Propuesta para la formación en Medicina Familiar y Comunitaria, desde la percepción, conceptualización y experiencia práctica de los enfoques de Salud Familiar / Proposal for training in Family and Community Medicine, from the perception, conceptualization and practical experience of Family Health approaches / Proposta de formação em Medicina Familiar e Comunitária, a partir da percepção, conceituação e experiência prática de abordagens de Saúde Familiar

Resumen La existencia de un Plan Decenal de Salud Pública para Colombia y la definición de una Política de Atención Integral en Salud concretaron un nuevo Modelo de Atención basado en la Atención Primaria de la Salud. Esto ubicó a la Salud Familiar y Comunitaria como núcleo fundamental y definió un rol al Médico y al Profesional Familiar y Comunitario, que dimensiona los procesos transdisciplinarios y la articulación de acciones individuales y colectivas, con esquemas pedagógicos holísticos transformadores. Este planteamiento generó un análisis y reflexión de la opinión de una muestra del 14,6% de los clasificados como Salubristas por el Observatorio Laboral del Ministerio de Educación quienes, con la respuesta a 13 preguntas enviadas por vía electrónica, libremente plantearon su percepción, conceptualización y experiencia práctica de los enfoques de Salud Familiar y Comunitaria. Con esta medición se definieron los contenidos básicos que se presentan en este documento con un nuevo enfoque transversal en el Pregrado y los Posgrados, de acuerdo con una propuesta pedagógica transformadora y con visión práctica, encontrándose aquí como destacable, la importante relación entre la educación y la salud integral; el concepto que en el 80% de las observaciones se expresó al denominar el poco compromiso de la comunidad y los profesionales de la salud con una "Cultura de la Salud Integralmente Concebida".

Abstract The existence of a Decennial Public Health Plan for Colombia and the definition of a Comprehensive Health Care Policy concretized a new Model of Care based on Primary Health Care. This placed Family and Community Health as a fundamental nucleus and defined a role for the Family and Community Physician and Practitioner, who dimension the transdisciplinary processes and the articulation of individual and collective actions, with transformational holistic pedagogical schemes. This approach generated an analysis and reflection of the opinion of a sample of 14.6% of those classified as Salubristas by the Labor Observatory of the Ministry of Education who, with the answer to 13 questions sent electronically, freely raised their perception, conceptualization and practical experience of Family and Community Health approaches. With this measurement the basic contents that are presented in this document with a new transversal approach in the Undergraduate and Postgraduates were defined, according to a pedagogical proposal transforming and with practical vision, being here like remarkable, the important relation between the education and integral health; the concept that in 80% of the observations was expressed when denominating the little commitment of the community and the professionals of the health with an "Culture of the Health Integrally Conceived".

Resumo A existência de um Plano de Saúde Pública de dez anos para a Colômbia ea definição de uma Política Integral de Saúde resultou em um novo Modelo de Cuidados Baseado em Atenção Primária à Saúde. Isso colocou a Familia e a Saúde Comunitária como um núcleo fundamental e definiu um papel para o Médico e o Profissional Familiar e Comunitário, que dimensiona os processos transdisciplinares e a articulação de ações individuais e coletivas, com esquemas pedagógicos transformadores holísticos. Esta abordagem gerou uma análise e reflexão da opinião de uma amostra de 14,6% das classificadas como Salubristas pelo Observatório do Trabalho do Ministério da Educação que, com a resposta a 13 questões enviadas eletronicamente, aumentou livremente sua percepção, conceituação e experiência prática de abordagens de saúde familiar e comunitária. Com esta medida, os conteúdos básicos apresentados neste documento foram definidos com um novo foco transversal em Estudos de Graduação e Pós-Graduação, de acordo com uma proposta pedagógica transformadora e com uma visão prática, sendo aqui a relação notável entre educação e saúde abrangente; o conceito de que em 80% das observações foi expressado chamando o pequeno compromisso da comunidade e os profissionais de saúde com uma "Cultura de Saúde Integralmente Concebida".

EXPLORING VALUES OF HEALTH TECHNOLOGY ASSESSMENT AGENCIES USING REFLECTIVE MULTICRITERIA AND RARE DISEASE CASE.

OBJECTIVES: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease. METHODS: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise. RESULTS: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions' values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of "alleviating or preventing patient suffering," "serving the whole population equitably," "upholding healthcare system sustainability," and "making decisions informed by evidence and context" but may help share the ethical reasoning behind decisions. Incorporating "Priorities" (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives. CONCLUSIONS: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

COST-UTILITY ANALYSIS OF PRIMARY PROPHYLAXIS, COMPARED WITH ON-DEMAND TREATMENT, FOR PATIENTS WITH SEVERE HEMOPHILIA TYPE A IN COLOMBIA.

OBJECTIVES: This article presents a cost-utility analysis from the Colombian health system perspective comparing primary prophylaxis to on-demand treatment using exogenous clotting factor VIII (FVIII) for patients with severe hemophilia type A. METHODS: We developed a Markov model to estimate expected costs and outcomes (measured as quality-adjusted life-years, QALYs) for each strategy. Transition probabilities were estimated using published studies; utility weights were obtained from a sample of Colombian patients with hemophilia and costs were gathered using local data. Both deterministic and probabilistic sensitivity analysis were performed to assess the robustness of results. RESULTS: The additional cost per QALY gained of primary prophylaxis compared with on-demand treatment was 105,081,022 Colombian pesos (COP) (55,204 USD), and thus not considered cost-effective according to a threshold of up to three times the current Colombian gross domestic product (GDP) per-capita. When primary prophylaxis was provided throughout life using recombinant FVIII (rFVIII), which is much costlier than FVIII, the additional cost per QALY gained reached 174,159,553 COP (91,494 USD). CONCLUSIONS: using a decision rule of up to three times the Colombian GDP per capita, primary prophylaxis (with either FVIII or rFVIII) would not be considered as cost-effective in this country. However, a final decision on providing or preventing patients from primary prophylaxis as a gold standard of care for severe hemophilia type A should also consider broader criteria than the incremental cost-effectiveness ratio results itself. Only a price reduction of exogenous FVIII of 50 percent or more would make primary prophylaxis cost-effective in this context.

TESTING MULTI-CRITERIA DECISION ANALYSIS FOR MORE TRANSPARENT RESOURCE-ALLOCATION DECISION MAKING IN COLOMBIA.

OBJECTIVES: In 2012, Colombia experienced an important institutional transformation after the establishment of the Health Technology Assessment Institute (IETS), the disbandment of the Regulatory Commission for Health and the reassignment of reimbursement decision-making powers to the Ministry of Health and Social Protection (MoHSP). These dynamic changes provided the opportunity to test Multi-Criteria Decision Analysis (MCDA) for systematic and more transparent resource-allocation decision-making. METHODS: During 2012 and 2013, the MCDA framework Evidence and Value: Impact on Decision Making (EVIDEM) was tested in Colombia. This consisted of a preparatory stage in which the investigators conducted literature searches and produced HTA reports for four interventions of interest, followed by a panel session with decision makers. This method was contrasted with a current approach used in Colombia for updating the publicly financed benefits package (POS), where narrative health technology assessment (HTA) reports are presented alongside comprehensive budget impact analyses (BIAs). RESULTS: Disease severity, size of population, and efficacy ranked at the top among fifteen preselected relevant criteria. MCDA estimates of technologies of interest ranged between 71 to 90 percent of maximum value. The ranking of technologies was sensitive to the methods used. Participants considered that a two-step approach including an MCDA template, complemented by a detailed BIA would be the best approach to assist decision-making in this context. Participants agreed that systematic priority setting should take place in Colombia. CONCLUSIONS: This work may serve as the basis to the MoHSP on its interest of setting up a systematic and more transparent process for resource-allocation decision-making.

EMERGENCE OF "DRIVERS" FOR THE IMPLEMENTATION OF HEALTH TECHNOLOGY ASSESSMENT.

BACKGROUND: Health technology assessment (HTA) examines the consequences of the application of health technologies and is aimed at better informing decision-makers. Over the past 30 years, different countries have implemented HTA organizations. Colombia established by law its own HTA agency (IETS) in 2011 which started operations in November 2012. The aim of this study was to assess the feasibility of conducting and using HTA to inform decision-making in this context. Through a qualitative approach, ten "drivers" emerged with the ability to help or hinder HTA development in this context: availability and quality of data, implementation strategy, cultural aspects, local capacity, financial support, policy/political support, globalization, stakeholder pressure, health system context, and usefulness perception. METHODS: Semi-structured interviews were conducted with key HTA researchers, after following rigorous transcription, and thematic content analysis, those aspects that may be barriers or facilitator for HTA development and use in Colombia were identified. RESULTS: Although HTA has become a tool to inform decision-making around the world, its use may vary according to setting. Determining those aspects which may enable or interfere with HTA development and use in Colombia may be useful for other countries when considering the establishment of HTA systems. CONCLUSIONS: The conceptual transferability of concepts like "drivers" with caveats may be of interest for similar settings trying to incorporate HTA processes and institutions into systematic decision-making.

The cost-effectiveness of enzyme replacement therapy (ERT) for the infantile form of Pompe disease: comparing a high-income country's approach (England) to that of a middle-income one (Colombia).

OBJECTIVES: Determining the cost-effectiveness of enzyme replacement therapy (ERT) for the classical infantile form of Pompe disease (complete acid a-glucosidase deficiency-related) in two different settings: England and Colombia. Pompe disease is very rare (1:40,000 births incidence). METHODS: A literature review was made and historic databases searched for National Health Service (NHS) reimbursed costs in England and by health insurers in Colombia; expert opinion was elicited. Two Markov models were constructed for comparing both countries; alive with symptoms and dead were the transition states used. Patients aged < 6 months receiving ERT were assumed to have 75 % survival rate and better health-related quality of life (HR-QoL) compared to those without treatment (0.700 HR- QoL using the EQ-5D scale). RESULTS: The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was £234,307.7 for England and £109,991 for Colombia. Uncertainty about Anal HR-QoL with ERT, disease progression and cost from palliative care had the biggest impact on the ICER in both models. If ERT costs were reduced to 10,000 times per dose and HR-QoL was 0.750-0.820 ICER, then £165,000 could be attainable for England and £65,000 for Colombia. Transaction costs per case in Colombia were high. CONCLUSIONS: ERT was more effective than no ERT in treating infantile Pompe disease, but high levels of uncertainty still remain about survival and progression rates and QoL in the long-run. ICERs were high compared to CE thresholds. Manufacturers' ERT costs and monopoly had a major impact on Anal CEA results.

The cost-effectiveness of enzyme replacement therapy (ERT) for the infantile form of Pompe disease: comparing a high-income country's approach (England) to that of a middle-income one (Colombia) / Costo-Efectividad de la terapia del reemplazo enzimático (TRE) para la forma infantil de la enfermedad Pompe: perspectiva económica comparativa de un país ingresos altos (Inglaterra) vs uno de ingresos medios (Colombia)

Objectives Determining the cost-effectiveness of enzyme replacement therapy (ERT) for the classical infantile form of Pompe disease (complete acid a-glucosidase deficiency-related) in two different settings: England and Colombia. Pompe disease is very rare (1:40,000 births incidence). Methods A literature review was made and historic databases searched for National Health Service (NHS) reimbursed costs in England and by health insurers in Colombia; expert opinion was elicited. Two Markov models were constructed for comparing both countries; alive with symptoms and dead were the transition states used. Patients aged < 6 months receiving ERT were assumed to have 75 % survival rate and better health-related quality of life (HR-QoL) compared to those without treatment (0.700 HR- QoL using the EQ-5D scale). Results The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was £234,307.7 for England and £109,991 for Colombia. Uncertainty about Anal HR-QoL with ERT, disease progression and cost from palliative care had the biggest impact on the ICER in both models. If ERT costs were reduced to 10,000 times per dose and HR-QoL was 0.750-0.820 ICER, then £165,000 could be attainable for England and £65,000 for Colombia. Transaction costs per case in Colombia were high. Conclusions ERT was more effective than no ERT in treating infantile Pompe disease, but high levels of uncertainty still remain about survival and progression rates and QoL in the long-run. ICERs were high compared to CE thresholds. Manufacturers' ERT costs and monopoly had a major impact on Anal CEA results.

Objetivo Determinar la costo-efectividad de la TRE como indicación para la forma clásica de la enfermedad de Pompe (relacionada con deficiencia completa de a-glucosidasa ácida) desde dos perspectivas, Inglaterra y Colombia. La enfermedad de Pompe es muy rara (incidencia 1:40000 nacimientos). Métodos Revisiónbibliográfica y bases de datos para calcular costosasociados al tratamiento en NHS en Inglaterra, aseguradores de salud en Colombia y opinión de expertos. Dos procesos de Markov fueron construidos para comparar entre países; los estados de transición fueron: vivo sintomático y fallecido. En pacientes de < 6 meses de edad con TRE, se asume un incremento de 75 % de sobrevida y mejor calidad de vida comparada con los que no reciben TRE (HR-QoL 0.700 usando EQ-5D). Resultados Inglaterra alcanzo ICER por QALY ganado £234307, 7 y Colombia £109991. Incertidumbre sobre HR-QoL con TRE, progresión de enfermedad y costo de cuidado paliativo tuvieron el mayor impacto en losICERs;sí el costo de TREfuera 10.000 menor y la HR-QoLalcanzara 0.750-0.820 ICERs de £165000y £65000 podrían obtenerse para Inglaterra y Colombia respectivamente. Los costos transaccionales en Colombia son representativos. Conclusiones La TRE es más efectiva que no dar tratamiento, pero incertidumbre sobre tasas desobrevida, progresión y HR-QoLpermanecen en el largo plazo. Los ICERsson altos comparados a los umbrales establecidos de CE. Los costos de TRE y el podermonopolístico del fabricante tienen un impacto importante en los resultados Anales de CEA. Investigación adicional debe realizarsea futuro.