Transferability of HTA results - Advance-HTA
Transcription
Transferability of HTA results - Advance-HTA
Transferability of HTA results Prof. Dr. Andrés Pichon-Riviere IECS-Instituto de Efectividad Clínica y Sanitaria Profesor de Salud Publica, Universidad de Buenos Aires Contenidos •Introducción al tema •Experiencias de transferabilidad en la región •Conclusiones Definiciones Generalizability Whether the results from a given study apply to other settings Transferability The extent to which the results from a given study can be adapted to apply to other settings. Por que es un tema relevante? • No hay recursos suficientes para hacer todos los estudios en todos los lugares • Frecuentemente los tomadores de decisión necesitan adaptar o interpretar datos de otras jurisdicciones/países • Los estudios presentados por la industria para solicitar cobertura suelen incluir datos y/o modelos provenientes de otros países Hay varios factores que difieren entre los países y que es esperable que impacten en los resultados • • • • Demografía y epidemiología de la enfermedad Precios relativos Práctica clínica / tasas de uso Distribución y disponibilidad de los recursos sanitarios • Incentivos a profesionales / instituciones • Utilidades de los estados de salud Los decisores sanitarios están utilizando documentos de evaluación de tecnologías sanitarias de otros países Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7. Resultados (2) – Tomadores de Decisión Los decisores reportaron que en el 76% de los casos en que debieron utilizar un reporte de ETS para tomar una decisión el reporte había sido realizado en otro país Origin of HTA reports used in decision making From their own countries, 24% From other regions (eg Europe, North America, Australia), 53% From Latin American countries, 23% 76% Al utilizar reportes de otros países la información que consideraron más útil fue la información sobre: •Descripción de la tecnología •Seguridad •Eficacia y Efectividad Les resultó menos útil y aplicable la información sobre: •Implicancias éticas y legales •Impacto presupuestario •Evaluación económica •Aspectos organizacionales Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Researchers – use of HTA from other jurisdictions Researchers (HTA “doers”) reported using HTA reports from other jurisdictions as an input/source when elaborating local HTA reports in 64% of the situations Origin of HTA reports used as an input /source for HTA From other regions (eg Europe, North America, Australia), 80% From Latin American countries, 20% When using reports from other jurisdictions they found more useful/adaptable the information regarding: •Description of the technology •Safety •Efficacy/Effectiveness •Method. of systematic review •as an aid in the comparisons of results •as a starting point from which to develop a new report Less useful/adaptable •Ethic/legal/social implications •Budget impact •Organizational issues •Economic evaluation Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Researchers – “adaptation” of HTA reports from other jurisdictions 33% of the researchers reported having adapted an HTA report to the local setting. In 75% of the cases the reports adapted came from other regions and just 25% where reports from other Latin American countries. Origin of HTA reports used for adaptation From Latin American countries, 25% From other regions (eg Europe, North America, Australia), 75% Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) CHALLENGES FACED BY DECISION MAKERS FROM MIDDLE INCOME COUNTRIES IN TRANSFERRING ECONOMIC EVALUATIONS FROM OTHER JURISDICTIONS Michael Drummond1, Federico Augustovski2 , Zoltán Kaló3, Bong-Min Yang4, Andres PichonRiviere2, Eun-Young Bae5, Sachin Kamal-Bahl6 • Interviews with representatives of decisionmaking bodies from jurisdictions in Asia, Central and Eastern Europe with at least one year’s experience of using economic evaluations • Representatives of the relevant organizations were interviewed in South Korea, Taiwan, Thailand, Croatia, Hungary, Poland, Slovakia, Argentina, Brazil, Colombia, Mexico and Uruguay Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 Uses of economic evaluations (N=number of organizations) 14 12 12 10 8 8 7 6 4 3 2 2 0 General information for the To inform reimbursement or To inform price negociations To develop clinical guidelines health care system coverage decisions or decisions Other 9 Ways in which the results from studies conducted in other jurisdictions are used? (N=number of organizations) 8 8 7 6 6 5 5 4 4 3 3 2 2 2 2 2 1 1 1 0 0 General background To check the validity of the data or To compare the conclusions in the As a basis for making a local decision, assumptions in the local dosser from local dossier with the conclusions in based on the foreign study's the manufacturer other jurisdictions recommendations Often Sometimes Never Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 Which categories of data from foreign studies are most often used in submissions you receive? (N= number of responses) 10 9 9 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1 0 0 0 0 0 0 0 Data on epidemiology of disease or baseline risk Data of relative treatment effect Data on resource use Often Sometimes Unit costs/prices Health state preference values/utilities Never Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 Figure 5 Which categories of foreign data do you consider to be transferable? (N= number of responses) 9 8 8 8 8 7 6 6 6 5 4 3 3 3 2 1 1 1 1 0 0 0 0 0 0 Data on epidemiology of disease Data of relative treatment effect or baseline risk Data on resource use Often Sometimes Unit costs/prices Health state preference values/utilities Never Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 Adaptation of foreign models by the organizations studied (N= Number of responses ) 6 5 5 4 4 3 3 2 2 2 1 0 0 Without any adaption to the model structure to reflect local circumstances Often Sometimes With adaptation to reflect local circumstances Never Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 OBSTACLES TO TRANFERRING ECONOMIC EVALUATIONS FROM OTHER JURISDICTIONS Other practice patterns, or the availability of facilities, are often different in my jurisdiction The current standard of care/ relevant comparator is often different in my jurisdiction Number of times mentioned 10 9 Studies are often conducted in countries with a higher GDP, so the results do not apply in my jurisdiction 8 Studies are often badly reported, or not enough details are given 8 It is often difficult or impossible to obtain an electronic copy of the model 7 The patient population is often different in my jurisdiction 6 Often, it is not possible to find local data to re-populate the model 6 Studies often have methodological deficiencies 5 Decision-makers in my jurisdiction much prefer a locally designed study Studies often use methods that are too advanced for decision-makers in my jurisdiction 5 Other obstacles (please list and rank) 3 Lack of local technical capability 1 . Decision-makers in my jurisdiction much prefer non-data driven arguments 1 Different resources & costs used in other jurisdictions 1 4 Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, Skills accessible to the organization surveyed (N=number of organizations) 12 11 10 10 10 9 8 8 6 4 2 0 Physicians/clinical specialists Pharmacists Epidemiologists Health economists Medical statisticians Use of International Resources • Websites frequently consulted; NICE, CRD(York), CADTH, SMC, PBAC • Very little use of transferability checklists (eg Eunethta checklist) • Very little use of studies undertaken in other countries in the region Source: Challenges Faced by Decision Makers from Middle Income Countries in Transferring Economic Evaluations from Other Jurisdictions. Drummond D, Augustovski F, Kalo Z, Yang B, Pichon-Riviere A, Bae E, Kamal-Bahl S. Health Technology Assessment International 2014 - 11th Annual Meeting, Washington, DC. Junio 2014 HEE methodological guidelines in Latin America Countries with HEE guidelines Brazil, Colombia, Cuba and Mexico MERCOSUR: Argentina, Brazil, Paraguay and Uruguay Grupo Andino: Bolivia, Chile, Colombia, Ecuador, Peru, Venezuela Most of these guidelines were produced or are being sponsored by the public government, suggesting their interest in going in that direction regarding decision making of new and existing technologies for reimbursement and financing purposes. A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) What these guidelines say about the use of data, models and information from other jurisdictions? MEXICO: If information from international sources or from clinical trials from different contexts is used, appropriate adjustments must be considered in relation to differences in resource use. Data should be validated and adjusted in relation to local practice, besides having into consideration the differences in resource use between routine practice and that developed for research purposes. BRAZIL: QALYs. It is preferable that local utilities are used. If these are not available can be used international sources. CHILE - Modeling section: If the model was developed and validated abroad (or in another context), its use for national reality must be justified and the model should be calibrated with national data CHILE – Costs section: When data on cost of resources is not available at the local level can be considered ultimately using international evidence. In these cases must include the (descriptive and quantitative) analysis regarding the generalizability and transferability potential. In all cases, the choice of methodologies, and assumptions must be clearly justified. A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) Welte R, Feenstra T, Jager H y Leidl R. A Decision Chart for Assessing and Improving the Transferability of Economic Evaluation Results Between Countries. Pharmacoeconomics 2004; 22 (13): 857876 Conclusion In Latin America is commonplace to deal with the issue of transferring analysis or data from other jurisdictions The use and adaptation of HTAs from other jurisdictions can be a valuable tool to overcome the scarcity of local information and the lack of time and resources to generate evidence in the short term. As the use of economic evaluations to inform reimbursement and coverage decisions increases in middle income countries, it will be increasingly important to ensure improved practices in evaluating and conducting transferability of foreign data. Inadequacies in dealing with transferability issues may lead to inappropriate coverage decisions and the inefficient use of healthcare resources. A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) In the short and medium term: •Define/Agree on methodologies to rigorously assess the degree of transferability • Invest in local data generation for those categories of data normally considered to have low transferability, such as unit costs, health state preference values and epidemiological data. •As the number of HTA organizations in LA increases, they could collaborate more fully within their region, since the transferability of economic evaluations within the region is likely to be greater than that between regions. (eg multi country economic evaluations) A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) Thank you! Andres Pichon-Riviere MD MSc PhD apichon@iecs.org.ar Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Source: Pichon-Riviere A, Augustovski F, Rubinstein A, Martí SG, Sullivan SD, Drummond MF. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010 Oct;26(4):421-7. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Muchas gracias! Andres Pichon-Riviere MD MSc PhD apichon@iecs.org.ar Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) General section about transferability: responses from HTA “users” and “doers” All respondents consider that using HTA reports from other jurisdictions is potentially very useful. This potential was considered to be higher for HTA reports from Latin America. They consider it useful to: •Improve the decision making process •Fewer resources needed •Obtain results faster •Avoid duplication of work Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Main barriers than limit the transferability of HTA reports: For HTA reports from Latin America • Low quantity of HTA reports available • Lack of guidelines/methods on how to adapt HTA reports • Poor methodological quality • Lack of transparency in the HTA reports published Barriers for transferability: Poor methodological quality For HTA reports from other regions • Differences in health care costs • Different epidemiological contexts • Different health care systems 6.6 7 6 5.3 5 4 3 2 1 0 HTA reports from other regions (eg Europe, North America, Australia) HTA reports from Latin American countries p<0.01 Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Main barriers than limit the transferability of HTA reports: For HTA reports from Latin America • Low availability of HTA reports • Lack of guidelines/methods on how to adapt HTA reports • Poor methodological quality • Lack of transparency in the HTA reports published Barriers for transferability: Low quantity of HTA reports available For HTA reports from other regions • Differences in health care costs • Different epidemiological contexts • Different health care systems 8 7 7 6 5.1 5 4 3 2 1 0 HTA reports from other regions (eg Europe, North America, Australia) HTA reports from Latin American countries p<0.01 Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Main barriers than limit the transferability of HTA reports: For HTA reports from Latin America • Low quantity of HTA reports available • Lack of guidelines/methods on how to adapt HTA reports • Poor methodological quality • Lack of transparency in the HTA reports published Barriers for transferability: Different epidemiological contexts For HTA reports from other regions • Differences in health care costs • Different epidemiological contexts • Different health care systems 8 7.25 7 6 6 5 4 3 2 1 0 HTA reports from other regions (eg Europe, North America, Australia) HTA reports from Latin American countries p<0.01 Source: Pichon-Riviere A, Augustovski F, García Martí S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: an exploratory survey of researchers and decision makers. Int J Technol Assess Health Care. 2012 Apr;28(2):180-6. Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Main barriers than limit the transferability of HTA reports: For HTA reports from Latin America • Low quantity of HTA reports available • Lack of guidelines/methods on how to adapt HTA reports • Poor methodological quality • Lack of transparency in the HTA reports published Barriers for transferability: Different healthcare costs For HTA reports from other regions • Differences in health care costs • Different epidemiological contexts • Different health care systems 8 7.6 6.5 7 6 5 4 3 2 1 0 HTA reports from other regions (eg Europe, North America, Australia) HTA reports from Latin American countries p<0.01 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar)