scholarly journals Cost-Effectiveness Analysis of Alirocumab in High Cardiovascular-Risk Patients in Italy

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Massimiliano Povero ◽  
Lorenzo Pradelli ◽  
Andrea Serra ◽  
Francesca Fanelli ◽  
Luca Gazzi
Keyword(s):  
Cardiovascular Risk ◽  
Cost Effectiveness ◽  
Density Lipoprotein ◽  
Cost Effective ◽  
Baseline Risk ◽  
High Cardiovascular Risk ◽  
Novel Therapy ◽  
Coronary Syndrome ◽  
Risk Patients ◽  
The Cost

OBJECTIVE: Dyslipidemia, in particular elevated total and low-density lipoprotein cholesterol (LDL-C), results in atherosclerosis and increases the risk of cardiovascular (CV) events. Despite treatment with statins, many patients fail to reduce their LDL-C enough to optimally minimize their risk. Novel therapy alirocumab, on top of background statin therapy, resulted efficacious in lowering CV risk by reducing LDL-C levels. Aim of the present paper is to evaluate the cost-effectiveness of alirocumab in high cardiovascular-risk patients in ItalyMETHODS: A 1-year cycles Markov model was developed to evaluate the cost-effectiveness of statins at maximum dose tolerated plus ezetimibe (MDTS+E) with or without alirocumab. Target population consisted of patients with high baseline risk of CV events. Patients entered the model in stable disease and could experience a non- fatal CV event (acute coronary syndrome, elective revascularization or ischemic stroke) or die. Results from the ODYSSEY trial were used to evaluate CV risk reduction due to alirocumab add-on. Pharmaceutical, CV events, and LDL-C levels’ detection costs are considered in the analysis from the perspective of Italian National Health Service.RESULTS: Simulated cohort was 75 years old on average, 66% male, 42% diabetes mellitus and baseline LDL-C level equal to 121mg/dl. Furthermore, 96% of subjects were hospitalized in the last 12 months. Alirocumab used as an add-on to MDTS+E was more costly (€ 45,358 vs € 13,208) but more effective (8.01LY vs 6.33LY) than MDTS+E, leading to an incremental cost effectiveness ratio of € 19,158 per LY. At a willingness to pay threshold of € 30,000 per LY, alirocumab had 96% probability to be cost effective vs. MDTS+E alone. Results were relatively more favorable in the patient subset with recent CV event (<12 months from index).CONCLUSION: The results indicate that alirocumab in addition to MDTS+E is cost-effective versus MDTS+E alone in a representative cohort of high CV risk patients in Italy.

scholarly journals Modelling the cost-effectiveness of person-centred care for patients with acute coronary syndrome

2020 ◽  
Vol 21 (9) ◽  
pp. 1317-1327 ◽  
Author(s):  
Laura Pirhonen ◽  
Hanna Gyllensten ◽  
Andreas Fors ◽  
Kristian Bolin
Keyword(s):  
Monte Carlo ◽  
Acute Coronary Syndrome ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Time Perspective ◽  
Controlled Trial ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Coronary Syndrome ◽  
The Cost

Abstract Background Person-centred care has been shown to be cost-effective compared to usual care for several diseases, including acute coronary syndrome, in a short-term time perspective (< 2 years). The cost-effectiveness of person-centred care in a longer time perspective is largely unknown. Objectives To estimate the mid-term cost-effectiveness of person-centred care compared to usual care for patients (< 65) with acute coronary syndrome, using a 2-year and a 5-year time perspective. Methods The mid-term cost-effectiveness of person-centred care compared to usual care was estimated by projecting the outcomes observed in a randomized-controlled trial together with data from health registers and data from the scientific literature, 3 years beyond the 2-year follow-up, using the developed simulation model. Probabilistic sensitivity analyses were performed using Monte Carlo simulation. Results Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective. Monte Carlo simulations suggest that the likelihoods of the person-centred care being cost-effective compared to usual care were between 80 and 99% and between 75 and 90% for a 2-year and a 5-year time perspective (using a 500,000 SEK/QALY willingness-to-pay threshold). Conclusions Person-centred care was less costly and more effective compared to usual care in a 2-year and a 5-year time perspective for patients with acute coronary syndrome under the age of 65.

scholarly journals Pharmacoeconomic Analysis of Therapy with Generic Statin Drugs in Patients with High and Very High Cardiovascular Risk (According to the Study PRIORITY)

2020 ◽  
Vol 16 (5) ◽  
pp. 693-698
Author(s):  
S. Yu. Martsevich ◽  
Yu. V. Lukina ◽  
N. P. Kutishenko
Keyword(s):  
Cardiovascular Risk ◽  
Cost Effectiveness ◽  
Statin Therapy ◽  
Pharmacoeconomic Analysis ◽  
Target Level ◽  
Cost Effectiveness Ratio ◽  
High Cardiovascular Risk ◽  
The Cost ◽  
Statin Drugs ◽  
Very High

Aim. To perform a pharmacoeconomical assessment of the use of generic statin drugs in patients with high and very high cardiovascular risk (CVR) in real clinical practice based on the data of the study PRIORITY.Material and methods. The PRIORITY study included 298 patients with high (29; 9.7%) and very high (269, 90.3%) CVR. All patients were recommended to take the reproduced drugs of atorvastatin and rosuvastatin in an individually prescribed dose. After 1 month (B1), if the target level of lowdensity lipoprotein cholesterol (LDL-C) was not reached, the statin dose was titrated. After 3 months of follow-up (B3), the hypolipidemic effect of statin therapy was evaluated. 295 people completed the study, 285 patients had the results of the lipid profile. To perform a pharmacoeconomic analysis and evaluate the “cost/effectiveness” ratio, we used the prices of generic statins in one of the online pharmacies. The effectiveness of statins was determined by the LDL-C reduction, as well as by the percentage of achieving the target LDL-C level.Results. At the first stage of the pharmacoeconomic analysis, the criterion for the effectiveness of 3-month lipid-lowering therapy was a decrease in LDL-C level by 1 mmol/l. The median and interquartile range of the ratio “cost/effectiveness” indicator for atorvastatin was 658.2 (431.5; 1257.1) RUB/mmol/l, and for rosuvastatin – 621.0 (390.7; 940.6) RUB/mmol/l (p=0.45). The results of a comparative assessment of the “cost/effectiveness” ratio (with the abovementioned effectiveness indicator) in subgroups of patients with high and very high CVR, with the achievement and nonachievement of the target level of LDL-C, adherent and non-adherent to statins, revealed the economic advantage of statins in groups of adherent patients (p=0.35), high-risk patients (p<0.0001) and individuals who reached the target level of LDL-C (p=0.002) when compared with the corresponding comparison groups. Despite the revealed high effectiveness of rosuvastatin at doses of 20-40 mg/day (assessed by the cost/effectiveness of achieving the target values of LDL-C for specific doses of statins), calculation of the “cost/effectiveness” ratio for each reproduced statin, in general, showed a higher economic effectiveness of atorvastatin.Conclusion. Pharmacoeconomic analysis of therapy with generic statin drugs, performed according to the data of the non-randomized uncontrolled study, allows to justify the economic efficiency and advantages of these drugs in various subgroups of patients who need statin therapy.

scholarly journals Pathogenetic role of cell-free circulating mitochondrial DNA in blood in the development of arterial hypertension

2021 ◽  
pp. 50-57
Author(s):  
С.А. Лепехова ◽  
Е.А. Трофимова ◽  
С.В. Кирильчик ◽  
В.В. Киреева ◽  
Ю.К. Усольцев ◽  
...  
Keyword(s):  
Mitochondrial Dna ◽  
Cardiovascular Risk ◽  
Arterial Hypertension ◽  
High Cardiovascular Risk ◽  
Pathogenetic Role ◽  
Quantitative Indicator ◽  
Coronary Syndrome ◽  
Risk Patients ◽  
Very High

Изучение свободно циркулирующей митохондриальной ДНК (мтДНК) плазмы крови вызывает растущий интерес. Предполагается, что показатель мтДНК может быть перспективным клиническим биомаркёром оценки рисков течения заболеваний. Целью исследования явилась оценка взаимосвязи количественного показателя мтДНК со стадией заболевания и сердечно-сосудистым риском у пациентов с артериальной гипертензией (АГ). Методы. В исследовании участвовал 70 пациентов, которые были разделены на группу с АГ (n = 51) и контрольную группу практически здоровых пациентов (n = 19). Все пациенты подписали информированное согласие на обследование и обработку данных в рамках научного исследования. Проведена оценка демографических данных, длительности заболевания АГ, факторов риска, наследственности, уровня физической активности, антропометрических данных, лабораторное и инструментальное обследование. Оценка уровня мтДНК проведена методом количественной полимеразной цепной реакции. Использовали фрагмент мтДНК с праймерами FmtMinArc 5'-CTAAATAGCCCACACGTTCCC-3' и RmtMinArc 5'-AGAGCTCCCGTGAGTGGTTA-3'. Результаты. На основании проведенного исследования оценки взаимосвязи количественного показателя мтДНК в крови пациентов с АГ, выявлено, что независимо от стадии заболевания, достоверных различий в показателях уровня мтДНК не выявлено, однако отметим, что количество копий имело тенденцию к увеличению по сравнению с условно здоровыми пациентами. При анализе сердечно-сосудистого риска обнаружено, что количественный показатель мтДНК не зависит от стадии АГ. В то же время уровень мтДНК статистически значимо повышается у пациентов с АГ очень высокого сердечно-сосудистого риска по сравнению с условно здоровыми субъектами: Me (Q1; Q3) - 56731 (42531; 129375) копий/мл против 35156 (18325; 54956) копий/мл соответственно (p = 0,015). Заключение. Уровень мтДНК у пациентов с АГ может явиться маркёром сердечно-сосудистого риска. Учитывая ранее показанную патогенетическую роль уровня мтДНК при остром коронарном синдроме, следует продолжить анализ, чувствительность которого может быть повышена за счет включения количественных показателей содержания ядерной ДНК. Studying cell-free circulating mitochondrial DNA (mtDNA) in blood plasma induces growing interest. It is assumed that an indicator of mtDNA may appear a promising clinical biomarker for assessment of the risks in the course of diseases. The aim of this study was evaluating the relationship between the quantitative indicator of mtDNA in the blood of patients with arterial hypertension (AH) and the stage of the disease and the cardiovascular risk. Methods The study included 70 patients who were divided into a group with AH (n = 51) and a control group of apparently healthy patients (n = 19). All patients signed the informed consent for examination and the processing of personal data as a part of the study. Demographic data, duration of hypertension, risk factors, heredity, physical activity, anthropometric data, results of slaboratory and instrumental examinations were recorded. Concentration of mtDNA was measured by the quantitative polymerase chain reaction. A mtDNA fragment with primers FmtMinArc 5'-CTAAATAGCCCACACGTTCCC-3' and RmtMinArc 5'-AGAGCTCCCGTGAGTGGTTA-3' was used. Results. Studying the relationships between the quantitative indicator of mtDNA in the blood and AH showed that there were no significant differences in the indicators for the level of mtDNA regardless of the AH stage. However, we noted that the number of copies tended to increase in comparison with that in conventionally healthy patients. Analysis of the cardiovascular risk showed that the quantitative indicator of mtDNA did not depend on the stage of hypertension. At the same time, the level of mtDNA was significantly increased in very high cardiovascular risk patients with AH as compared to conventionally healthy subjects: Me (LQ; UQ), 56731.2 (42531.25; 129375.0) copies/ml vs. 35156.00 (18325.00; 54956.00) copies/ml, respectively (p = 0.015). Conclusion. The level of mtDNA in AH patients is a potential a marker for cardiovascular risk as shown by the increase in mtDNA in very high cardiovascular risk patients. Taking into account the previously demonstrated pathogenetic role of the level of mtDNA in acute coronary syndrome, the analysis should be continued. The analysis sensitivity can be increased by inclusion of quantitative indicators for the content of nuclear DNA.

scholarly journals Cost-effectiveness Analysis of Evolocumab in Patients With Recent Acute Coronary Syndrome in China

2021 ◽  
Author(s):  
Xiaoyu Xi ◽  
Xin Wang ◽  
Wenwen Xie ◽  
Yu Jia ◽  
Santiago Zuluaga Sanchez ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Cost Effectiveness ◽  
Cardiovascular Events ◽  
Health Economic Evaluation ◽  
Cost Effective ◽  
Health State ◽  
Lifetime Horizon ◽  
Coronary Syndrome ◽  
Life Years ◽  
The Cost

Abstract Purpose: To assess the cost-effectiveness of evolocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, added to background statins therapy in patients with a recent acute coronary syndrome (ACS) event (in the past 12 months) and low-density lipoprotein cholesterol (LDL-C) levels ≥100 mg/dL in China.Methods: A health economic evaluation was performed from a Chinese healthcare perspective, using a Markov model over a lifetime horizon based on baseline CV event rate from claims database data and efficacy from the FOURIER trial. The health benefit was reflected in the decrease of LDL-C level, which led to the decrease of cardiovascular events. The cost of cardiovascular events and the utility value of each health state were derived from published literature. Sensitivity analysis were conducted to evaluate the effects of uncertainty in parameters and the robustness of the model. The cost-effectiveness of evolocumab was also explored in patients with recent MI, very high-risk (VHR) ASCVD and homozygous familiar hypercholesterolemia (HoFH).Results: In recent ACS patients, evolocumab was associated with incremental quality adjusted life years (QALYs) of 1.41 and incremental costs of 120,966 yuan vs. ezetimibe, both with background statins therapy, resulting in an ICER of 85,964 yuan per QALY gained. The probability that evolocumab is cost-effective at a threshold of 217,341 yuan (3 times per capita GDP, 2020) was 100% in patients with recent ACS, recent MI, VHR ASCVD and HoFH.Conclusion: Compared with ezetimibe, evolocumab was considered to be cost-effective in patients with a recent ACS event in China.

scholarly journals Cost-effectiveness of genetic and clinical predictors for choosing combined psychotherapy and pharmacotherapy in major depression

2020 ◽  
Author(s):  
Chiara Fabbri ◽  
Siegfried Kasper ◽  
Joseph Zohar ◽  
Daniel Souery ◽  
Stuart Montgomery ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Predictive Model ◽  
Combined Treatment ◽  
Cost Effective ◽  
Baseline Risk ◽  
Tolerability Profile ◽  
Clinical Risk ◽  
Life Years ◽  
The Cost ◽  
Effect Ratio

AbstractBackgroundPredictors of treatment outcome in major depressive disorder (MDD) could contribute to evidence-based therapeutic choices. This study tested the cost-effectiveness of a pharmacogenetic and clinical predictive model (PGx-CL-R) vs a clinical risk (CL-R) predictive model in guiding the assignment of combined pharmacotherapy and psychotherapy vs pharmacotherapy in MDD.MethodsWe hypothesized that the prescription of combined treatment, a strategy with evidence of increased efficacy vs pharmacotherapy, may be optimized based on the baseline risk of pharmacotherapy resistance, estimated through PGx-CL-R or CL-R predictive models. Both strategies were compared to standard care (ST, pharmacotherapy to all subjects). Treatment effects, costs and utilities (quality adjusted life years, QALYs) were based on the literature and included in a three-years Markov model.ResultsCL-R was cost-effective compared to PGx-CL-R, with ICER (incremental cost effect ratio) of £2341 (CL-R) and £3937 (PGx-CL-R) per QALY compared to ST. PGx-CL-R had similar or better ICER compared to ST only when 1) the cost of genotyping was £100 per subject or less or 2) the sensitivity of the PGx-CL-R test was at least 0.90 and the specificity at least 0.85. CL-R had ICER of £3664 and of £4110 when the CL-R model was tested in two independent samples.Limitationslack of validation in clinical trial.ConclusionsPrediction of pharmacotherapy resistance according to clinical risk might be a cost-effective strategy if confirmed on large samples from the general population. Combined treatment with drugs having a very good tolerability profile could be a cheaper alternative to psychotherapy.

scholarly journals Cost-Effectiveness of Serum Galactomannan Surveillance during Mould-Active Antifungal Prophylaxis

2021 ◽  
Vol 7 (6) ◽  
pp. 417
Author(s):  
Ai Leng Khoo ◽  
Ying Jiao Zhao ◽  
Glorijoy Shi En Tan ◽  
Monica Teng ◽  
Jenny Yap ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Antifungal Prophylaxis ◽  
Antifungal Treatment ◽  
Lifetime Horizon ◽  
Old Patients ◽  
Risk Patients ◽  
The Cost ◽  
Quality Adjusted Life

Serial galactomannan (GM) monitoring can aid the diagnosis of invasive aspergillosis (IA) and optimise treatment decisions. However, widespread adoption of mould-active prophylaxis has reduced the incidence of IA and challenged its use. We evaluated the cost-effectiveness of prophylaxis-biomarker strategies. A Markov model simulating high-risk patients undergoing routine GM surveillance with mould-active versus non-mould-active prophylaxis was constructed. The incremental cost for each additional quality-adjusted life-year (QALY) gained over a lifetime horizon was calculated. In 40- and 60-year-old patients receiving mould-active prophylaxis coupled with routine GM surveillance, the total cost accrued was the lowest at SGD 11,227 (USD 8255) and SGD 9234 (USD 6790), respectively, along with higher QALYs gained (5.3272 and 1.1693). This strategy, being less costly and more effective, dominated mould-active prophylaxis with no GM monitoring or GM surveillance during non-mould-active prophylaxis. The prescription of empiric antifungal treatment was influential in the cost-effectiveness. When the GM test sensitivity was reduced from 80% to 30%, as might be anticipated with the use of mould-active prophylactic agents, the conclusion remained unchanged. The likelihood of GM surveillance with concurrent mould-active prophylaxis being cost-effective was 77%. Routine GM surveillance remained cost-effective during mould-active prophylaxis despite lower IA breakthroughs. Cost-saving from reduced empirical antifungal treatment was an important contributing factor.

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