<?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>1025-028X</journal-id>
<journal-title><![CDATA[Vaccimonitor]]></journal-title>
<abbrev-journal-title><![CDATA[Vaccimonitor]]></abbrev-journal-title>
<issn>1025-028X</issn>
<publisher>
<publisher-name><![CDATA[Finlay Ediciones]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1025-028X2020000100014</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Nimotuzumab (CIMAher®) en pacientes cubanos con cáncer de cabeza y cuello estadios III/IV: Análisis de impacto presupuestario]]></article-title>
<article-title xml:lang="en"><![CDATA[Nimotuzumab (CIMAher®) in Cuban patients with head and neck cancer stage III/IV: Budget impact analysis]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez-Ruiz]]></surname>
<given-names><![CDATA[Leslie]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Mendoza]]></surname>
<given-names><![CDATA[Mauricio Mijaíl]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Soto-Molina]]></surname>
<given-names><![CDATA[Herman]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Galán-Álvarez]]></surname>
<given-names><![CDATA[Yaima]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Viada-González]]></surname>
<given-names><![CDATA[Carmen Elena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Collazo-Herrera]]></surname>
<given-names><![CDATA[Manuel Miguel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Inmunología Molecular (CIM)  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Consultoría Integral en Salud y Farmacéutica (CISFA) S.A de C.V  ]]></institution>
<addr-line><![CDATA[Ciudad de México ]]></addr-line>
<country>México</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Estudios Farmacoeconómicos (HS), S.A. de C.V  ]]></institution>
<addr-line><![CDATA[Ciudad de México ]]></addr-line>
<country>México</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Registro Nacional de Cáncer de Cuba Instituto Nacional de Oncología y Radiobiología ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af5">
<institution><![CDATA[,Instituto Nacional de Higiene, Epidemiología y Microbiología (INHEM)  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2020</year>
</pub-date>
<volume>29</volume>
<numero>1</numero>
<fpage>14</fpage>
<lpage>21</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2020000100014&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2020000100014&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2020000100014&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN En Cuba, el cáncer es la segunda causa de muerte con 24.902 defunciones en el 2018; de ellas, 795 fueron por tumores de laringe y 826 por tumores de labio, cavidad bucal y faringe. El anticuerpo monoclonal nimotuzumab (CIMAher®) está registrado como tratamiento combinado con radioterapia o quimioterapia para el cáncer de células escamosas de cabeza y cuello estadios avanzados. Del mismo se conoce su efectividad y perfil de seguridad, no así el impacto económico que acarrearía la incorporación del mismo al Sistema Nacional de Salud (SNS) cubano; de forma tal de asignar y reajustar presupuestos en la esfera de medicamentos. Por tanto, se hizo necesario realizar un análisis de impacto presupuestario, con el objetivo de estimar el impacto financiero de la incorporación del nimotuzumab (CIMAher®) al paquete de beneficios del SNS cubano. Se tomaron los datos de prevalencia e incidencia de la enfermedad en los estadios III/IV. Se estableció un escenario actual con la terapia radio/quimioterapia secuencial y una tasa de penetración de 100%. El escenario futuro fue radio/quimioterapia secuencial + nimotuzumab (CIMAher®) con tasa anual de penetración 20, 40, 60, 80 y 100%. La perspectiva fue desde el SNS y un horizonte temporal de 5 años (2019-2023). El análisis de impacto presupuestal mostró que, desde perspectiva, horizonte y tasa de penetración establecidos, el SNS debe invertir aproximadamente de 10 a 65 millones de pesos cubanos (CUP); cifras menores al presupuesto destinado a salud pública.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT In Cuba, cancer is the second cause of death with 24,902 deaths in 2018; 795 were due to laryngeal tumors and 826 due to tumors of the lip, oral cavity and pharynx. The monoclonal antibody nimotuzumab (CIMAher®) is registered as a combined treatment with radiotherapy or chemotherapy for advanced squamous cell carcinoma of the head and neck. Its effectiveness and safety profile are known, but not their economic impact into the Cuban National Health System (NHS); in order to allocate and readjust budgets in the field of medicines. Therefore, it was necessary to perform a budget impact analysis in order to estimate the financial impact of the incorporation of nimotuzumab (CIMAher®) into the benefits package of the Cuban NHS. Data on prevalence and incidence of the disease in stages III / IV were taken into account. The current scenario was with the therapy radio/sequential chemotherapy and penetration rate of 100%. The future scenario was radio/sequential chemotherapy + nimotuzumab (CIMAher®) and annual penetration rate of 20, 40, 60, 80 and 100%. The perspective was from the NHS and a time horizon of five years (2019-2023). The budget impact analysis showed that from an established perspective, horizon and penetration rate, the NHS must invest 10-65 million Cuban pesos (CUP) approximately; lower values than the budget allocated to Public Health.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[anticuerpos monoclonales]]></kwd>
<kwd lng="es"><![CDATA[cáncer de cabeza y cuello]]></kwd>
<kwd lng="es"><![CDATA[análisis de impacto presupuestario]]></kwd>
<kwd lng="es"><![CDATA[costos]]></kwd>
<kwd lng="en"><![CDATA[monoclonal antibodies]]></kwd>
<kwd lng="en"><![CDATA[head and neck cancer]]></kwd>
<kwd lng="en"><![CDATA[budgetary impact analysis]]></kwd>
<kwd lng="en"><![CDATA[costs]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="book">
<collab>Instituto Nacional del Cáncer</collab>
<source><![CDATA[Cánceres de cabeza y cuello]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Washington ]]></publisher-loc>
<publisher-name><![CDATA[NIH]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<source><![CDATA[Tratamiento del cáncer de cabeza y cuello en estadío avanzado inoperable mediante quimioterapia intraarterial y radioterapia concomitante]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Madrid ]]></publisher-loc>
<publisher-name><![CDATA[Universidad Complutense]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="book">
<collab>Brystol Myers Squibb</collab>
<source><![CDATA[European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Princenton ]]></publisher-loc>
<publisher-name><![CDATA[Brystol Myers Squibb]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Roco]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Cerda]]></surname>
<given-names><![CDATA[B]]></given-names>
</name>
<name>
<surname><![CDATA[Cayún]]></surname>
<given-names><![CDATA[JP]]></given-names>
</name>
<name>
<surname><![CDATA[Lavanderos]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Rubilar]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Cerro]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Farmacogenética, tabaco, alcohol y su efecto sobre el riesgo de desarrollar cáncer]]></article-title>
<source><![CDATA[Rev Chil Pediatr]]></source>
<year>2018</year>
<volume>89</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>432-40</page-range></nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="book">
<collab>MINSAP. Dirección Nacional de Registros Médicos y Estadística de Salud</collab>
<source><![CDATA[Anuario Estadístico de Salud 2018]]></source>
<year>2019</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[MINSAP]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Saúrez]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Bencomo]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Nimotuzumab, inmunoterapia eficaz para el tratamiento de tumores epiteliales malignos]]></article-title>
<source><![CDATA[Biotecnol Apl]]></source>
<year>2014</year>
<volume>31</volume>
<page-range>150-8</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Crombet]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Osorio]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Cruz]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Roca]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[del Castillo]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Mon]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Use of the Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody h-R3 in Combination with Radiotherapy in the Treatment of Locally Advanced Head and Neck Cancer Patients]]></article-title>
<source><![CDATA[J Clin Oncol]]></source>
<year>2004</year>
<volume>22</volume>
<numero>9</numero>
<issue>9</issue>
<page-range>1646-54</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Basavaraj]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Sierra]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Shivu]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Nimotuzumab with chemoradiation confers a survival advantage in treatment-naive head and neck tumors over expressing EGFR]]></article-title>
<source><![CDATA[Cancer Biol Ther]]></source>
<year>2010</year>
<volume>10</volume>
<numero>7</numero>
<issue>7</issue>
<page-range>673-81</page-range></nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Osorio]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Cruz]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[del Castillo]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Roca]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Azcue]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Neninger]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head and neck]]></article-title>
<source><![CDATA[Cancer Biol &amp; Ther]]></source>
<year>2010</year>
<volume>9</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>343-9</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Culyer]]></surname>
<given-names><![CDATA[AJ]]></given-names>
</name>
</person-group>
<source><![CDATA[The Dictionary of Health Economics, 3rd edition]]></source>
<year>2014</year>
<publisher-loc><![CDATA[Cheltenham ]]></publisher-loc>
<publisher-name><![CDATA[UK Edward Elgar Publishing]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Mauskopf]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Earnshaw]]></surname>
<given-names><![CDATA[SR]]></given-names>
</name>
<name>
<surname><![CDATA[Brogan]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Wolowacz]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Brodtkorb]]></surname>
<given-names><![CDATA[TH]]></given-names>
</name>
</person-group>
<source><![CDATA[Budget-Impact Analysis of Health Care Interventions. A practical guide]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Cham, Switzerland ]]></publisher-loc>
<publisher-name><![CDATA[Springer International Publishing AG]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<collab>Consejo de Salubridad General</collab>
<source><![CDATA[Guía para la Conducción de Estudios de Evaluación Económica para la Actualización del Cuadro Básico y Catálogo de Insumos del Sector Salud en México]]></source>
<year>2017</year>
<publisher-loc><![CDATA[México DF ]]></publisher-loc>
<publisher-name><![CDATA[Dirección General Adjunta de Priorización]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sullivan]]></surname>
<given-names><![CDATA[SD]]></given-names>
</name>
<name>
<surname><![CDATA[Mauskopf]]></surname>
<given-names><![CDATA[JA]]></given-names>
</name>
<name>
<surname><![CDATA[Augustovski]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Caro]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Lee]]></surname>
<given-names><![CDATA[KM]]></given-names>
</name>
<name>
<surname><![CDATA[Minchin]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Budget Impact Analysis-Principles of Good Practice Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force]]></article-title>
<source><![CDATA[Value in Health]]></source>
<year>2014</year>
<volume>17</volume>
<page-range>5-14</page-range></nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Puig]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Oliva]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Trapero]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Abellán]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Brosa]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<source><![CDATA[Guía y recomendaciones para la realización y presentación de evaluaciones económicas y análisis de impacto presupuestario de medicamentos en el ámbito del CatSalut [Internet]]]></source>
<year>2014</year>
<publisher-loc><![CDATA[Barcelona ]]></publisher-loc>
<publisher-name><![CDATA[Departament de Salut. Servei Català de la Salut]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="book">
<collab>Colectivo de autores</collab>
<source><![CDATA[Formulario nacional de medicamentos. En: Calvo Barbado DM, Delgado Martínez I, editores. Formulario nacional de medicamentos]]></source>
<year>2014</year>
<edition>4</edition>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[ECIMED]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="book">
<collab>EMCOMED</collab>
<source><![CDATA[Base de Precios. Subdirección Económica Empresa Comercializadora y Distribuidora de Medicamentos]]></source>
<year>2019</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[EMCOMED]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="book">
<collab>Ministerio de Salud Pública</collab>
<source><![CDATA[Dirección Nacional de Registros Médicos y Estadística de Salud. Anuario Estadístico de Salud 2017]]></source>
<year>2018</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[MINSAP]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B18">
<label>18</label><nlm-citation citation-type="book">
<collab>Asamblea Nacional del Poder Popular</collab>
<source><![CDATA[Propuesta de presentación del Proyecto de Presupuesto del Estado para el año 2018]]></source>
<year>2017</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[Granma]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B19">
<label>19</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Figueredo]]></surname>
<given-names><![CDATA[O]]></given-names>
</name>
<name>
<surname><![CDATA[Concepción]]></surname>
<given-names><![CDATA[JR]]></given-names>
</name>
<name>
<surname><![CDATA[Doimeadios]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Terrero]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Carmona]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
</person-group>
<source><![CDATA[¿Cuál es el Presupuesto del Estado cubano para 2019? [Internet]]]></source>
<year>2018</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[Cubadebate]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B20">
<label>20</label><nlm-citation citation-type="confpro">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Lara]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Calvo]]></surname>
<given-names><![CDATA[DM]]></given-names>
</name>
</person-group>
<source><![CDATA[Medicamentos de alto costo (MAC), desafíos para los sistemas de salud]]></source>
<year>2016</year>
<conf-name><![CDATA[ Taller de Farmacoeconomía: actas del Tercer Congreso Internacional de Investigación, Desarrollo e Innovación Tecnológica de la industria Biofarmacéutica IDIFARMA 2016]]></conf-name>
<conf-date>5 al 9 de Diciembre 2016</conf-date>
<conf-loc>La Habana </conf-loc>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[CIDEM]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
