<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1679-4974</journal-id>
<journal-title><![CDATA[Epidemiologia e Serviços de Saúde]]></journal-title>
<abbrev-journal-title><![CDATA[Epidemiol. Serv. Saúde]]></abbrev-journal-title>
<issn>1679-4974</issn>
<publisher>
<publisher-name><![CDATA[Secretaria de Vigilância em Saúde e Ambiente - Ministério da Saúde do Brasil]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1679-49742019000200017</article-id>
<article-id pub-id-type="doi">10.5123/s1679-49742019000200013</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Terapia-alvo versus dacarbazina no tratamento de primeira linha do melanoma avançado não cirúrgico e metastático: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde, 2018-2020]]></article-title>
<article-title xml:lang="es"><![CDATA[Terapia dirigida versus dacarbazina en el tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico: análisis de impacto presupuestario en la perspectiva del Sistema Nacional de Salud de Brasil, 2018-2020]]></article-title>
<article-title xml:lang="en"><![CDATA[Target therapy versus dacarbazine in first-line treatment of advanced non-surgical and metastatic melanoma: budget impact analysis from the perspective of the Brazilian National Health System, 2018-2020]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Corrêa]]></surname>
<given-names><![CDATA[Flávia de Miranda]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Guerra]]></surname>
<given-names><![CDATA[Renata Leborato]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernandes]]></surname>
<given-names><![CDATA[Ricardo Ribeiro Alves]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Souza]]></surname>
<given-names><![CDATA[Mirian Carvalho de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Zimmermann]]></surname>
<given-names><![CDATA[Ivan Ricardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Ministério da Saúde Instituto Nacional de Câncer José Alencar Gomes da Silva ]]></institution>
<addr-line><![CDATA[Rio de Janeiro RJ]]></addr-line>
<country>Brazil</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Ministério da Saúde Secretaria de Ciência, Tecnologia e Insumos Estratégicos ]]></institution>
<addr-line><![CDATA[Brasília DF]]></addr-line>
<country>Brazil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2019</year>
</pub-date>
<volume>28</volume>
<numero>2</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_arttext&amp;pid=S1679-49742019000200017&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_abstract&amp;pid=S1679-49742019000200017&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iec.gov.br/scielo.php?script=sci_pdf&amp;pid=S1679-49742019000200017&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Resumo  Objetivo:  estimar o impacto orçamentário incremental da terapia-alvo para tratamento de primeira linha do melanoma avançado não cirúrgico e metastático, em comparação à dacarbazina.  Métodos:  análise de impacto orçamentário na perspectiva do Sistema Único de Saúde (SUS) do Brasil; a partir de dados demográficos e estimativas da incidência, foi delimitada a população no horizonte temporal de três anos (2018-2020) e estimados os custos diretos médicos; foi considerado cenário de referência o tratamento com dacarbazina, e como cenários alternativos a terapia-alvo com vemurafenibe, dabrafenibe, vemurafenibe + cobimetinibe e dabrafenibe + trametinibe; a avaliação das incertezas foi conduzida mediante análise por cenários.  Resultados:  o impacto orçamentário incremental variou de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% dos gastos anuais totais com medicamentos ambulatoriais no SUS; no melhor e no pior cenário, os resultados variaram de R$ 289.160.835,00 a R$ 1.107.081.926,00.  Conclusão:  a terapia-alvo, comparada à dacarbazina, implica impacto excessivo no orçamento, desfavorecendo eventual incorporação.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Objetivo:  estimar el impacto presupuestario incremental de la terapia dirigida para tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico comparado con la dacarbazina.  Métodos: análisis de impacto presupuestario, en la perspectiva del Sistema Único de Salud (SUS) de Brasil; a partir de datos demográficos y estimaciones de incidencia se delimitó la población en un horizonte temporal de tres años (2018-2020) y se estimaron los costos directos médicos. El escenario de referencia fue el tratamiento con dacarbazina y los escenarios alternativos la terapia dirigida con vemurafenib, dabrafenib, vemurafenib + cobimetinib y dabrafenib + trametinib; la evaluación de incertidumbre se llevó a cabo mediante análisis por escenarios.  Resultados: el impacto presupuestario incremental varió de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% de gastos anuales totales con medicamentos de ambulatorios en el SUS; en el mejor y el peor escenario los resultados variaron de R$ 289.160.835,00 a R$ 1.107.081.926,00.  Conclusión:  el uso de terapia dirigida comparado a la dacarbazina implica en impacto excesivo en el presupuesto, desfavoreciendo una eventual incorporación.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Objective:  to estimate the incremental budget impact of target therapy for first-line treatment of advanced non-surgical and metastatic melanoma compared to dacarbazine treatment.  Methods:  budget impact analysis, from the Brazilian National Health System (SUS) perspective; based on demographic data and incidence estimates, the population over a three-year time horizon (2018-2020) was delimited and the direct medical costs were estimated; the reference scenario was treatment with dacarbazine, and the alternative scenarios were target therapy with vemurafenib, dabrafenib, vemurafenib + cobimetinib and dabrafenib + trametinib; uncertainty assessment was conducted through scenario analysis.  Results:  the incremental budget impact ranged from R$ 451,867,881.00 to R$ 768,860,968.00, representing 0.70 to 1.53% of total SUS annual outpatient drugs expenditure; in best and worst scenario, results ranged from R$ 289,160,835.00 to R$ 1,107,081,926.00.  Conclusion: the use of target therapy compared to dacarbazine implies an excessive impact on the budget, this bring unfovorable to its possible incorporation.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[Melanoma]]></kwd>
<kwd lng="pt"><![CDATA[Terapia de Alvo Molecular]]></kwd>
<kwd lng="pt"><![CDATA[Dacarbazina]]></kwd>
<kwd lng="pt"><![CDATA[Custos e Análise de Custo]]></kwd>
<kwd lng="pt"><![CDATA[Sistema Único de Saúde]]></kwd>
<kwd lng="es"><![CDATA[Melanoma]]></kwd>
<kwd lng="es"><![CDATA[Terapia Molecular Dirigida]]></kwd>
<kwd lng="es"><![CDATA[Dacarbazina]]></kwd>
<kwd lng="es"><![CDATA[Costos y Análisis de Costo]]></kwd>
<kwd lng="es"><![CDATA[Sistema Único de Salud]]></kwd>
<kwd lng="en"><![CDATA[Melanoma]]></kwd>
<kwd lng="en"><![CDATA[Molecular Targeted Therapy]]></kwd>
<kwd lng="en"><![CDATA[Dacarbazine]]></kwd>
<kwd lng="en"><![CDATA[Costs and Cost Analysis]]></kwd>
<kwd lng="en"><![CDATA[Brazilian National Health System]]></kwd>
</kwd-group>
</article-meta>
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