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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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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 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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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.
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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 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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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
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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
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
-
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.
-
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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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
Continua
-
Continuao
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
-
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
Continua
-
Continuao
Ttulo Referncia
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