Experiencias internacionales en priorización en evaluación de tecnologías

1. Experiencias internacionales en priorización en evaluación de tecnologías Antonio Sarría Santamera Agencia de Evaluación de Tecnologías Sanitarias Instituto de Salud Carlos III

2. ETS: El proceso • Evaluación de necesidades • Establecimiento de prioridades • Evaluación • Transferencia de conocimiento • Toma de decisiones • Implementación

3. Principios de la ETS para servir en la asignación de recursos HTAs should explicitly characterize uncertainty surrounding estimates HTAs should consider and address issues of generalizability and transferability Those conducting HTAs should actively engage all key stakeholder groups Those undertaking HTAs should actively seek all available data The implementation of HTA findings needs to be monitored HTA should be timely HTA findings need to be communicated appropriately to different decision makers The link between HTA findings and decision making processes needs to be in all transparent and clearly defined The goal and scope of HTA should be explicit and relevant to its use HTA should be an unbiased and transparent exercise HTA should include all relevant technologies A clear system for setting priorities for HTA should exist HTA should incorporate appropriate methods for assessing costs and benefits HTAs should consider a wide range of evidence and outcomes A full societal perspective should be considered when undertaking HTAs

4. Principios de la ETS para servir en la asignación de recursos HTAs should explicitly characterize uncertainty surrounding estimates HTAs should consider and address issues of generalizability and transferability Those conducting HTAs should actively engage all key stakeholder groups Those undertaking HTAs should actively seek all available data The implementation of HTA findings needs to be monitored HTA should be timely HTA findings need to be communicated appropriately to different decision makers The link between HTA findings and decision making processes needs to be in all transparent and clearly defined The goal and scope of HTA should be explicit and relevant to its use HTA should be an unbiased and transparent exercise HTA should include all relevant technologies A clear system for setting priorities for HTA should exist HTA should incorporate appropriate methods for assessing costs and benefits HTAs should consider a wide range of evidence and outcomes A full societal perspective should be considered when undertaking HTAs

5. El éxito de la ETS • Cómo se definen, reglamentan y consolidan los aspectos procesales y técnicos. • Los productos ETS deben ser tenidos en cuenta por quienes asignan los recursos. • Los médicos y profesionales de la salud deben ser involucrados de manera activa en la ETS. • Formular recomendaciones requiere revisar la evidencia existente, sobre coste y efectividad, aplicando estándares científicos así como la consideración de los valores sociales locales. • Los procesos de ETS y de toma de decisiones tienen que ser abiertos, y clarificando los conflictos de interés. • Es preciso priorizar los procesos de ETS • Querer hacerlo todo desde el comienzo puede llevar al fracaso. Comenzar con algo bien delimitado y factible con el recurso humano disponible va a permitir probar y ajustar.

6. El éxito de la ETS • Cómo se definen, reglamentan y consolidan los aspectos procesales y técnicos. • Los productos ETS deben ser tenidos en cuenta por quienes asignan los recursos. • Los médicos y profesionales de la salud deben ser involucrados de manera activa en la ETS. • Formular recomendaciones requiere revisar la evidencia existente, sobre coste y efectividad, aplicando estándares científicos así como la consideración de los valores sociales locales. • Los procesos de ETS y de toma de decisiones tienen que ser abiertos, y clarificando los conflictos de interés. • Es preciso priorizar los procesos de ETS • Querer hacerlo todo desde el comienzo puede llevar al fracaso. Comenzar con algo bien delimitado y factible con el recurso humano disponible va a permitir probar y ajustar.

7. El éxito de la ETS • Transparencia • Rigor • Ajustarse al tiempo • Múltiples implicados, múltiples niveles de toma de decisiones • Flexibilidad • Relevancia • Contextualización local • Institucionalizar el proceso: • Qué evaluar • Quién evalúa • Cómo se evalúa

8. UNIVERSAL CONTEXTO ETS Políticas EVALUACION ASSESSMENT VALORACION APPRAISAL Investigación Desarrollo Innovación Prestaciones Revisión y análisis de información Efectos clínicos Costes Utilización Impacto:Organización asistencial Perspectiva del paciente Ética/NormativaRecursos/Economía/Educación Guías Práctica clínica

9. La priorización es un proceso • Identificación de temas: listado de temas a priorizar • Ajuste de temas: preguntas clave y perspectiva de la evaluación • Selección de temas: priorizados para la evaluación

10. Consejo Interterritorial • Is responsible for the coordination, cooperation and liaison among the central and the regional public health administrations. • The decisions materialise through recommendations which are approved by consensus. • There are several technical committees, such as the Committee of Benefits, Insurance and Financing (CBIF) • The CBIF is responsible for the updating of the common portfolio of benefits of the NHS (Act 16/2003 and Royal Decree 1030/2006)

11. Actualización de la cartera de servicios • MINISTERIO • REGIONES • SEGUROS PUBLICOS INICIO Comité de Prestaciones, Aseguramiento y Financiación • Profesionales • Pacientes • Industria ¿Innovación significativa? PROPUESTA NO SI Pleno Consejo Inter-territorial AETS ± Otros EVALUACION DECISION (MINISTERIO)

12. Diferentes tipos/niveles de decisión, diferentes necesidades AGENCIA REGULATORIA DECISION SOBRE FINANCIACION (PRECIO) CONDICIONES LOCALES DE USO DECISIONES CLINICAS: A QUE PACIENTES

13. Priorización: principios (IOM 1992) • Must be consistent with the mission of the organization that uses it. For a public agency, the values of the public that the agency serves need to be incorporated into the priority-setting process (the potential of a technology to improve health outcomes, to reduce inappropriate expenditures, to redress inequity among those receiving health care, and to inform special social issues) • Must consider the information needs of users (specific clinical conditions and on alternative approaches to management of those conditions) • Must be efficient so that scarce resources are not needlessly consumed in the process of setting assessment priorities taking advantage of available data or, where data are lacking, of subjective judgments, rather than require the collection of new data.(simple mechanism). • Must be sensitive to its political context; it must be—and must appear to be—objective, open, and fair; it must invite input from a variety of interested parties; and it must present the logic of the process clearly and carefully to others.

14. Priorización: proceso (IOM 1992)

15. Proceso en AHRQ

16. Criterios generales • Necesidad, uso apropiado, beneficios clínicos • Eficiencia, incluyendo coste-efectividad • Equidad, solidarirdad, u otros valores éticos o sociales

17. Criterios utilizados en priorización

18. Criterios utilizados en priorización

19. Organizaciones que proponen temas

20. Proceso en diversos países

21. Priorización: criterios (IOM 1992) • Objetivos (datos cuantitativos) • Prevalencia • Coste de la tecnología • Variabilidad en la práctica clínica • Subjetivos (1-5): • Carga de enfermedad • Probabilidad de que los resultados de la evaluación produzcan cambios en • Resultados en los pacientes • Costes • Aspectos éticos, legales o sociales

22. Priorización: criterios (IOM 1992) • Prevalence (O): The number of persons with the condition per 1,000 persons in the general U.S population • Burden of illness (S): The difference in quality-adjusted life expectancy (QALE) between a patient who has the condition and receives conventional treatment and the QALE of a person of the same age who does not have the condition • Cost (O): The total direct and induced cost of conventional management per person with the clinical condition • Variation in rates of use (O): The coefficient of variation (standard deviation divided by the mean) • Potential of the results of an assessment to change health outcomes (S): The expected effect of the results of the assessment on the outcome of illness for patients with the illness • Potential of the results of an assessment to change costs (S): The expected effect of the results of the assessment on the cost of illness for patients with the illness • Potential of the results of an assessment to inform ethical, legal, or social issues (S): The probability that an assessment comparing two or more technologies will help to inform important ethical, legal, or social issues

23. Priorización: ejemplo (IOM 1992)

24. Oregon • Condition-level Criteria • Prevalence • Mortality • Morbidity • Cost • Variability • Priority Topic-level Criteria • Appropriateness of topic for CER • Information gaps and duplications • Gaps in translation

25. Alberta • Degree of potential impact or change that the health technology could have on individual and/or population health • Incremental health system costs • Feasibility of reviewing the technology • Timing of the review • Consequences of not reviewing the technology.

26. AHRQ • Alignment of priority setting with the overall strategic purpose of the program • Apply clear and consistent criteria for prioritization of potential program activities • Involve stakeholders • Conduct program prioritization activities with adequate transparency to allow public accountability • Engage in ongoing self-evaluation/process improvement

27. AHRQ • Patient Population Priorities • Low-income groups • Minority groups • Women • Children • The elderly • Special needs, chronic care, end of life care • Inner-city or rural areas

28. AHRQ

29. Effective Health Care

30. Drug Effectiveness Review Project • Solicitation includes rationale for choice and intended policy action • Pros and cons submitted by each participant • Production of briefing paper including summary of existing literature • Final vote at biannual governance conference

31. Medicaid Evidence-basedDecisions Project • Participants nominate up to 3 topics per state • MED staff scan core evidence sources • Full list of topics presented to group for discussion • Participants rank topics (1 to 5) on electronic tool • Topics scored and final list presented to group • Governance meeting vote finalizes topics

32. SBU-Suecia • There must exist sufficient scientific data in the field. • The subject should have a significant impact on mortality and health. • The subject must relate to a common health problem with large economic consequences for society. • The subject may have ethical implications. • The subject’s perceived importance should be demonstrable from an organizational or professional perspective. • The subject is either controversial or a cause of great concern in society.

33. Holanda: diversas instituciones

34. Holanda: Health Insurance Council • Degree of uncertainty concerning efficacy, effectiveness, or efficiency • Frequency of use • Costs • Extent to which the concerned technology could potentially decrease morbidity or mortality and increase quality of life • Extent to which technology assessment results could change the rate of use of the technology

35. Holanda • Actual burden of disease, given current treatment strategies for the individual patient • Potential benefit for the individual patient • Number of patients • Direct costs of the intervention per patient • Financial consequences of applying the intervention over time (impact on total costs of health care) • Additional aspects, with an impact on health policy (for example, rapid uncontrolled diffusion)

36. Holanda: criterios y pesos

37. State of Washington

38. Center for Medical Technology Policy

39. Center for Medical Technology Policy

40. Patient-Centered Outcomes Research Institute

41. Patient-Centered Outcomes Research Institute

42. EuroScan

43. Revisión sistemática

44. Revisión sistemática

45. CADHT

46. CADHT

47. CADHT

48. Cochrane Public Health&Health Promotion (1) Burden of disease, magnitude of problem, urgency (2) Importance to developing countries (3) Avoidance of duplication (4) Opportunity for action

49. Nueva Zelanda

50. Tailandia