RESUMO
Congress passed the Biologic Price Competition and Innovation Act of 2009, specifically to offer market competition as a counterweight to the rising costs of biologic medicines. As of April 15, 2024, 49 biosimilars have been approved by the US Food and Drug Administration in 15 biologic categories. Biosimilar competition has been undeniably successful: Through 2022, biosimilars have saved the US health system $23.6 billion, without significant care disruption or reduced quality. Through 2023, adalimumab biosimilar competition has added an additional $6.5 billion to this total, primarily through greater rebates from the reference manufacturer. Despite launching at discounts as great as 85%, adalimumab biosimilars have not been given preferred formulary positioning in the vast majority of cases and have thus gained only 3% of market share through 2023, largely because of payers' and pharmacy benefit managers' preference for rebates over discounts. This situation may negatively influence future biosimilar development, posing a threat to a biosimilar pipeline that represents hundreds of billions in savings over the next 10 years.
Assuntos
Medicamentos Biossimilares , Competição Econômica , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Humanos , Estados Unidos , Custos de Medicamentos , United States Food and Drug Administration , Adalimumab/economia , Adalimumab/uso terapêutico , Seguro de Serviços Farmacêuticos/economia , Aprovação de DrogasRESUMO
OBJECTIVE: To analyze the variation in the proportion of households living below the poverty line in Brazil and the factors associated with their impoverishment. METHODS: Income and expenditure data from the Household Budget Survey, which was conducted in Brazil between 2002-2003 (n = 48,470 households) and 2008-2009 (n = 55,970 households) with a national sample, were analyzed. Two cutoff points were used to define poverty. The first cutoff is a per capita monthly income below R$100.00 in 2002-2003 and R$140.00 in 2008-2009, as recommended by the Bolsa Família Program. The second, which is proposed by the World Bank and is adjusted for purchasing power parity, defines poverty as per capita income below US$2.34 and US$3.54 per day in 2002-2003 and 2008-2009, respectively. Logistic regression was used to identify the sociodemographic factors associated with the impoverishment of households. RESULTS: After subtracting health expenditures, there was an increase in households living below the poverty line in Brazil. Using the World Bank poverty line, the increase in 2002-2003 and 2008-2009 was 2.6 percentage points (6.8%) and 2.3 percentage points (11.6%), respectively. Using the Bolsa Família Program poverty line, the increase was 1.6 (11.9%) and 1.3 (17.3%) percentage points, respectively. Expenditure on prescription drugs primarily contributed to the increase in poor households. According to the World Bank poverty line, the factors associated with impoverishment include a worse-off financial situation, a household headed by an individual with low education, the presence of children, and the absence of older adults. Using the Bolsa Família Program poverty line, the factors associated with impoverishment include a worse-off financial situation and the presence of children. CONCLUSIONS: Health expenditures play an important role in the impoverishment of segments of the Brazilian population, especially among the most disadvantaged.
Assuntos
Financiamento Pessoal/economia , Renda , Seguro de Serviços Farmacêuticos/economia , Pobreza/economia , Medicamentos sob Prescrição/economia , Adulto , Brasil , Estudos Transversais , Características da Família , Feminino , Necessidades e Demandas de Serviços de Saúde , Humanos , Masculino , Fatores SocioeconômicosRESUMO
OBJECTIVE To analyze the variation in the proportion of households living below the poverty line in Brazil and the factors associated with their impoverishment. METHODS Income and expenditure data from the Household Budget Survey, which was conducted in Brazil between 2002-2003 (n = 48,470 households) and 2008-2009 (n = 55,970 households) with a national sample, were analyzed. Two cutoff points were used to define poverty. The first cutoff is a per capita monthly income below R$100.00 in 2002-2003 and R$140.00 in 2008-2009, as recommended by the Bolsa Família Program. The second, which is proposed by the World Bank and is adjusted for purchasing power parity, defines poverty as per capita income below US$2.34 and US$3.54 per day in 2002-2003 and 2008-2009, respectively. Logistic regression was used to identify the sociodemographic factors associated with the impoverishment of households. RESULTS After subtracting health expenditures, there was an increase in households living below the poverty line in Brazil. Using the World Bank poverty line, the increase in 2002-2003 and 2008-2009 was 2.6 percentage points (6.8%) and 2.3 percentage points (11.6%), respectively. Using the Bolsa Família Program poverty line, the increase was 1.6 (11.9%) and 1.3 (17.3%) percentage points, respectively. Expenditure on prescription drugs primarily contributed to the increase in poor households. According to the World Bank poverty line, the factors associated with impoverishment include a worse-off financial situation, a household headed by an individual with low education, the presence of children, and the absence of older adults. Using the Bolsa Família Program poverty line, the factors associated with impoverishment include a worse-off financial situation and the presence of children. CONCLUSIONS Health expenditures play an important role in the impoverishment of segments of the Brazilian population, especially among the most disadvantaged. .
OBJETIVO Analisar a variação na proporção de domicílios vivendo abaixo da linha de pobreza no Brasil e os fatores associados ao empobrecimento. MÉTODOS Foram analisados os dados de despesa e renda das Pesquisas de Orçamentos Familiares conduzidas no Brasil em 2002-2003 (n = 48.470 domicílios) e 2008-2009 (n = 55.970 domicílios) com amostra representativa nacional. Foram utilizados dois pontos de corte para definir pobreza. O primeiro, recomendado pelo Programa Bolsa-Família, considerou pobreza rendimento per capita mensal inferior a R$100,00 em 2002-2003 e a R$140,00 em 2008-2009. O segundo, proposto pelo Banco Mundial, incorpora a correção pela paridade do poder de compra, resultando em US$2,34 por dia, em 2002-2003, e US$3,54, em 2008-2009. Para identificar os fatores sociodemográficos associados ao empobrecimento dos domicílios foi utilizada regressão logística. RESULTADOS Houve acréscimo de domicílios vivendo abaixo da linha de pobreza no Brasil após subtração dos gastos em saúde. Considerando-se a linha de pobreza recomendada pelo Banco Mundial, em 2002-2003 o acréscimo foi 2,6 pontos percentuais (ou 6,8%) e, em 2008-2009, 2,3 pontos percentuais (ou 11,6%). Considerando-se a linha de pobreza utilizada pelo Programa Bolsa-Família, a variação foi 1,6 (11,9%) e 1,3 (17,3%), respectivamente. Gastos com medicamentos foram os que mais contribuíram para o aumento de domicílios pobres. Os fatores associados ao empobrecimento, segundo a linha de pobreza do Banco Mundial, foram apresentar pior situação econômica, ser chefiado por indivíduo com baixa escolaridade, presença de crianças e ausência de idosos. Utilizando-se a linha de pobreza do Bolsa-Família, os fatores associados foram apresentar pior situação econômica e presença de crianças. ...
Assuntos
Adulto , Feminino , Humanos , Masculino , Financiamento Pessoal/economia , Renda , Seguro de Serviços Farmacêuticos/economia , Pobreza/economia , Medicamentos sob Prescrição/economia , Brasil , Estudos Transversais , Características da Família , Necessidades e Demandas de Serviços de Saúde , Fatores SocioeconômicosRESUMO
The article conceptualizes the pharmaceutical pricing and reimbursement policies related to financial coverage in the context of health systems. It introduces the pharmaceutical market as an imperfect one, in which appropriate regulation is required. Moreover, the basis that guide the pricing and reimbursement processes are defined and described in order to generate a categorization based on whether they are intended to assess the 'added value' and if the evaluation is based on cost-effectiveness criteria. This framework is used to review different types of these policies applied in the international context, discussing the role of the Health Technology Assessment in these processes. Finally, it briefly discusses the potential role of these types of policies in the Chilean context.
Assuntos
Custos de Medicamentos , Indústria Farmacêutica/economia , Reembolso de Seguro de Saúde/economia , Seguro de Serviços Farmacêuticos/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Custos e Análise de Custo/economia , HumanosRESUMO
The article conceptualizes the pharmaceutical pricing and reimbursement policies related to financial coverage in the context of health systems. It introduces the pharmaceutical market as an imperfect one, in which appropriate regulation is required. Moreover, the basis that guide the pricing and reimbursement processes are defined and described in order to generate a categorization based on whether they are intended to assess the 'added value' and if the evaluation is based on cost-effectiveness criteria. This framework is used to review different types of these policies applied in the international context, discussing the role of the Health Technology Assessment in these processes. Finally, it briefly discusses the potential role of these types of policies in the Chilean context.
Assuntos
Humanos , Custos de Medicamentos , Indústria Farmacêutica/economia , Reembolso de Seguro de Saúde/economia , Seguro de Serviços Farmacêuticos/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Custos e Análise de Custo/economiaRESUMO
AIM: To determine the impact of health insurance and the government's Benefit Service Scheme, a system that provides free drugs to treat mostly chronic illnesses to persons aged 16 to 65 years, on the use of herbal remedies by Christian churchgoers in Barbados. METHODS: The eleven parishes of Barbados were sampled over a six-week period using a survey instrument developed and tested over a four-week period prior to administration. Persons were asked to participate and after written informed consent, they were interviewed by the research team. The data were analysed by the use of IBM SPSS version 19. The data were all nominal, so descriptive statistics including counts, the frequencies, odds ratios and percentages were calculated. RESULTS: More than half of the participants (59.2%) were female, a little less than a third (29.9%) were male, and one tenth of the participants (10.9%) did not indicate their gender The majority of the participants were between the ages of 41 and 70 years, with the age range of 51-60 years comprising 26.1% of the sample interviewed. Almost all of the participants were born in Barbados (92.5%). Approximately 33% of the respondents indicated that they used herbal remedies to treat various ailments including chronic conditions. The odds ratio of persons using herbal remedies and having health insurance to persons not using herbal remedies and having health insurance is 1.01 (95% CI 0.621, 1.632). There was an increase in the numbers of respondents using herbal remedies as age increased. This trend continued until the age group 71-80 years which showed a reduction in the use of herbal remedies, 32.6% of respondents compared with 38.3% of respondents in the 61-70-year category. CONCLUSIONS: The data demonstrated that only a third of the study population is using herbal remedies for ailments. Health insurance was not an indicator neither did it influence the use of herbal remedies by respondents. The use of herbal remedies may not be associated with affluence. The reduction in the use of herbal remedies in the age group 71-80 years could be due to primarily a lower response rate from this age group, and secondarily due to the Benefit Service Scheme offering free medication to persons who have passed the age of 65 years.
Assuntos
Cristianismo , Seguro Saúde , Seguro de Serviços Farmacêuticos , Preparações de Plantas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Barbados , Uso de Medicamentos , Feminino , Humanos , Seguro Saúde/economia , Seguro de Serviços Farmacêuticos/economia , Masculino , Pessoa de Meia-Idade , Religião e MedicinaRESUMO
PROBLEM: As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure. APPROACH: To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico's list of essential medicines. LOCAL SETTING: Mexico's public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines. RELEVANT CHANGES: Since 2008, the CCPNM has improved procurement practices in Mexico's public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure. LESSONS LEARNT: The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM.
Assuntos
Custos de Medicamentos/normas , Seguro de Serviços Farmacêuticos/economia , Preparações Farmacêuticas/economia , Cobertura Universal do Seguro de Saúde/economia , Controle de Custos/métodos , Custos de Medicamentos/tendências , Humanos , Seguro de Serviços Farmacêuticos/tendências , México , Negociação , Cobertura Universal do Seguro de Saúde/tendênciasRESUMO
AIM: To determine the impact of health insurance and the government's Benefit Service Scheme, a system that provides free drugs to treat mostly chronic illnesses to persons aged 16 to 65 years, on the use of herbal remedies by Christian churchgoers in Barbados. METHODS: The eleven parishes of Barbados were sampled over a six-week period using a survey instrument developed and tested over a four-week period prior to administration. Persons were asked to participate and after written informed consent, they were interviewed by the research team. The data were analysed by the use of IBM SPSS version 19. The data were all nominal, so descriptive statistics including counts, the frequencies, odds ratios and percentages were calculated. RESULTS: More than half of the participants (59.2%) were female, a little less than a third (29.9%) were male, and one tenth of the participants (10.9%) did not indicate their gender. The majority of the participants were between the ages of 41 and 70 years, with the age range of 51-60 years comprising 26.1% of the sample interviewed. Almost all of the participants were born in Barbados (92.5%). Approximately 33% of the respondents indicated that they used herbal remedies to treat various ailments including chronic conditions. The odds ratio of persons using herbal remedies and having health insurance to persons not using herbal remedies and having health insurance is 1.01 (95% CI 0.621, 1.632). There was an increase in the numbers of respondents using herbal remedies as age increased. This trend continued until the age group 71-80 years which showed a reduction in the use of herbal remedies, 32.6% of respondents compared with 38.3% of respondents in the 61-70-year category. CONCLUSIONS: The data demonstrated that only a third of the study population is using herbal remedies for ailments. Health insurance was not an indicator neither did it influence the use of herbal remedies by respondents. The use of herbal remedies may not be associated with affluence. The reduction in the use of herbal remedies in the age group 71-80 years could be due to primarily a lower response rate from this age group, and secondarily due to the Benefit Service Scheme offering free medication to persons who have passed the age of 65 years.
OBJETIVO: Investigar si el Seguro de Saludy el Plan de Servicios y Beneficios del Gobierno - un sistema que proporciona medicina libremente para tratar principalmente enfermedades crónicas en personas de 16 a 65 anos de edad - influyen en el uso de remedios herbarios por los feligreses cristianos en Barbados. MÉTODOS: Se realizó un muestreo en once provincias de Barbados por un período de seis semanas, usando como instrumento una encuesta desarrollada y probada durante un período de cuatro semanas antes de ser aplicada. Se le pidió participación a distintas personas y luego de obtener el consen-timiento informado por escrito, las mismas fueron entrevistadas por el equipo de investigación. Los datos fueron analizados mediante la versión 19 de IBM SPSS. Todos los datos eran nominales, de modo que se calcularon las estadísticas descriptivas, incluyendo conteos, frecuencia, cociente de probabilidades (odds ratio), y porcentajes. RESULTADOS: Más de la mitad de los participantes (59.2%) eran mujeres; poco menos de un tercio (29.9%) eran hombres; y una décima parte de los participantes (10.9%) no indicó su sexo. La mayoría de los participantes se encontraban entre las edades de 41 y 70 anos, para un rango de edad de 51-60 anos que comprendía el 26.1% de la muestra entrevistada. Casi todos los participantes nacieron en Barbados (92.5%). Aproximadamente 33% de los entrevistados indicaron que usaban remedios herbarios para tratar varias dolencias, incluyendo condiciones crónicas. El odds ratio de las personas que usan remedios herbarios y poseen seguro de salud es 1.01 (95% CI 0.621, 1.632). Seprodujo un aumento en el número de entrevistados que usaban remedios herbarios, según aumentaba su edad. Esta tendencia continuó hasta el grupo etario de 71-80 anos, el cual mostró una reducción en el uso de remedios herbarios, 32.6% de los entrevistados en comparación con el 38.3% de los entrevistados en la categoría de los 61-70 anos. CONCLUSIONS: Los datos mostraron que sólo una tercera parte de la población está usando remedios herbarios para sus dolencias. El seguro de salud no fue un indicador ni influyó sobre el uso de remedios herbarios por los entrevistados. El uso de remedios herbarios no puede asociarse con la afluencia. La reducción en el uso de remedios herbarios en el grupo etario 71-80 anos podrían deberse principalmente a una tasa de respuesta más baja de este grupo etario, y secundariamente al Plan de Servicios y Beneficios que ofrece medicamentos gratuitamente a personas que han pasado la edad de 65 anos.
Assuntos
Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cristianismo , Seguro Saúde , Seguro de Serviços Farmacêuticos , Preparações de Plantas/uso terapêutico , Barbados , Uso de Medicamentos , Seguro Saúde/economia , Seguro de Serviços Farmacêuticos/economia , Religião e MedicinaRESUMO
In this article presents the main results of an analysis of drug purchases made by all the states in Mexico, with the resources from the Popular Secure to cover the Health Services Univesal Catalog (CAUSES by its Spanish acronym) in the first half of 2009. The conclusion is that at least 50% of drugs keys have been purchased with a 20% extra in the reference price set by the authorities. Also, spending on drugs is low despite the fact that there is budget availability and that it varies widely among States. This provides robust evidence that the model of drug purchasing for the scheme is inefficient from the economic point of view, and inequitable from the social point of view.
Assuntos
Atenção à Saúde/normas , Seguro de Serviços Farmacêuticos/economia , Seguro de Serviços Farmacêuticos/normas , Comércio , Eficiência , Humanos , México , Justiça SocialRESUMO
OBJECTIVE: To compare the proportion of patients choosing surgical versus medical castration to treat prostate cancer, before and after the National Health Fund (NHF) of Jamaica began to subsidize hormone therapy. METHODS: A retrospective review was performed at the University Hospital of the West Indies (UHWI), Jamaica. The pathology database at UHWI was searched to identify patients who had prostate biopsies between January 2000 and December 2007. These were combined with records of biopsies at external institutions. Medical records of all patients with positive prostate biopsies were reviewed to determine if they had received androgen deprivation therapy (ADT). Patients were classified as having had surgical castration (bilateral orchiectomy) or medical castration. Chi-square statistics were used to determine the difference in proportions between those choosing medical versus surgical castration before and after March 2005, when the NHF began offering subsidies for ADT drugs. RESULTS: Of the 1,529 prostate biopsies performed during the study period, 680 (44.0%) cases of prostate cancer were diagnosed. Of these, 458 patients underwent ADT and had complete records available for analysis. The mean patient age was 72 years. During the entire study period, surgical castration was performed in 265 patients (58.0%) and medical castration in 193 (42.0%). A greater proportion of orchiectomies were performed before March 2005, rather than after (P < 0.001). Estrogens were the most common method of medical castration used before the NHF subsidy became available (62.0%); while luteinizing hormone-releasing hormone analogues (38.0%) and antiandrogens (36.5%) were most often chosen afterwards. CONCLUSIONS: Surgical castration was more common than medical castration before March 2005. After the NHF began to subsidize the cost of drugs for hormone therapy, medical castration was chosen more often. Increased access to drugs for hormone therapy has changed treatment patterns in Jamaica.