deviation of 9.5 (resp. 9.52) years. The basic assumption is that any individual of this subpopulation is already treated according to the rules of medical science. Two treatment strategies were modeled: (i) status quo, (ii) incremental treatment with PCSK9 inhibitor. Costs and utilities: In any annual period up the age of 99 years or up to death, direct medical costs associated with CHD events and cerebrovascular events are taken with an annual discount rate of 14
COST EFFECTIVENESS fatal non-CVD or CVD event additional non-fatal CHD event non-fatal CHD event status with at least one CHD event and no cerebrovascular event fatal non-CVD or CVD event status with no CHD and no cerebrovascular event non-fatal CHD and non-fatal cerebrovascular event additional non-fatal CHD or cerebrovascular event status with at least one CHD event and at least one cerebrovascular event non-fatal cerebrovascular event fatal non-CVD or CVD event death additional non-fatal cerebrovascular event non-fatal CHD event non-fatal cerebrovascular event status with no CHD event and at least one cerebrovascular event fatal non-CVD or CVD event fatal non-CVD or CVD event Figure 1: Model structure. 3 %. The direct medical costs (cf. [2, 3]) and the utility weights (cf. [4, 5]) are taken from the literature. Main outcomes and measures: The primary outcome was the incremental cost-effectiveness ratio (ICER; cost per quality-adjusted life-year) over the lifetime horizon in case of additional costs of 8,500 Euro per year and person for PCSK9I. Sensitivity Analysis: To analyze the dependence on the health status, we perform the analysis for adults with stable CAD having at least one and two of the following comorbidities: •• diagnosis of familial hypercholesterolemia (DLCN score >5), •• previous myocardial infarction, •• diabetes mellitus, •• renal insufficiency, •• heart failure. The dependence of the outcomes and measures on the age range at treatment initiation was analyzed by restriction on the following age groups: 70 years. The variation of the relative CV risk reduction in the sensitivity analysis covers the interval between 10 % and 50 % in 2 % increments. Results Assuming 8,500 Euro additional drug costs per year and person, the mean ICER (in 1,000 Euro) for women (resp. men) was 107 (resp. 98) with a standard deviation of 17 (resp. 8). The QALYs gained per one female (resp. male) person were 1.24 (resp. 1.28) with a standard deviation of 0.2 (resp. 0.11). The savings through avoided coronary/cerebrovascular events per one female (resp. male) person in 1,000 Euro were 2.32 (resp. 2.4) with standard deviation 0.76 (resp. 0.39). In Figure 2 (resp. Figure 3), we simulated ICERs in dependence of the relative CV risk reduction for women (resp. men). Therein, the magenta vertical line highlights a 32 percent relative CV risk reduction and the green horizontal line the 100,000 Euro threshold for the ICER. Regarding the dependence of the outcomes on the age range, for an age of less than 60 years (resp. 60–70 years [>70 years]), the mean ICER (in 1,000 Euro) for women was 165 (resp. 118 [80]) with a standard deviation of 51 (resp. 56 [15]); CONFERENCES 15
