Análise de custos de pacientes cirróticos descompensados recebendo albumina a longo prazo versus tratamento médico padrão nos sistemas de saúde público e privado do Brasil

TERRA, Carlos; VIAYNA, Elisabet; AYZIN, Laura; FUSTER, Cristina; ACEITUNO, Susana; TAFLA, Claudio

Carlos TERRA

validation

investigation

data curation

writing, review & editing

critically reviewed the manuscript

approved the final version and its submission

Universidade do Estado do Rio de Janeiro, Departamento de Gastroenterologia, Unidade de Fígado, Rio de Janeiro, RJ, Brasil.

Casa de Saúde São José, Unidade de Fígado, Rio de Janeiro, RJ, Brasil.

Hospital Federal da Lagoa, Unidade de fígado, Rio de Janeiro, RJ, Brasil.

http://orcid.org/0000-0003-3069-128X

Elisabet VIAYNA

conceptualization

methodology

software

investigation

data curation

writing of original draft

review & editing

supervision

approved the final version and its submission

Health Economics and Outcomes Research, Scientific and Medical Affairs, Sant Cugat del Valles, Espanha.

http://orcid.org/0000-0003-3253-0148

Laura AYZIN

conceptualization

data curation

writing

review & editing

approved the final version and its submission

International Market Access, Grifols International, Sant Cugat del Valles, Espanha.

http://orcid.org/0009-0001-4477-5604

Cristina FUSTER

data curation

writing

review & editing

approved the final version and its submission

Scientific and Medical Affairs, Grifols S.A, Sant Cugat del Valles, Espanha.

http://orcid.org/0000-0002-0808-8161

Susana ACEITUNO

conceptualization

methodology

software

investigation

data curation

writing

review & editing

approved the final version and its submission

Outcomes’10, Universitat Jaume I Parc Cientific Tecnologic i Empresarial Edificio Espaitec 2, Castellón de la Plana, Espanha.

http://orcid.org/0000-0002-2933-3998

Claudio TAFLA

validation

investigation

data curation

writing

review & editing

critically reviewed the manuscript

approved the final version and its submission

Nilo Saúde, São Paulo, SP, Brasil.

http://orcid.org/0009-0009-3250-4776

Corresponding author: Carlos Terra. E-mail: carlosterrario@hotmail.com

Declared conflict of interest of all authors: Carlos Terra is a consultant for Grifols. Elisabet Viayna, Laura Ayzin and Cristina Fuster are employees at Grifols. Susana Aceituno is employee at Outcomes’10, whose services were hired to support the project implementation. Claudio Tafla is a consultant for Grifols.

Figuras (3)
Tabelas (4)

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FIGURE 1
Incremental cost per cirrhotic patient treated with SMT + albumin vs SMT from the Brazilian public (A) and private (B) healthcare system perspectives A: Cost per patient per year treated with SMT and SMT + albumin and incremental difference from the public healthcare system perspective. B: Cost per patient per year treated with SMT and SMT + albumin and incremental difference from the private healthcare system perspective. *SMT + albumin vs SMT: negative values indicate savings. BRL: Brazilian real; SMT: standard medical treatment.

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FIGURE 2
Univariate sensitivity analysis showing the 10 variables that would have the highest impact on the incremental cost per cirrhotic patient treated with SMT + albumin (vs SMT) when a 20% increase and decrease is applied following the perspective of the Brazilian public (A) and private (B) healthcare systems. A: Tornado diagram presenting the results of a univariate sensitivity analysis of the incremental cost per patient per year treated with SMT + albumin vs SMT from the public healthcare system perspective. B: Tornado diagram presenting the results of a univariate sensitivity analysis of the incremental cost per patient per year treated with SMT + albumin vs SMT from the private healthcare system perspective. BRL: Brazilian real; HA: human albumin; SMT: standard medical treatment.

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FIGURE 3
Summary of the background, project objectives and main results and conclusions.

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TABLE 1
Twelve-month incidence rates of complications and treatments per patient following SMT and SMT + albumin infusions from the ANSWER trial¹⁴14. Caraceni P, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, et al. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. Lancet. 2018;391:2417-29.^,¹⁶16. Moctezuma-Velazquez C, Castro-Narro G, Simo P, Viayna E, Aceituno S, Soler M, et al. Economic evaluation of long-term albumin use in cirrhosis patients from the Mexican healthcare system perspective. Ann Hepatol. 2022;27:100673.

17. Fernandez J, Davis A, Aceituno S, Simo P, Soler M. Annual cost of long-term treatment with human albumin in patients with cirrhosis and uncomplicated ascites [abstract]. 2020. Available from: https://www.sefh.es/eventos/65congreso/img/libro-comunicaciones-65-congreso.pdf.
https://www.sefh.es/eventos/65congreso/i... ^-¹⁸18. Bennett K, Viayna E, Gunal M, Stacey D, Davis A, Southern D, et al. Long term albumin administration is associated with reduced healthcare resource use in patients with uncomplicated cirrhotic ascites: results from a simulation model. J Hepatol. 2022;77:S615..

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TABLE 2
Unit costs and source from the Brazilian public and private healthcare systems perspectives.

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TABLE 3
Average cost per patient treated with SMT and SMT + albumin and incremental difference based on the rates of complications, healthcare resource utilization and pharmacological treatment as per the ANSWER trials and unit costs from table 2 from the perspective of the public healthcare system.

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TABLE 4
Average cost per patient treated with SMT and SMT + albumin and incremental difference based on the rates of complications, healthcare resource utilization and pharmacological treatment as per the ANSWER trials and unit costs from table 2 from the perspective of the private healthcare system.

Complications / treatments	12-month incidence*
	SMT	SMT + albumin
Clinical complications
Refractory ascites	0.57	0.22
Spontaneous bacterial peritonitis	0.35	0.12
Other bacterial infections	0.86	0.64
Hepatic encephalopathy	1.08	0.52
Renal dysfunction	1.08	0.59
Hepatorenal Syndrome	0.20	0.07
Other HCRU
Large-volume paracentesis	3.50	1.55
Non-liver related hospitalization (days)	1.80	1.40
Follow up visit for albumin administration	0	48
Pharmacological treatments
Human albumin for regular infusions (g/administration)	0	40
Spironolactone (mg/day)	200	200
Furosemide (mg/day)	40	40

Complications/treatments	Public healthcare system*		Private healthcare system*
Complications/treatments	Cost (BRL, 2021)	Source	Cost (BRL, 2021)	Source
Cost of clinical complications
Refractory ascites (unit cost)	99,872 BRL	Rodriguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381.	77,231 BRL	Fonseca 2005²¹21. Fonseca MC, Araujo GT. Medical resource use and direct medical cost of chronic hepatitis C virus infection (HCV) in Brazil [abstract]. Value Health. 2005;6:A122-3. Fonseca 2009²²22. Fonseca MC, Araújo GT, Araújo DV. Cost effectiveness of peginterferon alfa-2B combined with ribavirin for the treatment of chronic hepatitis C in Brazil. Braz J Infect Dis. 2009;13:191-9.
Spontaneous bacterial peritonitis (unit cost)	35,885 BRL	Rodriguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381.	33,436 BRL	Rodiguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381. Sogayar 2008²³23. Sogayar AM, Machado FR, Rea-Neto A, Dornas A, Grion CM, Lobo SM, et al. A multicentre, prospective study to evaluate costs of septic patients in Brazilian intensive care units. Pharmacoeconomics. 2008;26:425-34.
Other bacterial infections (unit cost)	4,572 BRL	Osme 2020²⁴24. Osme SF, Almeida APS, Lemes MF, Barbosa WO, Arantes A, Mendes-Rodrigues C, et al. Costs of healthcare-associated infections to the Brazilian public Unified Health System in a tertiary-care teaching hospital: a matched case-control study. J Hosp Infect. 2020;106:303-10.	5,111 BRL	ANS²⁵25. Agência Nacional de Saúde Suplementar. 2022. Available from: https://www.gov.br/ans/ https://www.gov.br/ans/...
Hepatic encephalopathy (unit cost)	103,216 BRL	Rodriguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381.	263,385 BRL	Fonseca 2005²¹21. Fonseca MC, Araujo GT. Medical resource use and direct medical cost of chronic hepatitis C virus infection (HCV) in Brazil [abstract]. Value Health. 2005;6:A122-3.
Renal dysfunction (unit cost)	55,990 BRL	Gouveia 2017²⁶26. Gouveia DSES, Bignelli AT, Hokazono SR, Danucalov I, Siemens TA, Meyer F, et al. Analysis of economic impact between the modality of renal replacement therapy. J Bras Nefrol. 2017;39:162-71.	108,478 BRL	Gouveia 2017²⁶26. Gouveia DSES, Bignelli AT, Hokazono SR, Danucalov I, Siemens TA, Meyer F, et al. Analysis of economic impact between the modality of renal replacement therapy. J Bras Nefrol. 2017;39:162-71.
Hepatorenal syndrome (unit cost)	142,819 BRL	Rodriguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381.	69,444 BRL	Rodiguez 2021²⁰20. Rodriguez S, Da Motta F, Neto GB, Brandao A. P-15 Waiting list for liver transplantations: Clinical and economic burden, retrospective study [abstract]. Ann Hepatol. 2021;24:100381. Sogayar 2008²³23. Sogayar AM, Machado FR, Rea-Neto A, Dornas A, Grion CM, Lobo SM, et al. A multicentre, prospective study to evaluate costs of septic patients in Brazilian intensive care units. Pharmacoeconomics. 2008;26:425-34.
Cost of other HCRU
Large-volume paracentesis (unit cost)	793 BRL	Borges de Santana 2014²⁷27. Borges de Santana V, Bertocco de Paiva Haddad L, Morgado Conte T, Cortez Rizzon A, Miranda Barbosa V, Shield W 3rd, et al. MELD score and albumin replacement are related to higher costs during management of patients with refractory ascites. Transplant Proc. 2014;46:1760-3.	2,098 BRL	ANS²⁵25. Agência Nacional de Saúde Suplementar. 2022. Available from: https://www.gov.br/ans/ https://www.gov.br/ans/...
Non-liver related hospitalization (cost/day)	318 BRL	Schwambach 2020⁴4. Hepp Schwambach K, William Becker M, Aparecida Paz A, Fernanda da Costa Linch G, Helena Weis A, Raquel Blatt C. Hospital expenses and liver disease in Brazil. Jornal Brasileiro de Economia da Saúde. 2020;12:128-34.	2,535 BRL	ANS²⁵25. Agência Nacional de Saúde Suplementar. 2022. Available from: https://www.gov.br/ans/ https://www.gov.br/ans/... ANAHP²⁸28. ANAHP Associacao Nacional de Hospitals Privados. 2022. Available from: https://www.anahp.com.br https://www.anahp.com.br...
Follow up visit for albumin administration (cost/visit)	153 BRL	Brito 2019²⁹29. Brito NC, Machado de Assis TS, Rabello A, Cota G. Intralesional infiltration versus parenteral use of meglumine antimoniate for treatment of cutaneous leishmaniasis: A cost-effectiveness analysis. PLoS Negl Trop Dis. 2019;13:e0007856.	196 BRL	ANAHP²⁸28. ANAHP Associacao Nacional de Hospitals Privados. 2022. Available from: https://www.anahp.com.br https://www.anahp.com.br... CBHPM³⁰30. CBHPM, Classificaçao Brasileira Hierarquizada de Procedimentos Médicos. 2022. Available from: https://amb.org.br/cbhpm/ https://amb.org.br/cbhpm/...
Cost of pharmacological treatments
Human albumin (cost/g)	12.20 BRL	Banco de Preços em Saúde³¹31. Banco de Preços em Saúde. Available from: http://bps.saude.gov.br/login.jsf http://bps.saude.gov.br/login.jsf...	26.30 BRL	CMED³²32. CMED: Câmara de Regulação do Mercado de Medicamentos 2022. Available from: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/cmed https://www.gov.br/anvisa/pt-br/assuntos...
Spironolactone (cost/mg)	0.006 BRL		0.025 BRL
Furosemide (cost/mg)	0.013 BRL		0.012 BRL

Cirrhosis-related complications	SMT	SMT + albumin	Incremental cost*
Refractory ascites	57,227 BRL	21,872 BRL	-35,355 BRL
Spontaneous bacterial peritonitis	12,560 BRL	4,270 BRL	-8,289 BRL
Other bacterial infections	3,932 BRL	2,945 BRL	-988 BRL
Hepatic encephalopathy	110,957 BRL	53,569 BRL	-57,388 BRL
Renal dysfunction	60,189 BRL	32,922 BRL	-27,267 BRL
Hepatorenal syndrome - type 1	28,421 BRL	9,855 BRL	-18,567 BRL
Large volume paracentesis	2,774 BRL	1,229 BRL	-1,546 BRL
Hospitalization (non-liver-related)	573 BRL	446 BRL	-127 BRL
Total (clinical complications)	276,633 BRL	127,107 BRL	-149,526 BRL
Pharmacological treatment
Diuretics	618 BRL	618 BRL	0 BRL
Human albumin regular infusions**	0 BRL	30,767 BRL	30,767 BRL
Total (pharmacological cost)	618 BRL	31,385 BRL	30,767 BRL
TOTAL	277,251 BRL	158,492 BRL	-118,759 BRL

Cirrhosis-related complications	SMT	SMT + albumin	Incremental cost*
Refractory ascites	44,253 BRL	16,913 BRL	-27,340 BRL
Spontaneous bacterial peritonitis	11,703 BRL	3,979 BRL	-7,724 BRL
Other bacterial infections	4,395 BRL	3,291 BRL	-1,104 BRL
Hepatic encephalopathy	283,139 BRL	136,697 BRL	-146,442 BRL
Renal dysfunction	116,614 BRL	63,785 BRL	-52,829 BRL
Hepatorenal syndrome - type 1	13,819 BRL	4,792 BRL	-9,028 BRL
Large volume paracentesis	7,344 BRL	3,253 BRL	-4,092 BRL
Hospitalization (non-liver-related)	4,563 BRL	3,549 BRL	-1,014 BRL
Total (clinical complications)	485,831 BRL	236,259 BRL	-249,572 BRL
Pharmacological treatment
Diuretics	1,971 BRL	1,971 BRL	0 BRL
Human albumin regular infusions**	0 BRL	59,897 BRL	59,897 BRL
Total (pharmacological cost)	1,971 BRL	61,868 BRL	59,897 BRL
TOTAL	487,802 BRL	298,128 BRL	-189,675 BRL

[1] Corresponding author: Carlos Terra. E-mail: carlosterrario@hotmail.com

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Análise de custos de pacientes cirróticos descompensados recebendo albumina a longo prazo versus tratamento médico padrão nos sistemas de saúde público e privado do Brasil

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