Skip to main content
SpringerLink
Log in

Cost-Effectiveness Analysis of Lesinurad/Allopurinol Versus Febuxostat for the Management of Gout/Hyperuricemia in Italy

  • Original Research Article
  • Published:
PharmacoEconomics Aims and scope Submit manuscript

Abstract

Background

Until very recently the only therapeutic alternative for the management of patients affected by gout/hyperuricemia that did not respond to a first-line treatment based on allopurinol alone or who cannot tolerate allopurinol was febuxostat, a xanthine oxidase non-purine-selective inhibitor. Lately, however, a new therapeutic alternative has become available for the management of this pathology: lesinurad, a urate transporter inhibitor.

Objective

To objective of this study was to evaluate the cost effectiveness of lesinurad/allopurinol in comparison with febuxostat as a second-line therapeutic strategy for the management of patients affected by gout and hyperuricemia that did not respond to a first-line therapy based on allopurinol alone.

Methods

A Markov model was built based on the natural history of the pathology; patients entered the model according to their level of serum uric acid concentration and flowed across it according to their response to the therapy. The analysis was carried out considering the perspective of the Italian National Health Service on a lifetime horizon and 6-month cycles. Costs and quality-adjusted life-years (QALYs) were discounted at a 3.5% yearly rate. The results of the model were expressed in terms of incremental cost-effectiveness ratio (ICER). Both a one-way and a multi-way Monte–Carlo analysis were carried out in order to check the robustness of the results achieved.

Results

The ICER derived from the comparison was equal to €77.53/QALY on the lifetime horizon, as there was a higher level of costs associated with the combination as compared with febuxostat (€10,658.27 vs. €10,645.87, for a differential of €12.40) and a higher level of QALYs achieved (7.77 vs. 7.61, for a differential of 0.16).

Conclusions

The lesinurad/allopurinol combination is recommended for the treatment of patients affected by gout/hyperuricemia in the Italian Health System as it appears to be cost effective and thus sustainable for the Italian healthcare sector.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

Data Availability Statement

The data that support the findings of this study are available from Grünenthal Group but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with permission of Grünenthal Group.

References

  1. Zhang W, Doherty M, Bardin T, Pascual E, Barskova V, Conaghan P, et al. EULAR evidence based recommendations for gout. Part II: management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006;65(10):1312–24.

    Article  CAS  Google Scholar 

  2. Lin KC, Lin HY, Chou P. The interaction between uric acid level and other risk factors on the development of gout among asymptomatic hyperuricemic men in a prospective study. J Rheumatol. 2000;27(6):1501–5.

    CAS  PubMed  Google Scholar 

  3. Salaffi F, De Angelis R, Grassi W. Prevalence of musculoskeletal conditions in an Italian population sample: results of a regional community-based study. I. The MAPPING study. Clin Exp Rheumatol. 2004;23(6):819–28.

    Google Scholar 

  4. Saag KG, Choi H. Epidemiology, risk factors, and lifestyle modifications for gout. Arthritis Res Ther. 2006;8(1):S2.

    Article  Google Scholar 

  5. Chen LX, Schumacher HR. Gout: an evidence-based review. J Clin Rheumatol. 2008;14(5S):S55–62.

    Article  Google Scholar 

  6. Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004;31(12):2429–32.

    CAS  PubMed  Google Scholar 

  7. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353(23):2450–61.

    Article  CAS  Google Scholar 

  8. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478791.htm. Accessed 27 Sept 2017.

  9. Khanna D, Ahmed M, Yontz D, Ginsburg SS, Park GS, Leonard A, et al. The disutility of chronic gout. Qual Life Res. 2008;17(5):815–22.

    Article  Google Scholar 

  10. Istituto Nazionale di Statistica. http://www.istat.it/it. Accessed 19 May 2017.

  11. Gandhi PK, Gentry WM, Ma Q, Bottorff MB. Cost-effectiveness analysis of allopurinol versus febuxostat in chronic gout patients: a US payer perspective. J Manag Care Spec Pharm. 2015;21(2):165–75.

    PubMed  Google Scholar 

  12. Barendregt JJ. The half-cycle correction: banish rather than explain it. Med Decis Mak. 2009;29(4):500–2.

    Article  Google Scholar 

  13. Ruggeri M, Basile M, Coretti S, Drago C, Cicchetti A. Economic analysis and budget impact of tenofovir and entecavir in the first-line treatment of hepatitis B virus in Italy. Appl Health Econ Health Policy. 2017;15(4):479–90.

    Article  CAS  Google Scholar 

  14. Snow-Lampart A, Chappell BJ, Curtis M, et al. HBeAg + and HBeAg hepatitis B patients treated with tenofovir df showed no relationship between virologic breakthrough and emergence of genotypic changes in HBV polymerase. Hepatology. 2009;50(Suppl 4):523.

    Google Scholar 

  15. Bardin T, Keenan RT, Khanna PP, Kopicko J, Fung M, Bhakta N, et al. Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study). Ann Rheum Dis. 2017;76(5):811–20.

    Article  CAS  Google Scholar 

  16. Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, et al. SAT0329 Lesinurad, a novel selective uric acid reabsorption inhibitor, in combination with febuxostat, in patients with tophaceous gout: the CRYSTAL phase III clinical trial. Ann Rheum Dis. 2015;74(Suppl 2):778.

    Google Scholar 

  17. National Institute for Health Care Excellence. Single technology assessment—lesinurad for treating chronic hyperuricaemia in people with gout (2016). https://www.nice.org.uk/guidance/ta506/documents/committee-papers.

  18. Ministero della Salute. Nomenclatore tariffario dell’assistenza specialistica ambulatoriale. http://www.salute.gov.it/portale/temi/p2_6.jsp?id=1767&area=programmazioneSanitariaLea&menu=lea. Accessed Apr 2016.

  19. AIFA – Agenzia Italiana del Farmaco. Prontuario farmaceutico Nazionale. http://www.agenziafarmaco.gov.it/it/content/prontuario-farmaceutico-nazionale. Accessed Apr 2016.

  20. Saltelli A, Ratto M, Andres T, Campolongo F, Cariboni J, Gatelli D, et al. Global sensitivity analysis: the primer. Chichester: John Wiley & Sons; 2008.

    Google Scholar 

  21. Briggs AH, Claxton K, Sculpher MJ. Decision modelling for health economic evaluation. Handbooks in health economic evaluation. Oxford: Oxford University Press; 2006.

    Google Scholar 

  22. Doubilet P, Begg CB, Weinstein MC, Braun P, McNeil BJ. Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach. Med Decis Mak. 1984;5(2):157–77.

    Article  Google Scholar 

Download references

Acknowledgements

The model was adapted from work conducted by MDM Inc.; the original model was built by Kari Kelton, Vice President, Data & Analytics; James Gahn Sr., Research Analyst, Modeling & Computer Science; Robert Klein, Vice President, Healthcare Engineering; and Mark Day, Vice President, Strategy & Operations.

Author information

Authors and Affiliations

  1. Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168, Rome, Italy

    M. Ruggeri, M. Basile, F. R. Rolli & A. Cicchetti

  2. “Niccolò Cusano” University, Rome, Italy

    C. Drago

Authors
  1. M. Ruggeri
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. Basile
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. Drago
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. F. R. Rolli
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. A. Cicchetti
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

All authors made a substantial contribution to the conception, design, acquisition of data, and related analysis and interpretation and participated in drafting the article and revising it critically and according to its important intellectual content.

Corresponding author

Correspondence to M. Basile.

Ethics declarations

Funding

This study was funded by Grunenthal Italia. The views expressed here are those of the authors and not necessarily those of the funders.

Conflict of interest

None of the authors (Dr. Ruggeri, Dr. Basile, Dr. Drago, and Prof. Cicchetti) has any potential conflict of interest related to this study.

Electronic Supplementary Material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 52 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ruggeri, M., Basile, M., Drago, C. et al. Cost-Effectiveness Analysis of Lesinurad/Allopurinol Versus Febuxostat for the Management of Gout/Hyperuricemia in Italy. PharmacoEconomics 36, 625–636 (2018). https://doi.org/10.1007/s40273-018-0643-4

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40273-018-0643-4

Search

Navigation