ABSTRACT
BACKGROUND: A clinicalgenetic function (Cardio inCode®) was generated using genetic variants associated with coronary heart disease (CHD), but not with classical CHD risk factors, to achieve a more precise estimation of the CHD risk of individuals by incorporating genetics into risk equations [Framingham and REGICOR (Registre Gironí del Cor)]. OBJECTIVE: The objective of this study was to conduct an economic analysis of the CHD risk assessment with Cardio inCode®, which incorporates the patient's genetic risk into the functions of REGICOR and Framingham, compared with the standard method (using only the functions). METHODS: A Markov model was developed with seven states of health (low CHD risk, moderate CHD risk, high CHD risk, CHD event, recurrent CHD, chronic CHD, and death). The reclassification of CHD risk derived from genetic information and transition probabilities between states was obtained from a validation study conducted in cohorts of REGICOR (Spain) and Framingham (USA). It was assumed that patients classified as at moderate risk by the standard method were the best candidates to test the risk reclassification with Cardio inCode®. The utilities and costs (; year 2011 values) of Markov states were obtained from the literature and Spanish sources. The analysis was performed from the perspective of the Spanish National Health System, for a life expectancy of 82 years in Spain. An annual discount rate of 3.5 % for costs and benefits was applied. RESULTS: For a Cardio inCode® price of 400, the cost per QALY gained compared with the standard method [incremental cost-effectiveness ratio (ICER)] would be 12,969 and 21,385 in REGICOR and Framingham cohorts, respectively. The threshold price of Cardio inCode® to reach the ICER threshold generally accepted in Spain (30,000/QALY) would range between 668 and 836. The greatest benefit occurred in the subgroup of patients with moderatehigh risk, with a high-risk reclassification of 22.8 % and 12 % of patients and an ICER of 1,652/QALY and 5,884/QALY in the REGICOR and Framingham cohorts, respectively. Sensitivity analyses confirmed the stability of the study results. CONCLUSIONS: Cardio inCode® is a cost-effective risk score option in CHD risk assessment compared with the standard method.
