A Cost per Responder Analysis of Lipid-Lowering Therapies in Patients With Established Atherosclerotic Cardiovascular Disease in Italy
Author(s)
Paolo Angelo Cortesi, PhD1, Davide Marchesini, MSc2, Vita Manfreda, MSc3, Susan Sammak, PhD3, Ippazio Cosimo Antonazzo, Jr., PhD1, Lorenzo G Mantovani, DSc1.
1Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy, 2CHARTA Foundation, Milan, Italy, 3Amgen, Milano, Italy.
1Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy, 2CHARTA Foundation, Milan, Italy, 3Amgen, Milano, Italy.
OBJECTIVES: To assess the value of lipid lowering therapies (LLTs) in reaching low-density lipoprotein cholesterol (LDL-C) targets recommended by 2019 EAS/ESC guidelines, we performed a cost per responder analysis in patients with atherosclerotic cardiovascular disease (ASCVD) and uncontrolled hypercholesterolemia after statin therapy (an eligibility criterion for LLT per the Italian National Health system).
METHODS: A microsimulation analysis was performed to estimate the treatment costs per responder, defined as patient reaching LDL-C targets <40 mg/dL and <55 mg/dL with LLT (alirocumab, bempedoic acid±ezetimibe, evolocumab, and inclisiran) available in Italy. The simulation adopted the one-year time horizon and used efficacy data of LLTs obtained from a network meta-analysis of randomized clinical trials by Toth et al. Baseline characteristics of the Italian population were retrieved from the AT-TARGET-IT study (mean LDL-C ±standard deviation: 147.6±35.2 mg/dL). In a scenario analysis, alternative baseline LDL-C level (128.3±39.6 mg/dL) reported in the literature for the target population was tested.
RESULTS: In the base case analysis, the highest percentage of responders (LDL-C<40 mg/dL and <55 mg/dL) was reported for evolocumab (mean [95% confidence interval[CI]]: 25% [17%-33%] and 65% [53%-76%], respectively), followed by alirocumab (16% [7%-30%] and 51% [33%-72%]), inclisiran (2% [0%-5%] and 20% [13%-29%]), and bempedoic acid±ezetimibe (0% [0%-1%] and 5% [1%-15%]). The annual treatment cost per responder was the lowest (mean [95% CI]) for evolocumab (12,753€ [9,875€-17,278€] and 7,832€ [6,717€-9,540€]), followed by alirocumab (31,037€ [17,243 and 9,997€ [7,049€-15,237€]), and inclisiran (398,511€ [156,118€-1,892,927€] and 38,241€ [25,931€-60,332€]), at LDL-C<40 mg/dL and <55 mg/dL, respectively. The results of the scenario analysis also favored evolocumab where more patients with lower baseline LDL-C could reach their LDL-C targets overall.
CONCLUSIONS: Among LLTs available in Italy, evolocumab reported the highest value with the lowest cost per ASCVD patient effectively treated. This analysis can help decision makers identify the most cost-effective treatment to reach the desired clinical outcome.
METHODS: A microsimulation analysis was performed to estimate the treatment costs per responder, defined as patient reaching LDL-C targets <40 mg/dL and <55 mg/dL with LLT (alirocumab, bempedoic acid±ezetimibe, evolocumab, and inclisiran) available in Italy. The simulation adopted the one-year time horizon and used efficacy data of LLTs obtained from a network meta-analysis of randomized clinical trials by Toth et al. Baseline characteristics of the Italian population were retrieved from the AT-TARGET-IT study (mean LDL-C ±standard deviation: 147.6±35.2 mg/dL). In a scenario analysis, alternative baseline LDL-C level (128.3±39.6 mg/dL) reported in the literature for the target population was tested.
RESULTS: In the base case analysis, the highest percentage of responders (LDL-C<40 mg/dL and <55 mg/dL) was reported for evolocumab (mean [95% confidence interval[CI]]: 25% [17%-33%] and 65% [53%-76%], respectively), followed by alirocumab (16% [7%-30%] and 51% [33%-72%]), inclisiran (2% [0%-5%] and 20% [13%-29%]), and bempedoic acid±ezetimibe (0% [0%-1%] and 5% [1%-15%]). The annual treatment cost per responder was the lowest (mean [95% CI]) for evolocumab (12,753€ [9,875€-17,278€] and 7,832€ [6,717€-9,540€]), followed by alirocumab (31,037€ [17,243 and 9,997€ [7,049€-15,237€]), and inclisiran (398,511€ [156,118€-1,892,927€] and 38,241€ [25,931€-60,332€]), at LDL-C<40 mg/dL and <55 mg/dL, respectively. The results of the scenario analysis also favored evolocumab where more patients with lower baseline LDL-C could reach their LDL-C targets overall.
CONCLUSIONS: Among LLTs available in Italy, evolocumab reported the highest value with the lowest cost per ASCVD patient effectively treated. This analysis can help decision makers identify the most cost-effective treatment to reach the desired clinical outcome.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE8
Topic
Clinical Outcomes, Economic Evaluation
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas