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Transcript of Panorama geral da qualidade dos estudos farmacoeconomicos nacionais e internacionais segundo as...
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UNIVERSIDADE DE SO PAULO
FACULDADE DE CINCIAS FARMACUTICAS
Curso de Graduao em Farmcia-Bioqumica
Panorama geral da qualidade dos estudos farmacoeconomicos
nacionais e internacionais segundo as Diretrizes Metodolgicas de
Avaliaes Econmicas em Sade de 2009 (MS).
Andr Marques dos Santos
Trabalho de Concluso do Curso de
Farmcia-Bioqumica da Faculdade de
Cincias Farmacuticas da
Universidade de So Paulo.
Orientadora:
Profa. Dra Valentina Porta
So Paulo
2013
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SUMRIO
LISTA DE ABREVIATURAS __________________________________________ 1
LISTA DE FIGURAS _______________________________________________ 1
LISTA DE QUADROS E TABELAS ____________________________________ 1
RESUMO ________________________________________________________ 2
1. INTRODUO __________________________________________________ 4
2. OBJETIVO _____________________________________________________ 6
3. MATERIAL E MTODOS __________________________________________ 6
3.1. Estratgias de pesquisa ________________________________________ 7
3.2. Critrios de incluso __________________________________________ 7
3.3. Critrios de excluso __________________________________________ 8
3.4. Coleta e anlise dos dados _____________________________________ 8
3.5. Anlise estatstica ___________________________________________ 14
4. RESULTADOS _________________________________________________ 14
4.1 Levantamento bibliogrfico de artigos nacionais ____________________ 14
4.2 Levantamento bibliogrfico de artigos internacionais _________________ 15
4.3 Resultados estatsticos ________________________________________ 16
5. DISCUSSO __________________________________________________ 18
6. CONCLUSO __________________________________________________ 19
7. REFERNCIA _________________________________________________ 21
8. ANEXOS _____________________________________________________ 37
ANEXO I ______________________________________________________ 37
ANEXO II _____________________________________________________ 39
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LISTA DE ABREVIATURAS
ICER Razo de custo-efetividade incremental
ICUR Razo de custo-utilidade incremental
MS Ministrio da Fazendo
SUS Sistema nico de Sade
LISTA DE FIGURAS
Figura 1. Descrio da incluso e excluso das publicaes nacionais. _________ 15
Figura 2. Descrio da incluso e excluso das publicaes internacionais. _____ 16
LISTA DE QUADROS E TABELAS
Quadro 1. Critrios para avaliao da qualidade metodolgica ________________ 9
Quadro 2. Relao entre a nota e a quantidade de critrios presentes no estudo. __________________________________________________________ 10
Tabela 1. Pontuao obtida pela aplicao do questionrio adaptado a cada um dos trabalhos do grupo Nacional. Os artigos foram agrupados de acordo com a nota atribuda a cada um. ________________________________ 16
Tabela 2. Pontuao obtida pela aplicao do questionrio adaptado a cada um dos trabalhos do grupo Internacional. Os artigos foram agrupados de acordo com a nota atribuda a cada um. ______________________________ 17
Tabela 3. Resultados para os grupos Nacional e Internacional. ______________ 17
Tabela 4. Resultado do teste de Mann-Whitney apresentado pelo Minitab _____ 18
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RESUMO
SANTOS, A.M. Panorama geral da qualidade dos estudos farmacoeconmicos nacionais e internacionais segundo as Diretrizes Metodolgicas de Avaliaes Econmicas em Sade de 2009 (MS). 2013. Trabalho de Concluso de Curso de Farmcia-Bioqumica Faculdade de Cincias Farmacuticas Universidade de So Paulo, So Paulo, 2013. Palavras-chave: Farmacoeconmia, Custo-efetividade, Brasil, Diretrizes Metodolgicas. INTRODUO: A sade constitui um direito social bsico para as condies de cidadania da populao, um pas somente pode ser denominado desenvolvido se seus cidados forem saudveis, o que depende tanto da organizao e do funcionamento do sistema de sade quanto das condies gerais de vida associadas ao modelo de desenvolvimento vigente. No Brasil o uso da farmacoeconmia ainda precrio, porm o prprio Ministrio da Sade identifica a necessidade de uma ferramenta que possa auxiliar na racionalizao dos custos. "A avaliao , em especial, parte fundamental no planejamento e na gesto do sistema de sade. Um sistema de avaliao efetivo deve reordenar a execuo de aes e servios, redimensionando-os de forma a contemplar as necessidades de seu pblico, dando maior racionalidade ao uso dos recursos." (Ministrio da sade). Os estudos de custo e das implicaes econmicas relacionadas s chamadas avaliaes econmicas compreendem um grande grupo de mtodos usados na avaliao de tecnologias em sade. Essa ferramenta vem sendo objeto de muita ateno tanto por parte dos planejadores de sade como das agncias e demais organismos responsveis pela avaliao de tecnologias em sade em diversos pases. Esse interesse tem sido alimentado pelas preocupaes com a elevao dos gastos em sade, pelas presses sobre os gestores nas decises sobre a alocao de recursos e pela necessidade dos produtores de demonstrar os benefcios de suas tecnologias. Como resultado, observa-se significativo incremento no nmero de avaliaes econmicas na literatura, bem como tem existido um refinamento dos mtodos envolvidos com sua execuo. OBJETIVO: Traar um panorama geral da qualidade de estudos farmacoeconmicos nacionais, alm de compar-los a estudos internacionais de regies de referncia (Reino Unido, Canad e Austrlia) sobre a perspectiva das Diretrizes Metodolgicas de Avaliaes Econmicas em Sade (Ministrio da Sade, 2009). MATERIAIS E MTODOS: Os estudos farmacoeconmicos nacionais e internacionais sero selecionados a partir de uma reviso bibliogrfica realizada nas bases de dados MEDLINE, LILACS, SCIELO e EMBASE atravs de termos livres quanto MeSH (PUBMED) ou Emtree (Embase). Apenas trabalhos produzidos a partir de 2009 e que realizaram uma analise de custo-efetividade completa sero considerados. Os trabalhos sero avaliados atravs da aplicao de um questionrio adaptado.
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RESULTADOS: Aps os filtros serem aplicados na reviso da literatura, obtivemos um total de 29 artigos nacionais e 152 artigos internacionais nos quais foi aplicado o questionrio. Para ambos os grupos, nacionais e internacionais, foi calculado a mdia, sendo 0,80 e 0,92, respectivamente, de um total de 1,00. Atravs de uma anlise estatstica podemos observar que houve diferena entre essas mdias. CONCLUSO: A qualidade dos estudos internacionais mostrou-se superior qualidade dos estudos nacionais. Apesar disso, podemos considerar que os estudos nacionais apresentaram nota mdia alta, indicando cumprimento da maior parte dos critrios definidos pelas Diretrizes Metodolgicas de Avaliaes Econmicas em Sade9, as quais definem os pontos considerados essenciais no desenvolvimento de estudos de avaliao econmica.
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1. INTRODUO
Os medicamentos, recursos de diagnstico e teraputica, so um dos
elementos que integram a relao entre o Estado e populao na rea da sade.1
Os avanos no setor da sade propiciam uma progressiva e relevante melhora na
reduo da morbidade e da mortalidade das doenas, aumentando assim a
expectativa em qualidade de vida e a quantidade de tratamentos possveis para as
enfermidades.8,5 Vrias fatores podem influenciar o aumento dos gastos com a
sade, como a expanso de cobertura de medicamentos e procedimentos
financiados, surgimento de novos frmacos, adoo de novas tecnologias,
dinamismo epidemiolgico, envelhecimento da populao (aumento de doenas
crnico-degenerativas) e o uso inadequado de frmacos em diversas situaes
clnicas.3,4,5
Para exemplificar podemos citar a tecnologia mdica de alto custo, que
proporcionou uma melhoria na qualidade e eficcia dos servios de sade, porm
elevou os custos, pois alm do capital investido (equipamentos) so necessrios
recursos humanos qualificados para operar e interpretar as novas tecnologias.5
A sade constitui um direito social bsico para as condies de cidadania
da populao. Um pas somente pode ser denominado desenvolvido se seus
cidados forem saudveis, o que depende tanto da organizao e do
funcionamento do sistema de sade quanto das condies gerais de vida
associadas ao modelo de desenvolvimento vigente.6
Atravs do aumento do acesso sade o Estado obtm ganhos futuros.
Indivduos com melhor estado de sade possuem uma maior produtividade (na
idade adulta) e um melhor desenvolvimento, atravs de uma maior capacidade de
aprendizado (na infncia), o que ocasiona maior crescimento e desenvolvimento
econmico do pas, assim como a reduo com os custos futuros relativos a
tratamentos de alta complexidade. 3,7
Admitindo-se que os recursos para a sade so finitos, a utilizao da
farmacoeconomia como um dos pilares para tomada de deciso faz-se de extrema
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importncia, porque a carncia de recursos exige que sejam alcanados melhores
resultados atravs do uso mnimo de recursos. 2,5
Assim a farmacoeconomia torna-se uma importante ferramenta que auxilia
no objetivo de alcanar melhores resultados. Essa cincia fornece informaes
crticas para a tima alocao dos recursos de cuidados sade. A rea abrange
especialistas de diversos segmentos, tais como economia da sade, anlise de
risco, avaliao de tecnologia, avaliao clnica, epidemiologia, cincias da
deciso e pesquisa em servios da sade. 3,8
A funo da farmacoeconomia na tomada de deciso a racionalizao
atravs da otimizao de recursos que visam escolha de alternativas que
permitam reduzir os custos sem que a qualidade da assistncia seja perdida, ou
seja, uma ferramenta que nos auxilia na escolha das opes mais eficientes (no
que se trata do custo/benefcio) e isso nos ajuda na distribuio de recursos de
uma forma mais justa e equilibrada. 1,2,3,5
Assim, essa ferramenta vem sendo objeto de muita ateno tanto por parte
dos planejadores de sade como das agncias e demais organismos
responsveis pela avaliao de tecnologias em sade em diversos pases.
Observamos um aumento significativo no nmero de avaliaes econmicas, em
funo das preocupaes com a elevao dos gastos em sade, das presses
sobre os gestores nas decises sobre a alocao de recursos e da necessidade
dos produtores de demonstrar os benefcios de suas tecnologias. Porm as
avaliaes econmicas no devem servir como nico ou principal determinante
nas decises em sade e no difcil processo de planejar servios e sistemas de
sade.9
Em alguns pases, como Austrlia e Inglaterra, a farmacoeconomia tem
trazido um grande avano na rea da sade, no s relacionado racionalizao
dos recursos, mas tambm deteco de possveis abusos no uso de
medicamentos ou ainda ocorrncia de eventos adversos, contribuindo assim
para o uso racional de medicamentos. 1,3
No Brasil o uso da farmacoeconomia ainda precrio, porm o prprio
Ministrio da Sade identifica a necessidade de uma ferramenta que possa
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auxiliar na racionalizao dos custos. "A avaliao , em especial, parte
fundamental no planejamento e na gesto do sistema de sade. Um sistema de
avaliao efetivo deve reordenar a execuo de aes e servios,
redimensionando-os de forma a contemplar as necessidades de seu pblico,
dando maior racionalidade ao uso dos recursos." (Ministrio da Sade). 3,7
Para exemplificar a importncia dessa informao podemos citar as
avaliaes econmicas no SUS. Essas avaliaes permitem identificar e mapear
problemas e oportunidades para uso e aplicao de solues tecnolgicas e em
que investigam a efetividade, os custos e os impactos do uso de uma tecnologia
no sistema de sade, podem auxiliar na seleo das intervenes mais efetivas
por menor custo e agregar elementos para alteraes e aprimoramento das
polticas de sade, aumentando a eficincia e a efetividade dos servios e a
qualidade do cuidado em sade prestado.9
2. OBJETIVO
O estudo tem como objetivos:
Avaliar a qualidade de estudos farmacoeconmicos nacionais, com
base nas diretrizes publicadas em 2009 pelo Ministrio da Sade9 e
em compar-los a estudos internacionais de pases referncia (Reino
Unido, Canad e Austrlia).10, 11
Verificar se os estudos farmacoeconmicos nacionais avaliados
apresentam padronizao em relao aos mtodos empregados e
resultados obtidos.
Todos os dados sero obtidos atravs da aplicao de questionrio.
3. MATERIAL E MTODOS
Realizou-se a busca de artigos descrevendo avaliaes econmicas
completas realizadas no Brasil, Reino Unido, Austrlia e Canad, a partir das
bases de dados MEDLINE, LILACS, SCIELO e EMBASE. Uma avaliao
econmica completa corresponde a uma anlise sistemtica e comparativa de
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duas ou mais intervenes na rea da sade, considerando-se os custos e
benefcios proporcionados.12
Os artigos obtidos foram divididos em dois grupos:
Nacional: artigos descrevendo estudos realizados no Brasil;
Internacional: artigos descrevendo estudos realizados no Reino Unido,
Austrlia e Canad.
3.1. Estratgias de pesquisa
Nesta reviso bibliogrfica foram empregadas as seguintes palavras
chaves, isoladas ou combinadas entre si: economia em sade, avaliao
econmica, anlise de custos, economia de custo, anlise custo-minimizao,
anlise de custo-efetividade, anlise de custo-utilidade e anlise de custo-
benefcio, alm dos nomes dos pases escolhidos (Brasil, Reino Unido, Austrlia e
Canad). Foram utilizados tanto termos livres quanto MeSH (PUBMED) ou Emtree
(Embase). O levantamento bibliogrfico foi realizado em junho de 2012, sem
restrio de idiomas.
3.2. Critrios de incluso
Consideramos os seguintes critrios para a incluso dos estudos:
Avaliao econmica completa, ou seja, a anlise comparativa de
custos e benefcios de pelo menos duas alternativas;
Avaliao ou aplicao com foco nas seguintes regies: Brasil, Reino
Unido, Austrlia e Canad;
Publicado entre 2009 2012;
Anlises que consideravam uma comparao entre medicamentos;
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3.3. Critrios de excluso
Como critrios de excluso foram selecionados os seguintes:
Estudos multicntricos, quando um dos centros includos no
correspondia s regies pr-definidas;
Revises, cartas, psteres e editorais foram excludos;
Anlises que comparavam equipamentos, procedimentos ou
cuidados dos profissionais da sade;
3.4. Coleta e anlise dos dados
A avaliao dos artigos foi realizada por meio da aplicao de questionrio
desenvolvido por Chiou e colaboradores15 e adaptado de acordo com as Diretrizes
Metodolgicas de Avaliaes Econmicas em Sade9.
O questionrio de Chiou e colaboradores15 aborda pontos como a clareza
do objetivo, a perspectiva da anlise, a execuo de anlise estatstica e quais
anlises foram realizadas, a apresentao dos desfechos a curto e longo prazo, a
apresentao dos resultados negativos e a clareza do modelo econmico
(incluindo a estrutura), entre outros. As questes com opes de reposta alm de
sim ou no foram excludas do questionrio adaptado.
As Diretrizes estabelecem recomendaes em relao caracterizao do
problema, populao-alvo, desenho do estudo, perspectiva do estudo, horizonte
temporal, taxa de desconto, etc.
O formulrio (Quadro 1) apresenta os critrios finais definidos para o
presente estudo, que incluram informaes sobre objetivo do estudo, desenho,
metodologia e base de dados, alm de identificao das fontes financiadoras.
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Quadro 1. Critrios para avaliao da qualidade metodolgica
1 O objetivo do estudo foi apresentado de forma clara e bem definido?
2 A perspectiva da anlise foi declarada? (pblico, privado, sociedade, etc)
3 Foi realizado anlise de incerteza? (teste estatstico e/ou de sensibilidade)
4 O horizonte temporal do estudo foi suficiente para obteno de todos os resultados relevantes e importantes?
5 Quando o horizonte temporal foi maior que um ano, a taxa de desconto foi aplicada?
6 O ICER/ICUR foi calculado?
7 O numerador e denominador do ICER/ICUR foram apresentados?
8 A efetividade das estratgias comparadas foi adequadamente estabelecida (obtida atravs de dados primrios, ensaios clnicos ou revises sistemticas/metanlises)?
9 Todos os custos e desfechos importantes de cada estratgia foram identificados (considerar se foram suficientemente abrangentes para os objetivos do estudo)?
10 A descrio da fonte para obteno dos valores dos custos foi adequada?
11
As fontes utilizadas para obteno dos custos foram adequadas para os propsitos do estudo (por exemplo, valores de mercado, perspectiva dos pacientes ou usurios, perspectiva dos gestores, julgamento de profissionais de sade, etc)?
12 As limitaes do estudo foram apresentadas?
13 As concluses/recomendaes do estudo foram justificadas e com base nos resultados do estudo?
14 A fonte financiadora foi declarada?
As questes admitem dois tipos de respostas, sim ou no. Algumas
questes dependem de conhecimento prvio sobre a doena e do tipo de
desfecho esperado. As questo 4 e 9 so exemplos disso. As questes 10 e 11
exigem a avaliao das fontes dos dados e se estes so adequados perspectiva
do estudo, por exemplo, um estudo brasileiro sobre perspectiva pblica deve obter
custos do DATASUS (Banco de dados do Sistema nico de Sade), pois assim os
custos apresentados seriam os mesmos praticados pelo setor pblico.
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Para todos os estudos, utilizaram-se apenas as informaes obtidas na
publicao original. No entanto, em alguns casos em que os dados fornecidos no
foram suficientemente detalhados, as referncias do artigo foram consultadas para
que as informaes relevantes fossem extradas. Por exemplo, se os autores
citaram um segundo estudo como fonte para efetividade, esse foi consultado para
determinar se continha as informaes citadas.
O sistema sim/no, recomendado pelo Centre for Reviews and
Disseminations14, foi utilizado para completar os itens presentes no formulrio. A
alternativa a este sistema o uso de scores (por exemplo, muito bom, bom,
regular, ruim, pssimo), mas esse apresenta a desvantagem de dificultar o
entendimento do leitor da reviso, enquanto o sistema sim/no ilustra claramente
os aspectos em que o artigo apresentou falhas ou foi bem executado. O peso
atribudo a cada item depende dos pontos fortes e fracos dos mtodos
empregados e dos resultados obtidos e de suas implicaes sobre a confiabilidade
das concluses. No atual trabalho todos os itens do questionrio tem igual
importncia para o resultado final, portanto o mesmo peso.
De acordo com a quantidade de critrios que o estudo apresentou foi
atribudo uma nota, sendo a menor nota 0,00 e a maior 1,00. A relao entre a
quantidade de critrios e a nota atribuda pode ser observada na Quadro 2.
Quadro 2. Relao entre a nota e a quantidade de critrios presentes no estudo.
Qtd. Critrios
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Nota 0,07 0,14 0,21 0,29 0,36 0,43 0,50 0,57 0,64 0,71 0,79 0,86 0,93 1,00
A seguir apresentamos um exemplo do tipo de informao que esperamos
em cada questo, o artigo utilizado foi Economic evaluation of high-dose (80
mg/day) atorvastatin treatment compared with standard-dose (20 mg/day to 40
mg/day) simvastatin treatment in Canada based on the Incremental Decrease in
End-Points Through Aggressive Lipid-Lowering (IDEAL) trial186. Esse artigo
recebeu nota mxima (1,00), portanto foi utilizado para que pudssemos
exemplificar todos os itens do nosso questionrio.
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1. O objetivo do estudo foi apresentado de forma clara e bem definido?
To assess the cost-effectiveness of high-dose atorvastatin versus standard-
dose simvastatin treatment in patients with a history of MI from a Canadian
societal perspective.186
Comentrio: Cita os medicamentos envolvidos, a doena, o tipo de anlise e a
perspectiva do estudo, definindo o objetivo com clareza.
2. A perspectiva da anlise foi declarada? (pblico, privado, sociedade, etc)
Canadian societal perspective.186
Comentrio: A perspectiva da anlise foi definida e informada.
3. Foi realizado anlise de incerteza? (teste estatstico e/ou de sensibilidade)
For the Markov model, uncertainty was assessed using deterministic and
probabilistic sensitivity analyses. For the probabilistic sensitivity analysis,
distributions of each model parameter (ie, all transition probabilities, resource
use data and utility data) were constructed using nonparametric
bootstrapping. 186
Comentrio: Informa a realizao de anlise de incerteza por meio de mtodos
determinsticos e probabilsticos.
4. O horizonte temporal do estudo foi suficiente para obteno de todos os
resultados relevantes e importantes?
Over the median follow-up of 4.8 years 186
Comentrio: O modelo de Markov demanda em mdia um acompanhamento
de 5 anos, o que descrito no estudo.
5. Quando o horizonte temporal foi maior que um ano, a taxa de desconto foi
aplicada?
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All costs and benefits were discounted at 5% per year as recommended by
the guidelines of the Canadian Agency for Drugs and Technologies in
Health.186
Comentrio: Foi aplicada taxa de desconto de 5% para cada ano.
6. O ICER/ICUR foi calculado?
The resulting incremental cost-effectiveness ratio (ICER) was $17,573 per life-
year gained or $26,795/QALY gained from the societal perspective 186
Comentrio: Os dados so apresentados na Tabela 6 do referido artigo.
7. O numerador e denominador do ICER/ICUR foram apresentados?
Patients in the atorvastatin arm were projected to live an average of 0.0356
years longer and have 0.0234 more QALYs than patients in the simvastatin
arm. This improvement came at an increase of $1,375 in study drug costs;
33.9% of this incremental cost was offset by reduced expenditures for end
point-related hospitalization and an additional 20.5% by lower productivity
losses, leading to a total incremental cost of $627 per patient in the
atorvastatin arm. 186
Comentrio: Os dados so apresentados na Tabela 6 do referido artigo.
8. A efetividade das estratgias comparadas foi adequadamente estabelecida
(obtida atravs de dados primrios, ensaios clnicos ou revises
sistemticas/metanlises)?
a prospective, randomized, open-label, blinded end point trial. 186
Comentrios: A efetividade foi obtida atravs de dados primrios (ensaio
clnico).
9. Todos os custos e desfechos importantes de cada estratgia foram
identificados (considerar se foram suficientemente abrangentes para os
objetivos do estudo)?
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During each one-year cycle, patients could experience a nonfatal MI and
transition into the post-MI state, undergo a revascularization procedure (PCI
or CABG) and transition into the postrevascularization state, or die from any
cause. Patients in the post-MI and postrevascularization states could remain
in their respective health states or die. 186
Comentrio: Os desfechos apresentam-se apropriados com base nas
indicaes e usos teraputicos dos medicamentos.
10. A descrio da fonte para obteno dos valores dos custos foi adequada?
The cost per 40 mg or 80 mg atorvastatin pill used in the model was $2.236
and the cost per generic simvastatin 20 mg or 40 mg pill was $1.100, as listed
in the current Ontario Drug Benefit Formulary (17). Dispensing fees were not
included. 186
Comentrio: A descrio da fonte de obteno dos dados foi includa,
possibilitando reprodutibilidade, e garantindo obteno dos mesmos dados por
outros pesquisadores que utilizem os mtodos propostos no estudo.
11. As fontes utilizadas para obteno dos custos foram adequadas para os
propsitos do estudo (por exemplo, valores de mercado, perspectiva dos
pacientes ou usurios, perspectiva dos gestores, julgamento de profissionais
de sade, etc)?
Alm da informao j citada na Questo 10, temos outro trecho: Each type
of end point-related hospitalization was assigned a total cost of hospitalization
(including overhead) based on the Ontario Case Costing Initiative (OCCI). 186
Comentrio: Ambos os trechos descrevem a utilizao de preos obtidos em
bases de dados que representam a perspectiva da sociedade.
12. As limitaes do estudo foram apresentadas?
The present study needs to be considered in light of its limitations. 186
Comentrio: Em seguida a esta frase, o estudo apresenta um tpico falando
de todas as limitaes.
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13. As concluses/recomendaes do estudo foram justificadas e com base nos
resultados do estudo?
high-dose atorvastatin (80 mg/day) is cost effective compared with
standard-dose simvastatin (20 mg/day to 40 mg/day) from a Canadian societal
perspective. Furthermore, a within-trial analysis suggested that atorvastatin
would result in cost savings compared with simvastatin over a median of 4.8
years. 186
Comentrio: Concluso baseada nos resultados apresentados.
14. A fonte financiadora foi declarada?
This study was funded by Pfizer Inc. 186
Comentrio: H informao referente ao patrocinador do estudo.
3.5. Anlise estatstica
A aplicao do formulrio gerou uma nota para cada artigo. A partir dessas
notas, foram obtidos obtivemos os valores de mdia e desvio padro e os valores
mnimos e mximos. A diferena na mdia para publicaes nacionais e
internacionais foi avaliada atravs do teste Mann-Whitney. O software Minitab foi
utilizado para realizao dos clculos.
4. RESULTADOS
4.1 Levantamento bibliogrfico de artigos nacionais
A busca da literatura inicialmente identificou 408 publicaes potenciais,
sendo 172 da base PUBMED, 216 da base Embase e 20 das bases Scielo e
Lilacs. Dessas 408, 86 foram selecionadas para anlise do texto completo. A
maioria dos artigos foi descartada principalmente devido aos critrios
estabelecidos e alguns outros devido duplicidade (Figura 1).
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Em resumo, dos 86 artigos cujo texto completo foi analisado, 28 foram
includos para serem avaliados de acordo com o formulrio desenvolvido (Quadro
1). As publicaes selecionadas so apresentadas no ANEXO I.
Figura 1. Descrio da incluso e excluso das publicaes nacionais.
4.2 Levantamento bibliogrfico de artigos internacionais
A busca da literatura inicialmente identificou 3.443 publicaes potenciais,
sendo 726 da base PUBMED e 2.717 da base Embase. Dessas 3.443, 388 foram
selecionadas para anlise do texto completo. A maioria dos artigos foi descartada
principalmente devido aos critrios estabelecidos e alguns outros devido
duplicidade (Figura 2).
Em resumo, dos 388 artigos cujo texto completo foi analisado, 152 foram
includos para serem avaliados de acordo com o formulrio (Quadro 1)
desenvolvido. As publicaes selecionadas so apresentadas no ANEXO II.
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Figura 2. Descrio da incluso e excluso das publicaes internacionais.
4.3 Resultados estatsticos
A pontuao atribuda a cada artigo pela aplicao do questionrio
apresentada na Tabela 1 para os artigos nacionais e na Tabela 2 para os artigos
internacionais.
Tabela 1. Pontuao obtida pela aplicao do questionrio adaptado a cada um dos trabalhos do
grupo Nacional. Os artigos foram agrupados de acordo com a nota atribuda a cada um.
Artigos (Nmero da referncia bibliogrfica)
Nota Critrios presentes
21, 27, 30, 33 0,57 8
17, 18 0,64 9
29, 31, 35, 41 0,71 10
16, 23, 34, 36, 39, 40 0,79 11
18, 26 0,86 12
20, 24, 32, 37, 43 0,93 13
19, 22, 25, 38, 42 1,00 14
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Tabela 2. Pontuao obtida pela aplicao do questionrio adaptado a cada um dos trabalhos do
grupo Internacional. Os artigos foram agrupados de acordo com a nota atribuda a cada um.
Artigos (Nmero da referncia bibliogrfica)
Nota Critrios presentes
166, 195 0,71 10
50, 57, 62, 74, 80, 83, 97, 101, 107, 110, 112, 122, 124, 126, 133, 144, 154, 180, 192, 193
0,79 11
47, 53, 60, 70, 76, 77, 86, 88, 91, 93, 96, 104, 108, 118, 119, 121, 132, 135, 136, 138, 140, 143, 150, 153, 158, 159, 161,
162, 185
0,86 12
44, 46, 48, 51, 52, 55, 58, 59, 66, 67, 69, 73, 84, 85, 90, 95, 98, 100, 102, 106, 111, 115, 117, 123, 125, 128, 129, 131, 139, 141, 142, 146, 149, 151, 156, 157, 164, 169, 176, 178, 179, 181, 182, 184, 188, 191,
194
0,93 13
45, 49, 54, 56, 61, 63, 64, 65, 68, 71, 72, 75, 78, 79, 81, 82, 87, 89, 92, 94, 99, 103, 105, 109, 113, 114, 116, 120, 127, 130, 134, 137, 145, 147, 148, 152, 155, 160, 163, 165, 167, 168, 170, 171, 172, 173, 174, 175, 177, 183, 186, 187, 189,
190
1,00 14
A Tabela 3 apresenta os valores mdios, mnimos e mximos de pontuao
obtidos pelos trabalhos dos grupos Nacional e Internacional.
Tabela 3. Resultados para os grupos Nacional e Internacional.
Nacional Internacional
Mdia 0,80 0,92
Desvio Padro 0,15 0,08
Nota Mnima 0,57 0,71
Nota Mxima 1,00 1,00
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O teste de Mann-Whitney foi utilizado para testarmos estatisticamente a
diferena entre os resultados. Para isso utilizamos o software Minitab, o
resultado obtido apresentado na Tabela 4.
Tabela 4. Resultado do teste de Mann-Whitney apresentado pelo Minitab
5. DISCUSSO
O nmero absoluto de publicaes no Brasil ainda pequeno quando
comparado s regies do Reino Unido, Canad e Austrlia onde a avaliao
econmica uma das principais ferramentas para tomada de deciso poltica na
rea da sade. Porm existe sempre a possibilidade de vis de publicao, ou
seja, os estudos com resultado negativo ou nulo podem no terem sido
publicados. Portanto, nossos resultados podem subestimar o verdadeiro nmero
de anlises econmicas da sade na literatura.
Quando comparamos as mdias de ambos os grupos, nacional e
internacional, 0,80 e 0,92 respectivamente, observamos que os estudos
internacionais tem uma quantidade de informao maior do que os estudos
nacionais e portanto uma qualidade melhor segundo nosso formulrio de critrios
e podemos confirmar essa diferena atravs do teste de Mann-Whitney no qual
Grupo n Mediana
Nacional 28 0,7857
Internacional 152 0,9187
Estimao pontual -0,1429
Intervalo de Confiana (95%)
(-0,1428;-0,0715)
Soma das Categorias (sum of ranks)
1552,5
P 0,0001*
*considerou-se diferena significativa para p
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19
consideramos ndice de confiabilidade de 95%, sendo assim a hiptese nula (que
as mdias eram iguais estatisticamente) foi negada (p=0,0001), portanto as
mdias apresentam diferena estatisticamente significante.
Porm ao avaliar o grupo nacional isoladamente de acordo com as
recomendaes apresentadas pelas Diretrizes Metodolgicas de Avaliaes
Econmicas em Sade9, observamos que a sua mdia (0,80) alta quando
comparada com a escala na qual est inserida (0,00 1,00), ou seja, apresenta
uma mdia de 11 critrios presentes no total de 14. Porm o desvio padro
tambm alto o que demonstra uma grande variao na qualidade dos estudos,
portanto mesmo com uma diretriz publicada ainda existem muitos pesquisadores
que no seguem o padro sugerido por essa.
A base para esta avaliao foram as Diretrizes Metodolgicas de
Avaliaes Econmicas em Sade9 explicitadas em um questionrio para coleta
de dados sobre presena ou ausncia de caractersticas consideradas importantes
para este tipo de estudo. Esta metodologia apresentou a limitao de que no foi
possvel validar os mtodos utilizados para calcular os custos em cada estudo,
bem como no foi analisada a influncia da fonte financiadora sobre o resultado
do estudo.
Alm disso, o formulrio foi aplicado por um nico avaliador, sendo que
todos os resultados esto sobre a perspectiva do conhecimento do avaliador,
podemos ter um vis de interpretao, portanto um pool de avaliadores seria mais
adequado para o atual estudo.
6. CONCLUSO
A qualidade dos estudos internacionais mostrou-se superior qualidade
dos estudos nacionais. Apesar disso, podemos considerar que os estudos
nacionais apresentaram nota mdia alta, indicando cumprimento da maior parte
dos critrios definidos pelas Diretrizes Metodolgicas de Avaliaes Econmicas
em Sade9, as quais definem os pontos considerados essenciais no
desenvolvimento de estudos de avaliao econmica.
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20
Embora este resultado seja encorajador, os estudos ainda no esto
plenamente adequados s diretrizes que o Brasil possui e no podem ser
comparados a estudos de principais polos como Canada, Reino Unido e Austrlia.
O aumento da quantidade de estudos de avaliao econmica em sade deve ser
acompanhado de um aumento no rigor metodolgico do desenho do estudo,
construo do modelo, coleta de dados e outros aspectos.
Assim adequando nossos estudos as novas diretrizes podemos utilizar a
farmacoeconomia como um importante brao na tomada de deciso no nosso pas
e no apenas como um complemento de outros resultados.
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8. ANEXOS
ANEXO I
Lista de publicaes nacionais que foram avaliados segundo nossos critrios de qualidade.
Ttulo Referncia
Chronic hepatitis B treatment: the cost-effectiveness of interferon compared to lamivudine. 16
Analysis of the cost-effectiveness of thrombolysis with alteplase in stroke. 17
[Analysis of cost-effectiveness of simvastatin versus atorvastatin in the secondary prevention of
cardiovascular events within the Brazilian public healthcare system]. 18
Short-term therapy with enoxaparin or unfractionated heparin for venous thromboembolism in
hospitalized patients: Utilization study and cost-minimization analysis 19
Impact of treatment completion, intolerance and adverse events on health system costs in a
randomised trial of 4 months rifampin or 9 months isoniazid for latent TB. 20
Individualized treatment of chronic hepatitis C with pegylated interferon and ribavirin. 21
Economic evaluation of clodronate and zoledronate in patients diagnosed with metastatic bone
disease from the perspective of public and third party payors in Brazil. 22
A cost-minimization analysis of dexmedetomidine compared with midazolam for long-term sedation
in the intensive care unit. 23
Cost-effectiveness analysis of a universal infant immunization program with meningococcal C
conjugate vaccine in Brazil. 24
Cost-effectiveness of anastrozole, in comparison with tamoxifen, in the adjuvant treatment of early
breast cancer in Brazil. 25
Cost effectiveness of peginterferon alfa-2B combined with ribavirin for the treatment of chronic
hepatitis C in Brazil. 26
The potential economic value of a hookworm vaccine. 27
Economic evaluation of antipsychotic drugs for schizophrenia treatment within the Brazilian
Healthcare System. 28
Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: An
economic analysis from the Brazilian public health care perspective 29
Clinical evaluation of the use of three anesthetics in endodontics. 30
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Ttulo Referncia
Evaluation of the awareness, control and cost-effectiveness of hypertension treatment in a Brazilian
city: populational study. 31
Cost-effectiveness and budget impact of saxagliptine as additional therapy to metformin for the
treatment of diabetes mellitus type 2 in the Brazilian private health system. 32
Topical versus peribulbar anesthesia in non-penetrating deep sclerectomy. A cost-effectiveness
analysis. 33
Cost-effectiveness of fondaparinux in patients with acute coronary syndrome without ST-segment
elevation. 34
Cost-effectiveness of introducing the 10-valent pneumococcal conjugate vaccine into the universal
immunisation of infants in Brazil. 35
[Cost-effectiveness analysis of adjuvant anastrozol in post-menopausal women with breast cancer]. 36
An economic evaluation of antihypertensive therapies based on clinical trials. 37
Combination therapy for visceral leishmaniasis. 38
Cervical cancer screening among HIV-infected women: an economic evaluation in a middle-income
country. 39
Economic modelling assessment of the HPV quadrivalent vaccine in Brazil: a dynamic individual-
based approach. 40
Cost-effectiveness analysis on spinal anesthesia versus local anesthesia plus sedation for loop
colostomy closure. 41
Cost-effectiveness of telbivudine versus lamivudine for chronic hepatitis B. 42
Hepatitis A: The costs and benefits of the disease prevention by vaccine, Parana, Brazil 43
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ANEXO II
Lista de publicaes internacionais que foram avaliados segundo nossos critrios de qualidade.
Ttulo Referncia
Cost effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate gel
in the treatment of scalp psoriasis in Scotland 44
Cost-effectiveness evaluation of voriconazole versus liposomal amphotericin B as empirical therapy
for febrile neutropenia in Australia 45
Economic impact of caspofungin as compared with liposomal amphotericin B for empirical therapy in
febrile neutropenia in Australia 46
Pharmacoeconomic analysis of voriconazole vs. caspofungin in the empirical antifungal therapy of
febrile neutropenia in Australia 47
Cost-effectiveness of adalimumab in moderately to severely active ulcerative colitis 48
Impact and effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive
pneumococcal disease in the elderly in England and Wales 49
Cost-effectiveness of FOLFIRINOX for first-line treatment of metastatic pancreatic cancer 50
Cost-effectiveness of oxaliplatin in the adjuvant treatment of colon cancer in Canada 51
A one-year economic evaluation of six alternative strategies for the management of uninvestigated
upper gastrointestinal symptoms in Canadian primary care 52
Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in
the UK 53
Choice of angiotensin receptor blocker in moderate hypertension. A UK-based costbenefit
comparison of olmesartan- and candesartan-based regimens 54
Optimizing adherence in hypertension: A comparison of outcomes and costs using single tablet
regimens vs individual component regimens 55
Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR
in treating major depressive disorder in Scotland 56
An economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK 57
The cost effectiveness of rufinamide in the treatment of lennox-gastaut syndrome in the UK 58
Cost-utility of Intravenous Immunoglobulin (IVIG) compared with corticosteroids for the treatment of
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Canada 59
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Canadian cost-utility analysis of intravenous immunoglobulin for acute childhood idiopathic
thrombocytopenic purpura 60
The effectiveness and cost-effectiveness of donepezil, galantamine, rivastigmine and memantine for
the treatment of Alzheimer's disease (review of Technology Appraisal No. 111): a systematic review
and economic model.
61
Cost-effectiveness of denosumab (D) versus zoledronic acid (Z) for skeletal-related event (SRE)
reduction in bone-metastatic prostate cancer (mPC) in the United Kingdom 62
A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the treatment of mild-
to-moderate ulcerative colitis from a UK perspective 63
The cost-effectiveness of celecoxib vs diclofenac in the treatment of osteoarthritis in the UK; an
update to the NICE model using data from the CONDOR trial 64
Lenalidomide for multiple myeloma: cost-effectiveness in patients with one prior therapy in England
and Wales 65
The cost-effectiveness of solifenacin vs fesoterodine, oxybutynin immediate-release, propiverine,
tolterodine extended-release and tolterodine immediate-release in the treatment of patients with
overactive bladder in the UK National Health Service
66
The effect of methamphetamine and heroin price on polydrug use: A behavioural economics analysis
in Sydney, Australia 67
Sugammadex for the reversal of muscle relaxation in general anaesthesia: A systematic review and
economic assessment 68
Health economic comparison between continuous subcutaneous insulin infusion and multiple daily
injections of insulin for the treatment of adult type 1 diabetes in Canada 69
Cost-effectiveness of raltegravir in HIV/AIDS 70
Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for
pulmona