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Low-Density Lipoprotein Cholesterol Lowering Efficacy of Evolocumab May Reduce Need for Apheresis in Heterozygous Familial Hypercholesterolaemia Patients According to Russian Guidelines

      Objectives

      Heterozygous familial hypercholesterolaemia (HeFH) patients who receive standard of care (SOC) therapy yet still have significantly elevated low-density lipoprotein cholesterol (LDL-C) levels qualify for apheresis. Apheresis is an invasive, burdensome and resource intensive (RUR 2,406,252 per patient-year) LDL-C lowering procedure and should be retained for patients where other lipid-lowering therapies (LLTs) are insufficient. This analysis aims to evaluate the ability of evolocumab added to SOC to reduce apheresis use in HeFH patients through LDL-C lowering, and further to evaluate the economic impact associated with reducing apheresis use in accordance with Russian guidelines.

      Methods

      Patient characteristics and efficacy data were taken from the RUTHERFORD-2 phase-3 trial, due to lack of Russian data. The cohort had a baseline LDL-C level ≥160mg/dL with a mean (standard deviation) of 201 (43) mg/dL. The mean percentage reduction in LDL-C by evolocumab was 61.3%. Baseline LDL-C and LDL-C after evolocumab treatment were modeled by assuming log-normal distributions. Patients were deemed eligible for apheresis with LDL-C levels ≥300mg/dL in primary prevention (PP) or ≥200mg/dL in secondary prevention (SP) according to Russian guidelines. The use of apheresis was calculated with and without evolocumab treatment over a lifetime horizon, with costs assigned to LLTs. A previously published decision analytic model was used to track the proportion of the cohort with history of events and to account for mortality.

      Results

      The model predictions indicate that 3.1% (PP) and 34.6% (SP) of patients would receive apheresis at baseline. Mean survival was increased by 5.6 years, whilst the use of apheresis was reduced by 3.8 patient-years in evolocumab treated patients. Despite increased survival, treatment with evolocumab resulted in a per-patient saving of RUR 957,016 for the overall cost of LLTs.

      Conclusions

      Evolocumab may lead to a significant reduction in apheresis use according to Russian guidelines and a subsequent savings in apheresis costs.