Panorama Geral Da Qualidade Dos Estudos Farmacoeconomicos Nacionais e Internacionais Segundo As Diretrizes Metodológicas de Avaliações Econômicas em Saúde de 2009 (MS) .

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
Universidade de So Paulo.
Orientadora:
Profa. Dra Valentina Porta
So Paulo
2013
da
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
1
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
2
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:
Metodolgicas.
Farmacoeconmia,
Custo-efetividade,
Brasil,
Diretrizes
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.
3
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.
4
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
5
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
6
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
execuo
de
aes
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
7
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 custobenefcio, 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;
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.
9
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?
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?
A efetividade das estratgias comparadas foi adequadamente estabelecida
8 (obtida atravs de dados primrios, ensaios clnicos ou revises
sistemticas/metanlises)?
Todos os custos e desfechos importantes de cada estratgia foram
9 identificados (considerar se foram suficientemente abrangentes para os
objetivos do estudo)?
10 A descrio da fonte para obteno dos valores dos custos foi adequada?
As fontes utilizadas para obteno dos custos foram adequadas para os
propsitos do estudo (por exemplo, valores de mercado, perspectiva dos
11
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.
10
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
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.
11
1. O objetivo do estudo foi apresentado de forma clara e bem definido?

To assess the cost-effectiveness of high-dose atorvastatin versus standarddose 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?
12
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 lifeyear 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)?
13
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.
14
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
estabelecidos e alguns outros devido duplicidade (Figura 1).
aos
critrios
15
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.
16
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
17, 18
0,64
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
17
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
18
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
Grupo
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
0,0001*
*considerou-se diferena significativa para p<0,05.
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
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
desenvolvimento de estudos de avaliao econmica.
no
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.
21
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WELSH, R. C. et al. Cost-effectiveness of enoxaparin compared with unfractionated

heparin in ST elevation myocardial infarction patients undergoing pharmacological
reperfusion: A Canadian analysis of the Enoxaparin and Thrombolysis Reperfusion for
Acute Myocardial Infarction Treatment - Thrombolysis in Myocardial Infarction
(ExTRACT-TIMI) 25 trial. Canadian Journal of Cardiology, v. 25, n. 12, p. e399-e405,
2009.
189.
WEX-WECHOWSKI, J. et al. HP-HMG versus rFSH in treatments combining fresh and

frozen IVF cycles: Success rates and economic evaluation. Reproductive BioMedicine
Online, v. 21, n. 2, p. 166-178, 2010.
190.
WIELAGE, R. et al. The cost-effectiveness of duloxetine in chronic low back pain: A

Quebec societal perspective. Spine, 2012.
191.
WILBUR, K.; LYND, L. D.; SADATSAFAVI, M. Low-molecular-weight heparin versus
36
unfractionated heparin for prophylaxis of venous thromboembolism in medicine patients-A
pharmacoeconomic analysis. Clinical and Applied Thrombosis/Hemostasis, v. 17, n. 5, p.
454-465, 2011.
192.
WILSON, E. C. Cost effectiveness of imiquimod 5% cream compared with methyl

aminolevulinate-based photodynamic therapy in the treatment of non-hyperkeratotic, nonhypertrophic actinic (solar) keratoses: a decision tree model. In: (Ed.).
Pharmacoeconomics. New Zealand, v.28, p.1055-64, 2010.
193.
WILSON, E. C. et al. Cost effectiveness of leukotriene receptor antagonists versus longacting beta-2 agonists as add-on therapy to inhaled corticosteroids for asthma: a pragmatic
trial. Pharmacoeconomics, v. 28, n. 7, p. 597-608, 2010.
194.
WILSON, E. C. et al. Cost effectiveness of leukotriene receptor antagonists versus inhaled

corticosteroids for initial asthma controller therapy: a pragmatic trial.
Pharmacoeconomics, v. 28, n. 7, p. 585-95, 2010.
195.
WOODS, B. et al. Bendamustine versus chlorambucil for the first-line treatment of chronic
lymphocytic leukemia in England and Wales: A cost-utility analysis. Value in Health, v.
15, n. 5, p. 759-770, 2012.
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].
Short-term therapy with enoxaparin or unfractionated heparin for venous thromboembolism in
hospitalized patients: Utilization study and cost-minimization analysis
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.
Individualized treatment of chronic hepatitis C with pegylated interferon and ribavirin.
Economic evaluation of clodronate and zoledronate in patients diagnosed with metastatic bone
disease from the perspective of public and third party payors in Brazil.
A cost-minimization analysis of dexmedetomidine compared with midazolam for long-term sedation
in the intensive care unit.
Cost-effectiveness analysis of a universal infant immunization program with meningococcal C
conjugate vaccine in Brazil.
Cost-effectiveness of anastrozole, in comparison with tamoxifen, in the adjuvant treatment of early
breast cancer in Brazil.
Cost effectiveness of peginterferon alfa-2B combined with ribavirin for the treatment of chronic
hepatitis C in Brazil.
The potential economic value of a hookworm vaccine.
Economic evaluation of antipsychotic drugs for schizophrenia treatment within the Brazilian
Healthcare System.
Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: An
economic analysis from the Brazilian public health care perspective
Clinical evaluation of the use of three anesthetics in endodontics.
18
19
20
21
22
23
24
25
26
27
28
29
30
Continua
Continuao
Ttulo
Evaluation of the awareness, control and cost-effectiveness of hypertension treatment in a Brazilian
city: populational study.
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.
Topical versus peribulbar anesthesia in non-penetrating deep sclerectomy. A cost-effectiveness
analysis.
Cost-effectiveness of fondaparinux in patients with acute coronary syndrome without ST-segment
elevation.
Cost-effectiveness of introducing the 10-valent pneumococcal conjugate vaccine into the universal
immunisation of infants in Brazil.
Referncia
31
32
33
34
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.
Economic modelling assessment of the HPV quadrivalent vaccine in Brazil: a dynamic individualbased approach.
Cost-effectiveness analysis on spinal anesthesia versus local anesthesia plus sedation for loop
colostomy closure.
39
40
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
ANEXO II
Lista de publicaes internacionais que foram avaliados segundo nossos critrios de qualidade.
Ttulo
Cost effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate gel
in the treatment of scalp psoriasis in Scotland
Cost-effectiveness evaluation of voriconazole versus liposomal amphotericin B as empirical therapy
for febrile neutropenia in Australia
Economic impact of caspofungin as compared with liposomal amphotericin B for empirical therapy in
febrile neutropenia in Australia
Pharmacoeconomic analysis of voriconazole vs. caspofungin in the empirical antifungal therapy of
febrile neutropenia in Australia
Cost-effectiveness of adalimumab in moderately to severely active ulcerative colitis
Impact and effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive
pneumococcal disease in the elderly in England and Wales
Referncia
44
45
46
47
48
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
Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in
the UK
Choice of angiotensin receptor blocker in moderate hypertension. A UK-based costbenefit
comparison of olmesartan- and candesartan-based regimens
Optimizing adherence in hypertension: A comparison of outcomes and costs using single tablet
regimens vs individual component regimens
Economic evaluation of duloxetine versus serotonin selective reuptake inhibitors and venlafaxine XR
in treating major depressive disorder in Scotland
52
53
54
55
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
Continua
Continuao
Ttulo
Canadian cost-utility analysis of intravenous immunoglobulin for acute childhood idiopathic
thrombocytopenic purpura
Referncia
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
61
and economic model.

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
A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the treatment of mildto-moderate ulcerative colitis from a UK perspective
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
Lenalidomide for multiple myeloma: cost-effectiveness in patients with one prior therapy in England
and Wales
62
63
64
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
66
overactive bladder in the UK National Health Service

The effect of methamphetamine and heroin price on polydrug use: A behavioural economics analysis
in Sydney, Australia
Sugammadex for the reversal of muscle relaxation in general anaesthesia: A systematic review and
economic assessment
Health economic comparison between continuous subcutaneous insulin infusion and multiple daily
injections of insulin for the treatment of adult type 1 diabetes in Canada
Cost-effectiveness of raltegravir in HIV/AIDS
67
68
69
70
Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for
pulmonary arterial hypertension within their licensed indications: a systematic review and economic
71
evaluation
Dabigatran etexilate: an oral direct thrombin inhibitor for the management of thromboembolic
disorders
The clinical effectiveness and cost-effectiveness of primary stroke prevention in children with sickle
cell disease: a systematic review and economic evaluation.
72
73
Continua
Continuao
Ttulo
Docetaxel for the adjuvant treatment of early node-positive breast cancer: a single technology
appraisal
Access to the next wave of biologic therapies (Abatacept and Tocilizumab) for the treatment of
rheumatoid arthritis in England and Wales Addressing treatment outside the current NICE guidance
Referncia
74
75
Cost effectiveness of pregabalin in the treatment of fibromyalgia from a UK perspective
76
Improving the cost-effectiveness of cardiovascular disease prevention in Australia: a modelling study.
77
Cost-effectiveness of highly purified omega-3 polyunsaturated fatty acid ethyl esters in the treatment
of chronic heart failure: Results of Markov modelling in a UK setting
UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus
ciclosporin for pyoderma gangrenosum): Protocol for a randomised controlled trial
Cost effectiveness of tenofovir disoproxil fumarate for the treatment of chronic hepatitis b from a
canadian public payer perspective
Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to
metformin monotherapy in Type 2 diabetes mellitus
Cost effectiveness of travoprost versus a fixed combination of latanoprost/timolol in patients with
ocular hypertension or glaucoma: Analysis based on the UK general practitioner research database
Cost-effectiveness of zoledronic acid vs clodronic acid for newly-diagnosed multiple myeloma from
the United Kingdom healthcare system perspective
Cost-effectiveness of lapatinib plus capecitabine in women with HER2+ metastatic breast cancer who
have received prior therapy with trastuzumab
Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous
thromboembolism in Canada
Cost-effectiveness of onabotulinumtoxinA for the treatment of wrist and hand disability due to upperlimb post-stroke spasticity in Scotland
Cost-effectiveness of apixaban against current standard of care (SoC) for stroke prevention in atrial
fibrillation patients
Nab-Paclitaxel weekly or every 3 weeks compared to standard docetaxel as first-line therapy in
patients with metastatic breast cancer: An economic analysis of a prospective randomized trial
78
79
80
81
82
83
84
85
86
87
88
Continua
Continuao
Ttulo
A systematic review and economic evaluation of the use of tumour necrosis factor-alpha (TNF-alfa)
inhibitors, adalimumab and infliximab, for Crohn's disease
Referncia
89
Quality of life benefits and cost impact of prolonged release oxycodone/naloxone versus prolonged
release oxycodone in patients with moderate-to-severe non-malignant pain and opioid-induced
90
constipation: A UK cost-utility analysis

Cost-effectiveness of 2 + 1 dosing of 13-valent and 10-valent pneumococcal conjugate vaccines in
Canada
Treating pneumonia in critical care in the United Kingdom following failure of initial antibiotic: A costutility analysis comparing meropenem with piperacillin/tazobactam
Cost effectiveness of quetiapine in patients with acute bipolar depression and in maintenance
treatment after an acute depressive episode.
Potential cost-effectiveness of rifampin vs. isoniazid for latent tuberculosis: Implications for future
clinical trials
Cost-effectiveness of quetiapine plus mood stabilizers compared with mood stabilizers alone in the
maintenance therapy of bipolar I disorder: results of a Markov model analysis
Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD
Cost effectiveness of donepezil in the treatment of mild to moderate Alzheimer's disease: A UK
evaluation using discrete-event simulation
A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain
Cost-effectiveness of pentostatin compared with cladribine in the management of hairy cell leukemia
in the United Kingdom
Health economic assessment of ferric carboxymaltose in patients with iron deficiency and chronic
heart failure based on the FAIR-HF trial: an analysis for the UK.
Cost-effectiveness of adding cetuximab to platinum-based chemotherapy for first-line treatment of
recurrent or metastatic head and neck cancer
Cost effectiveness of rasagiline and pramipexole as treatment strategies in early Parkinson's disease
in the UK setting: an economic Markov model evaluation
Cost-effectiveness analysis of antiviral treatments for HBeAg-positive chronic hepatitis B in Canada
91
92
93
94
95
96
97
98
99
100
101
102
103
Continua
Continuao
Ttulo
Referncia
Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in

patients with overactive bladder
Cost-effectiveness of available treatment options for patients suffering from severe COPD in the UK:
a fully incremental analysis.
Cost-effectiveness of temsirolimus for first line treatment of advanced renal cell carcinoma
Cost-effectiveness of dasatinib and nilotinib for imatinib-resistant or -intolerant chronic phase chronic
myeloid leukemia
Cost-effectiveness of tapentadol prolonged release compared with oxycodone controlled release in
the UK in patients with severe non-malignant chronic pain who failed 1st line treatment with morphine
Cost Effectiveness of Etoricoxib Versus Celecoxib and Non-Selective NSAIDS in the Treatment of
Ankylosing Spondylitis
Accounting for the development of antibacterial resistance in the cost effectiveness of ertapenem
versus piperacillintazobactam in the treatment of diabetic foot infections in the UK
Comparing bivalent and quadrivalent human papillomavirus vaccines: Economic evaluation based on
transmission model
Adefovir dipivoxil and pegylated interferon alpha for the treatment of chronic hepatitis B: an updated
systematic review and economic evaluation
Dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation
in Canada: Comparative efficacy and cost-effectiveness
Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK
patients with atrial fibrillation
Lifetime cost-utility analyses of deferasirox in beta-thalassaemia patients with chronic iron overload: A
UK perspective
Cost-effectiveness of second-line antihyperglycemic therapy in patients with type 2 diabetes mellitus
inadequately controlled on metformin
Health and economic impact of PHiD-CV in Canada and the UK: A Markov modelling exercise
Treatment
persistence
and
cost-effectiveness
of
104
105
106
107
108
109
110
111
112
113
114
115
116
117
latanoprost/latanoprost-timolol,
bimatoprost/bimatoprost-timolol, and travoprost/travoprost-timolol in glaucoma: An analysis based on
118
the United Kingdom general practitioner research database
Continua
Continuao
Ttulo
Cost effectiveness of venlafaxine compared with generic fluoxetine or generic amitriptyline in major
depressive disorder in the UK
Cost-effectiveness of erlotinib versus docetaxel for second-line treatment of advanced non-small-cell
lung cancer in the United Kingdom
The economic value of primary prophylaxis using pegfilgrastim compared with filgrastim in patients
with breast cancer in the UK
Economic evaluation of etanercept in the management of chronic plaque psoriasis
Cost-effectiveness of insulin aspart compared to human insulin in pregnant women with type 1
diabetes in the UK
Oral versus i.v. antibiotics for community-acquired pneumonia in children: A cost-minimisation
analysis
Referncia
119
120
121
122
123
124
Cost-effectiveness analysis of degarelix for advanced hormone-dependent prostate cancer
125
Cost-effectiveness of alemtuzumab for T-cell prolymphocytic leukemia
126
Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes and
planned percutaneous coronary intervention: results from the trial to assess improvement in
therapeutic outcomes by optimizing platelet inhibition with Prasugrel-Thrombolysis in Myocardial
127
Infarction TRI..
Cost-effectiveness of infant vaccination with RIX4414 (Rotarix) in the UK
Health state preferences associated with subcutaneous injections and intravenous infusions for
treatment of bone metastases
Cost-effectiveness of combination therapy with etravirine in treatment-experienced adults with HIV-1
infection
Cost-effectiveness of rivaroxaban in the prevention of venous thromboembolism: A Canadian analysis
using the Ontario Ministry of Health Perspective.
Comparison of the metabolic and economic consequences of long-term treatment of schizophrenia
using ziprasidone, olanzapine, quetiapine and risperidone in Canada: a cost-effectiveness analysis
Cost-effectiveness of aldosterone antagonists for the treatment of post-myocardial infarction heart
failure
128
129
130
131
132
133
Continua
Continuao
Ttulo
Referncia
Cost-effectiveness analysis of anidulafungin versus fluconazole for the treatment of invasive

candidiasis
Cost effectiveness of paricalcitol versus a non-selective vitamin D receptor activator for secondary
hyperparathyroidism in the UK: A chronic kidney disease markov model
Rheumatoid arthritis comparison of active therapies in methotrexate suboptimal responders:
Validation of the strategy of conventional disease modifying anti-rheumatic drugs before biologicals
Using
the
Cardiff
Long
Term
Model
to
estimate
the
long-term
cost-utility
of
134
135
136
adding
Onglyza(trademark) (saxagliptin) versus a thiazolidinedione (TZD) in patients with type 2 diabetes

mellitus (T2DM) with insufficient glycemic control using maximal doses of metformin monotherapy and
137
after failure or contraindication to sulfonylurea combination therapy

Cost-effectiveness of switching to biphasic insulin aspart from human premix insulin in a US setting
Cost utility analysis based on a head-to-head phase 3 trial comparing ustekinumab and etanercept in
patients with moderate-to-severe plaque psoriasis: A Canadian perspective
Rituximab for the first-line treatment of stage III-IV follicular lymphoma (review of Technology
Appraisal No. 110): a systematic review and economic evaluation.
Cost-effectiveness of biologics compared with disease-modifying antirheumatic drugs in rheumatoid
arthritis
Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block:
a systematic review and economic evaluation
Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid
leukaemia: systematic reviews and economic analyses.
The cost-effectiveness of aripiprazole in the management of adolescent schizophrenia in the United
Kingdom
Cost-effectiveness analysis of prostaglandin E2 gel for the induction of labour at term
Comparative net cost impact of the utilization of romiplostim and intravenous immunoglobulin for the
treatment of patients with immune thrombocytopenia in Quebec
Economic evaluation of adjunctive eslicarbazepine acetate in patients with refractory partial-onset
seizures
138
139
140
141
142
143
144
145
146
147
Continua
Continuao
Ttulo
Referncia
The clinical effectiveness and cost-effectiveness of bortezomib and thalidomide in combination

regimens with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma:
148
a systematic review and economic evaluation

Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context:
Quantitative benefit-harm and economic analyses
Cost-effectiveness of a 3-dose pneumococcal conjugate vaccine program in the province of Quebec,
Canada
A UK Analysis of the Cost-Effectiveness of Humalog Mix75/25 and Mix50/50 Versus Long-Acting
Basal Insulin
An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the
UK
Evaluating the cost utility of racecadotril for the treatment of acute watery diarrhea in children: The
RAWD model
Cost-effectiveness of febuxostat in managing Hyperuricemia in gout patients in Canada
Cost effectiveness of a lidocaine 5% medicated plaster compared with pregabalin for the treatment of
postherpetic neuralgia in the UK: A Markov model Analysis
Dysport(registered trademark) versus Botox(registered trademark) in the treatment of idiopathic
detrusor overactivity: A financial and outcome evaluation
Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis: a systematic review and
economic evaluation
Bevacizumab in combination with a taxane for the first-line treatment of HER2-negative metastatic
breast cancer
Dasatinib and nilotinib for imatinib-resistant or -intolerant chronic myeloid leukaemia: a systematic
review and economic evaluation.
Vaccination of risk groups in England using the 13 valent pneumococcal conjugate vaccine: Economic
analysis
Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDS and anti-TNF
inadequate responders for the management of moderate to severe rheumatoid arthritis
Economic evaluation of voriconazole versus itraconazole for primary prophylaxis of invasive fungal
infection in allogeneic haematopoietic stem cell transplantation
149
150
151
152
153
154
155
156
157
158
159
160
161
162
Continua
Continuao
Ttulo
Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of
acute ST-segment elevation myocardial infarction
Use of analogue insulin in patients with Type 2 diabetes: An unnecessary expense for the NHS
Cost-effectiveness analysis of micafungin versus caspofungin for treatment of systemic Candida
infections in the UK
Referncia
163
164
165
Economic and health-related quality-of-life (HRQoL) comparison of lopinavir/ritonavir (LPV/r) and

atazanavir plus ritonavir (ATVRTV) based regimens for antiretroviral therapy (ART)-naive and -
166
experienced United Kingdom patients in 2011

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial
fibrillation: A Canadian payer perspective
167
A systematic review and economic evaluation of cilostazol, naftidrofuryl oxalate, pentoxifylline and
inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial
168
disease
Cost-effectiveness of latanoprost and timolol maleate for the treatment of glaucoma in Scandinavia
and the United Kingdom, using a decision-analytic health economic model
Economic evaluation of posaconazole versus standard azole therapy as prophylaxis against invasive
fungal infections in patients with prolonged neutropenia in Canada
Cost-effectiveness of systemic therapies for metastatic pancreatic cancer
Cost-effectiveness analysis of intranasal live attenuated vaccine (LAIV) versus injectable inactivated
influenza vaccine (TIV) for Canadian children and adolescents
The cost-effectiveness of macrogol 3350 compared to lactulose in the treatment of adults suffering
from chronic constipation in the UK
Cost-effectiveness of using an extensively hydrolysed formula compared to an amino acid formula as
first-line treatment for cow milk allergy in the UK
Budget impact analysis of boceprevir and telaprevir for the treatment of hepatitis C genotype 1
infection
Cost effectiveness of deferasirox compared to desferrioxamine in the treatment of iron overload in
lower-risk, transfusion-dependent myelodysplastic syndrome patients
Pharmaco-economic analysis of direct medical costs of metastatic colorectal cancer therapy with
XELOX or modified FOLFOX-6 regimens: Implications for health-care utilization in Australia
169
170
171
172
173
174
175
176
177
Continua
Continuao
Ttulo
Referncia
Cost-effectiveness of insulin detemir compared to NPH insulin for type 1 and type 2 diabetes mellitus
in the Canadian payer setting: Modeling analysis
Cost effectiveness of insulin glargine plus oral antidiabetes drugs compared with premixed insulin
alone in patients with type 2 diabetes mellitus in Canada
The cost-effectiveness of a 13-valent pneumococcal conjugate vaccination for infants in England
Cost-effectiveness of lanthanum carbonate in the treatment of hyperphosphatemia in dialysis patients:
a Canadian payer perspective.
Cost-effectiveness of lanthanum carbonate in the treatment of hyperphosphatemia in chronic kidney
disease before and during dialysis
Cost-utility analysis of rufinamide versus topiramate and lamotrigine for the treatment of children with
Lennox-Gastaut Syndrome in the United Kingdom
178
179
180
181
182
183
Estimating the quality-of-life impact and cost-effectiveness of alpha-blocker and anti-muscarinic

combination treatment in men with lower urinary tract symptoms related to benign prostatic
184
hyperplasia and overactive bladder

Cost-effectiveness of intensive lipid lowering therapy with 80 mg of atorvastatin, versus 10 mg of
atorvastatin, for secondary prevention of cardiovascular disease in Canada
185
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
186
End-Points Through Aggressive Lipid-Lowering (IDEAL) trial

Cost effectiveness of Apomorphine infusion in the treatment of advanced Parkinson's disease in the
UK
187
Cost-effectiveness of enoxaparin compared with unfractionated heparin in ST elevation myocardial

infarction patients undergoing pharmacological reperfusion: a Canadian analysis of the Enoxaparin
and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment - Thrombolysis in
188
Myocardial Infar..
HP-HMG versus rFSH in treatments combining fresh and frozen IVF cycles: Success rates and
economic evaluation
The cost-effectiveness of duloxetine in chronic low back pain: A Quebec societal perspective
Low-molecular-weight
heparin
versus
unfractionated
heparin
thromboembolism in medicine patients-A pharmacoeconomic analysis
for
prophylaxis
of
189
190
venous
191
Continua
Continuao
Ttulo
Referncia
Cost effectiveness of imiquimod 5% cream compared with methyl aminolevulinate-based

photodynamic therapy in the treatment of non-hyperkeratotic, non-hypertrophic actinic (solar)
192
keratoses: a decision tree model

Cost effectiveness of leukotriene receptor antagonists versus inhaled corticosteroids for initial asthma
controller therapy: A pragmatic trial
Cost effectiveness of leukotriene receptor antagonists versus long-acting beta-2 agonists as add-on
therapy to inhaled corticosteroids for asthma: A pragmatic trial
Bendamustine versus chlorambucil for the first-line treatment of chronic lymphocytic leukemia in
England and Wales: A cost-utility analysis
03/05/13
03/05/13
Andr Marques dos Santos
Valentina Porta
193
194
195

Panorama Geral Da Qualidade Dos Estudos Farmacoeconomicos Nacionais e Internacionais Segundo As Diretrizes Metodológicas de Avaliações Econômicas em Saúde de 2009 (MS) .

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UNIVERSIDADE DE SO PAULO

FACULDADE DE CINCIAS FARMACUTICAS

Panorama geral da qualidade dos estudos farmacoeconomicos

Andr Marques dos Santos

Trabalho de Concluso do Curso de

Razo de custo-efetividade incremental

Razo de custo-utilidade incremental

Sistema nico de Sade

LISTA DE QUADROS E TABELAS

INTRODUO: A sade constitui um direito social bsico para as condies de

Os medicamentos, recursos de diagnstico e teraputica, so um dos

Assim a farmacoeconomia torna-se uma importante ferramenta que auxilia

redimensionando-os de forma a contemplar as necessidades de seu pblico,

Para exemplificar a importncia dessa informao podemos citar as

Os artigos obtidos foram divididos em dois grupos:

3.1. Estratgias de pesquisa

Nesta reviso bibliogrfica foram empregadas as seguintes palavras

3.2. Critrios de incluso

Consideramos os seguintes critrios para a incluso dos estudos:

3.3. Critrios de excluso

Como critrios de excluso foram selecionados os seguintes:

cuidados dos profissionais da sade;

3.4. Coleta e anlise dos dados

A avaliao dos artigos foi realizada por meio da aplicao de questionrio

O horizonte temporal do estudo foi suficiente para obteno de todos os

6 O ICER/ICUR foi calculado?

As concluses/recomendaes do estudo foram justificadas e com base nos

14 A fonte financiadora foi declarada?

Disseminations14, foi utilizado para completar os itens presentes no formulrio. A

Quadro 2. Relao entre a nota e a quantidade de critrios presentes no estudo.

A seguir apresentamos um exemplo do tipo de informao que esperamos

(IDEAL) trial186. Esse artigo

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)

distributions of each model parameter (ie, all transition probabilities, resource

4. O horizonte temporal do estudo foi suficiente para obteno de todos os

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

9. Todos os custos e desfechos importantes de cada estratgia foram

12. As limitaes do estudo foram apresentadas?

13. As concluses/recomendaes do estudo foram justificadas e com base nos

14. A fonte financiadora foi declarada?

3.5. Anlise estatstica

4.1 Levantamento bibliogrfico de artigos nacionais

A busca da literatura inicialmente identificou 408 publicaes potenciais,

estabelecidos e alguns outros devido duplicidade (Figura 1).

Figura 1. Descrio da incluso e excluso das publicaes nacionais.

A busca da literatura inicialmente identificou 3.443 publicaes potenciais,

Figura 2. Descrio da incluso e excluso das publicaes internacionais.

A pontuao atribuda a cada artigo pela aplicao do questionrio

21, 27, 30, 33

29, 31, 35, 41

16, 23, 34, 36, 39, 40

20, 24, 32, 37, 43

19, 22, 25, 38, 42

50, 57, 62, 74, 80, 83, 97, 101,

47, 53, 60, 70, 76, 77, 86, 88,

44, 46, 48, 51, 52, 55, 58, 59,

45, 49, 54, 56, 61, 63, 64, 65,

A Tabela 3 apresenta os valores mdios, mnimos e mximos de pontuao

O teste de Mann-Whitney foi utilizado para testarmos estatisticamente a