Cost-utility analysis of adjunct repetitive transcranial magnetic stimulation for treatment resistant bipolar depression.

OBJECTIVE: To evaluate the cost-effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an adjunct to standard care from an Australian health sector perspective, compared to standard care alone for adults with treatment-resistant bipolar depression (TRBD). METHODS: An economic model was developed to estimate the cost per disability-adjusted life-year (DALY) averted and quality-adjusted life-year (QALY) gained for rTMS added to standard care compared to standard care alone, for adults with TRBD. The model simulated the time in three health states (mania, depression, residual) over one year. Response to rTMS was sourced from a meta-analysis, converted to a relative risk and used to modify the time in the depressed state. Uncertainty and sensitivity tested the robustness of results. RESULTS: Base-case incremental cost-effectiveness ratios (ICERs) were $72,299 per DALY averted (95 % Uncertainty Interval (UI): $60,915 to $86,668) and $46,623 per QALY gained (95 % UI: $39,676 - $55,161). At a willingness to pay (WTP) threshold of $96,000 per DALY averted, the base-case had a 100 % probability of being marginally cost-effective. At a WTP threshold of $64,000 per QALY gained, the base-case had a 100 % probability of being cost-effective. Sensitivity analyses decreasing the number of sessions provided, increasing the disability weight or the time spent in the depression state for standard care improved the ICERs for rTMS. CONCLUSIONS: Dependent on the outcome measure utilised and assumptions, rTMS would be considered a very cost-effective or marginally cost-effective adjunct to standard care for TRBD compared to standard care alone.

Cross-sectional analysis of pharmaceutical industry payments to authors of clinical practice guidelines for bipolar disorder and major depressive disorder in Japan.

OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan. METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020. RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs. CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

Trastorno bipolar: garantías explícitas de salud e implicancias para enfermería / Bipolar disorder: explicit guarantees of health and implications for nursing

El trastorno afectivo bipolar es una enfermedad mental grave catalogada dentro de los trastornos del ánimo en el DSM 5. En el año 2013, se incorpora a la lista de los problemas de salud incluidos en las Garantías Explícitas de Salud GES, siendo un avance importante en relación a los principios que sustentan el sistema y la reforma de salud en Chile. Se realiza una reflexión crítica de la canasta GES a la luz de los componentes del sistema de Salud chileno, destacando el rol fundamental que tiene el enfermero/a psiquiátrico en la implementación de las prestaciones y recomendaciones. Finalmente, se destaca la importancia de la participación en la micro, meso y macrogestión para la profesión.

Bipolar disorder is a serious mental illness cataloged within of mood disorders in DMS 5. In 2013, it has incorporated to the list of health problems included in the explicit guarantees of health (GES), which it was an important advance in relation to the values that underpin reform and system of health in Chile. It is performed a critical reflection of the set of service GES and its relation with the components of the Chilean health system, highlighting the fundamental role that psychiatric nurses have in the implementation of the services and recomendations. Finally, it highlights the importance pf the participation in the micro, meso and macromanagement to the profession.

I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes / I Registro Brasileiro de Insuficiência Cardíaca – Aspectos Clínicos, Qualidade Assistencial e Desfechos Hospitalares

Background: Heart failure (HF) is one of the leading causes of hospitalization in adults in Brazil. However, most of the available data is limited to unicenter registries. The BREATHE registry is the first to include a large sample of hospitalized patients with decompensated HF from different regions in Brazil. Objective: Describe the clinical characteristics, treatment and prognosis of hospitalized patients admitted with acute HF. Methods: Observational registry study with longitudinal follow-up. The eligibility criteria included patients older than 18 years with a definitive diagnosis of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators, hemodynamic profile and intrahospital events. Results: A total of 1,263 patients (64±16 years, 60% women) were included from 51 centers from different regions in Brazil. The most common comorbidities were hypertension (70.8%), dyslipidemia (36.7%) and diabetes (34%). Around 40% of the patients had normal left ventricular systolic function and most were admitted with a wet-warm clinical-hemodynamic profile. Vasodilators and intravenous inotropes were used in less than 15% of the studied cohort. Care quality indicators based on hospital discharge recommendations were reached in less than 65% of the patients. Intrahospital mortality affected 12.6% of all patients included. Conclusion: The BREATHE study demonstrated the high intrahospital mortality of patients admitted with acute HF in Brazil, in addition to the low rate of prescription of drugs based on evidence. .

Fundamento: A insuficiência cardíaca (IC) é uma das principais causas de hospitalização em adultos no Brasil, no entanto a maioria dos dados disponíveis é limitada a registros unicêntricos. O registro BREATHE é o primeiro a incluir uma ampla amostra de pacientes hospitalizados com IC descompensada de diferentes regiões do Brasil. Objetivo: Descrever as características clínicas, tratamento e prognóstico intra-hospitalar de pacientes admitidos com IC aguda. Métodos: Estudo observacional tipo registro, com seguimento longitudinal. Os critérios de elegibilidade incluíram pacientes acima de 18 anos com diagnóstico definitivo de IC, admitidos em hospitais públicos ou privados. Os desfechos avaliados incluíram causas de descompensação, uso de medicações, indicadores de qualidade assistencial, perfil hemodinâmico e eventos intra-hospitalares. Resultados: O total de 1.263 pacientes (64 ± 16 anos, 60% mulheres) foi incluído a partir de 51 centros de diferentes regiões do Brasil. As comorbidades mais comuns foram hipertensão arterial (70,8%), dislipidemia (36,7%) e diabetes (34%). Em torno de 40% dos pacientes apresentavam função sistólica do ventrículo esquerdo normal e a maioria foi admitida com perfil clínico-hemodinâmico quente-úmido. Vasodilatadores e inotrópicos endovenosos foram administrados a menos de 15% da amostra estudada. Indicadores de qualidade assistencial baseados nas orientações de alta hospitalar foram atingidos em menos de 65% dos pacientes. A mortalidade intra-hospitalar afetou 12,6% do total dos pacientes incluídos. Conclusão: O estudo BREATHE demonstrou a alta mortalidade intra-hospitalar dos pacientes admitidos com IC aguda no Brasil, somada à baixa taxa de prescrição de medicamentos baseados em evidências. .

Análisis del coste de las reacciones adversas del tratamiento del trastorno bipolar con aripiprazol y olanzapina en España / Cost analysis of the adverse reactions of bipolar disorder treatment with aripiprazole and olanzapine in Spain

Objetivo: Estimar el coste de las reacciones adversas (RA) al tratamiento del trastorno bipolar con dos antipsicóticos atípicos orales (AAO): aripiprazol (ARI) y olanzapina (OLA). Métodos: Se efectuó un análisis de costes, mediante unmodelo de Markov, considerándose los siguientes estados: sin RA (SRA), síntomas extrapiramidales (SEP), ganancia de peso (GP) y disfunción sexual (DS). Las probabilidades de transición entre los estados se calcularon a partir de metaanálisis de ensayos clínicos y de un estudio retrospectivo español. Los costes de cada estado de salud, se obtuvieron de un estudio español publicado. Se utilizaron los costes mínimos de adquisición por mg de la dosis media diaria, para cada AAO, considerado como un criterio relevante de eficiencia por los Servicios de Farmacia Hospitalaria. El horizonte temporal aplicado en el análisis fue de 12 meses. Se hicieron análisis probabilísticos para todas las variables del análisis, mediante simulaciones de Monte Carlo. Todos los costes se actualizaron a euros (Euros) de 2013, conforme al índice de precios sanitarios. Resultados: En comparación con OLA, el tratamiento con ARI generaría unos ahorros anuales medios por paciente de 289 Euros (IC95% 271; 308 Euros). En el caso hipotético de que ARI tuviera unas tasas de disfunción sexual similares a las de quetiapina (la menor tasa de los AAO) los gastos adicionales anuales medios por paciente ascenderían a 323 Euros (IC95%330; 317 Euros). Conclusión: Los resultados de este análisis muestran que los pacientes tratados con aripiprazol tienen menos reacciones adversas, en comparación con olanzapina. Esta diferencia puede generar ahorros significativos para el Sistema Nacional de Salud en el tratamiento del trastorno bipolar. La estabilidad de los resultados fue evaluada mediante análisis probabilísticos

Objective: This study investigates the healthcare costs of adverse events (AE) associated with treatment of bipolar disorder with two atypical oral antipsychotics (AOA): aripiprazole (ARI) and olanzapine (OLA). Methods: A cost analysis using a Markov model considering the following health states was performed: no existence of adverse events (NAE); extrapyramidal symptoms (EPS); weight gain (WG); and sexual dysfunction (SD). Transition probabilities amongst health states were estimated from meta-analyses of clinical trials and from a retrospective Spanish study. The healthcare costs associated to each health state were obtained from a published Spanish study. The minimum acquisition cost per mg of the mean daily dose for each AOA was used. This is considered to be a relevant efficiency criterion in Hospital Pharmacy Departments. The time horizon applied in the analysis was 12 months. A probabilistic sensitivity analysis was performed for all the variables involved in the analysis with Monte Carlo simulations. All costs were updated to 2013 costs using the Spanish Health System price index. Results: In comparison with OLA, treatment with ARI generates annual average cost savings per patient of Euros 289 (CI 95% Euros 271; Euros308). In the hypothetical scenario in which we assume that ARI may have a similar rate of sexual dysfunction as that of quetiapine (i.e. the lowest rate amongst AOAs), the additional cost per patient would be Euros 323 (CI95% Euros 330; Euros 317). Conclusion: The results of this analysis show that patients treated with aripiprazole demonstrate lower adverse events costs in comparison to olanzapine. This difference may generate significant cost savings in the Spanish health system in the treatment of patients affected by bipolar disorders. The robustness of the results was tested via a probabilistic analysis

Transtorno afetivo bipolar: carga da doença e custos relacionados / Bipolar disorder: burden of disease and related costs

CONTEXTO: O transtorno afetivo bipolar (TAB) é uma doença recorrente, crônica e grave. Comorbidades psiquiátricas e físicas, aumento do risco de suicídio, maior utilização de serviços de saúde e prejuízo na esfera social/profissional aumentam significativamente a carga e custos relacionados à doença. OBJETIVOS: Revisar aspectos clínicos, de carga da doença e conseqüentes desfechos financeiros do TAB. MÉTODOS: Pesquisa de base de dados MEDLINE/PubMed utilizando os termos bipolar disorder, epidemiology, burden of disease, comorbidity, cost of illness, outcomes e financial consequences, publicados entre 1980 e 2006. RESULTADOS: O TAB apresenta alta comorbidade com outros transtornos, o que agrava seu prognóstico e eleva os custos com os serviços de saúde. Os indivíduos com TAB apresentam mais fatores de risco cardiovascular e, conseqüentemente, maior risco de morte por evento cardíaco. O atraso e o erro diagnóstico no TAB elevam consideravelmente a carga e os custos da doença. CONCLUSÕES: As comorbidades, o risco de suicídio, o prejuízo social/profissional e a baixa adesão ao tratamento contribuem para a alta carga e os custos associados à doença. A pesquisa de comorbidades pode ajudar os médicos a ajustarem suas estratégias de tratamento, considerando cuidadosamente todos os fatores de risco e custos associados, fatores estes que devem ser levados em conta também pelos profissionais que trabalham com gestão de saúde, tanto no setor privado quanto público.

BACKGROUND: Bipolar disorder (BD) is a recurrent, chronic and severe disease. Mental and physical comorbidities, risk of suicide, health services use and impairment of social and professional domains significantly worsen the burden and increase the costs of illness. OBJECTIVES: Review clinical aspects, burden of disease, and consequent financial outcomes of BD. METHODS: MEDLINE/PubMed database search using the terms bipolar disorder, epidemiology, burden of disease, comorbidity, cost of illness, outcomes e financial consequences, published in MEDLINE from 1980 to 2006. RESULTS: BD has a high rate of comorbidities, which worsen the prognosis and increase costs with health services. Subjects with BD have more cardiovascular risk factors than the general population, and therefore a higher risk of death by cardiovascular event. Delay of diagnosis and misdiagnosis increase the costs of illness. DISCUSSION: Comorbidities, risk of suicide, social and professional impairment and low adherence to treatment increase the cost of illness. The search of comorbidities may help clinicians to adjust treatment strategies, taking into account all associated risk factors and costs, which may be considered also by professionals involved in health care management, either private or public.

Análisis económico de la olanzapine en el tratamiento de la esquizofrenia y el trastorno bipolar / Economic analyses of olanzapine in the treatment of shizophrenia and bipolar disorder

La esquizofrenia es una enfermedad que genera importantes costes para la sociedad, tanto directos, derivados principalmente de la hospitalización y el tratamiento ambulatorio, como indirectos, debidos a la pérdida de productividad de los pacientes. Los antipsicóticos atípicos como la olanzapina han supuesto un avance muy importante en el tratamiento de la esquizofrenia. Su mayor coste respecto a los antipsicóticos convencionales como el baloperidol ha impulsado la realización de estudios farmacoeconómicos encaminados a evaluar su rentabilidad. En el presente trabajo se revisan las evaluaciones farmacoeconómicas completas que comparan la olanzapina con el haloperidol y la risperidona comparando olazanzapina con el haloperidol y la risperidona en el tratamiento de la esquizofrenia. Los análisis de costes comparando olanzapina y haloperidol ponen de manifiesto que la olanzapina no añade costes al tratamiento de la esquizofrenia, produciendo incluso disminución en los mismos debido fundamentalmente a una menor hospitalización. En las evaluaciones económicas que comparaban olanzapina y risperidona los resultados no son concluyentes y en general los costes totales asociados a ambos tratamientos fueron similares. En el tratamiento del trastorno bipolar; aunque las evaluaciones económicas realizadas hasta la fecha son escasas, se observó una reducción en los costes de hospitalización asociada al tratamiento con olanzapina (AU)

Schizophrenia generates important cost for society-both direct. As a consequence of hospitalization and outpatient treatment, and indirect; related to loss of productivity. The atypical antipsychotics, such as olanzapine, have supposed an important advance in the treatment of schizophrenia. The greater cost of atypical antipsychotics with respect to conventional drugs had led to the conduction of pharmacoeconomic studies to determine its efficiency. This article reviews the complete pharmacoeconomic studies that compare olanzapine with haloperidol and risperidone in the treatment of schizophrenia. Cost analyses comparing olanzapine and haloperidol show that the former drug does not add increased cost to therapy, and even contributes to lessen expenses fundamentally as a result of a decrease in hospitalizations. In the economic evaluations comparing olanzapine and risperidone, the results are not conclusive, and in general, the total cost associated with both treatment were similar. In the treatments were similar: In the treatment of bipolar disorder, although few studies have estimated the economic impact of olanzapine, it has been observed a reduction of hospitalization costs associated to the treatment with olanzapine (AU)