Article Text

Download PDFPDF

Original research
Budget impact analysis of PCSK9 inhibitors costs from a community payers’ perspective in Apulia, Italy
  1. Natale Daniele Brunetti1,
  2. Luisa De Gennaro2,
  3. Lucia Tricarico1 and
  4. Pasquale Caldarola2
  1. 1Università degli Studi di Foggia, Foggia, Italy
  2. 2Presidio Ospedaliero San Paolo, Bari, Italy
  1. Correspondence to Dr Natale Daniele Brunetti; nd.brunetti{at}


Introduction Despite established clinical efficacy of PCSK9 inhibitors (PCSK9i) in reducing cardiovascular events, their cost still represents a big matter of debate. We therefore sought to estimate possible impact of PCSK9i therapy from a community taxpayers’ perspective with a budget impact analysis based on data coming from two randomised trials (FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab)).

Methods The analysis focused on Apulia region, South-Eastern Italy (4 million inhabitants). Costs per cardiovascular event saved were calculated from randomised trials data and annually indexed per Apulia’s inhabitants.

Results On the base of actual cost in Apulia, individual costs per saved adverse event ranged from €0.12 to €0.78, with just €1 annually spent per Apulia’s inhabitant, 2–8.3 events could be avoided thanks to the use of PCSK9i.

When considering high-risk subgroups (baseline cholesterol levels >100 mg/dL, multivessel coronary disease), the annual cost per Apulia’s inhabitant for one death avoided was more than halved to €0.19 and the cost for a saved major adverse cardiovascular event was €0.07. With €1 annually spent per Apulia’s inhabitant, 10.9–15 major adverse cardiovascular events and 5.3 deaths could be saved.

Conclusions When considered from a large taxpayers’ community perspective, relevant costs per cardiovascular event saved with PCSK9i may turn into very small individual costs per year. The selection of high-risk subgroups may further reduce individual costs.

  • cost analysis
  • evolocumab
  • alirocumab
  • PCSK9

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

View Full Text

Statistics from


  • Contributors PC conducted the study, LT gathered data, NDB analysed data, LDG and NDB wrote the paper, and PC and NDB supervised the study.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests NDB received honoraria from Sanofi as consultant.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no additional data available in this work.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.