Costo-efectividad de dos terapias antivirales para Hepatitis B crónica en el Perú: Entecavir y tenofovir / Cost-Fffectiveness of Two Antiviral Therapies for Chronic Hepatitis B in Peru: Entecavir and Tenofovir

RESUMEN Objetivos Comparar en términos de costo-efectividad a entecavir (ETV) y tenofovir (TDF) en el tratamiento del virus de la hepatitis B (HBV) en hospitales públicos del Perú. Materiales y métodos Estructuramos un modelo de Markov, definimos la efectividad en años de vida ajustados a calidad (AVAC). Incluimos los costos directos del tratamiento en soles desde la perspectiva del Ministerio de Salud del Perú. Calculamos la relación entre costo y efectividad incrementales (ICER). Realizamos análisis de sensibilidad determinístico y probabilístico, considerando un rango de disponibilidad de pago (WTP) desde uno hasta tres veces el producto bruto interno (PBI) per-cápita, y el beneficio monetario neto (BMN) o ICER en el caso del análisis de tornado. Resultados El tratamiento con TDF es más efectivo y menos costoso que ETV. El ETV tuvo un costo por AVAC de S/ 4482, y de S/ 1526 para TDF. El TDF mantiene un BMN progresivamente mayor conforme aumenta la WTP. La tasa de descuento fue la única variable con efecto significativo en la incertidumbre del modelo. Conclusiones El tratamiento con TDF es más costo-efectivo que ETV en hospitales públicos del Perú.

ABSTRACT Objetives To compare in terms of cost-effectiveness to entecavir (ETV) and tenofovir (TDF) in the treatment of hepatitis B virus (HBV) in public hospitals in Peru. Materials and methods We structured a Markov model. We define effectiveness adjusted life years for quality (QALY). We include the direct costs of treatment in soles from the perspective of the Ministry of Health of Peru. We estimate the relationship between cost and effectiveness ratios (ICER). We performed sensitivity analyzes considering a range of willingness to pay (WTP) from one to three times the Gross Domestic Product (GDP) per capita, and a tornado analysis regarding Monetary Net Profit (BMN) or ICER. Results Treatment with TDF is more effective and less expensive than ETV. The ETV had a cost per QALY of PEN 4482, and PEN 1526 TDF. The PTO maintains a progressively larger with increasing WTP BMN. The discount rate was the only variable with a significant effect on model uncertainty. Conclusion Treatment with TDF is more cost-effective than ETV in public hospitals in Peru.

Cost-Effectiveness and Clinical Impact of Antiviral Strategies of HBeAG-Positive and Negative Chronic Hepatitis B

ABSTRACT Introduction. Chronic hepatitis B (CHB) is associated with high burden and healthcare costs. Virologic response achieved with antivirals is associated with progression avoidance. This study aimed to estimate the efficiency and clinical impact of antiviral strategies in CHB patients. Material and methods. A Markov model estimated lifetime complications and direct costs in both, HBeAg-positive and HBeAg-negative cohorts. Strategy 1 (71% of treated population) and strategy 2 (100%), both based on pegylated interferon (peg-IFN) followed by oral tenofovir or entecavir, were compared to no treatment. Progression was based on HBV-DNA levels. Rescue therapy with oral antivirals was applied for peg-IFN failure. Disease costs (€, 2014) and utilities were obtained from literature. Results. Compared to natural history, strategy 1 increased QALY (3.98 in HBeAg-positive, 2.16 in -negative cohort). With strategy 2, survival was up to 5.60 (HBeAg-positive) and 3.05 QALY (in HBeAg-negative). The model predicted avoidance of 128 and 86 carcinomas in HBeAg-positive and -negative patients with strategy 1, and up to 181 and 121 in HBeAg-positive and -negative for strategy 2. Total cost increased up to €102,841 (strategy 1) and €105,408 (strategy 2) in HBeAg-positive, and €85,858 and €93,754 in HBeAg-negative. A€1,581/QALY gained ratio was estimated versus the natural history for both strategies. In conclusion, increasing antiviral coverage would be efficient, reducing complications.

Evaluación económica del tratamiento de la Hepatitis B crónica en la Provincia de Misiones / Economic Evaluation of Treatment of Chronic Hepatitis B in the Province of Misiones

La infección crónica por hepatitis B representa una importante carga sanitaria en el mundo y en Argentina. Existen varias estrategias terapéuticas, cuyo objetivo es reducir la carga viral. OBJETIVO: Evaluar la costo-efectividad de las diferentes estrategias de tratamiento, tanto en pacientes positivos como negativos al antígeno e de hepatitis B (HBeAg). MÉTODOS: Se utilizó un modelo de decisión determinístico, que contempló los principales estados de salud asociados al virus de la hepatitis B desde la perspectiva del sistema de seguridad social de Misiones en un lapso de 10 años. Se recabaron los costos de las drogas, de los eventos clínicos y sus complicaciones. Se efectuaron diversos análisis de sensibilidad de una vía para evaluar la incertidumbre. RESULTADOS: El tratamiento con monoterapia de tenofovir se asoció con menores costos y mayor eficacia. Esto se demostró tanto en pacientes positivos como negativos al HBeAg, donde se observó un ahorro, con un costo inferior a un producto bruto interno per cápita por año de vida ajustado por calidad y tasa de costo-efectividad incremental dominante en ambos escenarios. Los análisis de sensibilidad confirmaron los valores del escenario base (con el costo del tenofovir como variable de mayor influencia). CONCLUSIONES: El tratamiento con tenofovir resultó ser relativamente ahorrativo en términos de costos. Estos modelos podrían facilitar la toma de decisiones por parte de las autoridades de salud pública de Misiones...

Chronic infection by hepatitis B is a serious health burden worldwide and in Argentina.There are several therapeutic strategies aiming at reducing the viral load. OBJECTIVE: To evaluate the cost-effectiveness of different treatment strategies, both in hepatitis B e antigen (HBeAg)-positive and -negative patients. METHODS: A deterministic decision model was used, which considered the main health outcomes associated with hepatitis B virus from the perspective of social security system of the province of Misiones in a 10-year term. The study collected data about costs of drugs, clinical events and complications. Several one-way sensitivity analyses were performed to evaluate uncertainty. RESULTS: Treatment with Tenofovir monotherapy was associated with lower costs and higher efficacy. This was proved both in HBeAg-positive and -negativepatients, since Tenofovir treatment was cost-saving,with a cost lower than one gross domestic product per capita per quality-adjusted life year, being the incremental cost-effectiveness rate strategy dominant in both scenarios. Sensitivity analyses confirmed the values of the baselin escenario and showed that the most influential parameterwas Tenofovir cost. CONCLUSIONS: Tenofovir treatment proved to be relatively cost-saving. These models may beuseful for the decision-making by public health authoritiesin the province of Misiones...

Custo-efetividade dos análogos de nucleosídeos/nucleotídeos para hepatite crônica B / Cost-effectiveness of nucleoside/nucleotide analogues in chronic hepatitis B / Costo-efectividad de los análogos de nucleósidos/nucleótidos para hepatitis crónica B

.

OBJECTIVE: To conduct a cost-effectiveness analysis of drug alternatives with rescue therapy in case of relapse due to viral resistance for the treatment of patients with chronic hepatitis B (CHB). METHODS: Hypothetical cohort of patients with CHB, HBeAg-negative, without clinical or histological evidence of cirrhosis, detectable HBV DNA, histological diagnosis of the disease, positive serum HBsAg for longer than six months, high levels of alanine aminotransferase (ALT) (twice as high as the upper limit of normality) and mean age of 40 years. A Markov model was developed for chronic hepatitis B (HBeAg- negative) with a 40-year time horizon. Costs and benefits were discounted at 5%. Annual rates of disease progression, costs due to complications and the efficacy of medicines were obtained from the literature. One-way and probabilistic sensitivity analysis evaluated uncertainties. RESULTS: Initiation of treatments with entecavir resulted in an increase of 0.35 discounted life-years gained compared to lamivudine. The incremental cost-effectiveness ratio was R$16,416.08 per life-years gained. In the sensitivity analysis, the incremental cost-effectiveness ratio was more sensitive to variation in the probability of transition from chronic hepatitis B to compensated cirrhosis, discount rate and medicine prices (± 10%). In the probabilistic sensitivity analysis, the acceptability curve showed that beginning treatment with entecavir was the most cost-effective alternative in comparison with the use of lamivudine. CONCLUSIONS: The availability of entecavir is economically attractive as part of early treatment for patients with chronic hepatitis B without HIV co-infection.

.

Cost-effectiveness of telbivudine versus lamivudine for chronic hepatitis B

BACKGROUND AND AIM: Chronic hepatitis B is a highly prevalent disease worldwide, leading to serious consequences if not properly treated. Six treatment options for chronic hepatitis B are currently provided by the Brazilian public health system. Telbivudine is a nucleoside analogue that is neither included in the Brazilian clinical protocol nor in the therapeutic guidelines for chronic hepatitis B. OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of telbivudine for the viewpoint of the Brazilian public system, comparing it to lamivudine. METHODS: A Markov model was used to project lifetime complications and costs of treatment with lamivudine or telbivudine for chronic hepatitis B in both HBeAg-positive and HBeAg-negative patients. To evaluate disease progression, probabilities and utilities of virologic response, virologic resistance, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, treatment, interruption of treatment, death and seroconversion were collected in systematic reviews. Costs were collected in DATASUS, ABC da Saúde and scientific literature. RESULTS: Higher rate of virologic response and seroconversion was obtained with telbivudine, and also higher values of quality adjusted life years. However lamivudine is associated with lower costs and also lower cost-effectiveness values. The incremental cost-effectiveness ratios for telbivudine, when compared with lamivudine, were US$ 30,575 and US$ 40,457, respectively for HBeAg-positive and HBeAg-negative patients. CONCLUSION: In chronic hepatitis B lamivudine is a more cost-effective or even cost-saving strategy when compared with telbivudine.

Cost-effectiveness of entecavir versus lamivudine for the suppression of viral replication in chronic hepatitis B patients in Brazil

Hepatitis B virus infection is an important public-health issue. Chronic patients have a higher risk of death due to complications, which increases health-care expenses in. Cost-effectiveness analysis of entecavir (ETV) versus lamivudine (LVD) for treatment of chronic hepatitis B, in e antigen (AgHBe)-positive and negative patients, based on two phase 3, controlled and randomized studies. A decision analysis model was developed, using the following endpoints: cost per patient with undetectable viral load and cost per quality life year (QALY) gained. Risks for complications (compensated or decompensated cirrhosis and hepatocellular carcinoma) were based on the cohort study REVEAL, published in 2006. The REVEAL parameters were applied to the results of the viral load levels obtained from the clinical assay data. The complication costs were based on a study of the disease cost conducted in Brazil, in 2005. The cost data were obtained predominantly from Sistema Único de Saúde [SUS - Brazilian public health system] payment tables and drug price lists. The utility data were obtained from literature and life expectancy information was based on IBGE data. The analysis perspective was that of SUS. A discount rate of 3 percent per year was used. For the horizon of time of 10 years, the ETV had an incremental cost of approximately two million Brazilian Reais (R$) compared to LVD. Reducing the number of complications, ETV treatment reduced costs by around 3 million, reducing final costs by 1 million, for AgHBe-positive patients. ETV also reduced the incremental cost per QALY gained. ETV was found to be the most cost-effective alternative for AgHBe-positive and negative patients.

Problems faced by Korean patients with chronic liver disease and the role of the Korean Association for the Study of the Liver: Emphases on social discrimination, insufficiency of reimbursement coverage, and deficiency of the welfare system / 대한간학회지

No abstract available.

Estimativas de custo da hepatite crônica B no sistema único de saúde Brasileiro em 2005 / Cost estimates of chronic hepatitis B virus for the Brazilian unified health system in 2005

OBJETIVO: O objetivo deste estudo foi estimar o padrão de tratamento, a utilização de recursos e os gastos para cada estágio da HCVB, no ambiente do Sistema Único de Saúde (SUS) do Brasil, no ano 2005. MÉTODOS: Foi desenvolvido painel Delphi de especialistas para obter informação sobre o padrão de tratamento da HCVB no Brasil. Os dados foram coletados com dez médicos especialistas em hepatologia e doenças infecciosas. A valoração dos recursos foi obtida predominantemente das tabelas de pagamentos do Sistema Único de Saúde e tabelas de preços de medicamentos. As estimativas de custo tiveram a perspectiva do pagador público. Os dados foram analisados estatisticamente pelo programa SPSS 12.0 para Windows. RESULTADOS: Os gastos estimados dos pacientes foram separados em cada estágio da HCVB. O gasto estimado anual por paciente foi: R$ 980,89 para hepatite B crônica, sem cirrose e sem tratamento antiviral; R$ 1.243,17 para cirrose compensada sem tratamento antiviral; R$ 22.022,61 para cirrose descompensada; R$ 4.764,95 para o carcinoma hepatocelular; e R$ 87.372,60 para o transplante hepático. CONCLUSÃO: Os gastos estimados com procedimentos e medicamentos, excluindo antivirais, representaram os principais componentes do gasto da HCVB. Neste modelo, os gastos aumentam dramaticamente nos estágios mais avançados, sugerindo que retardar a progressão da doença poderá reduzir o gasto no longo prazo.

BACKGROUD: Chronic Hepatitis B Virus (CHBV) is a disease that places a large financial burden on healthcare systems and society. OBJECTIVE: The aim of this study was to estimate patient management patterns, and associated medical resource utilization and expenses, for each of the four stages of chronic HBV infection in the public unified healthcare system settings, in 2005. METHODS. An expert panel comprised of ten physicians, leading specialists in hepathology and infectious diseases, was convened to obtain information regarding management of CHBV patients in Brazil. Expense inputs were mainly obtained from government fee schedules and pharmaceutical price tables. Costs were estimated under the perspective of the public health system. Data were analyzed using Windows SPSS version 12.0. RESULTS: Estimated patient expenses were calculated for the four stages of CHBV infection. The estimated annual expenses per patient were: R$ 980.89 (US$ 392) for chronic hepatitis B with no cirrhosis and without antiviral therapy; R$ 1,243.17 (US$ 496) for compensated cirrhosis without antiviral therapy; R$ 22,022.61 (US$ 8809) for decompensated cirrhosis; R$ 4,764.95 (US$ 1,905) for hepatocellular carcinoma; and R$ 87,372.60 (US$ 34,948) for liver transplant. CONCLUSION: Estimated expenses associated with drugs and procedures represented the main components of the expenses of CHBV infection. In this model, expenses increase dramatically as the disease progresses to more advanced stages, suggesting that over the long term delaying progression may reduce costs.