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Introduction <p>Lipid-lowering therapy is central to cardiovascular disease (CVD) management. Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors (alirocumab, evolocumab) and inclisiran offer greater low-density lipoprotein cholesterol (LDL-C) reduction and improved outcomes beyond statins and ezetimibe, but high costs raise affordability concerns in low- and middle-income countries. This study reviews their cost-effectiveness in developing settings.</p> Methods <p>PubMed, Scopus, Web of Science, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched up to March 1, 2024. Studies were assessed for Quality-Adjusted Life Years (QALYs), Life Years Gained (LYGs), costs, and “Incremental Cost-Effectiveness Ratios” (ICERs). Quality and bias were evaluated using the “Integrated Health Economic Evaluation Reporting Standards” (CHEERS) and ECOBIAS checklists, following “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) guidelines.</p> Results <p>Of 580 records, 13 studies (2019–2024) from China (<i>n</i> = 8), Thailand, Mexico, Taiwan, Qatar, and Saudi Arabia met inclusion criteria, mostly evaluating evolocumab for primary and secondary prevention using Markov models (Time horizon: 2 years –lifetime, Discount rates: 3–5%). Studies were generally from a healthcare perspective. Evolocumab was not cost-effective in Chinese post-myocardial infarction (MI) patients (ICERs up to $281,762/QALY) but favorable in familial hypercholesterolemia(FH) ($57,018/QALY), and when evolocumab added to statins was cost-effective in patients with acute MI ($7,819 to $61,242 per QALY) and acute coronary syndrome (ACS) (vs. ezetimibe + statins) ($26,110/QALY) and atherosclerotic cardiovascular disease (ASCVD) (vs. placebo + statins)($4,268/QALY). Alirocumab ($490,198/QALY) and inclisiran ($335,404.88/QALY) were not cost-effective, while ezetimibe was ($22,965/QALY). In Thailand, PCSK9 inhibitors ($1,496,139/QALY), and ezetimibe ($33,246/QALY) exceeded thresholds. Evolocumab was cost-effective in Mexico ($37,925/QALY-$44,346/QALY) and Saudi Arabia ($49,502/QALY-$71,968/QALY) but not in Qatar. Sensitivity analyses identified drug prices, event risks, and utilities as key ICER drivers, with probabilistic analyses showing low cost-effectiveness in China (~ 2%) but higher in high-risk groups or at elevated thresholds.</p> Conclusion <p>Cost-effectiveness of PCSK9 inhibitors and inclisiran varies across developing countries, driven by drug prices, WTP thresholds, and healthcare perspectives. Evolocumab may be cost-effective in high-risk subgroups or in Mexico and Saudi Arabia but remains largely unaffordable elsewhere. Ezetimibe was consistently more favorable. Price reductions, tiered pricing, pooled procurement, and context-specific thresholds are essential to improve access and equity.</p>

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Fair pricing, fair access; a systematic review of cost-effectiveness of new hyperlipidemia injectable medication in developing countries

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月21日

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  • Samad Azari,
  • Hamid Pourasghari,
  • Mohammad Ali Rezaei,
  • Masoud Behzadifar,
  • Shahrzad Salehbeigi,
  • Soheila Rajaei,
  • Dariush Jafarzadeh,
  • Samira Soleimanpour,
  • Masih Tajdini

摘要

Introduction

Lipid-lowering therapy is central to cardiovascular disease (CVD) management. Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors (alirocumab, evolocumab) and inclisiran offer greater low-density lipoprotein cholesterol (LDL-C) reduction and improved outcomes beyond statins and ezetimibe, but high costs raise affordability concerns in low- and middle-income countries. This study reviews their cost-effectiveness in developing settings.

Methods

PubMed, Scopus, Web of Science, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched up to March 1, 2024. Studies were assessed for Quality-Adjusted Life Years (QALYs), Life Years Gained (LYGs), costs, and “Incremental Cost-Effectiveness Ratios” (ICERs). Quality and bias were evaluated using the “Integrated Health Economic Evaluation Reporting Standards” (CHEERS) and ECOBIAS checklists, following “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) guidelines.

Results

Of 580 records, 13 studies (2019–2024) from China (n = 8), Thailand, Mexico, Taiwan, Qatar, and Saudi Arabia met inclusion criteria, mostly evaluating evolocumab for primary and secondary prevention using Markov models (Time horizon: 2 years –lifetime, Discount rates: 3–5%). Studies were generally from a healthcare perspective. Evolocumab was not cost-effective in Chinese post-myocardial infarction (MI) patients (ICERs up to $281,762/QALY) but favorable in familial hypercholesterolemia(FH) ($57,018/QALY), and when evolocumab added to statins was cost-effective in patients with acute MI ($7,819 to $61,242 per QALY) and acute coronary syndrome (ACS) (vs. ezetimibe + statins) ($26,110/QALY) and atherosclerotic cardiovascular disease (ASCVD) (vs. placebo + statins)($4,268/QALY). Alirocumab ($490,198/QALY) and inclisiran ($335,404.88/QALY) were not cost-effective, while ezetimibe was ($22,965/QALY). In Thailand, PCSK9 inhibitors ($1,496,139/QALY), and ezetimibe ($33,246/QALY) exceeded thresholds. Evolocumab was cost-effective in Mexico ($37,925/QALY-$44,346/QALY) and Saudi Arabia ($49,502/QALY-$71,968/QALY) but not in Qatar. Sensitivity analyses identified drug prices, event risks, and utilities as key ICER drivers, with probabilistic analyses showing low cost-effectiveness in China (~ 2%) but higher in high-risk groups or at elevated thresholds.

Conclusion

Cost-effectiveness of PCSK9 inhibitors and inclisiran varies across developing countries, driven by drug prices, WTP thresholds, and healthcare perspectives. Evolocumab may be cost-effective in high-risk subgroups or in Mexico and Saudi Arabia but remains largely unaffordable elsewhere. Ezetimibe was consistently more favorable. Price reductions, tiered pricing, pooled procurement, and context-specific thresholds are essential to improve access and equity.