Pharmacotherapeutic follow-up in patients with type 1 diabetes in context of judicialization: possibility optimize costs

William Neves Oliveira; Maurílio Souza Cazarim; Thays Santos Mendonça; Paulo Roque Obreli Neto; Mariana Linhares Pereira; André Oliveira Baldoni

doi:10.1590/s2175-97902023e23264

Authors

William Neves Oliveira Universidade Federal de São João del-Rei, Divinópolis-MG, Brazil
Maurílio Souza Cazarim Universidade Federal de São João del-Rei. Faculdade de Farmácia, Divinópolis-MG, Brazil
Thays Santos Mendonça Universidade Federal de São João del-Rei, Divinópolis-MG, Brazil
Paulo Roque Obreli Neto Centro Universitário das Faculdades Integradas de Ourinhos, Ourinhos-SP, Brazil
Mariana Linhares Pereira Universidade Federal de São João del-Rei, Divinópolis-MG, Brazil
André Oliveira Baldoni Universidade Federal de São João del-Rei, Divinópolis-MG, Brazil https://orcid.org/0000-0001-6379-0415

DOI:

https://doi.org/10.1590/s2175-97902023e23264

Keywords:

Pharmaceutical care, Health’s judicialization, Economic analysis, Diabetes Mellitus, Insulin analogs

Abstract

In Brazil, insulin analogs stand out as one of the most demanded medications by judicial means. However, the guarantee of judicial access does not guarantee rational use. In context, pharmacotherapeutic follow-up (PF) is shown to be clinical effective strategy for patients with diabetes. To evaluate direct medical costs one year after performing PF in patients with type 1 diabetes mellitus using insulin analogs ordered by court in Public Health System (Sistema Único de Saúde - SUS). This is a partial economic analysis, nested within a quasi-experimental study. Patients with T1DM who receive insulin analogs by judicialization in a medium-sized Brazilian city participated. The PF was conducted following the method adapted from the Pharmacotherapy workup (PW). Data were collected considering the period of one year before the start of the intervention and one year after the start of the intervention. Direct medical costs were evaluated and the difference in costs was calculated. 28 patients participated in the intervention. After PF, direct costs were -$3,696.78. Sensitivity analysis showed that there is a 33.4 % chance for PF to present cost savings when compared to baseline. The PF has the potential to reduce direct medical costs from the perspective of the SUS.

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References

American Diabetes Association.(ADA). Diabetes Care. 2023;46(Supplement_1):S10-18. https://doi.org/10.2337/dc23-S001

» https://doi.org/10.2337/dc23-S001

Aquino JA, Baldoni AO, Di Lorenzo Oliveira C, Cardoso CS, de Figueiredo RC, Sanches C. Pharmacotherapeutic empowerment and its effectiveness in glycemic control in patients with Diabetes Mellitus. Diabetes Metab Syndr Clin Res Rev.2019;13(1):137-42. https://doi.org/10.1016/j.dsx.2018.08.002

» https://doi.org/10.1016/j.dsx.2018.08.002

Brazil. Ministry of Health. Ordinance Nº. 10, of February 21, 2017. Makes public the decision to incorporate fast-acting insulin analogues for the treatment of type I diabetes mellitus, within the scope of the Unified Health System. Diário Oficial da União, Brasilia: Ministry of Health, 2017. In Portuguese.

Brazil. Ministry of Health. Ordinance Nº. 19, of March 27, 2019. Establishes, defines and creates federal financial incentives for the implementation, costing and performance of multidisciplinary teams in Primary Health Care.. Diário Oficial da União, Brasilia: Ministry of Health, 2019. In Portuguese.

Brazil. Ministry of Health. Ordinance Nº. 635, of May 22, 2023. Makes public the decision to incorporate long-acting insulin analogues for the treatment of type I diabetes mellitus, within the scope of the Unified Health System. Diário Oficial da União, Brasilia: Ministry of Health, 2023. In Portuguese.

Brazilian Society of Diabetes. Guidelines of the Brazilian Society of Diabetes (SBD): 2022-2023. Brazilian Society of Diabetes; São Paulo, Brazil: 2023.

Chieffi AL, Barradas RDCB, Golbaum M. Legal access to medications: A threat to Brazil’s public health system? BMC Health Serv Res. 2017;17(1):499. https://doi.org/10.1186/s12913-017-2430-x

» https://doi.org/10.1186/s12913-017-2430-x

Des Jarlais DC, Lyles C, Crepaz N. Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement. Am J Public Health. 2004;94(3):361-6. https://doi.org/10.2105/AJPH.94.3.361

» https://doi.org/10.2105/AJPH.94.3.361

Desse TA, Vakil K, Namara KM, Manias E. Impact of clinical pharmacy interventions on health and economic outcomes in type 2 diabetes: A systematic review and meta-analysis. Diabet Med. 2021;38(6):e14526. https://doi.org/10.1111/DME.14526

» https://doi.org/10.1111/DME.14526

Figueiredo TA, Pepe VLE, Osorio-de-Castro CGS. A sanitary focus on medicines lawsuit. Physis. 2010;20(1):101-18. https://doi.org/10.1590/s0103-73312010000100007

» https://doi.org/10.1590/s0103-73312010000100007

Gonçalves ACO, Cazarim MDS, Sanches C, Pereira LRL, Camargos AMT, Aquino JA, et al. Cost-effectiveness analysis of a pharmacotherapeutic empowerment strategy for patients with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2019;7(1):e000647. https://doi.org/10.1136/bmjdrc-2018-000647

» https://doi.org/10.1136/bmjdrc-2018-000647

Hasan M, Atiqur-Rahman M, Chowdhury S, Esteak T, Naznin J, Shahi MS. Efficacy and Safety of Analog Insulin in Comparison With Human Insulin for Hyperglycemia in Hospitalized Patients With Acute Stroke: A Randomized, Open-Label, Single-Center Trial. Endocr Pract. 2023;29(1):18-23. https://doi.org/10.1016/j.eprac.2022.10.180

» https://doi.org/10.1016/j.eprac.2022.10.180

Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990;47(3):533-43. https://doi.org/10.1093/ajhp/47.3.533

» https://doi.org/10.1093/ajhp/47.3.533

Houle SKD, Chuck AW, McAlister FA, Tsuyuki RT. Effect of a pharmacist-managed hypertension program on health system costs: An evaluation of the study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Pharmacotherapy. 2012;32(6):527-37. https://doi.org/10.1002/j.1875-9114.2012.01097.x

» https://doi.org/10.1002/j.1875-9114.2012.01097.x

Hui X, Yinghua Z, Shengxiong X, Qingfa Z, Yingjun G. The effectiveness of daily humanistic care in pharmaceutical care of patients with type 2 diabetes. Med (United States). 2022;101(41):E30136. https://doi.org/10.1097/MD.0000000000030136

» https://doi.org/10.1097/MD.0000000000030136

International Diabetes Federation [IDF]. IDF Diabetes Atlas. 10th ed. 2021.

Jackson DL, Michaels NM, Melson B, Bruder E, Rhodes LA, Marciniak MW. Evaluation of the economic and clinical impact of community pharmacist-driven pharmacy benefit management services. J Am Pharm Assoc. 2019;59(4):S91-4. https://doi.org/10.1016/j.japh.2019.03.016

» https://doi.org/10.1016/j.japh.2019.03.016

Jeong S, Lee M, Ji E. Effect of pharmaceutical care interventions on glycemic control in patients with diabetes: a systematic review and meta-analysis. Ther Clin Risk Manag. 2018; 14:1813-29. https://doi.org/10.2147/TCRM.S169748

» https://doi.org/10.2147/TCRM.S169748

Khan YH, Alzarea AI, Alotaibi NH, Alatawi AD, Khokhar A, Alanazi AS, et al. Evaluation of Impact of a Pharmacist-Led Educational Campaign on Disease Knowledge, Practices and Medication Adherence for Type-2 Diabetic Patients: A Prospective Pre- and Post-Analysis. Int J Environ Res Public Health. 2022;19(16):10060. https://doi.org/10.3390/ijerph191610060

» https://doi.org/10.3390/ijerph191610060

Machado MA, Acurcio Fde A, Brandão CMR, Faleiros DR, Guerra AA Jr, Cherchiglia ML, et al. Judicialization of access to medicines in the State of Minas Gerais, Brazil. Rev Saude Publica. 2011;45(3):590-8. https://doi.org/10.1590/S0034-89102011005000015

» https://doi.org/10.1590/S0034-89102011005000015

Mannucci E, Caiulo C, Naletto L, Madama G, Monami M. Efficacy and safety of different basal and prandial insulin analogues for the treatment of type 2 diabetes: a network meta-analysis of randomized controlled trials. Endocrine. 2021;74(3):508-17. https://doi.org/10.1007/s12020-021-02889-6

» https://doi.org/10.1007/s12020-021-02889-6

Matzke GR, Moczygemba LR, Williams KJ, Czar MJ, Lee WT. Impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization. Am J Health Pharm. 2018;75(14):1039-47. https://doi.org/10.2146/ajhp170789

» https://doi.org/10.2146/ajhp170789

Mendonça TS, Oliveira WN, Belo VS, Silva ES, Pereira ML, Obreli-Neto PR, et al. Clinical and humanistic impact of pharmacotherapeutic follow-up in patients with type 1 diabetes mellitus treated judicially. Diabetol Metab Syndr. 2022;14(1):61. https://doi.org/10.1186/s13098-022-00835-8

» https://doi.org/10.1186/s13098-022-00835-8

Mendonça TS, Silva ES, Pereira ML, Obreli-Neto PR, Belo VS, Ferreira GC, et al. Patients in insulin analogues use via judicial litigation: do they use the Brazilian Public Health System (SUS)? Cad Saúde Coletiva. 2023;31(2):e31020102. https://doi.org/10.1590/1414-462x202331020102

» https://doi.org/10.1590/1414-462x202331020102

Moore JM, Shartle D, Faudskar L, Matlin OS, Brennan TA. Impact of a patient-centered pharmacy program and intervention in a high-risk group. J Manag Care Pharm. 2013;19(3):228-36. https://doi.org/10.18553/jmcp.2013.19.3.228

» https://doi.org/10.18553/jmcp.2013.19.3.228

Morley PC, Strand L, Cipolle R. Pharmaceutical Care Practice: The Clinician’s Guide, 2004.

Obreli-Neto PR, Marusic S, Guidoni CM, Baldoni A de O, Renovato RD, Pilger D, et al. Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: A 36-month randomized controlled clinical trial. J Manag Care Pharm. 2015;21(1):66-75. https://doi.org/10.18553/jmcp.2015.21.1.66

» https://doi.org/10.18553/jmcp.2015.21.1.66

Oliveira YMDC, Fonseca Braga BS, Farias AD, De Vasconcelos CM, Fernandes Ferreira MA. Judicialization of access to medicines: Analysis of lawsuits in the state of Rio Grande do Norte, Brazil. Cad Saude Publica. 2021;37(1):e00174619. https://doi.org/10.1590/0102-311X00174619

» https://doi.org/10.1590/0102-311X00174619

Papatheodorou K, Banach M, Bekiari E, Rizzo M, Edmonds M. Complications of Diabetes 2017. J Diabetes Res. 2018;2018:3086167. https://doi.org/10.1155/2018/3086167

» https://doi.org/10.1155/2018/3086167

Pinheiro P, Garcia J, Cardoso É, Luz D, Silva V. Pharmacoeconomics: expenses with insulin analogues acquired through judicialization in a municipality in the state of Pará, Brazil, in 2016. J Bras Econ Saúde. 2019;11(1):42-8. https://doi.org/10.21115/jbes.v11.n1.p42-8

» https://doi.org/10.21115/jbes.v11.n1.p42-8

Rascati KL. Essentials of pharmacoeconomics. Philadelphia (PA): Lippincott Williams & Wilkins, 2009.

Rivera JG, Quemel Bardález GKC, Silva VM da, Costa JG da, Silva KRP da, Costa JB. Literature review: Pharmacotherapeutic follow-up provided to type 2 diabetic patients treated at community pharmacies. Res Soc Dev. 2021;10(8):e9010817150. https://doi.org/10.33448/rsd-v10i8.17150

» https://doi.org/10.33448/rsd-v10i8.17150

Sant’Ana JMB, Pepe VLE, Osorio-De-Castro CGS, Ventura M. Essentiality and pharmaceutical assistance: Considerations on access to medicines through lawsuits in Brazil. Rev Panam Salud Publica/Pan Am J Public Health. 2011;29:138-44. https://doi.org/10.1590/S1020-49892011000200010

» https://doi.org/10.1590/S1020-49892011000200010

Santos ECB, Teixeira CRS, Zanetti ML, Istilli PT, Pereira LHTR, Torquato MTDCG. Judicialization of health: Access to treatment for users with diabetes mellitus. Texto Context Enferm. 2018;27(1):1-7. https://doi.org/10.1590/0104-070720180000800016

» https://doi.org/10.1590/0104-070720180000800016

Schultz BG, Tilton J, Jun J, Scott-Horton T, Quach D, Touchette DR. Cost-Effectiveness Analysis of a Pharmacist-Led Medication Therapy Management Program: Hypertension Management. Value Health. 2021;24(4):522-9. https://doi.org/10.1016/j.jval.2020.10.008

» https://doi.org/10.1016/j.jval.2020.10.008

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020;11(11):CD005613. https://doi.org/10.1002/14651858.CD005613.pub4

» https://doi.org/10.1002/14651858.CD005613.pub4

Simeone JC, Shah S, Ganz ML, Sullivan S, Koralova A, LeGrand J, et al. Healthcare resource utilization and cost among patients with type 1 diabetes in the United States. J Manag Care Spec Pharm. 2020;26(11):1399-410. https://doi.org/10.18553/JMCP.2020.26.11.1399

» https://doi.org/10.18553/JMCP.2020.26.11.1399

Travassos DV, Ferreira RC, Maria A, Vargas D, Núbia R, Moura V De, et al. The judicialization of health care: a case study of three state courts in Brazil. Cien Saude Colet. 2013;18(11):3419-3429. https://doi.org/10.1590/S1413-81232013001100031

» https://doi.org/10.1590/S1413-81232013001100031

Vasconcelos DMM, Chaves GC, Azeredo TB, da Silva RM. National Medicines Policy in retrospective: a review of (almost) 20 years of implementation. Cienc Saude Colet. 2017;22(8):2609-14. https://doi.org/10.1590/1413-81232017228.02432017

» https://doi.org/10.1590/1413-81232017228.02432017

Wang D. Courts as Healthcare Policy-Makers: The Problem, the Responses to the Problem and Problems in the Responses. SSRN Electron J. 2013. https://doi.org/10.2139/ssrn.2335145

» https://doi.org/10.2139/ssrn.2335145