The thesis aims to develop the analytical framework of relations between pharmaceutical innovatio... more The thesis aims to develop the analytical framework of relations between pharmaceutical innovation and access, exploiting the current public policies in construction related to the development of health-industrial complex in the pharmaceutical field. The methodology includes a revision systematic of related literature, the study of the Brazilian case in the generation of policies oriented to innovation and access in health (1990-2008), and an analysis of the perception of the organizational actors. It appears that the concepts analyzed, innovation and access, although coming from different areas of knowledge are strongly set in the dynamic development of the pharmaceutical industry. We identified the actors, organizations and institutions that make up the National System of Innovation (NSI) in health in Brazil. The tension of economic relations around the health and medical care are reproduced in their formulation and implementation of industrial policy and health policy. The state's role is fundamental in the governance of the NSI in health, in this sense the absence of social actors such as the medical practitioners and the representative bodies of civil society undermine the relationship between the NSI in health. The dynamics of innovation and access to pharmaceutical products are not naturally convergent. Not all pharmaceutical innovation reflects an improvement of access and not always higher quality access to medicines is linked to a greater uptake of innovations in health care.
Social Programs related to drugs in Peru have a long trajectory. Since the decade of 60, they hav... more Social Programs related to drugs in Peru have a long trajectory. Since the decade of 60, they have been part of the public policies of different governments in the country, and there have been inedit experiences looking for the best way to ensure access of low-income population to essential drugs. The World Health Organization has been promoting that the appropriate and sufficient supply of essential drugs to the population, is a very important component of the National Pharmaceutical Policy and part of the National Health Policy. Nevertheless, the absence of historic and individualized systematization of these processes in Peru, calls for the necessity of development, at this moment, of a model of evaluation, considering the classic aspects of program evaluation, and an accurate analysis about the characteristics of the implantation of the Programa de Administração Compartilhada de Farmácias (PACFARM), currently ongoing in the country. This investigation, relates to the process of implantation and the effects of the PACFARM and it’s relevance within the National Drug Policy of Peru. Considering the complexity of the subject, the methodologic approach is based in three dimensions: strategic analysis, implantation analysis, and complementary analysis of the Program in the categories of costs and compatibilization between the offer of drugs and the profile of morbidity, using instruments of qualitative and quantitative, investigation. The results show unequal degrees of implantation of PACFARM in the Sub-regions of Health, identifying between the explicative factors, organizational aspects and others external issues to the Program, related to the different regional contexts of development of PACFARM. The regional differences in relation to the observed effects are explained by the elements of the subjects related, such as gerencial capacity of human resources, presence of others institutional programs and the social-economics characteristics of the population; like this, the suprasistemic characteristics related to the Pharmaceutical Policy of the country will determine the degrees of implementation of the Program. Some bases for the support of an adequate National Drug Policy, are enabled by the process of development of PACFARM.
Biblioteca Digital De La Asociacion Latino Iberoamericana De Gestion Tecnologica, Jan 3, 2013
No Brasil, o Sistema Unico de Saude (SUS) esta estruturado nos valores de equidade, integralidade... more No Brasil, o Sistema Unico de Saude (SUS) esta estruturado nos valores de equidade, integralidade e universalidade na provisao dos cuidados da atencao sanitaria, com o objetivo privilegiado de acesso as tecnologias terapeuticas e diagnosticas necessarias para atingir boa saude com qualidade. Entretanto, o complexo das industrias da saude, e especialmente a industria farmaceutica utilizam a inovacao como estrategia de competitividade, ao tempo que mantem uma forte vinculacao ao progresso tecnico e aos avancos cientificos. Politicas publicas indutoras de inovacao na saude, com foco no acesso, e orientadas as necessidades do SUS sao indispensaveis para o desenvolvimento economico e social. Esse trabalho tem o objetivo de apresentar o marco analitico das recentes politicas publicas relacionadas ao desenvolvimento do complexo industrial da saude no campo farmaceutico no Brasil e como elas geram um ambiente de inovacao na saude. A metodologia utilizada incluiu uma revisao sistematica da literatura relacionada e o levantamento de marco juridico, estrutura organizacional e atores relevantes no caso brasileiro, na geracao de politicas orientadas a inovacao em saude, no periodo 1990-2010. Como resultados foram identificados os atores, organizacoes e instituicoes que estruturam o Sistema Nacional de Inovacao (SNI) em saude no Brasil, considerando seus campos especificos e sua posicao na arena das politicas publicas. Constata-se a construcao de um marco regulatorio que suporta a formulacao das politicas publicas voltadas para a inovacao em saude no campo farmaceutico. A estrutura e o arcabouco normativo se completa com a dimensao de financiamento e acoes de fomento para o setor. Conclui-se que a formulacao das recentes politicas publicas, envolvendo os distintos atores, vindos da academia, industria e setor governamental tem favorecido um ambiente de inovacao em saude no Brasil.
The main objective of this study was to identify, describe, classify and analyze the scientific h... more The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies. A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form. The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was redu...
To undertake a systematic review and meta-analysis to evaluate the test performance including sen... more To undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women. Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot. The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One stud...
Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with ... more Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Treatment costs of GT1-HCV patients were PPP$ 43,176.28 ...
Background: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been asso... more Background: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). Methods: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Results: Treatment costs of GT1-HCV patients were PPP$ 43,176.28 (US$ 24,020.16) for PEG-IFN/RBV, PPP$ 71,196.03 (US$ 39,578.23) for PEG-IFN/RBV/BOC and PPP$ 86,250.33 (US$ 47,946.92) for PEG-IFN/RBV/TEL. Treatment by all-oral interferon-free regimens were the less expensive approach: PPP$ 19,761.72 (US$ 10,985. 90) for SOF/DCV and PPP$ 21,590.91 (US$ 12,002.75) for SOF/SIM. The overview reported HCV eradication in up to 98% for SOF/DCV and 96% for SOF/SIM. Conclusion: Strategies with all oral interferon-free might lead to lower costs for management of GT1-HCV patients compared to IFN-based regimens in Brazil. This occurred mainly because of high discounts over international DAA prices due to negotiation between BMoH and pharmaceutical industries.
Visceral leishmaniasis (VL) is a severe form of the leishmaniasis-disease complex. Its importance... more Visceral leishmaniasis (VL) is a severe form of the leishmaniasis-disease complex. Its importance to public health relies on its high fatality rate in non-treated cases, the socioeconomic impact related to its morbidity, and its endemicity on different continents. The estimated burden of disease of VL varies from 1,969,000 to 2,357,000 Disability Adjusted Life Years (DALYs). VL is classified as a Neglected Tropical Disease (NTD), and is strongly related to poverty and its consequences. Visceral leishmaniasis calls for the development of cost-effective technologies for diagnosis and treatment. Objective The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies. Methods A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form. Results The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was reduced to 21 (20%) articles. After careful reading and application of exclusion criteria, 14 papers were eligible according to the description, classification and analysis process proposed by the study. When classified by type of economic evaluation, articles were 7 (50%) cost-effectiveness, 5 (36%) cost-minimization, 1(7%) cost-benefit, and 1(7%) budget impact. When classified by methodology, studies were mainly nested to clinical-trials (“piggy back”) 8(57%). Discount rates for outcomes and costs were present in 3 (43%) of the cost-effectiveness studies, and according to WHO's recommendations, the discount rate of 3% was used in all studies. Conclusions This article showed that health economic evaluations on visceral leishmaniasis used a wide range of technologies and methods. Nevertheless it is important to point out the geographic concentration of studies, which makes their transferability uncertain to different epidemiological scenarios, especially those concerning visceral leishmaniasis caused by Leishmania infantum.
Objectives: To undertake a systematic review and meta-analysis to evaluate the test performance i... more Objectives: To undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women. Methods: Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot. Results: The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively. Conclusions: This review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.
The thesis aims to develop the analytical framework of relations between pharmaceutical innovatio... more The thesis aims to develop the analytical framework of relations between pharmaceutical innovation and access, exploiting the current public policies in construction related to the development of health-industrial complex in the pharmaceutical field. The methodology includes a revision systematic of related literature, the study of the Brazilian case in the generation of policies oriented to innovation and access in health (1990-2008), and an analysis of the perception of the organizational actors. It appears that the concepts analyzed, innovation and access, although coming from different areas of knowledge are strongly set in the dynamic development of the pharmaceutical industry. We identified the actors, organizations and institutions that make up the National System of Innovation (NSI) in health in Brazil. The tension of economic relations around the health and medical care are reproduced in their formulation and implementation of industrial policy and health policy. The state's role is fundamental in the governance of the NSI in health, in this sense the absence of social actors such as the medical practitioners and the representative bodies of civil society undermine the relationship between the NSI in health. The dynamics of innovation and access to pharmaceutical products are not naturally convergent. Not all pharmaceutical innovation reflects an improvement of access and not always higher quality access to medicines is linked to a greater uptake of innovations in health care.
Social Programs related to drugs in Peru have a long trajectory. Since the decade of 60, they hav... more Social Programs related to drugs in Peru have a long trajectory. Since the decade of 60, they have been part of the public policies of different governments in the country, and there have been inedit experiences looking for the best way to ensure access of low-income population to essential drugs. The World Health Organization has been promoting that the appropriate and sufficient supply of essential drugs to the population, is a very important component of the National Pharmaceutical Policy and part of the National Health Policy. Nevertheless, the absence of historic and individualized systematization of these processes in Peru, calls for the necessity of development, at this moment, of a model of evaluation, considering the classic aspects of program evaluation, and an accurate analysis about the characteristics of the implantation of the Programa de Administração Compartilhada de Farmácias (PACFARM), currently ongoing in the country. This investigation, relates to the process of implantation and the effects of the PACFARM and it’s relevance within the National Drug Policy of Peru. Considering the complexity of the subject, the methodologic approach is based in three dimensions: strategic analysis, implantation analysis, and complementary analysis of the Program in the categories of costs and compatibilization between the offer of drugs and the profile of morbidity, using instruments of qualitative and quantitative, investigation. The results show unequal degrees of implantation of PACFARM in the Sub-regions of Health, identifying between the explicative factors, organizational aspects and others external issues to the Program, related to the different regional contexts of development of PACFARM. The regional differences in relation to the observed effects are explained by the elements of the subjects related, such as gerencial capacity of human resources, presence of others institutional programs and the social-economics characteristics of the population; like this, the suprasistemic characteristics related to the Pharmaceutical Policy of the country will determine the degrees of implementation of the Program. Some bases for the support of an adequate National Drug Policy, are enabled by the process of development of PACFARM.
Biblioteca Digital De La Asociacion Latino Iberoamericana De Gestion Tecnologica, Jan 3, 2013
No Brasil, o Sistema Unico de Saude (SUS) esta estruturado nos valores de equidade, integralidade... more No Brasil, o Sistema Unico de Saude (SUS) esta estruturado nos valores de equidade, integralidade e universalidade na provisao dos cuidados da atencao sanitaria, com o objetivo privilegiado de acesso as tecnologias terapeuticas e diagnosticas necessarias para atingir boa saude com qualidade. Entretanto, o complexo das industrias da saude, e especialmente a industria farmaceutica utilizam a inovacao como estrategia de competitividade, ao tempo que mantem uma forte vinculacao ao progresso tecnico e aos avancos cientificos. Politicas publicas indutoras de inovacao na saude, com foco no acesso, e orientadas as necessidades do SUS sao indispensaveis para o desenvolvimento economico e social. Esse trabalho tem o objetivo de apresentar o marco analitico das recentes politicas publicas relacionadas ao desenvolvimento do complexo industrial da saude no campo farmaceutico no Brasil e como elas geram um ambiente de inovacao na saude. A metodologia utilizada incluiu uma revisao sistematica da literatura relacionada e o levantamento de marco juridico, estrutura organizacional e atores relevantes no caso brasileiro, na geracao de politicas orientadas a inovacao em saude, no periodo 1990-2010. Como resultados foram identificados os atores, organizacoes e instituicoes que estruturam o Sistema Nacional de Inovacao (SNI) em saude no Brasil, considerando seus campos especificos e sua posicao na arena das politicas publicas. Constata-se a construcao de um marco regulatorio que suporta a formulacao das politicas publicas voltadas para a inovacao em saude no campo farmaceutico. A estrutura e o arcabouco normativo se completa com a dimensao de financiamento e acoes de fomento para o setor. Conclui-se que a formulacao das recentes politicas publicas, envolvendo os distintos atores, vindos da academia, industria e setor governamental tem favorecido um ambiente de inovacao em saude no Brasil.
The main objective of this study was to identify, describe, classify and analyze the scientific h... more The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies. A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form. The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was redu...
To undertake a systematic review and meta-analysis to evaluate the test performance including sen... more To undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women. Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot. The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One stud...
Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with ... more Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Treatment costs of GT1-HCV patients were PPP$ 43,176.28 ...
Background: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been asso... more Background: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). Methods: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Results: Treatment costs of GT1-HCV patients were PPP$ 43,176.28 (US$ 24,020.16) for PEG-IFN/RBV, PPP$ 71,196.03 (US$ 39,578.23) for PEG-IFN/RBV/BOC and PPP$ 86,250.33 (US$ 47,946.92) for PEG-IFN/RBV/TEL. Treatment by all-oral interferon-free regimens were the less expensive approach: PPP$ 19,761.72 (US$ 10,985. 90) for SOF/DCV and PPP$ 21,590.91 (US$ 12,002.75) for SOF/SIM. The overview reported HCV eradication in up to 98% for SOF/DCV and 96% for SOF/SIM. Conclusion: Strategies with all oral interferon-free might lead to lower costs for management of GT1-HCV patients compared to IFN-based regimens in Brazil. This occurred mainly because of high discounts over international DAA prices due to negotiation between BMoH and pharmaceutical industries.
Visceral leishmaniasis (VL) is a severe form of the leishmaniasis-disease complex. Its importance... more Visceral leishmaniasis (VL) is a severe form of the leishmaniasis-disease complex. Its importance to public health relies on its high fatality rate in non-treated cases, the socioeconomic impact related to its morbidity, and its endemicity on different continents. The estimated burden of disease of VL varies from 1,969,000 to 2,357,000 Disability Adjusted Life Years (DALYs). VL is classified as a Neglected Tropical Disease (NTD), and is strongly related to poverty and its consequences. Visceral leishmaniasis calls for the development of cost-effective technologies for diagnosis and treatment. Objective The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies. Methods A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form. Results The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was reduced to 21 (20%) articles. After careful reading and application of exclusion criteria, 14 papers were eligible according to the description, classification and analysis process proposed by the study. When classified by type of economic evaluation, articles were 7 (50%) cost-effectiveness, 5 (36%) cost-minimization, 1(7%) cost-benefit, and 1(7%) budget impact. When classified by methodology, studies were mainly nested to clinical-trials (“piggy back”) 8(57%). Discount rates for outcomes and costs were present in 3 (43%) of the cost-effectiveness studies, and according to WHO's recommendations, the discount rate of 3% was used in all studies. Conclusions This article showed that health economic evaluations on visceral leishmaniasis used a wide range of technologies and methods. Nevertheless it is important to point out the geographic concentration of studies, which makes their transferability uncertain to different epidemiological scenarios, especially those concerning visceral leishmaniasis caused by Leishmania infantum.
Objectives: To undertake a systematic review and meta-analysis to evaluate the test performance i... more Objectives: To undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women. Methods: Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot. Results: The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively. Conclusions: This review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.
Uploads
The results show unequal degrees of implantation of PACFARM in the Sub-regions of Health, identifying between the explicative factors, organizational aspects and others external issues to the Program, related to the different regional contexts of development of PACFARM. The regional differences in relation to the observed effects are explained by the elements of the subjects related, such as gerencial capacity of human resources, presence of others institutional programs and the social-economics characteristics of the population; like this, the suprasistemic characteristics related to the Pharmaceutical Policy of the country will determine the degrees of implementation of the Program. Some bases for the support of an adequate National Drug Policy, are enabled by the process of development of PACFARM.
Methods: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Results: Treatment costs of GT1-HCV patients were PPP$ 43,176.28 (US$ 24,020.16) for PEG-IFN/RBV, PPP$ 71,196.03 (US$ 39,578.23) for PEG-IFN/RBV/BOC and PPP$ 86,250.33 (US$ 47,946.92) for PEG-IFN/RBV/TEL. Treatment by all-oral interferon-free regimens were the less expensive approach: PPP$ 19,761.72 (US$ 10,985. 90) for SOF/DCV and PPP$ 21,590.91 (US$ 12,002.75) for SOF/SIM. The overview reported HCV eradication in up to 98% for SOF/DCV and 96% for SOF/SIM. Conclusion: Strategies with all oral interferon-free might lead to lower costs for management of GT1-HCV patients compared to IFN-based regimens in Brazil. This occurred mainly because of high discounts over international DAA prices due to negotiation between BMoH and pharmaceutical industries.
Objective
The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies.
Methods
A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form.
Results
The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was reduced to 21 (20%) articles. After careful reading and application of exclusion criteria, 14 papers were eligible according to the description, classification and analysis process proposed by the study. When classified by type of economic evaluation, articles were 7 (50%) cost-effectiveness, 5 (36%) cost-minimization, 1(7%) cost-benefit, and 1(7%) budget impact. When classified by methodology, studies were mainly nested to clinical-trials (“piggy back”) 8(57%). Discount rates for outcomes and costs were present in 3 (43%) of the cost-effectiveness studies, and according to WHO's recommendations, the discount rate of 3% was used in all studies.
Conclusions
This article showed that health economic evaluations on visceral leishmaniasis used a wide range of technologies and methods. Nevertheless it is important to point out the geographic concentration of studies, which makes their transferability uncertain to different epidemiological scenarios, especially those concerning visceral leishmaniasis caused by Leishmania infantum.
Methods: Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot.
Results: The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively.
Conclusions: This review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.
The results show unequal degrees of implantation of PACFARM in the Sub-regions of Health, identifying between the explicative factors, organizational aspects and others external issues to the Program, related to the different regional contexts of development of PACFARM. The regional differences in relation to the observed effects are explained by the elements of the subjects related, such as gerencial capacity of human resources, presence of others institutional programs and the social-economics characteristics of the population; like this, the suprasistemic characteristics related to the Pharmaceutical Policy of the country will determine the degrees of implementation of the Program. Some bases for the support of an adequate National Drug Policy, are enabled by the process of development of PACFARM.
Methods: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. Results: Treatment costs of GT1-HCV patients were PPP$ 43,176.28 (US$ 24,020.16) for PEG-IFN/RBV, PPP$ 71,196.03 (US$ 39,578.23) for PEG-IFN/RBV/BOC and PPP$ 86,250.33 (US$ 47,946.92) for PEG-IFN/RBV/TEL. Treatment by all-oral interferon-free regimens were the less expensive approach: PPP$ 19,761.72 (US$ 10,985. 90) for SOF/DCV and PPP$ 21,590.91 (US$ 12,002.75) for SOF/SIM. The overview reported HCV eradication in up to 98% for SOF/DCV and 96% for SOF/SIM. Conclusion: Strategies with all oral interferon-free might lead to lower costs for management of GT1-HCV patients compared to IFN-based regimens in Brazil. This occurred mainly because of high discounts over international DAA prices due to negotiation between BMoH and pharmaceutical industries.
Objective
The main objective of this study was to identify, describe, classify and analyze the scientific health economic evidence of VL-related technologies.
Methods
A web search of combinations of free text and Mesh terms related to the economic evaluation of visceral leishmaniasis was conducted on scientific publication databases (Web of Science, Scopus, Medline via the Pubmed and Lilacs). A manual search of references lists of articles previously identified by the authors was also included. Articles written in English, Portuguese, Spanish or French were considered suitable for inclusion. Articles that matched the inclusion criteria were screened by at least two researchers, who extracted information regarding the epidemiologic scenario and methodological issues on a standardized form.
Results
The initial search retrieved 107 articles, whose abstracts were inspected according to the inclusion criteria leading to a first selection of 49 (46%) articles. After the elimination of duplicates, the list was reduced to 21 (20%) articles. After careful reading and application of exclusion criteria, 14 papers were eligible according to the description, classification and analysis process proposed by the study. When classified by type of economic evaluation, articles were 7 (50%) cost-effectiveness, 5 (36%) cost-minimization, 1(7%) cost-benefit, and 1(7%) budget impact. When classified by methodology, studies were mainly nested to clinical-trials (“piggy back”) 8(57%). Discount rates for outcomes and costs were present in 3 (43%) of the cost-effectiveness studies, and according to WHO's recommendations, the discount rate of 3% was used in all studies.
Conclusions
This article showed that health economic evaluations on visceral leishmaniasis used a wide range of technologies and methods. Nevertheless it is important to point out the geographic concentration of studies, which makes their transferability uncertain to different epidemiological scenarios, especially those concerning visceral leishmaniasis caused by Leishmania infantum.
Methods: Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot.
Results: The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively.
Conclusions: This review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.