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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
        <publisher-loc>S&#227;o Paulo, SP, Brazil</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v3">R3QsH9Yk4qhQv5Bs43PGWgs</article-id>
      <article-id pub-id-type="other">00001</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v2">S0066-782X2005001400001</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v1">S0066-782X(05)08500101</article-id>
      <article-id pub-id-type="doi">10.1590/S0066-782X2005001400001</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Impacto econ&#244;mico do tratamento da cardiopatia isqu&#234;mica cr&#244;nica no Brasil: o desafio da incorpora&#231;&#227;o de novas tecnologias cardiovasculares</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Araujo</surname>
            <given-names>Denizar Vianna</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Ferraz</surname>
            <given-names>Marcos Bosi</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
      </contrib-group>
      <aff id="aff01">
        <addr-line>
          <named-content content-type="city">S&#227;o Paulo</named-content>
          <named-content content-type="state">SP</named-content>
        </addr-line>
        <institution content-type="orgname">Universidade Federal de S&#227;o Paulo</institution>
      </aff>
      <pub-date date-type="collection" publication-format="electronic">
        <month>07</month>
        <year>2005</year>
      </pub-date>
      <volume>85</volume>
      <issue>1</issue>
      <fpage>1</fpage>
      <lpage>2</lpage>
      <permissions>
        <license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/" xml:lang="en">
          <license-p>This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.</license-p>
        </license>
      </permissions>
      <pub-date publication-format="electronic" date-type="pub">
        <day>29</day>
        <month>09</month>
        <year>2005</year>
      </pub-date>
    </article-meta>
  </front>
  <body>
    <p>
      <bold>EDITORIAL</bold>
    </p>
    <p>Impacto econ&#244;mico do tratamento da cardiopatia isqu&#234;mica cr&#244;nica no Brasil. O desafio da incorpora&#231;&#227;o de novas tecnologias cardiovasculares </p>
    <p>
      <bold>Denizar Vianna Araujo; Marcos Bosi Ferraz </bold>
    </p>
    <p>Universidade Federal de S&#227;o Paulo - S&#227;o Paulo, SP</p>
    <p>
      <xref ref-type="corresp" rid="end">Endere&#231;o para correspond&#234;ncia</xref>
    </p>
    <p> As doen&#231;as cardiovasculares s&#227;o as principais causas de morbidade e mortalidade no Brasil, com impacto significativo no or&#231;amento do Minist&#233;rio da Sa&#250;de, principalmente na aten&#231;&#227;o da alta complexidade. A crescente demanda por recursos desencadeou a elabora&#231;&#227;o da Pol&#237;tica Nacional de Aten&#231;&#227;o Cardiovascular de Alta Complexidade pela Secretaria de Aten&#231;&#227;o &#224; Sa&#250;de do Minist&#233;rio da Sa&#250;de. </p>
    <p>No ano de 2002, ocorreram 1.216.394 interna&#231;&#245;es decorrentes de doen&#231;as do aparelho circulat&#243;rio, representando 10,3% do total das interna&#231;&#245;es no Sistema &#218;nico de Sa&#250;de (SUS). Em rela&#231;&#227;o ao valor financeiro, a parcela das interna&#231;&#245;es em cardiologia cl&#237;nica e cir&#250;rgica correspondeu a 17% do total, superando todos os outros grupos de especialidades isoladamente<sup>1</sup>. </p>
    <p>Entre as doen&#231;as do aparelho circulat&#243;rio, a insufici&#234;ncia card&#237;aca motivou 30,6% das interna&#231;&#245;es e o diagn&#243;stico de "outras doen&#231;as isqu&#234;micas do cora&#231;&#227;o" representou 10,6% das interna&#231;&#245;es. O impacto financeiro para o Sistema de Sa&#250;de &#233; maior do que o quantificado, pois os valores computados pelo SUS como despesa n&#227;o representam o custo verdadeiro com o tratamento das doen&#231;as cardiovasculares. Estudo recente sobre custo da insufici&#234;ncia card&#237;aca demonstrou a defasagem entre os valores reembolsados pelo SUS aos hospitais e o custo real da interna&#231;&#227;o por essa s&#237;ndrome<sup>2</sup>. </p>
    <p>Outro componente do impacto econ&#244;mico n&#227;o mensurado pelos formuladores de pol&#237;ticas de sa&#250;de &#233; o custo indireto representado por improdutividade, absente&#237;smo e morte prematura decorrente das doen&#231;as cardiovasculares. Estudo conduzido em hospital universit&#225;rio brasileiro demonstrou que 28,5% dos pacientes em tratamento para insufici&#234;ncia card&#237;aca foram aposentados precocemente por causa da s&#237;ndrome<sup>2</sup>. </p>
    <p>A alta preval&#234;ncia da cardiopatia isqu&#234;mica cr&#244;nica determina elevado consumo de recursos no tratamento e reabilita&#231;&#227;o. No ano de 2003, o SUS financiou a realiza&#231;&#227;o de 30.666 angioplastias coronarianas com implante de <italic>stent</italic> e 19.909 cirurgias de revasculariza&#231;&#227;o do mioc&#225;rdio, totalizando aproximadamente R$ 281 milh&#245;es de gastos. </p>
    <p>A incorpora&#231;&#227;o do <italic>Bare Metal Stent</italic> (BMS) no SUS em 1999 representou mudan&#231;a significativa na forma de tratamento intervencionista dos pacientes com cardiopatia isqu&#234;mica. At&#233; 1999, a cirurgia de revasculariza&#231;&#227;o do mioc&#225;rdio representava a principal modalidade de tratamento intervencionista. Nos tr&#234;s anos subseq&#252;entes, o n&#250;mero de procedimentos de angioplastia coronariana aumentou em mais de 100%, com redu&#231;&#227;o significativa no n&#250;mero de cirurgias de revasculariza&#231;&#227;o do mioc&#225;rdio no mesmo per&#237;odo. Os benef&#237;cios do tratamento com o <italic>stent</italic> convencional (BMS) foram importantes, por&#233;m com limita&#231;&#245;es em alguns subgrupos, principalmente pacientes diab&#233;ticos com vasos de pequeno calibre e maior extens&#227;o, em que a reestenose intra-<italic>stent</italic> &#233; significativa nos primeiros seis meses p&#243;s-procedimento. </p>
    <p>O desenvolvimento do <italic>Drug Eluting Stent</italic> (DES), n&#227;o-dispon&#237;vel no SUS, proporcionou taxas significativamente menores de reestenose intra-<italic>stent</italic> neste subgrupo de pacientes<sup>3,4</sup>, por&#233;m com aumento no custo inicial do tratamento. O dilema que o SUS enfrenta &#233; compatibilizar a restri&#231;&#227;o do or&#231;amento com a necessidade de avaliar e incorporar novas tecnologias cardiovasculares. </p>
    <p>Esse panorama conflitante tem despertado o interesse da comunidade acad&#234;mica na busca de solu&#231;&#245;es. Necessitamos de novas &#225;reas do conhecimento que possam nos auxiliar na dif&#237;cil tarefa de tomar decis&#245;es em ambiente de escassez de recursos. </p>
    <p>O processo de avalia&#231;&#227;o da incorpora&#231;&#227;o de tecnologia em sa&#250;de surge como &#225;rea do conhecimento interdisciplinar para auxiliar nesse processo de escolha. A avalia&#231;&#227;o da incorpora&#231;&#227;o de tecnologia em sa&#250;de deve contemplar o funcionamento e/ou impacto dos produtos e servi&#231;os, programas ou pol&#237;ticas de sa&#250;de na promo&#231;&#227;o, manuten&#231;&#227;o e produ&#231;&#227;o dos servi&#231;os de sa&#250;de. </p>
    <p>A avalia&#231;&#227;o de uma tecnologia a ser incorporada pelo sistema de sa&#250;de, p&#250;blico ou privado, caracteriza-se por revis&#227;o sistem&#225;tica, cr&#237;tica, criteriosa da literatura dispon&#237;vel, considerando-se aspectos como efetividade da interven&#231;&#227;o, an&#225;lise econ&#244;mica e seu potencial impacto no sistema de sa&#250;de, ou seja, sua contribui&#231;&#227;o para promo&#231;&#227;o, manuten&#231;&#227;o ou reabilita&#231;&#227;o da sa&#250;de. Aspectos &#233;ticos e quest&#245;es de eq&#252;idade devem ser considerados no processo de avalia&#231;&#227;o. </p>
    <p>Com o r&#225;pido incremento no desenvolvimento tecnol&#243;gico, especialmente na &#225;rea cardiovascular, tal processo de avalia&#231;&#227;o se torna imprescind&#237;vel, n&#227;o somente por identificar as interven&#231;&#245;es de valor para o sistema de sa&#250;de, mas tamb&#233;m pela necessidade do processo de escolha entre as alternativas que reconhecidamente agregam valor ao sistema de sa&#250;de. </p>
    <p>O Centro Paulista de Economia da Sa&#250;de (CPES) da Escola Paulista de Medicina (UNIFESP) em colabora&#231;&#227;o com a Sociedade Brasileira de Hemodin&#226;mica e Cardiologia Intervencionista est&#225; elaborando estimativa do impacto no or&#231;amento do SUS com a incorpora&#231;&#227;o do <italic>stent</italic> farmacol&#243;gico, utilizando dados do ano de 2003. </p>
    <p>As premissas do modelo de impacto no or&#231;amento s&#227;o: taxa de convers&#227;o do <italic>stent</italic> convencional para farmacol&#243;gico; n&#250;mero de <italic>stents</italic>/paciente/procedimento; porcentagem de reinterven&#231;&#245;es por reestenose no <italic>stent</italic> convencional; porcentagem de reinterven&#231;&#245;es por reestenose no <italic>stent</italic> farmacol&#243;gico; pre&#231;os dos <italic>stents</italic>; valores de AIH (Autoriza&#231;&#227;o de Interna&#231;&#227;o Hospitalar) remunerados pelo SUS aos hospitais para angioplastia e cirurgia de revasculariza&#231;&#227;o do mioc&#225;rdio; pre&#231;o do clopidogrel p&#243;s-procedimento. Esse modelo cont&#233;m premissas principais que variam significativamente conforme o porcentual hipot&#233;tico de acesso da popula&#231;&#227;o ao <italic>stent</italic> farmacol&#243;gico, pre&#231;o de aquisi&#231;&#227;o do <italic>stent</italic> farmacol&#243;gico e porcentual de reinterven&#231;&#245;es evitadas nos doze meses subseq&#252;entes. Essas varia&#231;&#245;es explicam os cen&#225;rios poss&#237;veis entre 12,8% e 24,4% (R$ 24.272.308,00 a R$ 44.458.162,00) de incremento no custo nos primeiros doze meses p&#243;s-procedimento para o SUS. </p>
    <p>Ag&#234;ncias de avalia&#231;&#227;o de tecnologia em sa&#250;de como NICE<sup>5</sup> e AETMIS<sup>6</sup> est&#227;o auxiliando os financiadores dos sistemas de sa&#250;de no Reino Unido e prov&#237;ncia de Qu&#233;bec no Canad&#225; na incorpora&#231;&#227;o do <italic>stent</italic> farmacol&#243;gico na pr&#225;tica cardiol&#243;gica. </p>
    <p>A discuss&#227;o sobre a incorpora&#231;&#227;o de novas tecnologias no SUS &#233; uma oportunidade para a Sociedade Brasileira de Cardiologia fomentar o desenvolvimento de m&#233;todos que auxiliem os formuladores de pol&#237;ticas de sa&#250;de cardiovascular no processo de escolha entre as alternativas dispon&#237;veis, mensurando o benef&#237;cio para cada unidade de custo e estimando o retorno para a sociedade na incorpora&#231;&#227;o de novas modalidades diagn&#243;sticas e terap&#234;uticas. </p>
    <p>
      <bold>Refer&#234;ncias</bold>
    </p>
    <p> 1. DATASUS 2002 (<ext-link ext-link-type="uri" xlink:href="http://www.datasus.gov.br">www.datasus.gov.br</ext-link>). </p>
    <p>2. Ara&#250;jo DV, Tavares LR, Ver&#237;ssimo R et al. Custo da Insufici&#234;ncia Card&#237;aca no Sistema &#218;nico de Sa&#250;de. Arq Bras Cardiol 2005; 84:422-7. </p>
    <p>3. Moses JW, Leon MB, Popma JJ et al. Sirolimus-Eluting Stens versus Standard Stents in Patients with Stenosis in a Native Coronary Artery. N Engl J Med 2003; 349:1315-23. </p>
    <p>4. Stone GW, Cox DA, Hermiller J et al. A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease. N Engl J Med 2004; 350:221-31. </p>
    <p>5. National Institute for Clinical Excellence (NICE). Guidance on the use of coronary artery stents. Technology Appraisal 71. October 2003. <ext-link ext-link-type="uri" xlink:href="http://www.nice.org.uk">www.nice.org.uk</ext-link>. </p>
    <p>6. Agence d'&#233;valuation des technologies et des modes d'intervention en sant&#233; (AETMIS). An Economic Analysis of Drug Eluting Coronary Stents: A Qu&#233;bec Perspective. Report prepared by James Brophy and Lonny Erickson. (AETMIS 04-04) Montr&#233;al: AETMIS, 2004, x-38p. <ext-link ext-link-type="uri" xlink:href="http://www.aetmis.gouv.qc.ca">www.aetmis.gouv.qc.ca</ext-link></p>
    <p>
      <fn id="end" fn-type="corresp">
        <label>
          <bold>Endere&#231;o para correspond&#234;ncia</bold>
        </label>
        <p> Denizar Vianna Araujo </p>
        <p> Av. Visconde Albuquerque, 1400/501 </p>
        <p> 22450-000 &#150; Rio de Janeiro, RJ </p>
        <p> E-mail: </p>
        <p>
          <email xlink:href="denizarvianna@cpes.org.br">denizarvianna@cpes.org.br</email>
        </p>
      </fn>
    </p>
  </body>
  <sub-article article-type="translation" id="TRen" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title xml:lang="en">Economic impact of chronic ischemic cardiopathy treatment in Brazil: the challenge of new cardiovascular technology inclusion</article-title>
      </title-group>
    </front-stub>
    <body>
      <p>
        <bold>EDITORIAL</bold>
      </p>
      <p>Economic impact of chronic ischemic cardiopathy treatment in Brazil. The challenge of new cardiovascular technology inclusion </p>
      <p>
        <bold>Denizar Vianna Araujo; Marcos Bosi Ferraz </bold>
      </p>
      <p>Universidade Federal de S&#227;o Paulo - S&#227;o Paulo, SP - Brazil</p>
      <p>
        <xref ref-type="corresp" rid="end-body2">Correspondence</xref>
      </p>
      <p> Cardiovascular diseases are the main cause of a morbidity and mortality in Brazil. They have a significant impact on the Health Ministry budget, especially concerning their high complexity. Due to the growing demand for funds, the Secretaria de Aten&#231;&#227;o &#224; Sa&#250;de do Minist&#233;rio da Sa&#250;de (Healthcare Secretariat of Health Ministry) prepared the Pol&#237;tica Nacional de Aten&#231;&#227;o Cardiovascular de Alta Complexidade (National Policy of High Complexity Cardiovascular Care). </p>
      <p>In 2002, 1,216,394 admissions due to circulatory system diseases were recorded, representing 10.3% from total hospitalizations in Sistema &#218;nico de Sa&#250;de &#150; Unified Healthcare System - (SUS). Financially, clinical and surgical cardiology admissions amounted to 17%, a rate higher than all other specialties<sup>1</sup>. </p>
      <p>Amidst the circulatory diseases, heart failure was responsible for 30.6% of admissions and the diagnosis of "other heart ischemic diseases", 10.6%. The financial impact for the Healthcare System is greater than the quantified one. SUS values regarded as expenses do not correspond to the real cost with cardiovascular disease treatment. A recent study on heart failure cost showed the difference between values refunded by SUS to hospitals and the real cost for hospitalization due to that disease<sup>2</sup>. </p>
      <p>The indirect cost represented by unproductiveness, absenteeism and early death due to cardiovascular diseases is another economic component. A Brazilian university hospital study showed that 28.5% of heart failure treatment patients had early retirement due to the syndrome<sup>2</sup>. </p>
      <p>The high prevalence of chronic ischemic cardiopathy accounts for the extraordinary use of funds in treatment and rehabilitation. In 2003, SUS financed 30,666 coronary angioplasties with stent implantation and 19,909 myocardial revascularization surgeries, representing a total of approximately R$ 281 million. </p>
      <p>The integration of Bare Metal Stent (BMS) to SUS, in 1999, has produced a significant change in the intervention treatment of ischemic cardiopathy patients. Myocardial revascularization was the main type of intervention treatment until 1999. Three years later, the number of coronary angioplasties increased in more than 100%. In the same period, there was a significant reduction in myocardial revascularization surgeries. Conventional stent (BMS) treatment benefits were important, but with limitations in some subgroups, especially within the little caliper and greater extension vessel diabetic patients, in which intra-stent restenosis is considerable in the first six post-procedure months. </p>
      <p>Despite the increase of treatment initial cost, Drug Eluting Stent (DES) development, non-available at SUS, provided significantly lower intra-stent restenosis rates in this subgroup of patients<sup>3,4</sup>. Matching budget restriction with the need for assessing and including new cardiovascular technologies is an impasse faced by SUS. </p>
      <p>Such contradictory scenario has been raising interest among academicians in the search for new solutions, as we need new areas of knowledge to help us make decisions in a fund scarce environment. </p>
      <p>Healthcare technology incorporation assessment is an interdisciplinary knowledge area to help that selection process. It must take into consideration the functioning and/or impact of healthcare products and services, programs or policies on healthcare service promotion, maintenance and production. </p>
      <p>Assessment of a technology to be incorporated by healthcare system, either public or private, is characterized by a systematic, critical and thorough review on the available literature. Aspects as intervention effectiveness, its economic analysis and potential impact on healthcare system, which means, its contribution to health promotion, maintenance or rehabilitation, must be taken into consideration. Ethic aspects and rightness matters must be regarded in assessment the process. </p>
      <p>As a result of the fast technological development, especially in cardiovascular sector, such assessment process becomes indispensable, not only for identifying valuable interventions for the healthcare system, but also for the need of a selecting process among alternatives which beyond doubt add value to the healthcare system. </p>
      <p>The Centro Paulista de Economia da Sa&#250;de &#150; Healthcare Economics Center of S&#227;o Paulo (CPES) of Escola Paulista de Medicina (UNIFESP) has been preparing an estimate of the impact on SUS budget with the use of pharmacological stent, with data from 2003. </p>
      <p>Impact model premises on budget are: conversion from conventional to pharmacological stent, number of stents/patient/procedure; % of re-interventions through conventional stent restenosis; % of re-interventions through pharmacological stent restenosis; stent prices, SUS-paid HAA (Hospital Admission Authorization) values to hospitals for angioplasty and myocardial revascularization surgery; post-procedure Clopidogrel price. Such model has variable premises according to hypothetical population access percentage to and purchase price of pharmacological stent, and percentage of avoided re-intervention in the following 12 months. Those variations explain possible circumstances from 12.8% to 24.4% (R$ 24,272,308.00 to R$ 44,458,162.00) of price increase in the first 12 post-procedure months for SUS. </p>
      <p>Healthcare technology assessment agencies as NICE<sup>5</sup> and AETMIS<sup>6</sup> have been helping healthcare system sponsors in the United Kingdom and the province of Quebec, in Canada, to incorporate pharmachological stent in cardiological practice. </p>
      <p>Dispute on new technology inclusion in SUS is an opportunity for Sociedade Brasileira de Cardiologia (Brazilian Cardiology Association) to promote method development to assist cardiovascular healthcare policy formulators in the selection process among available alternatives, by quantifying benefits for each cost unit and estimating the advantages of incorporating new diagnoses and therapies for the general public. </p>
      <p>
        <bold>References</bold>
      </p>
      <p> 1. DATASUS 2002 (<ext-link ext-link-type="uri" xlink:href="http://www.datasus.gov.br">www.datasus.gov.br</ext-link>). </p>
      <p>2. Ara&#250;jo DV, Tavares LR, Ver&#237;ssimo R et al. Custo da Insufici&#234;ncia Card&#237;aca no Sistema &#218;nico de Sa&#250;de. Arq Bras Cardiol 2005; 84:422-7. </p>
      <p>3. Moses JW, Leon MB, Popma JJ et al. Sirolimus-Eluting Stens versus Standard Stents in Patients with Stenosis in a Native Coronary Artery. N Engl J Med 2003; 349:1315-23. </p>
      <p>4. Stone GW, Cox DA, Hermiller J et al. A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease. N Engl J Med 2004; 350:221-31. </p>
      <p>5. National Institute for Clinical Excellence (NICE). Guidance on the use of coronary artery stents. Technology Appraisal 71. October 2003. <ext-link ext-link-type="uri" xlink:href="http://www.nice.org.uk">www.nice.org.uk</ext-link>. </p>
      <p>6. Agence d'&#233;valuation des technologies et des modes d'intervention en sant&#233; (AETMIS). An Economic Analysis of Drug Eluting Coronary Stents: A Qu&#233;bec Perspective. Report prepared by James Brophy and Lonny Erickson. (AETMIS 04-04) Montr&#233;al: AETMIS, 2004, x-38p. <ext-link ext-link-type="uri" xlink:href="http://www.aetmis.gouv.qc.ca">www.aetmis.gouv.qc.ca</ext-link></p>
      <p>
        <fn id="end-body2" fn-type="corresp">
          <label>
            <bold>Correspondence to</bold>
          </label>
          <p> Denizar Vianna Araujo </p>
          <p> Av. Visconde Albuquerque, 1400/501 </p>
          <p> 22450-000 &#150; Rio de Janeiro, RJ</p>
          <p> E-mail: </p>
          <p>
            <email xlink:href="denizarvianna@cpes.org.br">denizarvianna@cpes.org.br</email>
          </p>
        </fn>
      </p>
      <p>English version by Bridge Ingl&#234;s Personalizado </p>
    </body>
  </sub-article>
</article>
