RESUMO
BACKGROUND: Symptomatic hypocalcemia is a common complication of total thyroidectomy. Management strategies include responsive treatment initiation for symptoms or prevention by routine or parathyroid hormone-directed calcium supplementation. The comparative cost-effectiveness of even the most often utilized strategies is unclear. METHODS: A Markov cohort model was created to compare routine supplementation with calcium alone (RS), postoperative parathyroid hormone-based selective supplementation with calcium and calcitriol (SS), and no supplementation (NS) in asymptomatic patients. Patients could remain asymptomatic or develop symptomatic hypocalcemia, managed with outpatient oral supplementation or intravenous calcium infusion and administered either inpatient or outpatient. Effectiveness was measured in quality-adjusted life years. Sensitivity analyses were performed to test model parameter assumptions. RESULTS: RS was the preferred strategy, costing $329/patient and resulting in 0.497 quality-adjusted life years, which was only marginally better compared to SS ($373 for 0.495 quality-adjusted life years). NS was most costly at $4,955 for 0.491 quality-adjusted life years. Preference for RS over SS was sensitive to the probability of developing symptoms and the probability of symptom treatment with intravenous supplementation. On probabilistic sensitivity analysis, RS was preferred in 75.4% of scenarios. CONCLUSION: After total thyroidectomy, a preventative calcium supplementation strategy should be strongly considered. In this data-driven theoretical model, RS was the least costly option and resulted in an incremental gain in quality-adjusted life years.
Assuntos
Análise Custo-Benefício , Suplementos Nutricionais/economia , Hipocalcemia/economia , Complicações Pós-Operatórias/tratamento farmacológico , Tireoidectomia/efeitos adversos , Calcitriol/administração & dosagem , Calcitriol/economia , Cálcio/administração & dosagem , Cálcio/economia , Simulação por Computador , Custos de Medicamentos/estatística & dados numéricos , Humanos , Hipocalcemia/tratamento farmacológico , Hipocalcemia/etiologia , Hipocalcemia/prevenção & controle , Cadeias de Markov , Modelos Econômicos , Hormônio Paratireóideo/sangue , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/etiologia , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective. Methods: A Markov decision model was developed for patients ≥ 50 years old with end stage renal disease in dialytic treatment and SHPT. Quarterly cycles and a lifetime time horizon were considered. Life years (LY) gained were assessed as clinical outcome. Clinical and economic inputs were obtained from systematic literature review and official databases. Costs are presented in Brazilian real (BRL), for the year 2014. Results: In the base case: paricalcitol generated a clinical benefit of 16.28 LY gained versus 14.11 LY gained with calcitriol, total costs of BRL 131,064 and BRL 114,262, respectively, determining an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. The data robustness was confirmed by the sensitivity analysis. Conclusions: According to cost-effectiveness threshold recommended by the World Health Organization for 2013, the treatment of SHPT in patients on dialysis with paricalcitol is cost-effective when compared to calcitriol, from the public healthcare system perspective, in Brazil.
Introdução: O hiperparatireoidismo secundário (HPTS) é uma consequência da doença renal crônica. O tratamento no SUS é realizado com calcitriol, que favorece a hipercalcemia e/ou hiperfosfatemia, dificultando o controle do HPTS. Uma opção clinicamente relevante é o paricalcitol, que ocasiona a supressão do paratormônio (PTH) de forma mais rápida que o calcitriol e com menores alterações nas taxas séricas de cálcio, fósforo e do produto cálcio-fósforo. Objetivo: Este trabalho tem como objetivo desenvolver uma análise de custo-efetividade de paricalcitol versus calcitriol para pacientes em diálise com HPTS, perspectiva do SUS. Métodos: Foi desenvolvido um modelo de decisão de Markov para a população ≥ 50 anos, com DRC em diálise e HPTS. Foram considerados ciclos trimestrais e um horizonte temporal lifetime. O desfecho clínico avaliado foram os anos de vida ganhos. Dados foram obtidos a partir de revisão sistemática da literatura e bases de dados oficiais. Custos em reais (R$), ano de 2014. Resultados: No caso base: paricalcitol gerou benefício clínico de 16,28 anos de vida ganhos versus 14,11 anos de vida ganhos com calcitriol, custos totais de R$ 131.064 e R$ 114.262, respectivamente. A razão de custo-efetividade incremental de R$ 7.740 por ano de vida salvo. Dados robustos confirmados pela análise de sensibilidade. Conclusão: De acordo com o limiar de custo-efetividade recomendado pela Organização Mundial de Saúde para o ano de 2013, o tratamento de pacientes com HPTS em diálise com paricalcitol é custo-efetivo, comparado ao calcitriol, perspectiva SUS.
Assuntos
Conservadores da Densidade Óssea/economia , Conservadores da Densidade Óssea/uso terapêutico , Calcitriol/economia , Calcitriol/uso terapêutico , Análise Custo-Benefício , Ergocalciferóis/economia , Ergocalciferóis/uso terapêutico , Hiperparatireoidismo Secundário/tratamento farmacológico , Hiperparatireoidismo Secundário/economia , Diálise Renal , Brasil , Atenção à Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Abstract Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective. Methods: A Markov decision model was developed for patients ≥ 50 years old with end stage renal disease in dialytic treatment and SHPT. Quarterly cycles and a lifetime time horizon were considered. Life years (LY) gained were assessed as clinical outcome. Clinical and economic inputs were obtained from systematic literature review and official databases. Costs are presented in Brazilian real (BRL), for the year 2014. Results: In the base case: paricalcitol generated a clinical benefit of 16.28 LY gained versus 14.11 LY gained with calcitriol, total costs of BRL 131,064 and BRL 114,262, respectively, determining an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. The data robustness was confirmed by the sensitivity analysis. Conclusions: According to cost-effectiveness threshold recommended by the World Health Organization for 2013, the treatment of SHPT in patients on dialysis with paricalcitol is cost-effective when compared to calcitriol, from the public healthcare system perspective, in Brazil.
Resumo Introdução: O hiperparatireoidismo secundário (HPTS) é uma consequência da doença renal crônica. O tratamento no SUS é realizado com calcitriol, que favorece a hipercalcemia e/ou hiperfosfatemia, dificultando o controle do HPTS. Uma opção clinicamente relevante é o paricalcitol, que ocasiona a supressão do paratormônio (PTH) de forma mais rápida que o calcitriol e com menores alterações nas taxas séricas de cálcio, fósforo e do produto cálcio-fósforo. Objetivo: Este trabalho tem como objetivo desenvolver uma análise de custo-efetividade de paricalcitol versus calcitriol para pacientes em diálise com HPTS, perspectiva do SUS. Métodos: Foi desenvolvido um modelo de decisão de Markov para a população ≥ 50 anos, com DRC em diálise e HPTS. Foram considerados ciclos trimestrais e um horizonte temporal lifetime. O desfecho clínico avaliado foram os anos de vida ganhos. Dados foram obtidos a partir de revisão sistemática da literatura e bases de dados oficiais. Custos em reais (R$), ano de 2014. Resultados: No caso base: paricalcitol gerou benefício clínico de 16,28 anos de vida ganhos versus 14,11 anos de vida ganhos com calcitriol, custos totais de R$ 131.064 e R$ 114.262, respectivamente. A razão de custo-efetividade incremental de R$ 7.740 por ano de vida salvo. Dados robustos confirmados pela análise de sensibilidade. Conclusão: De acordo com o limiar de custo-efetividade recomendado pela Organização Mundial de Saúde para o ano de 2013, o tratamento de pacientes com HPTS em diálise com paricalcitol é custo-efetivo, comparado ao calcitriol, perspectiva SUS.
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Calcitriol/economia , Calcitriol/uso terapêutico , Análise Custo-Benefício , Conservadores da Densidade Óssea/economia , Conservadores da Densidade Óssea/uso terapêutico , Brasil , Ergocalciferóis/economia , Ergocalciferóis/uso terapêutico , Diálise Renal , Atenção à Saúde , Hiperparatireoidismo Secundário/economia , Hiperparatireoidismo Secundário/tratamento farmacológicoRESUMO
BACKGROUND: Chronic kidney disease (CKD) is a disorder with high morbidity and mortality worldwide whose complications generate multiple costs. In Ecuador, only a few healthcare institutions have implemented management protocols aimed to reduce costs and to improve the quality of life of patients. The aim of this study is to evaluate the short-term (1-year) and long-term (5-year) costs and savings in the management of secondary hyperparathyroidism (SHPT) of hemodialyzed CKD patients by comparing calcitriol and paricalcitol in a large social security hospital in Quito, Ecuador. METHODS: The estimation model assessed the resources used in the management of SHPT by comparing prospectively the cost savings within 1-year and 5-year time horizon with calcitriol and paricalcitol. Hospitalization, erythropoietin (EPO), treatment doses, intravenous iron consumption, and medical supplies were estimated according international references, based on the initial parathormone level (iPTH) of patients. The Ecuadorian National Reference costs (2014-2015) and institutional costs were used to calculate treatment costs. A statistical sensitivity analysis was also performed. RESULTS: The study was based on data from 354 patients of whom 147 (41.4 %) had a value of iPTH in the range 300-600 pg/ml, 45 (12.8 %) in the range 601-800 pg/ml, and 162 (45.7 %) over 800 pg/ml. The 1-year estimated costs per patient for calcitriol and paricalcitol, respectively, were: medication, 63.88 USD and 1,123.44 USD; EPO, 19,522.95 USD and 16,478 USD; intravenous iron 143.21 USD and 187.76 USD. Yearly hospitalization costs per patient were 11,647.99 USD with calcitriol and 8,019.41 USD with paricalcitol. Total yearly costs per patient amounted to 31,378.02 USD with calcitriol and 25,809.50 USD with paricalcitol. Total savings using paricalcitol were 5,568.52 USD per patient compared with calcitriol. The 5-year cumulative medication costs were 319 USD for calcitriol and 2,403 USD for paricalcitol; EPO with calcitriol was 97,615 USD and with paricalcitol 82,394 USD; intravenous iron with calcitriol was 716 USD and paricalcitol 939 USD. Hospitalization costs for patients with calcitriol and paricalcitol were 43,095 USD and 62,595 USD, respectively. Total savings using paricalcitol amounted 32,414 USD per patient compared with calcitriol. CONCLUSIONS: Paricalcitol use generated more cost savings than calcitriol after 1 and 5 years.
Assuntos
Orçamentos , Hiperparatireoidismo Secundário/tratamento farmacológico , Hiperparatireoidismo Secundário/economia , Falência Renal Crônica , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/economia , Calcitriol/administração & dosagem , Calcitriol/economia , Custos e Análise de Custo , Custos de Medicamentos , Equador , Ergocalciferóis/administração & dosagem , Ergocalciferóis/economia , Feminino , Hospitalização/economia , Humanos , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Qualidade de Vida , Diálise Renal , Estudos RetrospectivosRESUMO
Objective Hypocalcaemia is a frequently arising complication following total thyroidectomy. Routine postoperative prophylactic administration of vitamin D or metabolites and calcium reduce the incidence of symptomatic hypocalcaemia; this article reports evaluating its cost-effectiveness in Colombia. Methods Meta-analysis was used for comparing the administration of vitamin D or metabolites to oral calcium or no treatment at all in patients following total thyroidectomy and a cost-effectiveness analysis was designed based on a decision-tree model with local costs. Results The OR value for the comparison between calcitriol and calcium compared to no treatment and to exclusive calcium treatment groups was 0.32 (0.13-0.79 95 %CI) and 0.31 (0.14-0.70 95 %CI), respectively. The most cost-effective strategy was vitamin D or metabolites and calcium administration, having a US $0.05 incremental cost-effectiveness ratio. Conclusion Prophylactic treatment of hypocalcaemia with vitamin D or metabolites + calcium or calcium alone is a cost-effective strategy.
Objetivos La hipo calcemia es la complicación más frecuente después de tiroidectomía. La administración profiláctica de vitamina D o metabolitos y calcio reduce la incidencia de hipocalcémia sintomática. Se evalúa su costo-efectividad en Colombia. Materiales y métodos Utilizamos la información de un meta-análisis que comparó la administración de vitamina D o metabolitos contra calcio no tratamiento en pacientes llevados a tiroidectomía total y diseñamos un análisis de costo-efectividad basados en un modelos de decisiones con costos locales. Resultados El valor del OR para la comparación entre calcitriol y calcio comparado con no tratamiento o calcio exclusivo fue de 0.32 (95 % IC, 0.13- 0.79) y 0.31 (95 % IC, 0.14-0.70), respectivamente. La estrategia más costo-efectiva fue la administración de vitamina D o metabolitos y calcio, con una relación de costo-efectividad incremental de US $0.05. Conclusiones El tratamiento profiláctico de la hipo calcemia con vitamina D o metabolitos y calcio o calcio exclusivo después de tiroidectomía total es una estrategia costo-efectiva.
Assuntos
Humanos , Calcitriol/uso terapêutico , Carbonato de Cálcio/uso terapêutico , Gluconato de Cálcio/uso terapêutico , Hipocalcemia/prevenção & controle , Cuidados Pós-Operatórios/economia , Complicações Pós-Operatórias/prevenção & controle , Tireoidectomia , Calcitriol/administração & dosagem , Calcitriol/economia , Carbonato de Cálcio/administração & dosagem , Carbonato de Cálcio/economia , Gluconato de Cálcio/administração & dosagem , Gluconato de Cálcio/economia , Cálcio/sangue , Colômbia , Análise Custo-Benefício , Árvores de Decisões , Custos de Medicamentos , Emergências/economia , Hipocalcemia/economia , Hipocalcemia/epidemiologia , Hipocalcemia/etiologia , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/tratamento farmacológico , Complicações Pós-Operatórias/etiologia , Probabilidade , Tetania/epidemiologia , Tetania/etiologia , Tetania/prevenção & controleRESUMO
OBJECTIVE: Hypocalcaemia is a frequently arising complication following total thyroidectomy. Routine postoperative prophylactic administration of vitamin D or metabolites and calcium reduce the incidence of symptomatic hypocalcaemia; this article reports evaluating its cost-effectiveness in Colombia. METHODS: Meta-analysis was used for comparing the administration of vitamin D or metabolites to oral calcium or no treatment at all in patients following total thyroidectomy and a cost-effectiveness analysis was designed based on a decision-tree model with local costs. RESULTS: The OR value for the comparison between calcitriol and calcium compared to no treatment and to exclusive calcium treatment groups was 0.32 (0.13-0.79 95 %CI) and 0.31 (0.14-0.70 95 %CI), respectively. The most cost-effective strategy was vitamin D or metabolites and calcium administration, having a US $0.05 incremental cost-effectiveness ratio. CONCLUSION: Prophylactic treatment of hypocalcaemia with vitamin D or metabolites + calcium or calcium alone is a cost-effective strategy.