RESUMO
Rotavirus (RV) is the main cause of acute gastroenteritis (AGE) in young children. The San Luis province of Argentina introduced RV vaccination in May 2013. We estimate vaccine impact (RVI) using real-world data. Data on all-cause AGE cases and AGE-related hospitalisations for San Luis and the adjacent Mendoza province (control group) were obtained and analysed by interrupted time-series methods. Regardless of the model used for counterfactual predictions, we estimated a reduction in the number of all-cause AGE cases of 20-25% and a reduction in AGE-related hospitalisations of 55-60%. The vaccine impact was similar for each age group considered (<1 year, <2 years and <5 years). RV vaccination was estimated to have reduced direct medical costs in the province by about 4.5 million pesos from May 2013 to December 2014. Similar to previous studies, we found a higher impact of RV vaccination in preventing severe all-cause AGE cases requiring hospitalisation than in preventing all-cases AGE cases presenting for medical care. An assessment of the economic value of RV vaccination could take other benefits into account in addition to the avoided medical costs and the costs of vaccination.
Assuntos
Gastroenterite/prevenção & controle , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus , Doença Aguda , Argentina/epidemiologia , Pré-Escolar , Análise Custo-Benefício , Feminino , Gastroenterite/economia , Gastroenterite/epidemiologia , Gastroenterite/virologia , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Masculino , Infecções por Rotavirus/economia , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus/economia , Resultado do Tratamento , Vacinação/economiaRESUMO
The success of Gavi, the Vaccine Alliance depends on the vaccine markets providing appropriate, affordable vaccines at sufficient and reliable quantities. Gavi's current supplier base for new and underutilized vaccines, such as the human papillomavirus (HPV), rotavirus, and the pneumococcal conjugate vaccine is very small. There is growing concern that following globalization of laws on intellectual property rights (IPRs) through trade agreements, IPRs are impeding new manufacturers from entering the market with competing vaccines. This article examines the extent to which IPRs, specifically patents, can create such obstacles, in particular for developing country vaccine manufacturers (DCVMs). Through building patent landscapes in Brazil, China, and India and interviews with manufacturers and experts in the field, we found intense patenting activity for the HPV and pneumococcal vaccines that could potentially delay the entry of new manufacturers. Increased transparency around patenting of vaccine technologies, stricter patentability criteria suited for local development needs and strengthening of IPRs management capabilities where relevant, may help reduce impediments to market entry for new manufacturers and ensure a competitive supplier base for quality vaccines at sustainably low prices.
Assuntos
Propriedade Intelectual , Vacinas contra Papillomavirus/economia , Vacinas contra Papillomavirus/isolamento & purificação , Vacinas Pneumocócicas/economia , Vacinas Pneumocócicas/isolamento & purificação , Vacinas contra Rotavirus/economia , Vacinas contra Rotavirus/isolamento & purificação , Brasil , China , Países em Desenvolvimento , Indústria Farmacêutica/tendências , Humanos , Índia , Tecnologia Farmacêutica/economia , Tecnologia Farmacêutica/métodosRESUMO
BACKGROUND: Rotavirus diarrhea is one of the most important vaccine-preventable causes of severe diarrhea in children worldwide. There are two live-attenuated virus vaccines licensed, Rotarix (RV1) a monovalent vaccine by GlaxoSmithKline and a pentavalent vaccine, RotaTeq(RV5), by Merck & Co., with similar results. This study aim was to evaluate the cost-effectiveness of the utilization of RV1 compared with RV5 in Argentina. METHODS: A deterministic Markov model based on the lifetime follow up of a static cohort was used. Quality Adjusted Life Years (QALYs) as a measure of results, the perspective of the health care system and a 5% discount rate for health benefits and costs has been used. A review of the literature to obtain epidemiologic and resources utilization of rotavirus diarrhea was performed. The sources used to estimate epidemiologic parameters were the National Health Surveillance System, the national mortality statistics and national database of hospital discharges records. Costs were obtained from different health subsectors and are expressed in local currency. RESULTS: Both vaccination alternatives were less costly and more effective than the strategy without vaccination (total costs $ 69,700,645 and 2575 total QALYs lost). When comparing RV1 vs. RV5, RV1 was less expensive ($ 60,174,508 vs. $ 67,545,991 total costs) and more effective (1105 vs. 1213 total QALYs lost) than RV5, RV1 being therefore a dominating strategy. Probabilistic sensitivity analysis showed results to be robust with a 100% probability of being cost-effective at a WTP threshold of 1 GDP per capita when comparing the RV1 vs. no vaccination. CONCLUSION: Both RV1 and RV5 schedules dominate the no vaccination strategy and RV5 was dominated by RV1. This information is a valuable input regarding the incorporation of this kind of vaccines into the national vaccination programs.
Assuntos
Programas de Imunização/economia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/economia , Argentina/epidemiologia , Pré-Escolar , Análise Custo-Benefício , Diarreia/epidemiologia , Diarreia/virologia , Humanos , Lactente , Cadeias de Markov , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Rotavirus , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus/uso terapêutico , Vacinação/economia , Vacinas Atenuadas/economia , Vacinas Atenuadas/uso terapêuticoRESUMO
BACKGROUND: Rotavirus is a leading cause of severe diarrhea in children under 5. In Argentina, the most affected regions are the Northeast and Northwest, where hospitalizations and deaths are more frequent. This study estimated the cost-effectiveness of adding either of the two licensed rotavirus vaccines to the routine immunization schedule. METHODS: The integrated TRIVAC vaccine cost-effectiveness model from the Pan American Health Organization's ProVac Initiative (Version 2.0) was used to assess health benefits, costs savings, life-years gained (LYGs), DALYs averted, and cost/DALY averted of vaccinating 10 successive cohorts, from the health care system and societal perspectives. Two doses of monovalent (RV1) rotavirus vaccine and three doses of pentavalent (RV5) rotavirus vaccine were each compared to a scenario assuming no vaccination. The price/dose was US$ 7.50 and US$ 5.15 for RV1 and RV5, respectively. We ran both a national and sub-national analysis, discounting all costs and benefits 3% annually. Our base case results were compared to a range of alternative univariate and multivariate scenarios. RESULTS: The number of LYGs was 5962 and 6440 for RV1 and RV5, respectively. The cost/DALY averted when compared to no vaccination from the health care system and societal perspective was: US$ 3870 and US$ 1802 for RV1, and US$ 2414 and US$ 358 for RV5, respectively. Equivalent figures for the Northeast were US$ 1470 and US$ 636 for RV1, and US$ 913 and US$ 80 for RV5. Therefore, rotavirus vaccination was more cost-effective in the Northeast compared to the whole country; and, in the Northwest, health service's costs saved outweighed the cost of introducing the vaccine. Vaccination with either vaccine compared to no vaccination was highly cost-effective based on WHO guidelines and Argentina's 2011 per capita GDP of US$ 9090. Key variables influencing results were vaccine efficacy, annual loss of efficacy, relative coverage of deaths, vaccine price, and discount rate. CONCLUSION: Compared to no vaccination, routine vaccination against rotavirus in Argentina would be highly cost-effective with either vaccine. Health and economic benefits would be higher in the Northeast and Northwest regions, where the intervention would even be cost-saving.
Assuntos
Infecções por Rotavirus/economia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/economia , Vacinas contra Rotavirus/imunologia , Vacinação/economia , Argentina/epidemiologia , Pré-Escolar , Análise Custo-Benefício , Diarreia/economia , Diarreia/epidemiologia , Diarreia/mortalidade , Diarreia/prevenção & controle , Política de Saúde , Humanos , Programas de Imunização , Lactente , Recém-Nascido , Modelos Estatísticos , Infecções por Rotavirus/epidemiologia , Infecções por Rotavirus/mortalidade , Vacinas contra Rotavirus/administração & dosagem , Vacinação/métodos , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/economia , Vacinas Atenuadas/imunologiaRESUMO
BACKGROUND: The competing choices of vaccination with either RV1 or RV5, the potential budget impact of vaccines on the EPI with different prices and new evidence make important an updated analysis for health decision makers in each country. The objective of this study is to assess cost-effectiveness of the monovalent and pentavalent rotavirus vaccines and impact on children deaths, inpatient and outpatient visits in 116 low and middle income countries that represent approximately 99% of rotavirus mortality. METHODS: A decision tree model followed hypothetical cohorts of children from birth up to 5 years of age for each country in 2010. Inputs were gathered from international databases and previous research on incidence and effectiveness of monovalent and pentavalent vaccines. Costs were expressed in 2010 international dollars. Outcomes were reported in terms of cost per disability-adjusted life-year averted, comparing no vaccination with either monovalent or pentavalent mass introduction. Vaccine price was assumed fixed for all world low-income and middle-income countries. RESULTS: Around 292,000 deaths, 3.34 million inpatient cases and 23.09 million outpatient cases would occur with no vaccination. In the base-case scenario, monovalent vaccination would prevent 54.7% of inpatient cases and 45.4% of deaths. Pentavalent vaccination would prevent 51.4% of inpatient cases and 41.1% of deaths. The vaccine was cost-effective in all world countries in the base-case scenario for both vaccines. Cost per disability-adjusted life-year averted in all selected countries was I$372 for monovalent, and I$453 for pentavalent vaccination. CONCLUSION: Rotavirus vaccine is cost-effective in most analyzed countries. Despite cost-effectiveness analysis is a useful tool for decision making in middle-income countries, for low-income countries health decision makers should also assess the impact of introducing either vaccine on local resources and budget impact analysis of vaccination.
Assuntos
Transmissão de Doença Infecciosa/economia , Transmissão de Doença Infecciosa/prevenção & controle , Infecções por Rotavirus/economia , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/economia , Pré-Escolar , Análise Custo-Benefício , Países em Desenvolvimento , Hospitalização/economia , Humanos , Lactente , Recém-Nascido , Modelos Estatísticos , Visita a Consultório Médico/economia , Infecções por Rotavirus/mortalidade , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/imunologia , Análise de SobrevidaRESUMO
BACKGROUND: Rotavirus is the most common cause of severe acute diarrhea among children in both developed and developing countries. Vaccination can reduce the disease burden and its incorporation into health care systems should consider future costs and benefits. OBJECTIVES: To systematically review studies on costs due to rotavirus infection in Latin America and Caribbean (LAC) region, considering their methods and results. METHODS: A search of relevant databases including the Cochrane Central Register of Controlled Trials, Embase, MEDLINE via PubMed, the Latin American and Caribbean Health Sciences Literature database (LILACS), and the Brazilian Thesis Databank was performed. Inclusion criteria for studies were: (a) economic evaluation or cost-of-illness studies; (b) conducted in the LAC region; (c) assess economic burden of rotavirus disease or the economic impact of rotavirus vaccination programs. Two authors independently screened the studies for eligibility. RESULTS: Of 444 studies initially retrieved, 21 met the eligibility criteria and were included (14 cost-effectiveness analyses of vaccination programs and 7 cost-of-illness studies). Direct medical costs were assessed in all 21 studies, but only 10 also investigated indirect and non-medical direct costs. The most commonly observed methods for cost estimation were retrospective database analysis and hospital-based surveillance study. Only one study was a household-based survey.A wide cost range was identified (e.g., inpatient care US$79.91 to US$858.40 and outpatient care US$13.06 to US$64.10), depending on the methods, study perspective, and type of costs included. CONCLUSION: Rotavirus-associated costs were assessed in 21 studies across the Latin America and Caribbean region. The majority of studies were made alongside economic evaluations of vaccination programs. Methods are broadly different among studies but administrative databases seem to be the most employed source of data.
Assuntos
Efeitos Psicossociais da Doença , Programas de Imunização/economia , Infecções por Rotavirus/economia , Região do Caribe/epidemiologia , Pré-Escolar , Análise Custo-Benefício , Diarreia/epidemiologia , Diarreia/virologia , Eficiência , Custos de Cuidados de Saúde , Humanos , América Latina/epidemiologia , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus/economiaRESUMO
OBJECTIVE: To review the approaches used in the cost-effectiveness analysis (CEAs) literature to estimate the cost of expanded program on immunization (EPI) activities, other than vaccine purchase, for rotavirus and pneumococcal vaccines. METHODS: A systematic review in PubMed and NHS EED databases of rotavirus and pneumococcal vaccines CEAs was done. Selected articles were read and information on how EPI costs were calculated was extracted. EPI costing approaches were classified according to the method or assumption used for estimation. RESULTS: Seventy-nine studies that evaluated cost effectiveness of rotavirus (n=43) or pneumococcal (n=36) vaccines were identified. In general, there are few details on how EPI costs other than vaccine procurement were estimated. While 30 studies used some measurement of that cost, only one study on pneumococcal vaccine used a primary cost evaluation (bottom-up costing analysis) and one study used a costing tool. Twenty-seven studies (17 on rotavirus and 10 on pneumococcal vaccine) assumed the non-vaccine costs. Five studies made no reference to additional costs. Fourteen studies (9 rotavirus and 5 pneumococcal) did not consider any additional EPI cost beyond vaccine procurement. For rotavirus studies, the median for non-vaccine cost per dose was US$0.74 in developing countries and US$6.39 in developed countries. For pneumococcal vaccines, the median for non-vaccine cost per dose was US$1.27 in developing countries and US$8.71 in developed countries. CONCLUSIONS: Many pneumococcal (52.8%) and rotavirus (60.4%) cost-effectiveness analyses did not consider additional EPI costs or used poorly supported assumptions. Ignoring EPI costs in addition to those for vaccine procurement in CEA analysis of new vaccines may lead to significant errors in the estimations of ICERs since several factors like personnel, cold chain, or social mobilization can be substantially affected by the introduction of new vaccines.
Assuntos
Programas de Imunização/economia , Vacinas Pneumocócicas/economia , Vacinas contra Rotavirus/economia , Análise Custo-Benefício , Países Desenvolvidos/economia , Países em Desenvolvimento/economia , Custos de Cuidados de Saúde , HumanosRESUMO
INTRODUCTION: Rotavirus vaccine efficacy ranges from >90% in high socio-economic settings (SES) to 50% in low SES. With the imminent introduction of rotavirus vaccine in low SES countries, understanding reasons for reduced efficacy in these settings could identify strategies to improve vaccine performance. METHODS: We developed a mathematical model to predict rotavirus vaccine efficacy in high, middle and low SES based on data specific for each setting on incidence, protection conferred by natural infection and immune response to vaccination. We then examined factors affecting efficacy. RESULTS: Vaccination was predicted to prevent 93%, 86% and 51% of severe rotavirus gastroenteritis in high, middle and low SES, respectively. Also predicted was that vaccines are most effective against severe disease and efficacy declines with age in low but not high SES. Reduced immunogenicity of vaccination and reduced protection conferred by natural infection are the main factors that compromise efficacy in low SES. DISCUSSION: The continued risk of severe disease in non-primary natural infections in low SES is a key factor underpinning reduced efficacy of rotavirus vaccines. Predicted efficacy was remarkably consistent with observed clinical trial results from different SES, validating the model. The phenomenon of reduced vaccine efficacy can be predicted by intrinsic immunological and epidemiological factors of low SES populations. Modifying aspects of the vaccine (e.g. improving immunogenicity in low SES) and vaccination program (e.g. additional doses) may bring improvements.
Assuntos
Infecções por Rotavirus/economia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/economia , Vacinas contra Rotavirus/imunologia , Distribuição por Idade , Pré-Escolar , Inglaterra/epidemiologia , Gastroenterite/epidemiologia , Gastroenterite/imunologia , Gastroenterite/prevenção & controle , Gastroenterite/virologia , Humanos , Incidência , Índia/epidemiologia , Lactente , Recém-Nascido , México/epidemiologia , Modelos Biológicos , Infecções por Rotavirus/epidemiologia , Infecções por Rotavirus/imunologia , Fatores Socioeconômicos , Resultado do TratamentoAssuntos
Programas de Imunização/economia , Infecções por Rotavirus/epidemiologia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/administração & dosagem , Centers for Disease Control and Prevention, U.S. , Mortalidade da Criança , Pré-Escolar , Ensaios Clínicos como Assunto , Contaminação de Medicamentos , Humanos , Lactente , Recém-Nascido , Intussuscepção/induzido quimicamente , México , Vacinas contra Rotavirus/efeitos adversos , Vacinas contra Rotavirus/economia , Estados Unidos/epidemiologia , Vacinação/tendênciasRESUMO
BACKGROUND: In Bolivia, in 2008, the under-five mortality rate is 54 per 1000 live births. Diarrhea causes 15% of these deaths, and 40% of pediatric diarrhea-related hospitalizations are caused by rotavirus illness (RI). Rotavirus vaccination (RV), subsidized by international donors, is expected to reduce morbidity, mortality, and economic burden to the Bolivian state. Estimates of illness and economic burden of RI and their reduction by RV are essential to the Bolivian state's policies on RV program financing. The goal of this report is to estimate the economic burden of RI and the cost-effectiveness of the RV program. METHODS: To assess treatment costs incurred by the healthcare system, we abstracted medical records from 287 inpatients and 6751 outpatients with acute diarrhea between 2005 and 2006 at 5 sentinel hospitals in 4 geographic regions. RI prevalence rates were estimated from 4 years of national hospital surveillance. We used a decision-analytic model to assess the potential cost-effectiveness of universal RV in Bolivia. RESULTS: Our model estimates that, in a 5-year birth cohort, Bolivia will incur over US$3 million in direct medical costs due to RI. RV reduces, by at least 60%, outpatient visits, hospitalizations, deaths, and total direct medical costs associated with rotavirus diarrhea. Further, RV was cost-savings below a price of US$3.81 per dose and cost-effective below a price of US$194.10 per dose. Diarrheal mortality and hospitalization inputs were the most important drivers of rotavirus vaccine cost-effectiveness. DISCUSSION: Our data will guide Bolivia's funding allocation for RV as international subsidies change.