Assessment of the Economic Impact of Belimumab for the Treatment of Systemic Lupus Erythematosus in the Italian Setting: A Cost-Effectiveness Analysis

PLoS One. 2015 Oct 21;10(10):e0140843. doi: 10.1371/journal.pone.0140843. eCollection 2015.

Abstract

Objective: The purpose of this analysis is to evaluate the cost-effectiveness of belimumab, a new biological treatment specifically developed for the treatment of Systemic Lupus Erythematosus (SLE), in the Italian setting. SLE is a chronic non-organ specific autoimmune disease characterized by a disregulation of the immune system that involves many organs and systems.

Methods: A cost-effectiveness micro-simulation model with a lifetime horizon originally developed for the UK was adapted to the Italian setting. The analysis compared Standard of Care (SoC) alone vs belimumab plus SoC from a National Healthcare Service (NHS) and societal perspective. Health-economic consequences of treatments and organ damage progression were calculated. When available, Italian data were used, otherwise UK costs were converted using Purchasing Power Parities (PPPs). Utility values were based on the EQ-5D™ assessments in the belimumab clinical trials (BLISS 52 and 76). Results were discounted with 3% for costs and effects. A maximum belimumab treatment duration of 6 years was assumed and wastage costs were considered.

Results: Cost per life year gained (Incremental Cost-Effectiveness Ratio, ICER) and cost per Quality Adjusted Life Year (QALY) (Incremental Cost-Utility Ratio, ICUR) were €22,990 and €32,859, respectively. These values reduced to €20,119 and €28,754, respectively, when indirect costs were included.

Conclusions: It may be concluded that in the Italian setting and according to the guidelines of the Italian Association of Health Economics (IAHE), belimumab was shown to be cost-effective, in terms of both ICER and ICUR, (€25-40,000/QALY).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / economics*
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Cost-Benefit Analysis*
  • Female
  • Humans
  • Immunosuppressive Agents / economics*
  • Immunosuppressive Agents / therapeutic use
  • Italy
  • Lupus Erythematosus, Systemic / drug therapy*
  • Male
  • Quality of Life
  • Quality-Adjusted Life Years
  • Surveys and Questionnaires

Substances

  • Antibodies, Monoclonal, Humanized
  • Immunosuppressive Agents
  • belimumab

Grants and funding

The work was supported by GlaxoSmithKline which sponsored the study. The authors declare that their university has received a research grant from the company in order to carry out the project. The funder provided support in the form of salaries for one author [LP]. The specific roles of these authors are articulated in the ‘author contributions’ section. GlaxoSmithKline played a marginal role in the study design and data collection. GlaxoSmithKline did not play role in the analysis of the data and did not oppose the authors' decision to publish the study after having read the manuscript. Pharmerit International provided support in the form of salaries for author MT, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the ‘author contributions’ section.