Advertisement

Pharmacoeconomics of Biosimilars: What Is There to Gain from Them?

  • Filipe C. Araújo
  • João Gonçalves
  • João Eurico FonsecaEmail author
Biosimilars (E Mysler, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Biosimilars

Abstract

Despite representing a breakthrough in the treatment of immune-mediated rheumatic diseases, the direct costs of biotechnological therapies represent a burden to healthcare budgets worldwide. Furthermore, several studies demonstrated that socioeconomically constrained countries have poorer access to these therapies and this has consequences on the optimal management of rheumatic patients. Experience with small peptide biosimilars like filgrastim and epoetin confirmed significant cost savings but revealed variable market uptake. In this report, we summarize the available budget impact models and discuss possible determinants of the pharmacoeconomic performance of antirheumatic biosimilar drugs.

Keywords

Biosimilars Pharmacoeconomics Antirheumatic agents Rheumatoid arthritis CT-P13 

Notes

Compliance with Ethical Standards

Conflicts of Interest

FCA reports personal fees from Pfizer, outside the submitted work. JG reports personal fees from Pfizer, Merck, Abbvie, Roche, Celltrion, and Sandoz, outside the submitted work. JEF reports institutional grants from UCB and Pfizer, personal fees from Jansen, Pfizer, Abbvie, MSD, and Roche, and advisory board service for Celgene, Novartis and Hospira, outside the submitted work.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. 1.
    European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed 21 Feb 2016.
  2. 2.
    European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf. Accessed 21 Feb 2016.
  3. 3.
    European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf. Accessed 21 Feb 2016.
  4. 4.
    World Health Organisation. Guidelines on evaluation of similar biotherapeutic products. 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 21 Feb 2016.
  5. 5.
    U.S. Food and Drug Administration. scientific considerations in demonstrating biosimilarity to a reference product—Guidance for Industry. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 21 Feb 2016.
  6. 6.
    European Medicines Agency. Remsima assessment report. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf. Accessed 28 Feb 2016.
  7. 7.
    Samsung bioepis enters the European biopharmaceutical market with Benepali ®, the First fusion protein biosimilar approved by the European Commission. 2016. http://www.samsungbioepis.com/newsroom2/newsroom_12.html. Accessed 28 Feb 2016.
  8. 8.
    Araújo F, Gonçalves J, Fonseca JE. Biosimilar DMARDs: what does the future hold? Drugs. 2016;76:629–37.CrossRefPubMedGoogle Scholar
  9. 9.
    U.S. Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade. 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Accessed 30 April 2016.
  10. 10.
    Simoens S. Biosimilar medicines and cost-effectiveness. Clinicoecon Outcomes Res. 2011;3:29–36.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Palazzo C, Ravaud JF, Trinquart L, et al. Respective contribution of chronic conditions to disability in France: results from the national disability-health survey. PLoS ONE. 2012;7:e44994. doi: 10.1371/journal.pone.0044994.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS ONE. 2014;9:e90633. doi: 10.1371/journal.pone.0090633.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Branco JC, Rodrigues AM, Gouveia N, et al. Prevalence of rheumatic and musculoskeletal diseases and their impact on health-related quality of life, physical function and mental health in Portugal: results from EpiReumaPt—a national health survey. RMD Open. 2016;2:e000166. doi: 10.1136/rmdopen-2015-000166.CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Gulácsi L, Brodszky V, Baji P, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015;11 Suppl 1:S43–52.CrossRefPubMedGoogle Scholar
  15. 15.
    Kawatkar A, Jacobsen S, Levy G, et al. Direct medical expenditure associated with rheumatoid arthritis in a nationally representative sample from the medical expenditure panel survey. Arthritis Care Res. 2012;64:1649–56.CrossRefGoogle Scholar
  16. 16.•
    Huscher D, Mittendorf T, von Hinüber U, et al. Evolution of cost structures in rheumatoid arthritis over the past decade. Ann Rheum Dis. 2015;74:738–45. This study showed that the increase in treatment costs over the 2002–2011 time period associated with lower hospitalisation rates, better functional status and a lower incidence of work disability, offsetting a large proportion of risen drug costs.CrossRefPubMedGoogle Scholar
  17. 17.
    Chevreul K, Haour G, Lucier S, et al. Evolution of direct costs in the first years of rheumatoid arthritis: impact of early versus late biologic initiation—an economic analysis based on the ESPOIR cohort. PLoS ONE. 2014;9:e97077. doi: 10.1371/journal.pone.0097077.CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Philippidis A. The top 25 best-selling drugs of 2014. 2015. http://www.genengnews.com/insight-and-intelligence/the-top-25-best-selling-drugs-of-2014/77900383/?kwrd=top%20selling&page=1. Accessed 20 Feb 2016.
  19. 19.
  20. 20.•
    IMS Institute for Health Informatics. Global medicines use in 2020. 2015. http://www.imshealth.com/en/thought-leadership/ims-institute/reports/global-medicines-use-in-2020. Accessed 20 Feb 2016. This report provides an outlook on the use and global spending with medicines through 2020 in both developed and pharmerging markets for different types of molecules.
  21. 21.
    Sokka T, Kautiainen H, Pincus T, et al. Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST–RA database. Ann Rheum Dis. 2009;68:1666–72.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Putrik P, Ramiro S, Keszei AP, et al. In wealthier countries, patients perceive worse impact of the disease although they have lower objectively assessed disease activity: results from the cross-sectional COMORA study. Ann Rheum Dis. 2015;75:715–20.CrossRefPubMedGoogle Scholar
  23. 23.••
    Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73:198–206. This study performed in 46 European countries showed that those with lower income have less access to synthetic and especially biologic DMARDs. Furthermore, the annual price of biological treatment surpassed the GDP in more than half of these countries.CrossRefPubMedGoogle Scholar
  24. 24.
    Putrik P, Ramiro S, Kvien TK, et al. Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country’s wealth? Ann Rheum Dis. 2014;73:2010–21.CrossRefPubMedGoogle Scholar
  25. 25.
    Pentek M, Poor G, Wiland P, et al. Biological therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur J Health Econ. 2014;15 Suppl 1:S35–43.CrossRefPubMedGoogle Scholar
  26. 26.
    Joensuu JT, Huoponen S, Aaltonen KJ, et al. The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review. PLoS ONE. 2015;10:e0119683. doi: 10.1371/journal.pone.0119683.CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Kvamme MK, Lie E, Uhlig T, et al. Cost-effectiveness of TNF inhibitors vs synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: a Markov model study based on two longitudinal observational studies. Rheumatology (Oxford). 2015;54:1226–35.CrossRefGoogle Scholar
  28. 28.
  29. 29.
    Gascón P, Tesch H, Verpoort K, et al. Clinical experience with Zarzio® in Europe: what have we learned? Support Care Cancer. 2013;21:2925–32.CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    IMS Institute for Health Informatics. Assessing biosimilar uptake and competition in European markets. 2014. https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf. Accessed 12 Mar 2016.
  31. 31.
    Aapro M, Cornes P, Abraham I. Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. J Oncol Pharm Pract. 2011;18:171–9.CrossRefPubMedGoogle Scholar
  32. 32.•
    Sun D, Andayani T, Altyar A, MacDonald K, Abraham I. Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European union G5 countries: a simulation study. Clin Ther. 2015;37:842–57. Using three different models, this study demonstrated significant cost-savings as a result of switching from reference filgrastim and pegfilgrastim to biosimilar filgrastim, as well as additional patients treated with antineoplastic monoclonal antibodies and number of patients needed to convert to provide access to these therapies.CrossRefPubMedGoogle Scholar
  33. 33.
    Abraham I, Han L, Sun D, MacDonald K, Aapro M. Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol. 2014;10:1599–609.CrossRefPubMedGoogle Scholar
  34. 34.
    Bocquet F, Paubel P, Fusier I, Cordonnier AL, Le Pen C, Sinègre M. Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis. Appl Health Econ Health Policy. 2014;12:315–26.PubMedGoogle Scholar
  35. 35.
    Bocquet F, Paubel P, Fusier I, Cordonnier AL, Le Pen C, Sinègre M. Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience. Appl Health Econ Health Policy. 2015;13:47–59.CrossRefPubMedGoogle Scholar
  36. 36.
    IMS Institute for Health Informatics. The impact of biosimilar competition. 2015. http://ec.europa.eu/DocsRoom/documents/14547/attachments/1/translations/en/renditions/native. Accessed 28 Feb 2016.
  37. 37.
    Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol. 2010;28:28–31.CrossRefPubMedGoogle Scholar
  38. 38.
    Vermeer NS, Straus SM, Mantel-Teeuwisse AK, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013;36:617–25.CrossRefPubMedGoogle Scholar
  39. 39.
    Cutroneo PM, Isgrò V, Russo A, et al. Safety profile of biological medicines as compared with non-biologicals: an analysis of the Italian spontaneous reporting system database. Drug Saf. 2014;37:961–70.CrossRefPubMedGoogle Scholar
  40. 40.
    Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47:8–32.CrossRefPubMedGoogle Scholar
  41. 41.
    Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12:1473–85.CrossRefPubMedGoogle Scholar
  42. 42.
    Haustein R, de Millas C, Höer A, Häussler B. Saving money in the European healthcare systems with biosimilars. GaBI J. 2012;1:120–6.CrossRefGoogle Scholar
  43. 43.
    Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol. 2014;41:S13–20.CrossRefPubMedGoogle Scholar
  44. 44.••
    Brodszky V, Baji P, Balogh O, Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in sex Central and Eastern European countries. Eur J Health Econ. 2014;15:S65–71. Budget impact analysis of biosimilar infliximab for rheumatoid arthritis showing significant cost savings and hundreds of additional treated patients in six central and eastern European countries in two different uptake scenarios.CrossRefPubMedGoogle Scholar
  45. 45.••
    Jha A, Upton A, Dunlop W, Akehurst R. The budget impact of biosimilar infliximab (Remsima) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32:742–56. Budget impact analysis of biosimilar infliximab in RA, AS, PsA, PsO and IBD showing significant cost savings and hundreds of additional treated patients in five of the biggest European pharmaceutical markets, in three different discount scenarios.CrossRefPubMedPubMedCentralGoogle Scholar
  46. 46.
    Lucioni C, Mazzi S, Caporali R. Analisi di budget impact del biosimilare di infliximab: lo scenario italiano. Glob Reg Health Technol Assess. 2015;2(2):78–88.Google Scholar
  47. 47.
    Kim J, Hong J, Kudrin A. 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. Arthritis Rheum. 2014;66(Suppl):S512.Google Scholar
  48. 48.
    McCarthy G, Bitoun CE, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health. 2013;16:A558.CrossRefGoogle Scholar
  49. 49.
    Ruff L, Rezk MF, Uhlig T, Gommers JW. Budget impact analysis of an etanercept biosimilar for the treatment of rheumatoid arthritis in Europe. Value Health. 2015;18:A639.Google Scholar
  50. 50.
    Ruff L, Rezk MF, Uhlig T, Gommers JW. Budget impact analysis of an etanercept biosimilar for the treatment of all licensed etanercept indications for adults in Europe. Value Health. 2015;18:A639.Google Scholar
  51. 51.
    Whitehouse J, Walsh K, Papandrikopoulou A, Hoad R. The cost saving potential of utilizing biosimilar medicines in biologic naive severe rheumatoid arthritis patients. Value Health. 2013;16:A573.CrossRefGoogle Scholar
  52. 52.
    Smolen J, Landewé R, Breedveld F, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509.CrossRefPubMedGoogle Scholar
  53. 53.
    Van Arnum P. Biosimilars: market weaknesses and strengths. 2012. http://www.pharmtech.com/biosimilars-market-weaknesses-and-strengths?pageID=1. Accessed 3 Mar 2016.
  54. 54.
    Farfan-Portet MI, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ. 2014;15:223–8.CrossRefPubMedGoogle Scholar
  55. 55.
    IMS Institute for Health Informatics. Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. 2011. http://weinberggroup.com/pdfs/Shaping_the_biosimiliars_opportunity_A_global_perspective_on_the_evolving_biosimiliars_landscape.pdf. Accessed 4 Mar 2016.
  56. 56.
    Asbjørn M. Norway, biosimilars in different funding systems. What works? GaBI J. 2015;4:90–2.CrossRefGoogle Scholar
  57. 57.
    Stanton D. Biosimilar discounts and switching will wipe-out J&J’s Remicade in Norway, says regulator. 2015. http://www.biopharma-reporter.com/Markets-Regulations/Biosimilar-discounts-will-wipe-out-Janssen-s-Remicade-sales-in-Norway. Accessed 10 Mar 2016.
  58. 58.
    Rådet for Anvendelse af Dyr Sygehusmedicin. RADS anbefaling vedrørende brug af biosimilært infliximab. 2015. http://www.regioner.dk/medicinsite/rads/behandlingsvejledninger/~/media/EBAF50AB3BA44DE2BF75A03A2F7E83A3.ashx. Accessed 10 Mar 2016.
  59. 59.
    Blamont M. Exclusive—Hospira wins French biosimilar drug tender at 45 percent discount. 2015. http://uk.reuters.com/article/uk-france-biosimilars-exclusive-idUKKCN0PD1W320150703. Accessed 11 Mar 2016.
  60. 60.
    Kim SC, Choi N-K, Lee J, et al. Uptake of the first biosimilar infliximab since its approval in South Korea. Presented at ACR Annual Meeting, San Francisco, USA; November 2015. Abstract #1273.Google Scholar
  61. 61.
    National Institute for Health and Care Excellence. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed. 2016. https://www.nice.org.uk/guidance/ta375/chapter/1-Recommendations. Accessed 27 Apr 2016.
  62. 62.
    Baji P, Gulácsi L, Lovász BD, et al. Treatment preferences of originator vs. biosimilar drugs in Crohn’s disease; discrete choice experiment among gastroenterologists. Scand J Gastroenterol. 2015;51:22–7.CrossRefPubMedGoogle Scholar
  63. 63.
    Storvik AG. Huge drug discount astonishes. 2015. http://www.dagensmedisin.no/artikler/2015/01/29/huge-drug-discount-astonishes/. Accessed 2 Feb 2015.

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Filipe C. Araújo
    • 1
  • João Gonçalves
    • 2
  • João Eurico Fonseca
    • 3
    • 4
    Email author
  1. 1.Rheumatology UnitHospital Ortopédico de Sant’Ana, SCMLParedePortugal
  2. 2.iMed-Research Institute of MedicinesFaculdade de Farmácia da Universidade de LisboaLisboaPortugal
  3. 3.Rheumatology Department, Lisbon Academic Medical CentreHospital de Santa MariaLisboaPortugal
  4. 4.Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de MedicinaUniversidade de LisboaLisboaPortugal

Personalised recommendations