Cost impact of the ESC/EAS 2019 dyslipidemia guidelines recommended use of PSCK9i in very-high-risk patients with an LDL <1.8mmol/L for secondary prevention

Abstract

Abstract   ESC/EAS 2019 dyslipidemia guidelines give a class 1 recommendation to achieve a goal LDL-C of 1.4mmol/L in patients deemed very high risk. It is recommended to use a high dose statin and ezetimibe as first/second line therapies(1). In secondary prevention a class 1 recommendation is given for the addition of a PCSK9 inhibitors, if an LDL-C of 1.4mmol/L is not achieved. ODYSSEY and FOURIER used an LDL-C of >1.8mmol/l for trial inclusion, mean baseline LDL-C 2.25mmol/L and 2.38mol/l respectively(2, 3). Current Irish reimbursement criteria limit availability of PCSK9i due to high cost. Our aim was to determine the cost of PCSK9i therapy in patients post-PCI with an LDL-C of 1.5 – 1.8mmol/L and the potential cardiovascular benefit of a 1mmol/L reduction in LDL-C in this cohort. Methods We retrospectively analyzed patients at 6 - 8 weeks post-PCI in University Hospital Limerick (UHL) between January 2016 to December 2019. The cost analysis was based on a hierarchal analysis of patients on high dose statin, with an LDL-C >1.4mmol/L. Due to a low rate of prescribed ezetimibe we calculated the expected LDL-C, in patients on high dose statin with a presumed 25% reduction in LDL-C with the addition of ezetimibe. PCSK9i cost was based on the cohort of patients who would have an expected LDL-C >1.4 & <1.8mmol/L despite treatment with high dose statin and ezetimibe. Cost was based on current pack reimbursement price of evoculmab, €8117.17 yearly. To calculate the benefit of a 1mmol/L LDL-C reduction in secondary prevention with PCSK9i therapy, we used a number needed to treat (NNT) of 21 over 5 years to prevent 1 CV death or myocardial infarctions based on meta-analysis data(4). Results A total of 784 patients were included in our analysis, who would be potentially eligible for a PCSK9i based on current ESC/EAS 2019 dyslipidemia guidelines with an expected LDL-C >1.4mmol/L. Baseline characteristics, mean age 63.6years, male 76.8%, 64.28% hypertension, 51.4% diabetes mellitus, smoking history 23.5%. Of the 784 patients potentially eligible for a PCSK9i, 375/784 (47.8%) had LDL-C of between 1.4mmol/L – 1.8mmol/L. Current cost for PSCK9i therapy for this patient cohort at our institution would result in potential total cost of €3,043,938.75 per year. In comparison expected cost of statin therapy in this group is €81,883.2 per year. 5 years of treatment with PCSK9i, assuming at least 1mmol/L reduction in LDL-C would be expected to prevent 17.8 CV deaths or MI’s in our cohort or €171,007.79 per event. In comparison the cost of statin therapy in this total cohort is €81,883.2 per year. Discussion Current cost of PCSK9i therapy in relation to first/second line lipid therapies makes prescribing prohibitive for patients with an LDL-C <1.8mmol/L. Additionally, the estimated cost of PCSK9i therapy to prevent one CVD/MI, limits the ability for this to become standard practice in Ireland, within the cohort of post-PCI patients with an LDL 1.4 – 1.8mmol/L.