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Budget Impact Analysis of the FreeStyle Libre Flash Continuous Glucose Monitoring System® in Patients with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus with Multiple Daily Insulin Injections in Argentina

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Abstract

Objective

To estimate the budget impact of the potential coverage of FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for glycemia monitoring in all type 1 diabetes mellitus (T1DM) patients and in those with type 2 diabetes mellitus (T2DM) with multiple daily insulin injections, from the social security and the private third-party payer’s perspective in Argentina.

Methods

A budget impact model was developed to estimate the cost difference between the self-monitoring of blood glucose (standard of care) and FSL over 5 years. Input parameters were retrieved from local literature complemented by expert opinion. Health care costs were estimated by a micro-costing approach and reported in USD as of April 2022 (1 USD = 113.34 Argentine pesos). One-way sensitivity and scenario analyses were conducted.

Results

From a social security third-party payer perspective, the incorporation of FSL was associated with net savings per member per month (PMPM) of $0.026 (Year 1) to $0.097 (Year 5) and net savings PMPM of $0.002 (Year 1) to $0.008 (Year 5) for T1DM and T2DM patients, respectively. Similar findings are reported from the private third-party payer perspective. The budget impact results were more sensitive to the acquisition costs of the FSL and test strips.

Conclusion

The potential coverage of FSL in patients with T1DM and T2DM with multiple daily insulin injections could be associated with small financial savings considering current technology acquisition costs (FSL and test strips) for social security and the private sector third-party payers in Argentina.

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References

  1. Tan SY, Wong JLM, Sim YJ, Wong SS, Elhassan SAM, Tan SH, et al. Type 1 and 2 diabetes mellitus: a review on current treatment approach and gene therapy as potential intervention [Internet]. Diabetes Metab Syndr Clin Res Rev. 2019;13:364–72. https://doi.org/10.1016/j.dsx.2018.10.008.

    Article  Google Scholar 

  2. Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition [Internet]. Diabetes Res Clin Pract. 2019;157: 107843. https://doi.org/10.1016/j.diabres.2019.107843.

    Article  PubMed  Google Scholar 

  3. Flood D, Seiglie JA, Dunn M, Tschida S, Theilmann M, Marcus ME, et al. The state of diabetes treatment coverage in 55 low-income and middle-income countries: a cross-sectional study of nationally representative, individual-level data in 680 102 adults. Lancet Healthy Longev [Internet]. 2021;2(6): e340–51. https://doi.org/10.1016/s2666-7568(21)00089-1.

    Article  Google Scholar 

  4. Ministry of Health. Fourth National Survey of Risk Factors [Internet]. Ministry of Health; 2019. https://bancos.salud.gob.ar/sites/default/files/2020-01/4ta-encuesta-nacional-factores-riesgo_2019_principales-resultados.pdf.

  5. Kahanovitz L, Sluss PM, Russell SJ. Type 1 diabetes—a clinical perspective. Point Care [Internet]. 2017;16(1):37. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5606981/.

  6. Gagliardino J, Costa Gil J, Faingold M, Litwak L, Fuente G. Insulina y control de la diabetes en la Argentina. Medicina [Internet]; 2013. http://www.scielo.org.ar/scielo.php?pid=S0025-76802013000800002&script=sci_abstract&tlng=es.

  7. Commendatore V, Linari M, Dieuzeide G, Ferraro M, Lapertosa S, Puchulu F, et al. Automonitoreo y monitoreo de glucosa y cetonas en la persona con diabetes. Rev Soc Arg Diab; 2005.

  8. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline J-P, Rayman G. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther [Internet]. 2017;8(1):55–73. https://doi.org/10.1007/s13300-016-0223-6.

    Article  CAS  PubMed  Google Scholar 

  9. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet [Internet]. 2016;388(10057):2254–63. https://doi.org/10.1016/S0140-6736(16)31535-5.

    Article  PubMed  Google Scholar 

  10. Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, et al. Effect of flash glucose monitoring on glycemic control, hypoglycemia, diabetes-related distress, and resource utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care [Internet]. 2020 [cited 2022 Aug 12];43(9):2153. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440900/.

  11. Lameijer A, Fokkert MJ, Edens MA, Gans ROB, Bilo HJG, van Dijk PR. Two-year use of flash glucose monitoring is associated with sustained improvement of glycemic control and quality of life (FLARE-NL-6). BMJ Open Diabetes Res Care [Internet]. 2021. https://doi.org/10.1136/bmjdrc-2021-002124.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Al Hayek A, Robert A, Al Dawish M. Impact of the FreeStyle Libre flash glucose monitoring system on diabetes- self-management practices and glycemic control among patients with type 2 diabetes in Saudi Arabia: a prospective study. Diabetes Metab Syndr Clin Res Rev [Internet]. 2021;15(2):557–63. https://doi.org/10.1016/j.dsx.2021.02.027.

    Article  CAS  Google Scholar 

  13. Abbott Press Release. Abbott’s FreeStyle® Libre 14 Day Flash Glucose Monitoring System Now Approved in U.S.; 2018 [cited 2022 Jul 8]. https://abbott.mediaroom.com/2018-07-27-Abbotts-FreeStyle-R-Libre-14-Day-Flash-Glucose-Monitoring-System-Now-Approved-in-U-S.

  14. National Administration of Drugs, Food and Medical Technology (ANMAT). ANMAT Provisión no. 6054/16 [Internet]. ANMAT; 2016. http://www.anmat.gov.ar/boletin_anmat/junio_2016/Dispo_6054-16.pdf.

  15. Rubinstein A, Zerbino MC, Cejas C, López A. Making universal health care effective in Argentina: a blueprint for reform. Health Syst Reform [Internet]. 2018;4(3):203–13. https://doi.org/10.1080/23288604.2018.1477537.

    Article  PubMed  Google Scholar 

  16. Palacios A, Espinola N, Rojas-Roque C. Need and inequality in the use of health care services in a fragmented and decentralized health system: evidence for Argentina. Int J Equity Health [Internet]. 2020;19(1):67. https://doi.org/10.1186/s12939-020-01168-6.

    Article  PubMed  Google Scholar 

  17. Hellmund R, Weitgasser R, Blissett D. Cost calculation for a flash glucose monitoring system for UK adults with type 1 diabetes mellitus receiving intensive insulin treatment. Diabetes Res Clin Pract [Internet]. 2018;138:193–200. https://doi.org/10.1016/j.diabres.2018.01.028.

    Article  PubMed  Google Scholar 

  18. Oyagüez I, Merino-Torres JF, Brito M, Bellido V, Cardona-Hernandez R, Gomez-Peralta F, et al. Cost analysis of the flash monitoring system (FreeStyle Libre 2) in adults with type 1 diabetes mellitus. BMJ Open Diabetes Res Care [Internet]. 2020. https://doi.org/10.1136/bmjdrc-2020-001330.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Oyagüez I, Gómez-Peralta F, Artola S, Carrasco FJ, Carretero-Gómez J, García-Soidan J, et al. Correction to: cost analysis of FreeStyle Libre® 2 system in type 2 diabetes mellitus population. Diabetes Ther [Internet]. 2021;12(8):2263–4. https://doi.org/10.1007/s13300-021-01093-z.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Shi L, Hellmund R, et al. Cost comparison of flash continuous glucose monitoring with self-monitoring of blood glucose in adults with type 1 or type 2 diabetes using intensive insulin—from a US private payer perspective [Internet]. US Endocrinol. 2020;16:24. https://doi.org/10.17925/use.2020.16.1.24.

    Article  Google Scholar 

  21. Bilir SP, Hellmund R, Wehler B, Li H, Munakata J, Lamotte M. Cost-effectiveness analysis of a flash glucose monitoring system for patients with type 1 diabetes receiving intensive insulin treatment in Sweden. Eur Endocrinol [Internet]. 2018;14(2):73–9. https://doi.org/10.17925/EE.2018.14.2.73.

    Article  PubMed  Google Scholar 

  22. Scottish Health Technology Group (SHTG). What is the clinical and cost effectiveness of Freestyle Libre® flash glucose monitoring for patients with diabetes mellitus treated with intensive insulin therapy? [Internet]. Scottish Health Technology Group (SHTG); 2018. Report No.: Evidence note number 81. https://shtg.scot/media/1799/freestyle-libre-flash-glucose-monitoring-shtg-evidence-note-81-endocrinology-and-diab.pdf.

  23. Zhao X, Ming J, Qu S, Li HJ, Wu J, Ji L, et al. Cost-effectiveness of flash glucose monitoring for the management of patients with type 1 and patients with type 2 diabetes in China. Diabetes Ther [Internet]. 2021;12(12):3079–92. https://doi.org/10.1007/s13300-021-01166-z.

    Article  CAS  PubMed  Google Scholar 

  24. Gil-Ibáñez MT, Aispuru GR. Cost-effectiveness analysis of glycaemic control of a glucose monitoring system (FreeStyle Libre®) for patients with type 1 diabetes in primary health care of Burgos. Enferm Clin [Internet]. 2020;30(2):82–8. https://doi.org/10.1016/j.enfcli.2019.07.011.

    Article  Google Scholar 

  25. Bilir SP, Li H, Wehler EA, Hellmund R, Munakata J. Cost effectiveness analysis of a flash glucose monitoring system for type 1 diabetes (T1DM) patients receiving intensive insulin treatment in Europe and Australia. Value Health [Internet]. 2016;19(7):A697–8. https://doi.org/10.1016/j.jval.2016.09.2015.

    Article  Google Scholar 

  26. Li H, Bilir SP, Wehler EA, Hellmund R, Munakata J. Cost effectiveness analysis of a flash glucose monitoring system for type 2 diabetes (T2DM) patients receiving intensive insulin treatment in Europe [Internet]. Value Health. 2016;19:A698. https://doi.org/10.1016/j.jval.2016.09.2016.

    Article  Google Scholar 

  27. Blissett R, Blissett D, Levrat-Guillen F, Deshmukh H, Wilmot EG, Ryder REJ, et al. FreeStyle Libre flash glucose monitoring system for people with type 1 diabetes in the UK: a budget impact analysis. BMJ Open Diabetes Res Care [Internet]. 2022. https://doi.org/10.1136/bmjdrc-2021-002580.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health [Internet]. 2014;17(1):5–14. https://doi.org/10.1016/j.jval.2013.08.2291.

    Article  PubMed  Google Scholar 

  29. Ministerio de Salud y Acción Social. Ley N° 23.753 [Internet]. Ley N° 23.753 sobre Diabetes; 2019 [cited 2022 Jul 5]. https://www.argentina.gob.ar/justicia/derechofacil/leysimple/diabetes.

  30. Zimlich R, RN, BSN. Medicare coverage for Freestyle Libre [Internet]. Healthline; 2021 [cited 2022 Jul 5]. https://www.healthline.com/health/medicare/does-medicare-cover-freestyle-libre.

  31. INDEC, Ciudad Autónoma de Buenos Aires : Secretaría de Gobierno de Salud de la Nación 2019. 4° Encuesta Nacional de Factores de Riesgo. Resultados definitivos. 1a ed. Ciudad Autónoma de Buenos Aires: Instituto Nacional de Estadística y Censos (Libro digital, PDF. Archivo Digital).

  32. Caporale JE, Elgart JF, Gagliardino JJ. Diabetes in Argentina: cost and management of diabetes and its complications and challenges for health policy. Global Health [Internet]. 2013;9:54. https://doi.org/10.1186/1744-8603-9-54.

    Article  PubMed  Google Scholar 

  33. Commendatore V, Dieuzeide G, Faingold C, Fuente G, Luján D, Aschner P, et al. Registry of people with diabetes in three Latin American countries: a suitable approach to evaluate the quality of health care provided to people with type 2 diabetes. Int J Clin Pract [Internet]. 2013;67(12):1261–6. https://doi.org/10.1111/ijcp.12208.

    Article  CAS  PubMed  Google Scholar 

  34. Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia [Internet]. 2018;61(3):539–50. https://doi.org/10.1007/s00125-017-4527-5.

    Article  CAS  PubMed  Google Scholar 

  35. Munoz CE, Weinstock RS, Brown TD, Gabbay RA. Women and the American Diabetes Association [Internet]. Diabetes. 2021;70:1638–9. https://doi.org/10.2337/dbi21-0024.

    Article  CAS  PubMed  Google Scholar 

  36. Costa Gil J, Linari MA, Pugnaloni N, Zambon FG, Pérez Manghi F, Rezzónico M, et al. Hypoglycaemia in patients with type 1 and type 2 diabetes mellitus on insulin therapy. Results of the global HAT study in Argentina. Medicina [Internet]. 2017;77(6):449–57. https://www.ncbi.nlm.nih.gov/pubmed/29223934.

  37. Grupo Alfa Beta. Grupo Alfa Beta [Internet]. Precios de medicamentos; 2022 [cited 2022 Jul 5]. http://www.alfabeta.net/precio/.

  38. Kairos Web. Kairos Web [Internet]. Precios de medicamentos; 2022 [cited 2022 Jul 5]. https://ar.kairosweb.com/.

  39. Ministerio de Hacienda y Finanzas Públicas. Informes de cadenas de valor. Salud, farmacia y equipamiento médico. Ministerio de Hacienda y Finanzas Públicas, Secretaría de Política Económica y Planificación del Desarrollo; 2016. Report No.: 21.

  40. Central Bank of Argentina. Exchange rate by date [Internet]. Central Bank of Argentina; 2022 [cited 2022 Apr 26]. http://www.bcra.gov.ar/PublicacionesEstadisticas/Cotizaciones_por_fecha_2.asp.

  41. Mogyorosy Z, Smith P. The main methodological issues in costing health care services: a literature review. Working Papers [Internet]; 2005 [cited 2022 Jul 5]. https://ideas.repec.org//p/chy/respap/7cherp.html.

  42. Tomky D. Detection, prevention, and treatment of hypoglycemia in the hospital. Diabetes Spectr [Internet]. 2005 [cited 2022 Jul 5];18(1):39–44. https://diabetesjournals.org/spectrum/article/18/1/39/1876/Detection-Prevention-and-Treatment-of-Hypoglycemia.

  43. Veronese G, Marchesini G, Forlani G, Saragoni S, DegliEsposti L, Centis E, et al. Costs associated with emergency care and hospitalization for severe hypoglycemia. Nutr Metab Cardiovasc Dis [Internet]. 2016;26(4):345–51. https://doi.org/10.1016/j.numecd.2016.01.007.

    Article  CAS  PubMed  Google Scholar 

  44. Heller SR, Frier BM, Hersløv ML, Gundgaard J, Gough SCL. Severe hypoglycaemia in adults with insulin-treated diabetes: impact on health care resources. Diabet Med [Internet]. 2016;33(4):471–7. https://doi.org/10.1111/dme.12844.

    Article  CAS  PubMed  Google Scholar 

  45. Palacios A, Balan D, Garay OU, Mena M, Souto A, Augustovski F, et al. Base de costos unitarios en Salud en Argentina: Una fuente de información continuamente actualizada para evaluaciones economicas y analisis de impacto presupuestario en un sistema de Salud fragmentado. Value Health Reg Issues [Internet]. 2019;19:S8. https://doi.org/10.1016/j.vhri.2019.08.042.

    Article  Google Scholar 

  46. Pichon-Riviere A, Drummond M, Martí SG, Augustovski F. Aplicación de la evidencia económica en la evaluación de tecnologías sanitarias y la toma de decisiones sobre asignación de recursos sanitarios en América Latina: siete temas clave y una propuesta preliminar de implementación [Internet]; 2021. https://doi.org/10.18235/0003649.

  47. INDEC, Instituto Nacional de Estadística y Censos de la República de Argentina. INDEC: Instituto Nacional de Estadística y Censos de la República Argentina [Internet]; 2019 [cited 2022 Jul 5]. https://www.indec.gob.ar/indec/web/Nivel4-Tema-3-9-47.

  48. Nuijten MJC, Mittendorf T, Persson U. Practical issues in handling data input and uncertainty in a budget impact analysis. Eur J Health Econ [Internet]. 2011;12(3):231–41. https://doi.org/10.1007/s10198-010-0236-4.

    Article  CAS  PubMed  Google Scholar 

  49. McCabe C, Paulden M, Awotwe I, Sutton A, Hall P. One-way sensitivity analysis for probabilistic cost-effectiveness analysis: conditional expected incremental net benefit. Pharmacoeconomics [Internet]. 2020;38(2):135–41. https://doi.org/10.1007/s40273-019-00869-3.

    Article  PubMed  Google Scholar 

  50. American Diabetes Association. American Diabetes Association [Internet]. American Diabetes Association; 2022 [cited 2022 Jul 8]. https://www.diabetes.org/.

  51. National Clinical Guideline Centre (UK). Type 1 diabetes in adults: diagnosis and management [Internet]. London: National Institute for Health and Care Excellence (NICE); 2015. https://www.ncbi.nlm.nih.gov/pubmed/26334079.

  52. Costa Gil J, Linari M, Pugnaloni N, Zambón F, Pérez F, Rezzónico M. Hipoglucemia en pacientes con diabetes tipo 1 y tipo 2 en tratamiento con insulina. Resultados del estudio HAT en Argentina. Medicina Buenos Aires [Internet]. 2017 [cited 2022 Jul 27];77. https://www.medicinabuenosaires.com/indices-de-2010-a-2017/volumen-77-ano-2017-no-6-indice/hipoglucemia-en-pacientes-con-diabetes-tipo-1-y-tipo-2-en-tratamiento-con-insulina-resultados-del-estudio-hat-en-argentina/.

  53. Health Improvement Scotland. What is the clinical and cost effectiveness of Freestyle Libre® flash glucose monitoring for patients with diabetes mellitus treated with intensive insulin therapy? 2018.

  54. Parekh W, Hoskins N, Baker-Knight J, RamirezdeArellano A, MezquitaRaya P. The economic burden of insulin-related hypoglycemia in Spain. Diabetes Ther [Internet]. 2017;8(4):899–913. https://doi.org/10.1007/s13300-017-0285-0.

    Article  PubMed  Google Scholar 

  55. Evans M, Welsh Z, Seibold A. Reductions in HbA1c with flash glucose monitoring are sustained for up to 24 months: a meta-analysis of 75 real-world observational studies. Diabetes Ther [Internet]. 2022;13(6):1175–85. https://doi.org/10.1007/s13300-022-01253-9.

    Article  CAS  PubMed  Google Scholar 

  56. Lage MJ, Boye KS. The relationship between HbA1c reduction and health care costs among patients with type 2 diabetes: evidence from a U.S. claims database. Curr Med Res Opin [Internet]. 2020 [cited 2022 Jul 5];36(9). https://pubmed.ncbi.nlm.nih.gov/32643451/.

  57. Boye KS, Lage MJ, Thieu VT. The association between HbA1c and 1-year diabetes-related medical costs: a retrospective claims database analysis. Diabetes Ther [Internet]. 2022;13(2):367–77. https://doi.org/10.1007/s13300-022-01212-4.

    Article  CAS  PubMed  Google Scholar 

  58. Real-world flash glucose monitoring in Argentina—RAEM [Internet] [cited 2022 Sep 5]. https://raem.org.ar/articulos_raem/real-world-flash-glucose-monitoring-in-argentina/.

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Correspondence to Alfredo Palacios.

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Funding

This study was funded with an independent research grant from Abbott Argentina.

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The authors declare no conflicts of interest. As an independent research grant, Abbott Argentina was not involved in this study's design, methodology, analysis, or any other stage.

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All the data generated in the study are available in the main manuscript and its online Supplementary Material.

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The model is available upon reasonable request.

Author contributions

Concept and design: AP. Formal analysis: AP, FRC, DB, CRR, AB. Supervision: AP, AB, APR, FA. Review, interpretation, and discussion of the results: AP, FRC, DB, CRR, BB, AB, APR, FA. Writing original draft: AP, FRC, CCR, CML. Writing, review and editing: AP, FRC, AB, CRR, APR, FA.

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Palacios, A., Rodriguez-Cairoli, F., Balan, D. et al. Budget Impact Analysis of the FreeStyle Libre Flash Continuous Glucose Monitoring System® in Patients with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus with Multiple Daily Insulin Injections in Argentina. Appl Health Econ Health Policy 21, 637–650 (2023). https://doi.org/10.1007/s40258-023-00800-0

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