HTAi 2021 LAPF

2021 Latin 2021 Foro de America Policy Políticas en Forum Evaluación de Tecnología Sanitaria en Latinoamérica Deliberative processes Procesos deliberativos For informed decision para la toma de decision Making by health informada por la evaluación de Technology assessment tecnologías sanitarias VIRTUAL FORUM FORO VIRTUAL October 25-27, 2021 25-27 de octubre de 2021



Dear Colleagues, Welcome | Bienvenida Welcome to the VI HTAi Latin America Forum on Health Technology Assessment Policies! As in previous years, our Forum continues to provide a space for neutral and independent debate on issues of common interest for senior professionals from public and private institutions in connection with strategic decision-making concerning medical technologies. This year has been challenging for everyone, but we have made the greatest effort to develop a program of the highest level and content. To that effect we will have guests from public institutions from 12 countries in the region, as well as representatives from 9 health technology companies. We are pleased to welcome a representative of the Pan American Health Organization (PAHO). We have also embraced the recommendation of the Forums Organizing Committee to invite two patient representatives, thus showing our commitment to the end users of health technology innovations. The topic chosen for this occasion, \"Deliberative Processes for Informed Decision Making in Health Technology Assessment\" is of special relevance in countries seeking to achieve a Universal Health Coverage in an equitable and sustainable manner; particularly in our region, where the frequency of court rulings aiming to grant access to innovative technologies, or to those technologies not initially or dynamically included in each country’s benefit plans is a fundamental piece in the process of systematic prioritization in healthcare. It should be noted that ever since our first Forum, which was held in 2016, this topic has been one of the principles associated with good practices in Health Technology Assessment in the region. The pandemic has forced us to readapt the Forum to a virtual format. Therefore, we have made adjustments in terms of time and content to ensure that attendees can participate and interact with their peers and attain the utmost benefit from their attendance. We are taking this opportunity to formally thank all the speakers and members of the Forum who have kindly agreed to make their presentations. We also thank the Latin America Policy Forum Organizing Committee for their contribution and guidance in the development of the base document, as well as in the design of the agenda. Once again, we welcome all participants to the VI Latin America Policy Forum and appreciate their interest and continued commitment to HTAi, and to this event in particular. We hope you find this event as stimulating and rewarding as the previous ones have been. Dr. Héctor E. Castro-J Chair HTAi Latin America Health Technology Assessment Policy Forum 1

Welcome | Bienvenida Apreciados colegas, ¡Bienvenidos al VI Foro Latinoamericano HTAi de Políticas de Evaluación de Tecnología Sanitaria! Como en años anteriores, nuestro Foro continúa ofreciendo un espacio de debate neutral e independiente sobre temas de interés común para profesionales senior de instituciones públicas y privadas en relación con la toma de decisiones estratégicas relacionadas a las tecnologías médicas. Este año ha sido desafiante para todos, pero hemos hecho el mayor esfuerzo por desarrollar una jornada del más alto nivel y contenido; es así como contaremos con la presencia de invitados de instituciones públicas de 12 países de la región y también con representantes de 9 empresas del área de tecnologías en salud. Estamos complacidos de contar con la presencia de un representante de la Organización Panamericana de la Salud- PAHO. Acogimos la recomendación del Comité Coordinador del Foros y hemos invitado también a dos representantes de pacientes, mostrando así nuestro compromiso con los usuarios finales de las innovaciones tecnológicas en salud. El tema elegido en esta ocasión, “Procesos Deliberativos Para La Toma De Decisión Informada Por La Evaluación De Tecnologías Sanitarias” es de especial relevancia en países que buscan la Cobertura Universal en Salud de manera equitativa y sostenible. En nuestra región en particular, donde la frecuencia de fallos judiciales en búsqueda de otorgar acceso a tecnologías innovadoras o no incluidas de manera inicial o dinámica en los planes de beneficios de cada país constituye una pieza fundamental del proceso de priorización sistemática en salud. Cabe resaltar que desde nuestro primer Foro desarrollado en 2016 este tema surgió como uno de los principios asociados a buenas prácticas en la Evaluación de Tecnología Sanitaria en la región. La pandemia ha hecho que tengamos que adaptar de nuevo el Foro a un formato virtual, por lo que hemos hecho los ajustes en cuanto a tiempos y contenido garantizando que los participantes puedan participar e interactuar con sus pares y logren el mayor beneficio de su asistencia. Aprovechamos esta ocasión para agradecer formalmente a todos los oradores y a los miembros del Foro que amablemente han accedido a hacer las presentaciones. También agradecemos al Comité Organizador del Foro por sus contribuciones y direccionamiento en la ejecución del documento de base, así como en el diseño de la agenda. Reiteramos la bienvenida a todos los participantes del VI Foro y agradecemos el interés y compromiso continuo con HTAi y en particular para este evento. Deseamos que encuentren este evento tan estimulante y gratificante como han sido los anteriores. Dr. Héctor E. Castro-J Presidente Foro Latinoamericano de Políticas de Evaluación de Tecnología Sanitaria de HTAi 2

Meeting Information Welcome | Bienvenida The 2021 HTAi Virtual Latin America Policy Forum will take place virtually at 11:00 a.m. Argentina/Brazil/ Chile/Paraguay/Uruguay time (UTC -3), 8:00 a.m. Costa Rica/El Salvador, 9:00 a.m. Mexico/Colombia/Ecuador/ Panama/Peru, 10:00 a.m. Washington (EST), 16:00 p.m. Europe on October 25, 26, and 27, 2021. (Please click here to find the correct time in your time zone) The topic for the meeting is: “Deliberative processes for informed decision-making by health technology assessment” Please connect to the meeting using the following details HTAi LATIN AMERICA POLICY FORUM: OPEN SESSION - October 25, 2021 https://zoom.us/j/92208529960?pwd=M2RISWozMHJrS1gwOEx1KzVjcjdxZz09 Meeting ID: 922 0852 9960 Access code: 568504 HTAi LATIN AMERICA POLICY FORUM: CLOSED FORUM - October 26-27, 2021 https://zoom.us/j/96299328782?pwd=dDc5dk9kZ3gwVFcxbm40dytWbTVsZz09 Meeting ID: 962 9932 8782 Access code: 367450 We prefer all attendees join using a PC or other personal device to ensure functionality of breakout groups, however if you require a toll-free dial in number please contact us at [email protected] Social Media information HTAi would like to encourage Forum members to share their thoughts and experiences on social media. However, please keep in mind the HTAi 2021 Virtual Latin America Policy Forum is held under the Chatham House Rule, so neither the identity nor affiliation of the speaker(s), nor that of any other participant, may be revealed. Official hashtag: #2021LATAMPF Social media handles: • Twitter: @HTAiOrg • LinkedIn: Health Technology Assessment International (HTAi) • Facebook: @HTAiOrg 3

Welcome | Bienvenida Información de la reunión Foro de Políticas en Evaluación de Tecnología Sanitaria en Latinoamérica Foro On-line de 8:00 a.m. a 11:30 a.m. Hora de La Montaña MDT (14:00 p.m. – 17:30 p.m. Hora Universal Coordinada UTC) los días 25, 26 y 27 de octubre de 2021 (Haga clic aquí para encontrar la hora correcta en su zona horaria) El tema de la reunión es: \"Procesos deliberativos para la toma de decisión informada por la evaluación de tecnologías sanitarias\" Conéctese a la reunión utilizando los siguientes detalles HTAi LATIN AMERICA POLICY FORUM: SESIÓN ABIERTA - 25 de octubre de 2021 https://zoom.us/j/92208529960?pwd=M2RISWozMHJrS1gwOEx1KzVjcjdxZz09 ID de reunión: 922 0852 9960 Código de acceso: 568504 HTAi LATIN AMERICA POLICY FORUM: CLOSED FORUM - 26-27 de octubre de 2021 https://zoom.us/j/96299328782?pwd=dDc5dk9kZ3gwVFcxbm40dytWbTVsZz09 ID de reunión: 962 9932 8782 Código de acceso: 367450 Preferimos que todos los asistentes se unan utilizando una PC u otro dispositivo personal para garantizar la funcionalidad de los grupos de discusión, sin embargo, si necesita un número de marcado gratuito, contáctenos en [email protected] Información de redes sociales A HTAi le gustaría animar a los miembros del Foro a compartir sus pensamientos y experiencias en las redes sociales. Sin embargo, tenga en cuenta que el Foro Virtual de Políticas de América Latina HTAi 2021 se lleva a cabo en el marco de Chatham House Rule, por lo que ni la identidad ni la afiliación del o los oradores, ni la de ningún otro participante, puede ser revelado. Hashtag oficial: # 2021LATAMPF Maneja de redes sociales: • Twitter: @HTAiOrg • LinkedIn: Health Technology Assessment International (HTAi) • Facebook: @HTAiOrg 4

Networking Reception Welcome | Bienvenida The 2021 HTAi Latin America Policy Forum networking reception will take place virtually on October 25, 2021, at 16:00 p.m. Argentina/Brazil/Chile/Paraguay/Uruguay time (UTC -3), 13:00 p.m. Costa Rica/El Salvador, 14:00 p.m. Mexico/Colombia/Ecuador/Panama/Peru, 15:00 p.m. Washington (EST), 21:00 p.m. Europe on October 25, 26, and 27, 2021. (Please click here to find the correct time in your time zone) Please connect to the meeting using the following details HTAi LATIN AMERICA POLICY FORUM: NETWORKING RECEPTION - October 25, 2021 https://zoom.us/j/95597443281?pwd=M2JPSTU2SnN4S1ZMNnYvdzhNd0t6Zz09 Meeting ID: 955 9744 3281 Access code: 071722 We prefer all attendees join using a PC or other personal device to ensure functionality of breakout groups, however if you require a toll-free dial in number please contact us at [email protected] Agenda Activity Facilitator(s) Wine and Chocolate class Cocktail Guru Time Informal networking ALL 13:00 - 13:45 MDT 3:45 - 14:00 5

Welcome | Bienvenida Recepción de networking La recepción de networking del Foro de Políticas de América Latina HTAi 2021 se llevará a cabo de manera virtual el 25 de octubre de 2021, a las 16:00 p.m. Argentina/Brazil/Chile/Paraguay/Uruguay time (UTC -3), 13:00 p.m. Costa Rica/El Salvador, 14:00 p.m. Mexico/Colombia/Ecuador/Panama/Peru, 15:00 p.m. Washington (EST), 21:00 p.m. Europe. (Haga clic aquí para encontrar la hora correcta en su zona horaria) Conéctese a la reunión utilizando los siguientes detalles HTAi LATIN AMERICA POLICY FORUM: RECEPCIÓN DE NETWORKING - 25 de octubre de 2021 https://zoom.us/j/95597443281?pwd=M2JPSTU2SnN4S1ZMNnYvdzhNd0t6Zz09 ID de reunión: 955 9744 3281 Código de acceso: 071722 Preferimos que todos los asistentes se unan utilizando una PC u otro dispositivo personal para garantizar la funcionalidad de los grupos de networking, sin embargo, si necesita un número de marcado gratuito, contáctenos en [email protected] Agenda Actividad Facilitador(es) Clase de Vino y Chocolate Gurú de la coctelería Hora Networking informal TODO 13:00 - 13:45 MDT 13:45 - 14:00 6

How to Participate in a Welcome | Bienvenida Zoom Meeting Using the “Attendee Controls” https://support.zoom.us/hc/en-us/articles/200941109-What-Are-the-Attendee-Controls- About When you join a Zoom meeting hosted by another user, you are considered an attendee. The user who scheduled the meeting or was selected as the alternative host (if the host is unable to join) will have host controls, including muting audio, using video, sharing your screen and more. Join a Meeting Join a meeting by clicking on a Zoom link provided by the meeting host => follow the prompts to download and run Zoom => enter the meeting ID if prompted => click to join the audio conference. When you’re in the meeting, you may click on the Start Video button to start your video. Mute/Unmute & Audio Settings You can mute and unmute your microphone. The host also has the ability to mute you. If you click on the arrow next to the mute button, you will have additional options for audio settings. You can change your microphone, leave the computer audio or access the audio options. 7

Welcome | Bienvenida Start/Stop Video & Video Settings You can turn your camera on or off with the Start/Stop Video button. By clicking on the arrow next to the start/stop video button, you can change webcams, access your Zoom video settings, or select a virtual background (if enabled). Participants If you click on Participants, you can see who is currently in the meeting. The participants list also gives you the option to raise your hand or rename yourself. • Raise Hand - notifies host and shows a prompt to simulate hand raise • Rename - hover over your name to change it as it is seen in the participants list and video window Share Screen If the host allows, you can share your screen in the meeting. The host will have the ability to stop your screen share. Chat Chat with individuals or everyone in the meeting. Click Chat to open up the chat window and chat with other participants or view chat messages. Select the drop down next to To: to change who you are chatting with. Record (if host has given permission) The host will need to give you permission to record the meeting. If you try to click on this before the host has given permission, you will receive the following message. Note: the host is not notified that you have requested recording permission. You will need to ask them through the chat or audio to give you recording permission (available in their Manage Participants list). 8

Choose video layout Welcome | Bienvenida At the upper right of the Zoom window, you can switch between active speaker view and gallery view. You can also switch between a shared screen and the video by clicking on a button available in this location during a screen share. Enter/Exit Full Screen At the top right of the Zoom window, you can enter or exit full screen mode. You can also exit full screen by clicking Esc. Pin video Pin video makes a user the primary speaker for you, instead of switching between the active speaker video. You can pin a video by right-clicking on the video of the person you want to pin or double click on their video window. Co-annotate on screen share If the host allows, you can annotate on their shared screen or share whiteboard. To do this, click on View Options at the top of your screen and choose Annotate. Leave Meeting You can leave the meeting at any time by clicking on the Leave Meeting option at the lower right corner of the Zoom window. 9

Welcome | Bienvenida For More Information Contact Technical Support: https://support.zoom.us/hc/en-us/articles/201362003-Zoom-Technical-Support Zoom Help Center: https://support.zoom.us/hc/en-us Getting Started: https://support.zoom.us/hc/en-us/categories/200101697-Getting-Started Tutorials: https://support.zoom.us/hc/en-us/sections/201740096-Training Mobile: https://support.zoom.us/hc/en-us/sections/200305413-Mobile 10

¿Cómo participo de Welcome | Bienvenida una reunión en Zoom? 1. Ingrese a Zoom mediante el enlace o la invitación que le hayan enviado. En caso de que sea la primera vez que lo utiliza, se descargará a su computadora el programa necesario para conectarse. Cuando finalice la descarga haga clic en el botón “Ejecutar” Si el software fue previamente instalado, se le solicitará confirmación para abrir el programa de videoconferencia. Haga clic en el botón “Abrir Zoom Meetings” 11

Welcome | Bienvenida Cuando finalice de abrir Zoom Meetings, haga clic en el botón “Entrar al audio por computadora”. Con este último paso habrá ingresado a reunión. 2. Acerca de las funcionalidades básicas cuando participa de una reunión: A. Para silenciar su micrófono, haga clic en “Silenciar” B. Para activar su micrófono, haga clic en “Re-Iniciar Audio” C. Para apagar su cámara, haga clic en “Detener video” D. Para iniciar su video, haga clic en “Iniciar Video” E. Para ver la lista de participantes, haga clic en “Participantes” F. Para levantar la mano, y de esta manera solicitar la palabra, haga clic en “Participantes” y luego en el botón “Levantar la mano” El moderador puede bajarle la mano, pero en caso de que usted quiera bajarla, en la lista de participantes haga clic en el botón “Bajar la mano”. G. Para chatear con los moderadores u otros participantes haga clic en el icono “Chatear” . 12

Por defecto lo que escriba es para todos los participantes, Welcome | Bienvenida en caso de querer escribirle a un participante en particular, selecciónelo en “Enviar a:” modificando en lugar de todos el participante con cual usted desea chatear. H. Para minimizar la venta de la reunión y así poder ver otras ventanas que tenga abiertas, arriba a la derecha, haga clic en el icono de minimizar. I. En caso de ser necesario, y si el moderador lo permite, usted puede compartir su pantalla. Haga clic en el botón “Compartir pantalla” , seleccione cual ventana desea compartir y haga clic en el botón “Compartir pantalla”. J. Para salir de la reunión, haga clic en “Salir de la reunión” . 13

Welcome | Bienvenida K. Es posible ingresar a una reunión de prueba para validar el funcionamiento de su cámara, micrófono y parlantes. La dirección de acceso es: https://zoom.us/test/ Haga clic en “Entrar”, esto iniciará automáticamente Zoom en su máquina Luego que Zoom inicie, si ve su imagen, significa que su cámara funciona correctamente. Para probar el audio y micrófono haga clic en “Probar el audio de la computadora”. En la nueva ventana puede ver los botones para verificar el micrófono y parlantes. Para probar que sus parlantes funcionen bien, haga clic en “Altavoz” lo cual reproduce la música que debería escuchar. Para probar su micrófono, haga clic en el botón “Micrófono” para que comience a grabar lo que usted diga y de manera automática lo reproduce. 14

L. Existen 3 diseños diferentes o vistas: Ventana completa, Galería y Mini Welcome | Bienvenida 1) Ventana completa o normal Para ingresar al modo “Ventana completa” haga doble clic en cualquier parte de la ventana de Zoom, o haciendo clic en el icono “Pantalla completa” que se encuentra arriba a la derecha. Para salir del modo ventana completa, puede utilizar cualquiera de las dos formas descriptas previamente. 2) Vista de Galería o del hablante Es posible ver a los participantes de dos maneras diferentes, puede utilizar la “Vista del hablante” o “Vista de Galería”. En la “Vista del hablante” muestra grande a quien habla en ese momento. En la “Vista de galería” podrá ver a todos los participantes (hasta 25) en una misma ventana, y recuadra con otro color la imagen de quien habla en ese momento. Para seleccionar la vista que desee, haga clic arriba a la derecha donde dice “Vista de galería” o “Vista del Hablante”. 3) Vista mini (o minimizada) La vista minimizada es la forma más pequeña en que se puede ver la ventana de la aplicación Zoom. Para minimizar, haga clic en el icono de minimizar la ventana. La ventana minimizada permite ver una miniatura del video y algunos comandos básicos. Para salir de la ventana minimizada, haga clic en el botón de “Maximizar”. M. En el momento que ingresa a una reunión se le solicita que especifique su nombre, si luego desea modificarlo, es posible de la siguiente manera. Haga clic en participantes, y en la nueva ventana, busque su nombre y vera un botón que dice “Renombrar”. Luego ingrese en el nombre que desee y haga clic en “Ok”. 15

Welcome | Bienvenida 3. Recomendaciones generales 1. Es recomendable utilizar auriculares con micrófono, en lugar del micrófono y parlantes incorporados en la computadora o notebook. 2. Se recomienda utilizar una conexión por cable para conectarse a Internet. Si bien es posible utilizar WiFi, por cómo funciona este tipo de conexión es posible que la calidad del audio y el video se vea degradada. 3. Elija un lugar tranquilo y sin ruidos para participar de la videoconferencia. 4. Ingrese algunos minutos antes del comienzo, para verificar que todo funcione correctamente. 5. Silencie su micrófono si no va a participar verbalmente. 6. Levante la mano para pedir la palabra. 16

Agenda Agenda VI Latin America Health Technology Assessment Policy Forum Virtual Forum \"Deliberative processes for informed decision-making by health technology assessment\" Meeting 25-27 October 2021 11 hs. ART (UTC -3) Duration 2:30 hs. each day Monday, October 25, 2021 11:00 - 11:15 Welcome and opening of the Dr. Héctor E. Castro-J, Chair, HTAi's Latin American Forum (15 min) Health Technology Assessment Policy Forum, 11:15 - 12:10 Colombia 11:15 - 11:25 Wija Oortwijn, Radboud University Medical Center, 11:25 - 11:35 Department of Health Evidence, Vice President, 11:35 - 11:45 HTAi, The Netherlands 11:45 - 12:10 12:10 - 12:20 Deliberative processes for informed decision-making by health technology assessment (Pre-recorded presentations to be seen before the event) Deliberative processes and Wija Oortwijn, Radboud University Medical Center, decision-making: What is the Department of Health Evidence, Vice President of significance of deliberative HTAi, The Netherlands processes in HTA? (10 min) NICE's experience in deliberative Pilar Pinilla Domínguez, NICE - National Institute processes. (10 min) for Health and Care Exccellence, Senior Scientifc Advisor - NICE International & Scientific, England Incorporating the values of Mireille Goetghebeur, Professor at the University decision makers into the process of Montreal, School of Public Health, Department – from theory to practice. (10 min) of Administration, Health Assessment and Policy, Canada Clarification questions and All attendees answers (25 min) Coffee break (10 min) 12:20 - 13:25 Experiences related to deliberative processes in the region 12:20 - 12:35 Countries of the region: Brazil, Moderator: Alexandre Lemgruber, Regional Advisor, Colombia, Chile (15 min): Technology Assessments, PAHO, Brazil • Current status of deliberative Vania Cristina Canuto Santos, CONITEC, Ministry of processes and future plans Health, Brazil Adriana María Robayo García, Institute of Health Technology Assessment IETS (Instituto de Evaluación Tecnológica en Salud), Colombia Dino Sepúlveda Viveros, Ministry of Health, Chile 17

Agenda 12:35 - 12:45 Networking activity (10 min) All attendees 12:45 - 12:55 Debora Aligieri, Diabetes and Democracy, Brazil Patient and user perspective 12:55 - 13:05 (10 min) Joice Valentim, F. Hoffmann-La Roche, Switzerland 13:05 - 13: 25 All attendees Industry perspective (10 min) 13:25 - 13:30 Andrés Pichon-Riviere - IECS Clarification questions and answers (20 min) Presentation and instructions for discussion groups Tuesday, October 26, 2021 11:00 - 11:30 Opening Dr. Héctor E. Castro-J • Summary, day 1 (10 min) Andrés Pichon-Riviere • Presentation and instructions for Andrés Pichon-Riviere discussion groups (10 min) • Networking activity (10 min) All attendees Division of participants into small groups 11:30 - 12:30 Group activity 1 (60 min) All attendees - 4 interactive work 12:30 - 12:45 groups • Discussion about the current situation of the region (Issues and challenges): What might be the reason why many of the countries in the region have not implemented, at least formally, deliberative processes in the evaluation and decision-making in HTA? What consequences/problems does this situation currently entail? • What are the main weaknesses/barriers and the main strengths/facilitators for establishing deliberative processes in the region? Coffee break All attendees Preparation of conclusions in each group Facilitator and Secretaries 12:45 - 13:30 Plenary session Dr. Héctor E. Castro-J and Secretaries 12:45 - 13:05 Presentations by discussion groups Dr. Héctor E. Castro-J and all attendees (5 min per group) 13:05 - 13:30 Plenary discussion (25 mins) 18

Wednesday, October 27, 2021 Agenda 11:00 - 11:25 Opening Dr. Héctor E. Castro-J 11:25 - 12:20 • Summary, days 1 and 2 (10 min) Andrés Pichon-Riviere 12:20 - 12:30 • Presentation and instructions for Andrés Pichon-Riviere discussion groups (5 min) • Networking activity (10 min) All attendees Distribution of participants into small groups Group activity 2 (55 min) All attendees - 4 interactive work groups • Considering the debates and results of the previous day, during this group activity the following aspects will be discussed on the subject: What are the stages of an HTA when it is more important to move forward with deliberative processes in the region? • What stakeholders should participate in such deliberative processes, and what role should they play? • What recommendations can be made to LAC health systems and what actions should be taken? Coffee break All attendees Preparation of conclusions in each group Facilitator and Secretary 12:30 - 13:10 Plenary session Dr. Héctor E. Castro-J and Secretaries 12:30 - 12:50 Presentations by the discussion groups (5 min per group) Dr. Héctor E. Castro-J and all attendees 12:50 - 13:10 Plenary discussion (20 min) Moderator: Dr. Héctor E. Castro-J 13:10 - 13:30 What keeps me awake? All attendees Possible topics for future Forums Dr. Héctor E. Castro-J. 13:30 Farewell and closure Wija Oortwijn 19

Agenda Agenda VI Foro de Políticas en Evaluación de Tecnología Sanitaria en Latinoamérica Foro On-line “Procesos deliberativos para la toma de decisión informada por la evaluación de tecnologías sanitarias” Reunión 25-27 de octubre 2021 11 hs. ART (UTC -3) Duración 2:30 hs. cada día Lunes 25 de octubre, 2021 11:00 a 11:15 Bienvenida y apertura del Foro Dr. Héctor E. Castro-J, Presidente Foro 11:15 a 12:10 (15 min) Latinoamericano de Políticas de Evaluación de Tecnologías Sanitarias de HTAi, Colombia Wija Oortwijn, Centro Médico de la Universidad de Radboud, Departamento de Evidencia Sanitaria, Vicepresidente de HTAi, Países Bajos Procesos deliberativos para la toma de decisión informada por la evaluación de tecnologías sanitarias (Presentaciones pregrabadas a ser vistas antes del evento) 11:15 a 11:25 Procesos deliberativos y la toma Wija Oortwijn, Centro Médico de la Universidad de de decisión: ¿Qué representan los Radboud, Departamento de Evidencia Sanitaria, 11:25 a 11:35 procesos deliberativos en HTA? Vicepresidente de HTAi, Países Bajos 11:35 a 11:45 (10 min) La experiencia en procesos Pilar Pinilla Domínguez, NICE - National Institute 11:45 a 12:10 deliberativos de NICE. (10 min) for Health and Care Exccellence, Asesor científico 12:10 a 12:20 principal - NICE International & Scientific, Inglaterra Incorporando los valores de Mireille Goetghebeur, Profesora en la Universidad los tomadores de decisión en de Montreal, Escuela de Salud Pública, el proceso – de la teoría a la Departamento de Administración, Evaluación y práctica. (10 min) Política Sanitaria, Canadá Preguntas y respuestas de Todos los asistentes clarificación (25 min) Pausa café (10 min) 12:20 a 13:25 Experiencias en relación a procesos deliberativos en la región 12:20 - 12:35 Países de la región: Brasil, Moderador: Alexandre Lemgruber, Asesor Regional, Colombia, Chile (15 min): Evaluaciones Tecnológicas, PAHO, Brasil 20

• Estado actual de los procesos Vania Cristina Canuto Santos, CONITEC, Ministerio Agenda deliberativos y planes futuros de Salud, Brasil Adriana María Robayo García, IETS-Instituto de Evaluación Tecnológica en Salud, Colombia Dino Sepúlveda Viveros, Ministerio de Salud, Chile 12:35 a 12:45 Actividad de networking (10 min) Todos los asistentes 12:45 a 12:55 12:55 a 13:05 Perspectiva de los pacientes y Debora Aligieri, Diabetes y Democracia, Brasil 13:05 a 13: 25 usuarios (10 min) 13:25 a 13:30 Perspectiva desde la industria Joice Valentim, F. Hoffmann-La Roche, Suiza (10 min) Preguntas y respuestas de Todos los asistentes clarificación (20 min) Presentación e instrucciones Andrés Pichon-Riviere - IECS para los grupos de discusión Martes 26 de octubre, 2021 11:00 a 11:30 Apertura Dr. Héctor E. Castro-J • Resumen día 1 (10 min) Andrés Pichon-Riviere • Presentación e instrucciones para los grupos Andrés Pichon-Riviere de discusión (10 min) 11:30 a 12:30 • Actividad de networking (10 min) Todos los asistentes 12:30 a 12:45 Division of participants into small groups Todos los asistentes - 4 grupos de Actividad grupal 1 (60 min) trabajo interactivos • Actividad de discusión sobre la situación Todos los asistentes actual de la región (Retos y desafíos): ¿Cuáles pueden ser los motivos por los cuales gran parte de los países de la región no han implementado, al menos formalmente, procesos deliberativos en la evaluación y toma de decisión de ETESA? Que consecuencias/problemas acarrea actualmente esta situación? • ¿Cuáles son las principales debilidades/ barreras y las principales fortalezas/ facilitadores para establecer procesos deliberativos en la región? Pausa café Preparación de conclusiones de cada grupo Facilitador y secretarios 12:45 a 13:30 Sesión plenaria Dr. Héctor E. Castro-J y Secretarios 12:45 a 13:05 Presentaciones de los grupos de discusión Dr. Héctor E. Castro-J y todos los (5 min x grupo) asistentes 13:05 a 13:30 Discusión plenaria (25 min) 21

Agenda Miércoles 27 de octubre, 2021 11:00 a 11:25 Apertura Dr. Héctor E. Castro-J 11:25 a 12:20 • Resumen día 1 y 2 (10 min) Andrés Pichon-Riviere 12:20 a 12:30 • Presentación e instrucciones Andrés Pichon-Riviere para los frupos de discusión (5 min) • Actividad de networking Todos los asistentes (10 min) Distribución de los participantes en pequeños grupos Actividad grupal 2 (55 min) Todos los asistentes - 4 grupos de trabajo interactivo • Considerando los debates y resultados del día anterior, durante esta actividad grupal se debatirán los siguientes aspectos sobre el tema: ¿En qué etapas de la ETESA resulta más prioritario avanzar en procesos deliberativos en la región? • ¿Qué actores y con qué rol deberían participar de los procesos deliberativos? • ¿Qué recomendaciones se pueden hacer a los sistemas de salud de LAC y cuáles serían las principales acciones a seguir? Pausa café Todos los asistentes Preparación de conclusiones de Facilitador y Secretario cada grupo 12:30 a 13:10 Sesión plenaria 12:30 a 12:50 Presentaciones de los grupos de Dr. Héctor E. Castro-J y Secretarios 12:50 a 13:10 discusión (5 min x grupo) 13:10 a 13:30 Discusión plenaria (20 min) Dr. Héctor E. Castro-J y todos los asistentes 13:30 ¿Qué me mantiene despierto? Moderador: Dr. Héctor E. Castro-J Posibles temas para futuros Foros Todos los asistentes Despedida y cierre Dr. Héctor E. Castro-J. Wija Oortwijn 22

HTAi 2021 Latin America Background Paper | Documento de Antecedentes Health Technology Assessment Policy Forum Background Paper Deliberative processes for informed decision making by health technology assessment Virtual Forum October 2021 23

Background Paper | Documento de Antecedentes Contents Introduction Background and Methodology Deliberative processes in health technology assessment References International experiences Australia Canada Scotland United Kingdom This document has been drawn up by: Andres Pichon-Riviere, Federico Augustovski, Verónica Alfie, Sebastián García Martí, and Andrea Alcaraz. Institute for Clinical Effectiveness and Health Policy (IECS) Buenos Aires. Argentina. We thank Héctor Castro, Chair of the Latin American Policy Forum 2021 of HTAi, and the members of the organizing committee: Adriana María Robayo (Colombia) - Institute of Technological Evaluation in Health; Alicia Granados (Spain) - Sanofi; Dino Sepúlveda Viveros (Chile) - Ministry of Health Government of Chile; Fernanda Laranjeira (Brazil) - Janssen-Cilag Farmacêutica Ltda.; Francisco Tellechea (Argentina) - Roche SAQeI Products; Graciela Fernandez (Uruguay) - National Resource Fund; Homer Monsanto (United States) Merck & Co.; Vania Cristina Canuto Santos (Brazil) - CONITEC, Ministry of Health, for their comments and suggestions in the preparation of this document. 24

Introduction Background Paper | Documento de Antecedentes Deliberative processes are not new in the world of health technology assessment (HTA). An HTA seeks to determine the value of technologies for the purpose of providing information for a decision-making process (O'Rourke et al., 2020), and these decisions will affect a wide range of stakeholders in society: patients, citizens, industry, professionals, among many others. It has long been recognized that one of the most important principles that should guide good practices in HTA, and that is essential for ensuring its legitimacy, is the involvement of these relevant stakeholders in the various stages of assessment and decision-making (Daniels et al., 1997; Drummond et al., 2008; Pichon-Riviere et al., 2008&2010). This is one of the explanations for the growing interest in deliberative processes, and for the efforts to find the most appropriate methods and processes to be incorporated into the HTA (Abelson et al., 2016; Oortwijn et al, 2020; Bond et al., 2020). There are basically three mechanisms by which HTA agencies and processes can engage stakeholders. The first, and most basic one, is the communication of its actions and results (for example its assessment reports), making this information available to all those stakeholders who might have an interest in the subject. The second mechanism is consultation, in which by means of surveys, forms, expert panels, or other means, different stakeholders are allowed to contribute information or express their opinion on a certain topic or on the results of the HTA (such as reports or the prioritization results). Finally, and as we will see throughout this document, deliberative processes are a distinctive form of engagement, which emphasizes active participation and open dialogue. However, there is still a great heterogeneity, both worldwide and in Latin America, in the way these deliberative processes are carried out by the different HTA agencies, and in the role they play in the different stages of the assessment and decision-making process. In turn, in Latin America it also happens that the HTA itself exhibits a very heterogeneous degree of development, with some countries in the initial stages of adoption and others where decision-making processes are more strongly associated with the assessment. In this regional scenario, the willingness to move towards strengthening good practices and generating informed and deliberative decision-making processes is real and challenging at the same time. (Lessa et al. , 2017; Pichon-Riviere et al. , 2018) The objective of the 2021 6th Latin America Health Technology Assessment Policy Forum will be to discuss and understand the application of deliberative processes to HTA, and to analyze the problems that HTA agencies and the various stakeholders face in connection with these processes. It will also seek to define a series of key principles and actions that can serve to guide the establishment, development, strengthening, and improvement of deliberative processes in health technology assessment in Latin America. What is Health Technology Assessment (HTA)? HTA is a multidisciplinary process that uses explicit methodologies to determine the value of a health technology throughout its life cycle (O'Rourke 2020). Its purpose is to inform the decision-making process in order to promote equitable, efficient, and high-quality health systems. This information is used by health systems to make decisions that primarily affect the manner in which health resources are allocated, such as the decision to cover a certain health technology, or the decision to incorporate it into a benefits package. Health technologies are now an indispensable part of any health system, and their use has increased in recent decades. The introduction of new technologies has generally brought about significant benefits, in terms of prevention, safety, improvements in health, and quality of life or reduction of adverse effects. However, in a scenario in which resources are limited, the correct incorporation and distribution of technologies has become a challenge and, in some cases, a serious problem. 25

Background Paper | Documento de Antecedentes The rapid emergence of technologies and the increasing volume of available evidence are now a reality for all health systems. Providing healthcare services involves making decisions about which interventions should be offered (and implicitly or explicitly, which ones should not), the manner in which the health system will be organized, who will pay for these interventions; as well as how and who should provide them. The challenge is to achieve adequate health outcomes with the available resources, contemplating the social values, expectations, and demands of the population as well. Many countries have now committed themselves to achieving universal health coverage (UHC) for their population, that being one of the objectives prioritized by the World Health Organization (WHO). In the context of the UHC, the prioritization of interventions is a central strategy, and in the documents they develop, the WHO considers it to be of the utmost importance that it be carried out based on the best available evidence and through a deliberative process that takes social values into account (Terwindt et al 2015; WHO 2014). In this context, health decision-makers have begun to need more and more reliable and detailed information that allows them to make transparent and legitimate decisions when setting priorities to attain the maximum benefit on limited budgets. The growth and development of HTA reflects this demand for solid and transparent information that serves as a guarantee to make decisions on the development, incorporation, and dissemination of health technologies (Gabbay 2006). The origin of HTA was precisely this growing concern about the expansion of new and expensive health technologies in the 1970s and the limitations of health systems to finance their use. As a discipline it has evolved since the 70's to become a multidisciplinary specialty whose purpose is to unite and review the available evidence in order to help health decision makers, health practitioners, and patients understand the relative value of technologies. The development of HTA has been particularly remarkable over the last 20 years and is today an essential component of health systems in many countries. Several initiatives have emerged in the Latin American and Caribbean (LA) region. Argentina, Brazil, Colombia, Chile, Mexico, and Uruguay have HTA agencies that are members of INAHTA (acronym for the International Network of HTA Agencies), and several Latin American countries currently apply the HTA, to different extents, to making decisions on the allocation of resources. Most of these initiatives in the region are grouped together into RedETSA, the Latin American health technology assessment network (http://redetsa. org/), coordinated by the Pan American Health Organization (PAHO). The HTA is potentially an extremely useful tool for decision makers. However, if not done and used properly, there is a risk of producing an inefficient allocation of resources, covering interventions of little or no benefit, preventing or delaying patient access to useful health technologies, exposing patients to unnecessary risks, and sending the wrong messages to technology producers, among others (Wilsdon 2005). Furthermore, HTA is not a purely technical practice, and the decision-making process must consider increasingly broad dimensions. For these reasons, since the decisions to be made through the HTA process have the potential to affect a large number of individuals and institutions, a number of basic principles have been proposed for HTA to abide by. These principles include aspects such as transparency in the process of carrying out HTA and the consequent decision- making, the involvement of relevant stakeholders, the existence of explicit procedures to decide which technologies should be assessed, and the existence of a clear link between assessment and decision-making (Daniels et al., 2008; Drummond et al., 2008; Pichon-Riviere et al., 2008&2010). Many of these aspects have been addressed in the different editions of the HTAi Latin America Policy Forum (Pichon-Riviere et al., 2018-2021). 26

Background and objectives of the Forum Background Paper | Documento de Antecedentes The Health Technology Assessment Policy Forum is an activity organized by HTAi (Health Technology Assessment International). It was created in 2004 with the aim of providing a neutral space to carry out strategic discussions on the present state of HTA, its development, and its implications for health systems, industry, patients, and other stakeholders. It convenes representatives of three main groups of institutions: 1) decision-makers on the coverage and reimbursement/prices of medicines and devices in health systems; (2) agencies carrying out HTA in support of these decisions; and 3) technology producing biomedical companies. It has been held for 16 years mainly in Europe and the USA, and for the last 9 years, in Asia. In 2016 it began to be held in Latin America as well, this being the sixth Forum to be held in the region. The approach, agenda and logistical details were developed by an Organizing Committee composed of the Chair of the Forum and representatives of the participating institutions (three representatives of the public sector and three representatives of the field of technology producing companies). The Institute for Clinical Effectiveness and Health Policy (IECS – www.iecs.org.ar) acted as the Scientific Secretariat. The process of selecting the topic for this Forum began during the fifth Forum and included the following steps: 1. A list of potentially relevant topics was drawn up based on the proposals/topics suggested by the members of the 2020 Latin American Forum at its conclusion. 2. This list was sent to the members of the Organizing Committee for their comments/suggestions. 3. The final topic was selected through a deliberative process with the participation of all members of the Forum Based on this process, the topic selected for this sixth forum was \"Deliberative processes for informed decision-making by health technology assessment\". This sixth edition of the Latin American Policy Forum linked together with the previous five editions: 2016 Policy Forum: The first LA Policy Forum was held in Costa Rica. This meeting involved a discussion on the \"Principles of good practices in the application of Health Technology Assessment to decision-making in Latin America\". As a result of this, the principles prioritized as the most relevant to promote the application of HTA in LA were: • Transparency in the processes of carrying out HTA and communicating its results • Involvement of relevant stakeholders in the HTA process • The existence of appeal procedures • The existence of clear mechanisms for setting priorities in HTA • The existence of a clear link between assessment and decision-making 2017 Policy Forum: This second Policy Forum, held in Lima, had as its central theme the stakeholder involvement in the Health Technology Assessment process, an aspect that had been identified as a priority during the first Policy Forum. 2018 Policy Forum: It was held in Montevideo in 2018 and it included a discussion about value frameworks in HTA. 2019 Policy Forum: It was held in Buenos Aires, and it was focused on the relationship between HTA and decision-making. 2020 Policy Forum: It was held online, and it included a discussion on the mechanisms used by HTA agencies to prioritize the assessments to be performed. (All the results of the discussions held during these five Policy Forums are available in a series of articles: Pichon- Riviere et al 2018-2021) 27

Background Paper | Documento de Antecedentes As can be seen, throughout these years the Policy Forum Latin American participants have identified and discussed principles and processes that are closely associated with the implementation of deliberative processes, which were considered as the key to improving HTA in the region: transparency in processes of HTA development and communication of its results, relevant stakeholders’ involvement, the existence of clear mechanisms for establishing priorities in HTA, and the existence of a clear link between assessment and decision-making. The main objectives of this 6th Latin America Health Technology Assessment Policy Forum will be: • Exploring the fundamental aspects of the implementation of deliberative processes within the framework of an HTA and the main experiences at the global level • Exploring the positive and negative aspects of the deliberative processes that are currently being used in Latin America, and the way they are linked to decision-making on resource allocation • Exploring the limitations/barriers/risks and opportunities/facilitators for the implementation and/or deepening of deliberative processes in the Region • Discussing and identifying the main contextual aspects that should be contemplated in the region when implementing/deepening deliberative processes, as well as the principles of good practice and the requirements that a health system should meet to execute them • Discussing the potential applicability of the various models used around the world to Latin America and identifying the main recommendations for health systems in the Region. The purpose of this base document is to provide information that serves as a starting point for the discussions that will take place at the 2021 Latin America HTAi Policy Forum to be held virtually online on October 25 - 27, 2021. The document is focused on the one hand on introducing the basic concepts of deliberative processes, and on presenting a selection of international experiences on the other. The information is based on a bibliographic search in connection with deliberative processes and HTA and on a review of agencies’ and health systems’ websites. Deliberative processes in health technology assessment Context: a demand for a greater legitimacy in decision-making processes As mentioned above, the HTA seeks to determine the value of health technologies for the purpose of informing a decision-making process (O'Rourke et al., 2020). A typical situation occurs when a health system must decide on the coverage of a certain technology, or its inclusion in the country's benefits package (although HTA applies throughout the entire life cycle of health technologies, from providing evidence for regulatory approval to guiding disinvestment decisions in obsolete technologies). This assessment of the value of technologies addresses both the direct and desired consequences of technologies and the indirect and unintended ones. The consequences of using a given technology, compared to the existing alternatives, are evaluated in several dimensions typically including clinical effectiveness, safety, costs, economic implications, and the ethical, social, cultural, legal, organizational, and environmental aspects, as well as broader implications for patients, their relatives, caregivers, and the general population. The conclusion about the value of the technology, which will be reached after this whole process, may vary depending on the perspectives taken into account, the stakeholders involved, and the context considered for making the decision. So how do you ensure that fair decisions can be made when the information being considered is of such complexity, when evidence is highly uncertain, and values may conflict? While not all health systems have necessarily the same goals, the HTA seeks to inform decision-making processes to promote equitable, efficient, and high-quality health systems. Moreover, society demands greater legitimacy in decision-making, which implies that it is perceived as the result of a fair process, from the perspective of the different stakeholders. One of the main issues that many health systems around the world 28

seek to solve nowadays is precisely how they can achieve these objectives in HTA processes, in which it is Background Paper | Documento de Antecedentes common to deal with extremely complex information, uncertain evidence, and values that may differ among the different parties that will be affected by the decision (WHO 2014, Daniels et al., 1997, Castro et al., 2020). Deliberative processes appear as an increasingly recognized approach to improving the quality of assessments, and to dealing with many of the complexities inherent in health decision-making (Abelson 2016, Bond 2020, Oortwijn et al., 2020&2021). In all HTA processes, but particularly when decisions are being made on the allocation of health resources, there are often bound to be \"winners\" and \"losers\". Decisions will not always suffice to meet the needs or views of everyone involved. Take, for example, the decision not to prioritize a given technology for assessment, or the decision not to provide coverage, or not to include a technology in the benefits package, as a result of an assessment. The group of patients affected by these types of decisions, or the producers of the technology themselves, may rightly feel that the decision is not fair from the point of view of their needs. It is not reasonable to expect all the parties concerned to always agree on a decision or consider every decision to be fair from their point of view. But it is actually possible, and in fact it would be desirable, for all those who will be potentially affected by the decision to believe that the process through which the decision was reached was a fair process based on \"clear-cut rules\", regardless of whether or not they approve the decision. As Daniels and Sabin (Daniels 1997 & 2008) note, because it would be impossible to establish a consensus regarding a set of ethical standards of distributive justice to guide the incorporation of new technologies, it is the existence of a fair decision-making process that will allow for a consensus to be reached on what is considered to be legitimate and fair. They refer to this conceptual framework as \"Accountability for Reasonableness.\" This framework proposes that decision-making on the use of limited resources becomes a part of a broader public deliberative process that allows for a fair protection of the health of populations having diverse needs. Within this framework, for decision-making on the allocation of health resources to be adequate, certain conditions must be met, such as transparency, which entails that those decisions and their motives are open to the public, that the reasons on which decisions are based are relevant to the context in question and agreed upon by stakeholders (i.e. that it is an inclusive process), that it is possible to appeal the decisions, and finally, that there are means to ensure that these conditions are met. In short, decisions will be considered legitimate when they are perceived as the result of a fair process by all stakeholders. For this to happen, one of the most important requirements is that all parties feel that they have had the opportunity to participate, and that their voice has been heard and taken into consideration, even if the end result of the decision is not necessarily favored by everyone involved. These are some of the reasons that have led in recent years to the recognition that the participation of those who may be affected by decisions is one of the most important principles of good practice in HTA (Daniels et al., 1997; Drummond et al., 2008; Pichon-Riviere et al., 2008&2010). The interest in deliberative processes stems from this development that has occurred in HTA, especially in the last decade. What are deliberative processes? Deliberative processes seek to facilitate a participatory decision-making, through the discussion of objective data and values (Gauvin 2009). Up to this date, the concept of deliberation has been frequently associated with any type of stakeholder involvement, stakeholders being considered as those who can be affected by a decision. This concept includes individuals, organizations, or communities with a direct interest in the process and outcomes of a health technology assessment, such as patients, funders, technology producers, family members or caregivers, citizens, or health practitioners. This stakeholder involvement is typically implemented by many HTA agencies, especially in Latin America, in the form of consultations, or requests for opinion, or information exchange (in other words, a rather \"testimonial\" involvement). However, not just any kind of stakeholder involvement can be considered a deliberative process. Then, what sets deliberative processes apart from other forms of engagement? Unlike the traditional approach used by most agencies so far, focused mainly on informing the HTA on the views of some experts or stakeholders, deliberative processes are distinguished by their participatory characteristics and by focusing on discussion and open dialogue among the parties, with the aim 29

Background Paper | Documento de Antecedentes of revealing and understanding the assumptions, values, and underlying arguments that govern the standpoint of each of the parties. This implies an active participation of all those involved in the deliberative process. It attempts to promote a setting that favors the enrichment of stakeholders’ views on a certain topic, with arguments and evidence that perhaps would not have been taken into account outside the deliberative space. At present, many health systems and HTA agencies have incorporated deliberative components into their assessment and decision-making processes. However, the manner in which these processes are performed, and their influence on the assessment and the subsequent recommendations, is very heterogeneous. There is currently no definition or consensus about what constitutes a deliberative process in the context of an HTA, or any good practice recommendations to carry it out. An example of the growing interest in promoting and enhancing deliberative processes by the HTA community was the recent 2020 HTAi (Health Technology Assessment International) Global Policy Forum, where the subject discussed was: prospects, problems, and policy proposals for the establishment of deliberative processes (Bond et al., 2020). Moreover, HTAi and ISPOR (International Society for Pharmacoeconomics and Outcomes Research) have recently established a Task Force for the purpose of steering and developing a guideline for those who seek to implement deliberative processes in HTA. As part of this initiative, still under development, it is established that deliberation in HTA is the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. It is emphasized that deliberation provides opportunities for exchange through participatory processes, which highlight the rationale leading to a deeper understanding of differences among participants, or provide critical insight into differences among participants, including the manner in which these differences could be resolved. A deliberative process in HTA consists of the procedures, activities, and events that support deliberation. These deliberative processes must further be designed and conducted appropriately in order to meet the participation needs required to achieve a greater legitimacy in decision-making. These aspects are particularly relevant in Latin America, a region where the various countries have a highly heterogeneous status, and in many cases, there are no explicitly defined formal mechanisms for stakeholder involvement in the HTA processes. In countries where some stakeholders have begun to be formally involved in HTA processes, these mechanisms are usually still partial, in that they do not always involve all potential stakeholders, or in that they apply only to some of the components of the HTA process, for instance, only at the assessment stage itself, but not in the prioritization of the technologies to be assessed, or in decision-making (Pichon-Riviere et al 2018). What role can deliberative processes play in HTA? We can distinguish two major roles: on the one hand, that of informing and enhancing the performance of the different stages of the HTA (from the identification of the topics to be evaluated to the recommendation and decision-making stage); and on the other hand, that of being a relevant component at the more \"macro\" level, in the design of the structure and governance of HTA agencies. This is another particularly relevant aspect in Latin America, where many countries are still at the stage of defining their institutionalization. Deliberative processes can thus constitute a valuable tool to contribute to the creation of HTA agencies, units, or programs whose mandates, structures and processes are in line with what society expects from their health systems. However, the implementation of deliberative processes implies dedicating resources and time to their execution, both assets being scarce in all HTA agencies. Therefore, the objectives pursued with their implementation must be clear; deliberative processes should be conducted in accordance with the context and in a manner that represents a proper use of the resources available in the various HTA agencies in the region. All these aspects will be discussed in the sections below. 30

Deliberative processes in HTA Background Paper | Documento de Antecedentes As mentioned above, deliberative processes can play a role in defining the structure, governance, and processes of HTA agencies, and in informing the different stages of the HTA process. These stages include: 1. Identification of technologies and interventions that could be candidates for assessment, for example through an active search (horizon scanning), nomination by different stakeholders (such as industry, patients, or health practitioners), or at the request of different health authorities 2. Prioritization of technologies and interventions to be assessed 3. The assessment itself. For that purpose, the approach to be used in the document (scoping) and the comparators must be defined, in order to clarify what the questions to be answered are, and in what way they are linked to the information needed by decision-makers. This assessment is the analytical process, both scientific and technical, of identifying and summarizing information on relevant aspects of the technology in question. It usually includes a systematic identification and synthesis of the evidence on effectiveness and other dimensions such as cost-effectiveness, and in many cases, it may also include the generation of new evidence. This process should follow well-defined methodological steps and should be potentially replicable in other contexts. 4. After the assessment itself, the next step is the one that allows the health system to reach a decision. This stage is sometimes known as contextualization or \"Appraisal,\" and refers to the political process of making a recommendation or making a decision, taking into account the elements provided by the assessment, as well as other factors (Stevens & Milne 2004). This involves making a judgment about the applicability of the evidence, such as the cost-effectiveness threshold, and other considerations comprising broader social values. In all these stages of the HTA, in order to arrive at a decision or a recommendation, certain formal criteria should be contemplated, such as effectiveness or cost-effectiveness. In addition to these formal criteria, however, there are also contextual factors such as the severity of the disease targeted by a technology, the impact on equity, patients’ perception, or human rights aspects. In some cases, some of these contextual factors are integrated into the formal criteria considered in the assessment and/or decision-making process. For example, at the 2018 HTAi Latin America Policy Forum held in Montevideo, a series of criteria considered \"essential\" were identified at the time of deciding on the coverage of a new technology: burden of disease and severity of the condition, effectiveness and safety of the technology, quality of evidence, cost-effectiveness and budget impact; and the 2020 HTAi Latin America Policy Forum identified the most important criteria to consider when prioritizing technologies for assessment: burden of disease, potential clinical benefit, alignment with national health priorities, potential impact on equity, absence of other alternatives for patients, and potential economic impact. In addition, when evaluating these aspects in all stages of the HTA, starting from the identification and prioritization of those technologies to be assessed until the final coverage decision, both objective elements (facts) and values will be considered. For example, the incremental cost-effectiveness ratio (ICER) of a given technology may be a formal aspect that a health system needs to evaluate when making a coverage decision. However, judging to what extent such ICER justifies coverage or non-coverage, or whether other dimensions relevant to patients are being adequately encompassed in the ICER, or the weight that other elements such as the severity of the condition or the impact on quality should have, will depend on the values and views of the different stakeholders, and those of the society in which they are immersed. This implies that similar health systems could come up with different decisions when evaluating the same evidence. Let's look at the following example, focused on the recommendation and decision-making stage of an HTA. In a given country, a Technology A is being covered for the management of a certain health condition, and it has now become necessary to decide whether or not to incorporate an additional new Technology B into the coverage for the management of this very condition. To make this type of decisions in the country, aspects such as the effectiveness of the technology, quality of the evidence, safety, cost-effectiveness, and budget impact are evaluated. Suppose the result of this assessment determines that the effectiveness of Technology B would be similar to the effectiveness of Technology A, although with a greater degree of uncertainty in the 31

Background Paper | Documento de Antecedentes evidence, mainly due to the lower number of studies involving the more recent Technology B. In fact, due to this uncertainty, it cannot be ruled out that the effectiveness of Technology B is slightly lower. The cost of Technology B is approximately 10% higher than that of Technology A. With this information it might seem reasonable to decide not to include the new Technology B in the coverage, because it has not proven to be superior to the technology currently available, there is greater uncertainty in the evidence, and the cost is slightly higher. Decision-makers might consider that there are not even enough elements to justify any attempt at negotiating the price with the producer of the technology. However, there could be some aspects that are not being sufficiently considered, as we will see in the examples below. Not all countries assess the same dimensions in their HTA reports, and in some cases, these reports can be very broad and encompass many of the dimensions discussed below. However, it is common for low- and middle-income countries to have no resources, or time, to conduct comprehensive and more elaborate assessments of all the technologies on which a decision is required, and reports are in many cases rapid reviews focused on effectiveness, quality of evidence, safety, and a few economic aspects. The following examples show some aspects that may not arise in the technical component of the assessment, or that could be difficult to assess in a faster HTA process, but that could nevertheless be captured in a deliberative process that involves the stakeholders of interest: • Clinical experts, healthcare providers and patient groups note that Technology A is now widely available only in large urban centers. Due to its characteristics (e.g. personnel or specialized equipment requirement, storage conditions, etc.) Technology A is not available to a large part of the rural population (50% of the country's population). The incorporation of Technology B would reduce the inequity that exists today in the management of this condition. • Patients and caregivers highlight the advantages in the way technology B is applied, which were not adequately contemplated in the evaluation of effectiveness and cost-effectiveness. These advantages could make it more desirable than Technology A, even if it were less effective (for example, Technology A has a more rigid dosage scheme requiring pediatric patients to be medicated at school every day, which has practical and social implications. Technology B allows for a more flexible scheme that would avoid this drawback.) • Clinical experts note that due to specific barriers (for example, cultural, social, or geographical) in one country, adherence to Treatment A is noticeably lower than the one observed in clinical studies in other countries. Technology B does not present these barriers and therefore its adoption could represent an increase in population effectiveness in the management of this condition. • Funders believe that although the unit cost of Technology A is lower, for certain healthcare providers it could be more expensive than Technology B (due to, for example, logistical requirements for storage or administration to patients). • The technology industry notes that the effectiveness assessment of Technology B presented in the HTA report was only performed for the entire set of patients. However, analyses showing that in certain subgroups of patients the effectiveness of Technology B could be greater than that of Technology A and with a good level of evidence have not been taken into account. They suggest that instead of refusing the coverage of technology B, this technology could be restricted to this subgroup of patients alone. • Patients and clinical experts point out that there are certain patients who have contraindications to Technology A and that there are currently no other treatment options available for them. Many of these aspects could have arisen in the HTA report, but the focus of all assessments can hardly be always so broad and comprehensive as to ensure that all dimensions have been well captured. One of the advantages of deliberative processes is that they allow to expand the spectrum of criteria and dimensions under consideration. Even in cases where these aspects have been identified in the technical component of the development of the HTA report, the assessment and decision-making process will be enriched by understanding the valuation and views that each stakeholder has on them. Deliberative processes provide a framework for these elements to be contemplated, especially when differences in views and values among stakeholders are likely to arise. This does not necessarily imply a 32

modification of the decision that would have been made. But even the decision of no coverage will have Background Paper | Documento de Antecedentes greater legitimacy if it can guarantee that it was made after all the relevant aspects have been heard and examined. This example shows how a deliberative process can enrich the recommendation and decision-making stage. However, it is important to note that, as mentioned above, deliberative processes can play an important role in all stages of an HTA. For example, a deliberative process can be very valuable in the initial stages of scoping and assessment, in which different stakeholders can express their views in order to decide what the outcomes to be expected will be, or which should be the most relevant comparators to include in the assessment. In fact, this early stakeholder involvement could avert many of the problems mentioned in the previous example, which arise precisely due to the lack of attention given in the assessment to the relevant outcomes for patients, providers, industry, or funders. In turn, deliberative processes can also play a very significant role in the identification and prioritization stage of the technologies to be assessed; for example, by helping not to ignore potentially extremely beneficial interventions, which do not necessarily have a sponsor to promote their assessment; or to ensure, when prioritizing the technologies to be assessed, that all aspects that are relevant for those who will be affected by the decision are being considered. Elements to be considered for the implementation of deliberative processes One of the first steps in the implementation of deliberative processes is that of identifying which perspectives need to be considered. This includes different stakeholders such as patients, citizens, funders, or technology producers, as well as experts (such as experts in the fields of medicine, bioethics, economics, etc.) whose views are relevant to a given topic. Furthermore, it is necessary to define the manner in which these different perspectives will be represented in the deliberative process, including the identification and selection of participants, and the measures to be taken to allow for the participation and open dialogue between the parties (for example, the role of the coordinator and how to control the power balance among participants). The number of participants should also be adequate for the deliberative process to operate properly (e.g. 10-15). In some cases, the result of the deliberative process will likely be a consensus, and in others, it is to be expected that the result will be a decision or recommendation. In these cases, it will be necessary to identify who will only be allowed to speak and who will be allowed to speak and vote. Another important element is what information, and in what format, will be available to participants in the deliberative process. This may include, for example, HTA documents, which assess dimensions such as effectiveness and cost-effectiveness. But it can also include other items contributed by experts or interested parties, or the adaptation of materials for the various audiences that need to be reached. Finally, the manner in which the results of the deliberative process will be communicated and which of its aspects will be made public and which will not, must be defined. At the 2020 HTAi Global Policy Forum there was a discussion about the most important principles that should drive the introduction of deliberative processes into the HTA (Bond et al 2020). These were: • Transparency: both the deliberative process and the rationale for recommendations and/or decisions should be explicitly described and made public. • Inclusivity: Deliberations in HTA are best informed when all stakeholders can work together. Appropriate perspectives must be included so that the decision-making process has the best chance of reflecting the reality of those who will be affected by the decision. • Impartiality: the deliberative process used for each decision, as well as those who participate in it, should be perceived as free from undue influences, both internal (such as from the HTA agency conducting the process) and external (such as personal interests). 33

Background Paper | Documento de Antecedentes However, neither the implementation of these principles nor some aspects of the deliberative process can be taken apart from the context where they will be carried out, this being the aspect we will discuss in the next section. The context in which deliberative processes will be implemented Deliberative processes are not an isolated element that can be planned without taking the context into consideration. The scope, the objectives, and the type of deliberative processes that can be effectively implemented will be greatly influenced by factors that are internal and external to the HTA (Kapiriri et al., 2020). Internal factors include aspects such as the agency's financial resources, the availability of information, and trained personnel. External factors, such as the existing mechanisms for incorporating evidence into the decision-making process, or the degree of institutionalization of the HTA, may be even more influential. The degree of participation and influence that the different stakeholder groups have (such as patients, politicians, technology producers, or suppliers) is another contextual element that must be considered. If a country or health system conducts deliberative processes that are not properly planned and/or implemented to manage these power balances, there is a risk that the decision-making process will be negatively affected and delayed (Mohara et al 2012, Pichon-Riviere et al 2018). At the 2017 Latin America Policy Forum, when exploring the concerns and barriers to the implementation of stakeholder involvement, one of the most mentioned barriers was the lack of qualified personnel and the difficulty in facing the additional costs and times arising from modifications in HTA processes aimed at achieving greater participation. In addition, a series of concerns were mentioned about the potential negative consequences of a stakeholder involvement that was not adequately planned or that did not properly consider the context of the health system in each country. Among other potential consequences, reference was made to the excessive influences that the different stakeholders (such as industry or patient representatives) could exert both on the prioritization of the technologies to be assessed and on the HTA process itself, and the generation of delays due to the existence of a demand that exceeds the resources required to satisfy it. This concern was more noticeable in countries with weaker or incipient HTA structures and mechanisms, and with a lower degree of institutionality. Therefore, it is not possible to define an \"ideal\" deliberative process for all health agencies or systems to implement, nor would it be appropriate to take a deliberative process that has worked well in another setting and reproduce it without considering the local context. As noted at the Global Policy Forum (Bond et al 2020), low- and middle-income countries, in particular, may face significant challenges in adopting some of the principles associated with deliberative processes due to corruption in decision-making processes, mismanagement of conflicts of interest, lack of capacity to produce and analyze scientific evidence, and little political willingness to use scientific evidence in decision-making. During the 2020 Global Policy Forum (2020 Background paper, Bond et al., 2020) three problems potentially associated with the implementation of deliberative processes were also identified: • Diversity of stakeholders: Patients, HTA agencies, industry, and payers come to the discussion table with different perspectives. A cultural change is required to facilitate the involvement of different parties. For example, while it is recognized that industry participation in deliberations could strengthen diversity and enhance the legitimacy of decisions, many HTA agencies around the world do not yet allow industry participation in deliberative processes. • Resource constraints: It is not possible for low- and middle-income countries to \"import\", transfer, or \"copy and paste\" the results of a deliberation (as might be done with the results of an effectiveness evaluation). This implies the need to invest time and resources to carry out their own deliberative processes. Moreover, in certain contexts, there may be less maturity to engage patients and users, and decision-making processes themselves may not be adequately established. • External pressures: aspects that are both internal and external to the agency and the HTA process will 34

influence the way in which stakeholders can be engaged. Potential external pressures from different Background Paper | Documento de Antecedentes stakeholders are one of those factors that can compromise the implementation of certain principles of the deliberative process. For example, tensions can arise with the application of the principle of transparency, as participants in the deliberative process (such as experts, patients, or decision-makers) could be exposed to criticism or pressure if their opinions or votes are made public. For those reasons it cannot be assumed that the introduction of any deliberative process will automatically improve decision-making. A health system in which there is not yet an adequate process to assess the evidence and integrate it into the decision-making process, as well as a well-defined set of criteria and values based on which to prioritize the allocation of resources, will hardly be able to integrate deliberative processes effectively. The following section describes how certain countries carry out an HTA and what role deliberative processes play therein. These four countries (Australia, Canada, Scotland, and the United Kingdom) were selected because the Policy Forum participants are familiarized with their health systems, which were presented and discussed in previous editions of the forum, and which have well-established HTA processes into which different forms of deliberative processes have been incorporated. References: Abelson J, Wagner F, DeJean D. et al. Public and patient involvement in health technology assessment: a framework for action: Int J Technol Assess Health Care. 2016, 32(4), 256-264. doi:10.1017/S0266462316000362 Background Paper – “Deliberative Processes in Health Technology Assessment: Prospects, Problems, and Policy Proposals” K. Bond, on behalf of the HTAi Global Policy Forum 2020 Bond K, Stiffell R, Ollendorf D. Principles for deliberative processes in health technology assessment. Int J Technol Assess Health Care. 2020, 1-8. doi:10.1017/S0266462320000550 Castro HE, Kumar R, Suharlim C, et al. 2020. A Roadmap for Systematic Priority Setting and Health Technology Assessment (HTA). Arlington, VA: USAID/MSH, 2020 Daniels N, Sabin J. Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philosophy & Public Affairs, 1997; 26 (4), 303-350. https://doi.org/10.1111/j.1088-4963.1997.tb00082.x Daniels N, Sabin J. Setting limits fairly: learning to share resources for health. 2nd ed. New York: Oxford University Press; 2008 Drummond MF, Schwartz JS, Jönsson B, Luce BR, Neumann PJ, Siebert U, Sullivan SD. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008. Summer;24(3):244-58; discussion 362-8. doi: 10.1017/S0266462308080343. PubMed, PMID: 18601792. Gabbay J, Walley T. Introducing new health interventions. BMJ. 2006;332(7533):64-65. Gauvin FP. Factsheet What is a deliberative process? Publication No. 1193. The National Collaborating Centre for Healthy Public Policy, 2009. Available at: http://www.ncchpp.ca/docs/DeliberativeDoc1_EN_pdf.pdf Kapiriri L, Baltussen R, Oortwijn W. Implementing evidence-informed deliberative processes in health technology assessment: a low income country perspective. Int J Technol Assess Health Care. 2020;36(1):29-33. doi: 10.1017/ S0266462319003398. Mohara A, Youngkong S, Velasco RP, Werayingyong P, Pachanee K, Prakongsai P, Tantivess S, Tangcharoensathien V, Lertiendumrong J, Jongudomsuk P, Teerawattananon Y. Using health technology assessment for informing coverage decisions in Thailand. J Comp Eff Res. 2012 Mar;1(2):137-46. doi: 10.2217/cer.12.10. PMID: 24237374 Oortwijn W, Jansen M, Baltussen R. Use of Evidence-informed Deliberative Processes by Health Technology Assessment Agencies Around The Globe. International Journal of Health Policy and Management, 2020; 9(1): 27-33. doi: 10.15171/ ijhpm.2019.72 Oortwijn W, Jansen M, Baltussen R. Evidence-informed deliberative processes. A practical guide for HTA bodies for legitimate benefit package design, 2nd version. Nijmegen, the Netherlands, 2021. Available from: https://www. radboudumc.nl/global-health-priorities 35

Background Paper | Documento de Antecedentes O'Rourke B, Oortwijn W, Schuller T; International Joint Task Group. The new definition of health technology assessment: A milestone in international collaboration. Int J Technol Assess Health Care. 2020;36(3):187-190 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. Pichon-Riviere A, Soto NC, Augustovski FA, García Martí S, Sampietro-Colom L. [Health technology assessment for decision-making in Latin America: good practice principles]. Rev Panam Salud Publica. 2018 Feb 19; 41:e138. Spanish. PubMed PMID: 29466522. Pichon-Riviere A, Soto NC, Augustovski FA, García Martí S, Sampietro-Colom L. Health techonolgy assessment for decision making in Latin America: good practice principles. Int J Technol Assess Health Care, 34:3 (2018), 1-7. doi:10.1017/S0266462318000326 Pichon-Riviere A, Soto NC, Augustovski FA, Sampietro-Colom L. Stakeholder involvement in health technology assessment process in Latin America. Int J Technol Assess Health Care, 34:3 (2018), 1-6. doi:10.1017/ S0266462318000302 Pichon-Riviere A, GarciaMarti S, Oortwijn W, Augustovski F, SampietroColom L (2019). Defining the Value of Health Technologies in Latin America: Developments in Value Frameworks to Inform the Allocation of Healthcare Resources. International Journal of Technology Assessment in Health Care 35, 64–68. https://doi.org/10.1017/ S0266462319000072 Pichon-Riviere A, Augustovski F, García Martí S, Alfie V, Sampietro-Colom L (2020). The link between health technology assessment and decision making for the allocation of health resources in Latin America. International Journal of Technology Assessment in Health Care 36, 173–178. https://doi.org/10.1017/S0266462320000033 Pichon-Riviere A, Augustovski F, García Martí S, Alcaraz A, Alfie V, Sampietro-Colom L (2021). Identification and selection of health technologies for assessment by agencies in support of reimbursement decisions in Latin America. International Journal of Technology Assessment in Health Care 1–8. https://doi.org/10.1017/S0266462321000416 Stevens, A. & Milne, R., 2004. Health technology assessment in England and Wales. International journal of technology assessment in health care, 20(1), pp.11–24. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15176173 [Accessed January 30, 2019]. Terwindt F, Rajan D, Soucat A. Priority-setting for national health policies, strategies and plans. In: Schmets G, Rajan D, Kadandale S, eds. Strategizing national health in the 21st century: a handbook: World Health Organization (WHO); 2015:71. Wilsdon T, Serota A. A comparative analysis of the role and impact of health technology assessment. . London:UK: Charles River Associates; 2011: http://www.phrma.org/sites/default/files/pdf/hta_final_comparison_report_13_ may_2011_stc1.pdf. World Health Organization (WHO). Making fair choices on the path to universal health coverage. Final report of the WHO Consultative Group on Equity and Universal Health Coverage 2014: http://apps.who.int/iris/ bitstream/10665/112671/1/9789241507158_eng.pdf?ua=1. Accessed 11-3-2016. 36

International Experiences Section Background Paper | Documento de Antecedentes This section outlines health systems and the role of deliberative processes within the framework of an HTA in four countries. Australia Canada Scotland United Kingdom Australia Australia has a general tax-funded universal health system that provides free care to the entire population (approximately 26 million people) through its National Medicare healthcare program. The private subsector covers approximately the remaining 10% of healthcare spending. Responsibility for both health policies and the provision of services is regulated by the Australian Department of Health through the Pharmaceutical Benefits Scheme (PBS) which regulates the provision of medicines to the population, the Medicare Benefits Scheme (MBS) which regulates the provision of other health technologies and the National Immunization Programme (NIP), which regulates the provision of vaccines. Australia has two government agencies that develop health technology assessments for services provided by the Australian public health system. The Pharmaceutical Benefit Advisory Committee (PBAC) conducts health technology assessment of drugs that will later be included in the PBS and advises the Department of Health on the effectiveness and cost-effectiveness of the technologies to be included in the PBS, MBS, and NIP. It is a body of independent experts, though appointed by the Australian government. It is made up of physicians, health professionals, health economists, and representatives of patients and the general public. It has two subcommittees to assist in the analysis and advise in these areas: Drug Utilization Subcommittee; and Economics Subcommittee. The PBAC, when issuing its opinion on a technology, mentions that there are situations where it may be unable to issue a recommendation regarding a technology based solely on cost effectiveness, either because it presents an insufficient degree of clinical effectiveness and / or a high price. In those cases, the PBAC has the resource of establishing meetings with the various stakeholders, mainly when it comes to technologies for the treatment of serious, disabling, or life-threatening diseases, where there are no other realistic treatment options for that condition, the cost-effectiveness profile does not allow for their incorporation into the list of benefits. Within the group of stakeholders they can convene, they include technology producers, patient groups, physicians, and other health professionals, including specialists and general practitioners as long as they have a special interest in the technology, as well as members of the Department of Health and Aged Care. The purpose of these meetings, as mentioned, is to inform stakeholders about the situation, seek their views and, if possible, to define a listing restriction acceptable to the parties which will give the best possible cost-effectiveness profile. The PBAC clearly establishes that in no way does this type of deliberative process constitute an opportunity for producers of the technology under assessment to appeal the decision, but that it does not preclude the technologies from being re-submitted for assessment after these meetings. They mention that it is common for producers of a technology that is being excluded from the listing to try to find an error of law in the decision and choose to litigate against it. Therefore, it is a necessary condition for this type of dialogue process that there is no judicial decision pending at the time. What happens in these meetings and their outcome is considered confidential, and attendees must sign an agreement to that effect. The guidelines for conducting these stakeholder meetings are clearly established by guidelines (available on the PBAC website https://www.pbs.gov.au/info/industry/listing/elements/initiation-of-stakeholder-meetings), which state as follows: 37

Background Paper | Documento de Antecedentes 1. Stakeholder meetings may be initiated by the PBAC or the sponsor on occasions when the PBAC Chair, in consultation with other PBAC members as appropriate, understands that each of the following has been met: • the drug is indicated for a serious, disabling, or life-threatening condition for which there is no other realistic management option. This could include drugs which are indicated where other management options have failed for such conditions (last resort); and • the PBAC is unable to recommend a listing because the cost-effectiveness is such that it makes approval through the usual process unlikely; and • all reasonable normal options, which may include a re-submission of a request to be included in the listing, have been exhausted; and • the PBAC considers that there are grounds to o define a listing restriction which would be accepted by the stakeholders and would give the best possible cost effectiveness under the “rule of rescue”; and • the PBAC and the producer agree there is a reasonable likelihood that progress will be able to be made which will assist the PBAC in reaching a recommendation. The request for a stakeholder meeting can then emanate from either the PBAC or the technology producer. The process would differ as follows, depending on who requests it: • When it is the PBAC who makes the request: The PBAC secretariat will notify the producer and any key stakeholders at least 10 working days in advance that a stakeholder meeting will be convened. The PBAC secretariat will state specifically in writing the terms to be considered by the stakeholder meeting. The PBAC will not use the stakeholder meetings for any other purpose than to resolve matters raised by the PBAC in its review of the application that has prevented a positive recommendation of the product from occurring. The PBAC will not convene a stakeholder meeting unless it has a reasonable belief that it will resolve the issues that prevented a positive recommendation to list the product. • When requested by the producer: The producer will send a request to convene a stakeholder meeting to the PBAC Chair and the PBAC secretariat outlining the reasons for such a request, which must demonstrate that the criteria for convening a stakeholder meeting have been met. In that case, the PBAC secretariat will seek to notify the sponsor within 10 working days as to whether the request has been accepted or declined. If the request is declined the PBAC must be able to demonstrate that the criteria for a stakeholder meeting have not been met. If the request is accepted, though, the PBAC secretariat will notify the Sponsor and any key stakeholders at least 10 working days in advance that a stakeholder meeting will be convened. Another characteristic of these meetings is their exceptional nature. Therefore, they will be held in uncommon circumstances and are expected not to exceed about four per year. Participants will be subject to confidentiality provisions as established by the National Health Act; they will have access to the main elements of the PBS presentation and will be informed in detail of the outcome of any additional PBAC consideration resulting from the stakeholder meeting. Each party will sign a confidentiality agreement and declare any potential conflict of interest before participating in the meeting. Legal representatives are not accepted at these meetings. The meeting is usually composed of the Chair or delegate of the PBAC, who will chair the meeting, together with one or more members of the PBAC, representatives of the company, representatives of patient groups (where appropriate); physicians (appointed by the relevant professional agency). The outcome of this process will be entirely considered for the next meeting of the PBAC to address the issue, though it will not be binding. The PBAC anticipates that the conclusion of the meeting will help the producer prepare a new submission to the PBAC within the usual time limit. After the meeting is accepted, an agenda, the attendees, and a date will be jointly established by the parties, and once an agreement is reached, this information will be made available prior to the meeting. The agenda will contain the complete grounds for the PBAC not having recommended the inclusion of the product under discussion in the PBS, and it is on these points that the exchange of opinions between the parties will take 38

place. A draft minutes will be prepared and circulated to all attendees. The parties will have 5 working days Background Paper | Documento de Antecedentes to respond. The final minutes will be distributed to all attendees and the full PBAC Committee within a further 5 days after the response deadline. The final minutes will note any areas where one or more of the parties are not able to agree on the detail of what transpired or was agreed at the meeting. Bibliography 1. Australia - Pharmaceuticals. https://tools.ispor.org/HTARoadMaps/Australia_Pharm.asp. Accessed September 7, 2021. 2. Jackson TJ. Health technology assessment in Australia: challenges ahead. Med J Aust. 2007;187(5):262-264. http:// www.ncbi.nlm.nih.gov/pubmed/17767428. Accessed September 7, 2021. 3. Glover L. Australia : International Health Care System Profiles. https://international.commonwealthfund.org/ countries/australia/. Accessed September 7, 2021 4. Australian Government. Health Technology Assessment (HTA). http://www.health.gov.au/hta. Accessed September 7, 2021 5. ECORYS. Mapping of Health Technology Assessment Developing and testing an evaluation matrix in selected countries. 2012;(February). 6. Oortwijn W, Determann D, Schiffers K, Tan SS, van der Tuin J. Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries. Value Heal. 2017;20(8):1121-1130. doi:10.1016/j.jval.2017.03.011. https://www.pbs.gov.au/info/industry/listing/elements/initiation-of-stakeholder-meetings. Accessed September 7, 2021 7. https://www.pbs.gov.au/info/industry/listing/elements/initiation-of-stakeholder-meetings. Accessed September 7, 2021 Canada Canada has a health system that is publicly funded through federal, provincial, and territorial general taxes. Roles and responsibilities are divided among these different levels of government. Each province is responsible for managing and providing health care, which must meet national standards. The five principles in the Canada Health Act are: (1) The administration must be public; 2) Plans must provide all the necessary medical and dental services of the hospital sector; 3) They are universal; (4) They must be accessible; and 5) portable: they must cover citizens outside the province or the country. There is an extensive network of primary and secondary/ hospital care. The national regulatory agency is Health Canada. There is a main HTA agency (independent, non-profit) CADTH; and some provinces also have their own agencies (Health Quality Ontario; INESS in Quebec, etc.) In the following summary we will mainly refer to CADTH, describe its HTA process in the different stages, and the role of deliberative processes. 1) Prioritization All new drugs and indications approved by the regulatory agency are assessed, therefore there is no prioritization process. The industry submits dossiers, which are evaluated on a first-come, first-served basis. There is a period of six months from the acceptance of the submission until the recommendation is published. Companies can send the dossier to be evaluated by an HTA, simultaneously with the submission to the regulatory area. In these cases, if the drug is not approved, the HTA is not published. In the case of medical devices, diagnostics, procedures, programs, and other interventions, a selection and prioritization process must be performed, since not all existing or new ones are assessed. Some provincial agencies work on that, in addition to the \"pan-Canadian HTA Collaborative\", which supports the centralized identification and prioritization of topics for the entire country. To request a technology assessment, the petition is filed by producers with different areas of the CADTH; 39

Background Paper | Documento de Antecedentes in case it is for drugs, with the \"Common Drug Review (CDR)\" or the pan-Canadian Oncology Drug Review Process (pCODR). There is a common procedure for submission so that not only producers, but other stakeholders as well, such as groups of cancer patients asking the pCODR to consider a technology of interest, can request that a drug be reviewed. The CADTH itself can initiate an HTA on a topic that it considers relevant for all of Canada, although the reasons for this petition may not be explicit. CDR's internal and external experts, for instance, review the petitions, interact with the industry; and then this review is sent to the Canadian Drug Expert Committee (CDEC) which meets monthly and issues the recommendations. Any worker in the public health system (clinician or decision-maker) can ask for a Rapid Assessment on a particular topic. 2) Assessment There are various types of processes, from complete HTA documents to quick reviews, and several intermediate procedures. They are performed by CADTH internally or with \"trusted contractors\" (individuals, academic groups, and small companies). In the case of Quebec there are two agencies, INESS and Conseil du Médicament. The criteria used are basically Clinical Effectiveness and Cost-effectiveness. Budget Impact is also evaluated. Depending on the type of drug to be assessed, different stakeholders are convened and coordinated by CADTH. In CDR, a clinical-economic expert group, or in pCODR. a clinical panel (Clinical Guidance Panel), performs the clinical review and hears the opinions of other stakeholders while another panel performs the economic review (Economic Guidance Panel) and considers the opinions of several stakeholders, including those of the Clinical Guidance Panel. There is also a process of consulting the person who sends the dossier, the manufacturer (if not the same), the group of pre-registered patients; and the \"Provincial Advisory Group\". Decision makers are also involved during this process in various ways: on the board there are several \"senior government officials\", \"Advisory Committees\" with representatives of provincial and territorial governments, which help prioritize topics, inter alia. There is a CADTH \"Liaison Officer\" in all provinces and territories, such that decision makers can be readily contacted. All decision makers can observe the deliberations of the expert panels issuing the recommendations. Decision makers can also formally file a \"Request for Advice\" to request clarification about any recommendations issued by the expert committees. They also participate in recommendation committees (such as CEDEC or pERC). Finally, these experts review all the information presented and reach a conclusion by using a deliberative framework. They subsequently issue an initial recommendation. 3) Recommendation and decision-making There are three expert committees who issue and justify recommendations. All recommendations are public and subject to a public consultation process. These committees are: • Oncology Drugs: Pan-Canadian Oncology Drug Review Expert Review Committee (pERC) • All other drugs: Canadian Drug Expert Committee (CDEC) • Medical devices, diagnostics, procedures, programs, and other interventions: Health Technology Expert Review Panel (HTERP) The existence of specific assessments and recommendations according to the type of technology assessed is peculiar to Canada. In general, even though there may be differences among the committees, the main aspects taken into account when deliberating and then issuing a recommendation are: patient outcomes, safety evidence, efficacy, effectiveness; therapeutic advantages and disadvantages; cost and cost-effectiveness in relation to the currently accepted treatment, that the technology is aligned with the patients’ concept of value, that its implementation within the health system is feasible, among others. These committees provide recommendations to the provinces that will then, in a decentralized manner, make a decision regarding the coverage of the technology. There is no formal appeal process. Stakeholders have different dialogue instances until the issuance of the final recommendation. There is even an \"embargoed recommendation \" that is confidentially sent to the stakeholders 10 working days before the CDEC meeting where the final recommendation is to be issued, so that they can express their opinion. 40

4) Implementation Background Paper | Documento de Antecedentes Committee recommendations are published in a listing (\"formulary listing recommendations\") for all types of drug plans to be covered. The coverage decision is implemented by each territory through the publication of the current drug listing. Deliberative Processes The 2020 HTAi Global Policy Forum material summarizes aspects pertaining to deliberative processes (the context, the sources used, the work method, the stakeholders and their participation, the mechanism for reaching a recommendation, and the results-outputs). CADTH uses a qualitative approach and tries to conduct its deliberations explicitly, systematically, and consistently by using standard decision-making frameworks and processes in its committees. Decision-making criteria or \"decision modifiers\" provide guidance on specific criteria that the committee may consider, such as on CADTH's definition of what constitutes a \"significant unmet need.\" Committees consisting of 14 members who are in charge of advising and recommending (\"advisory\") but not making the final decision. This link summarizes, and contains a video of the way the three committees (oncological drugs, non-oncological drugs and the one on devices and other interventions) deliberate , https://cadth.ca/events/how-cadth-expert-committees-deliberate. Clinical evidence is provided by the agency, the economic evidence by the producer of the technology, and patients can participate by filling a form. There is then deliberation in a closed location without the participation of any stakeholders outside the committee, and the recommendation is made \"by simple majority\". There are no formal instances for stakeholders to provide feedback on preliminary recommendations, and feedback is provided to them in writing. No public records of the deliberation are kept. Institutionalization HTA reports are one of the fundamental pieces used by committees (CDEC and pERC, for example) to issue their recommendations. The final recommendation is recognized as an extremely valuable element for the final decision-making, although it is not binding. Furthermore, HTA reports often serve to negotiate the prices with the manufacturer at the federal, provincial, and territorial levels (confidential negotiations). The HTA is highly institutionalized in this decision-making process. In its bylaws, the CADTH regulates the characteristics of the assessment process. Bibliography 1. Bond, K. 2020 HTAi Global Policy Forum Deliberative Processes in Health Technology Assessment: Prospects, Problems, and Policy Proposals. January 2020 2. Bond, K., Stiffell, R., & Ollendorf, D. (2020). Principles for deliberative processes in health technology assessment. International Journal of Technology Assessment in Health Care, 36(4), 445-452. doi:10.1017/S0266462320000550 3. Webinar. Deliberative processes in CADTH https://youtu.be/utaBmfIgHUM 4.Canadian Agency for Drugs and Technologies in Health (CADTH). Recommendation framework for CADTH Common Drug Review and pan-Canadian Oncology Drug Review Programs: Guidance for CADTH’s Drug Expert Committees. Ottawa, ON: CADTH, 2016. 5.Canadian Drug Expert Committee (CDEC) Terms of Reference. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH). 6.Devidas Menon, et al. Health Technology Assessment in Canada: 20 Years Strong? Value in Health. Volume 12 • Supplement 2 • 2009. S14-S19. 7. Julie Polisena. Health Technology Assessment of Medical Devices: The Canadian Experience. EMBEC & NBC 2017, IFMBE Proceedings 65, DOI: 10.1007/978-981-10-5122-7_236. 8. Renaldo N. Battista et al. Health technology assessment in Canada. International Journal of Technology Assessment in Health Care, 25:Supplement 1 (2009), 53–60. doi:10.1017/S0266462309090424. 9. Janet Martin et al. Local health technology assessment in canada: current state and next steps. International Journal of 41

Background Paper | Documento de Antecedentes Technology Assessment in Health Care, 32:3 (2016), 175–180. 10. PCODR Expert Review Committee Deliberative Framework.; 2011. www.pcodr. ca. Accessed January 22, 2019. 11. Procedure and Submission Guidelines for the CADTH Common Drug Review.; 2018. https://cadth.ca/sites/default/ files/cdr/process/Procedure_and_Guidelines_for_CADTH_CDR.pdf. Accessed January 22, 2019. 12. CADTH Common Drug Review (CDR) | CADTH.ca. https://www.cadth.ca/about-cadth/what-we-do/products-services/ cdr. Accessed January 22, 2019. 13. CADTH pan-Canadian Oncology Drug Review Process. https://cadth.ca/sites/default/files/pcodr/pCODR%27s Drug Review Process/pcodr_review_process_map.pdf. Accessed January 22, 2019. 14. PCODR Procedures.; 2018. www.cadth.ca/pcodr. Accessed January 22, 2019. 15. CADTH pan-Canadian Oncology Drug Review. Process in Brief | CADTH.ca. https://cadth.ca/pcodr/process-in-brief. Accessed January 22, 2019. 16. Programs and Services | CADTH.ca. Drug reimbursement recommendations. https://www.cadth.ca/about-cadth/ what-we-do/products-services. Accessed January 22, 2019. 17. Implementation Support and Liaison Officers | CADTH.ca. https://www.cadth.ca/contact-us/liaison-officers. Accessed January 22, 2019. 18. CADTH FAQs | CADTH.ca What does CADTH do? https://www.cadth.ca/about-cadth/who-we-are/faqs. Accessed January 22, 2019. 19. CADTH 2018-2019. Annual Business Plan. https://www.cadth.ca/sites/default/files/corporate/planning_ documents/2018 2019 Business Plan FINAL.pdf. Accessed January 22, 2019. 20. Transforming How We Manage Health Technologies in Support of Better Health, Better Patient Experience, and Better Value. https://www.cadth.ca/sites/default/files/corporate/planning_documents/CADTH_2018-2021_Strategic_Plan. pdf. Accessed January 22, 2019. 21. Pharmaceutical HTA and Reimbursement Processes - Canada. https://tools.ispor.org/htaroadmaps/CanadaPharm.asp. Accessed January 22, 2019. 22. Government of Canada . Canada’s Health Care System - Canada.ca. https://www.canada.ca/en/health-canada/ services/health-care-system/reports-1. publications/health-care-system/canada.html. Accessed January 22, 2019. Scotland Scotland has a population of about 5 million people. Life expectancy is slightly lower than in the UK or the rest of Europe. The three main causes of death are: cardiovascular disorders, cancer, or chronic respiratory diseases. Scotland has a universal tax-funded health system, free of charge for the entire population. The private subsector is extremely small. Responsibility for both health policies and service provision lies with the Scottish Cabinet Secretary for Health and Social Care office. These functions are delegated on 14 territorial jurisdictions. Beyond the independence in the provision of services by these jurisdictions, some services are provided at the national level such as ambulance transport, generation of information, education and training, and quality improving initiatives. Approximately 85% of health expenditure is public, with the remaining 15% being private, usually used in dental or ophthalmological care. Approximately 90% of health services are provided by general practitioners who work as part of multidisciplinary teams made up of nurses, obstetricians, social workers, and administrators. Scotland has two government bodies that develop health technology assessments. The Scottish Health Technologies Group (SHTG), which assesses non-drug technologies, and the Scottish Medicines Consortium (SMC), which assesses drugs. Both bodies provide advice to Scottish national health system jurisdictions on the effectiveness and cost- 42

effectiveness of new technologies. Using a drug in Scotland is not possible if it was not previously assessed by Background Paper | Documento de Antecedentes the SMC. Technologies recommended for use by the SHTG or SMC must be provided by the health system jurisdictions. If a technology has received a no-use recommendation, jurisdictions may seek approval by means of an Individual Patient Treatment Request (IPTR). Decision-making process within the SMC The role of the SMC is to provide recommendations on the incorporation of new drugs into the National Health System in Scotland (NHS Scotland). The SMC is a committee made up of attending physicians, pharmacists, NHS Scotland representatives, representatives of the pharmaceutical industry, and the general public. It currently consists of 27 members, though it can possibly include up to 40. The SMC meets once a month; meetings are public, and attendance is possible by prior registration. The incorporation process begins with the assessment request that is usually made by the pharmaceutical industry, although sometimes it can also be initiated by groups of patients. Initially, applications are evaluated by the NDC (New Drugs Committee). This support committee makes a preliminary recommendation to the SMC. It also meets once a month. It is composed of attending physicians, pharmacists, and representatives of the pharmaceutical industry. The NDC evaluates the clinical and economic evidence submitted by the producers of the technology, collects information from relevant clinical experts from different parts of Scotland, and sometimes (usually at the request of the industry) it incorporates information from patient and physician representatives. After this technical evaluation, feedback is provided to the applicant company so that it can reevaluate those points that may require further development prior to being assessed by the SMC. All members of the various committees are required to file a declaration of conflict of interest every year. In the subsequent assessment by the SMC, more extensive information than the one evaluated by the NDC is considered (clinical and economic evidence); even modifiers are contemplated for the incorporation of drugs intended for the final stage of life, orphan diseases, or rare or ultra-rare diseases. The final decision by the SMC is made by non-public voting. All committee members have one vote. No explicit decision criteria are specified. Decisions, as well as supporting information, are available on the SMC website. The SMC may make one of the following three decisions: Incorporation is accepted, accepted with restrictions, or not accepted. Some common reasons for non-incorporation are: the new drug is no better than the less expensive products currently incorporated; the estimated additional benefits are not deemed to be valuable enough in relation to their costs; or there is too much uncertainty, either in the clinical or economic evidence, for their incorporation. The whole process, from the assessment request to the recommendation takes approximately 18 weeks. Bibliography 1. Steel D, Cylus J. United Kingdom (Scotland): Health system review. Health Syst Transit. 2012;14(9):xv-xxii, 1-150. http:// www.ncbi.nlm.nih.gov/pubmed/23579054. Accessed January 30, 2019. 2. SMC | Scottish Medicine Consortium. Accessed September 15, 2021. https://www.scottishmedicines.org.uk/media/3574/20180712-a-guide-to-the-scottish-medicines-consortium.pdf https://www.scottishmedicines.org.uk/about-us/who-we-are/ https://www.scottishmedicines.org.uk/how-we-decide/ 43

Background Paper | Documento de Antecedentes United Kingdom Public health in England is managed by the National Health Service (NHS). The NHS provides universal and mostly free coverage at all levels of health care from primary to hospital care, though the system is strongly based on primary care. It is mainly financed through central government taxes and national insurance contributions. The upper levels in the reporting system are responsible for coordination and policy formulation and the lower levels for health care management. The NHS has a legal obligation to fund and provide resources for medicines and treatments recommended by NICE (National Institute for Health and Care Excellence) technology assessments within three months after a recommendation is issued. NICE is an independent non-departmental public agency responsible for providing guidance for health promotion, and the prevention and treatment of disease in England’s National Health System. Officially it only issues recommendations for England. However, it provides certain products and services to Wales, Scotland, and Northern Ireland. Decisions on how it is implemented in these countries are made by decentralized agencies, which are often involved and consulted. NICE's role is to improve outcomes for people using the NHS and other public health and social assistance services, so the health technology assessment process is only part of its role. It is also responsible for: producing evidence-based guidance and advice for health, public health, and social assistance professionals; developing quality standards and performance metrics for those who provide and commission health, public health, and social assistance services; and providing a range of information services for commissioners, professionals, and managers across the spectrum of health care and social assistance. The identification of new and emerging health technologies that might be suitable for evaluation is carried out by the National Institute for Health Research (NIHR) Innovation Observatory at Newcastle University (independent research team). This center notifies NICE about new medicines under development. Data sources include trial records, scientific literature, regulatory agencies (including the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA)), clinical experts, patients or patient organizations, the media and tertiary sources, as well as consultation with producing companies. Public and patient consultation is a critical element in the work of the observatory, which hosts the national public patient forum known as VOICE (Valuing Our Intellectual Capacity and Experience). Healthcare professionals and researchers can also suggest potential technologies for NICE to assess. If it is the production company that wishes to propose a new medicine (which has not yet received a marketing authorization) it can do so through the UKPharmaScan platform up to three years prior to its launching in the United Kingdom or prior to the onset of phase III clinical development. In turn, the government or the NHS may request review of a certain technology or disease in which it has a special interest. Health technologies that may enter the NICE Technology Assessment Program are medicinal products, medical devices, diagnostic techniques, surgical procedures, or other therapeutic techniques, and care and screening systems. NICE manages this process on behalf of the Department of Health and Social Care and can only start assessing a technology when it has been formally referred to them by the Secretary of State for Health. For the prioritization of issues there is an explicit process through a National Health Technology Assessment program, which is supported by expert advisory panels composed of technical members and clinical experts. The topics to be evaluated must be relevant to patients, their caregivers, health practitioners, suppliers, and public health, and help make better use of health system resources. Topic selection follows a standardized process, which is performed as quickly as possible, ensuring that topic nomination is inclusive, open, transparent, and consistently applied. The prioritization criteria for selecting which technologies will be assessed (abstracting evidence for medicines) include the following aspects: clinical impact, clinical practice variation, information needs, and impact on resources. A list of possible topics is given to the assessment team to generate the drafts of the scope (approach) of the assessment to be developed for a particular technology. For that purpose, criteria such as the expected value 44

of the intervention in terms of reduction of uncertainty, temporal proximity to obtain results, potential cost- Background Paper | Documento de Antecedentes effectiveness, importance of early assessment, political considerations, prevalence of the disease, and social or ethical concerns are used. These drafts define the issues to be submitted to the health department to formally request the assessment of the technology. Health technology assessments are developed by academic centers or specialists. Reports adopt one of three forms: Single Technology Appraisal, Fast Track Appraisal, or Multiple Technology Appraisal that typically covers more than one technology, or one technology for more than one indication. The following analysis dimensions are included: burden of disease, end of life and unmet needs; therapeutic and safety impact; level of innovation; cost-effectiveness and budget impact analysis; alignment with NHS health priorities; ethical considerations; clinical and political significance; presence of inappropriate variation in practice; potential factors affecting the timeliness of the guide to be produced; impact on public health and quality of life, reduction of health inequalities, or delivery of quality programs or interventions. The decisions taken reflect England's social values. Recommendations of NICE's technology assessments are developed by an independent advisory committee referred to as Technology Assessment Committee (TAC). Its members, who are elected among NHS members, representatives of patient and care organizations, academics, and representatives of the pharmaceutical and medical device industry, are appointed for a three-year term. Meetings are public, and the technical presentation, but not the process of deliberation and recommendation, may be witnessed; dates are published on the NICE website. For the process of issuing a recommendation, different stakeholders (consultee organizations and commentator organizations) are convened, who in turn can assume different roles. Consultee organizations include: national groups representing patients and caregivers; bodies representing health professionals; producers of the technology; the Department of Health; the Welsh Government Assembly; specialized commissioning groups, and primary care trusts, as well as local health boards. These consultees can present evidence during the assessment, comment on the assessment documents, and appeal the final recommendations of the Assessment Committee. In addition, advisory organizations (except for manufacturers) are requested to nominate patient experts or clinical specialists. Commentator organizations include: manufacturers of technologies that are comparable to the one being assessed; NHS Quality Improvement Scotland; the National Collaborating Center that is developing the clinical guidelines for the relevant pathology; research groups working in that area; as well as other groups, including the NHS Confederation, the NHS Procurement and Supply Agency, the British National Formulary, the Scottish Medicines Consortium, the Medicines and Healthcare Products Regulatory Agency, the Northern Ireland Department of Health, Social Services and Public Safety, and Professional or Patient Organizations covering Wales alone. These organizations are invited by NICE to participate in the assessment process and comment on the various documents produced during the process. Commentators cannot appeal the final appraisal determination. The recommendation is made by the TAC at the final meeting. The deliberative process includes face-to-face meetings, usually on two occasions, in which the technical team presents all the evaluated domains as well as patients’ considerations. A protracted discussion is held about the recommendation to be issued so that a consensus can be achieved. The committee must consider the cost-benefit balance, the degree of necessity, and the desirability of promoting the innovation, and comply with the Social Value Judgments document as well. There are explicit decision rules and thresholds regarding cost-effectiveness. In case of discrepancy, it is resolved by simple vote. The final decision on the recommendation is made by the chair of the committee. The decision-making process is strongly related to the assessment process, since there is an early interaction between the assessment team and the recommendation committee, who have an initial meeting to examine the technology, and afterwards a meeting where results are presented and where additional considerations arise about the HTA document. 45

Background Paper | Documento de Antecedentes These assessments are used as a tool to inform coverage recommendations related to the reimbursement status of the relevant technologies, and to set the price at which the technology should be marketed, although the final price is usually the result of a subsequent negotiation process. Each technology appraisal may contain more than one recommendation, which fall into five categories: recommended; optimized; only in research; not recommended; and recommended for use in the Cancer Drugs Fund. In addition to these types of technology appraisal recommendations, an appraisal committee may make a preliminary recommendation to seek clarification from the manufacturer or sponsor on the key evidence presented for a technology. This will result in a recommendation stating that \"the committee intends not to recommend [the technology]..\" and expresses the requested information/clarification. The decision is implemented through clinical prescription guidelines and drug forms. The NHS is legally obliged to implement the guidelines and coverage recommendations, within 3 months after a recommendation is issued. NICE has developed a program to support and monitor the implementation of technology guidelines and assessments. BIBLIOGRAPHY 1. ECORYS. Mapping of Health Technology Assessment Developing and testing an evaluation matrix in selected countries. 2012;(February). 2. NICE. What we do | About. Available on: https://www.nice.org.uk/about/what-we-do. Accessed September 7, 2021. 3. NICE. Who we are | About. Available on: https://www.nice.org.uk/about/who-we-are. Accessed September 7, 2021. 4. NICE. Technology Appraisal Committee | Meetings in public | Get involved |. Available on: https://www.nice.org.uk/get- involved/meetings-in-public/technology-appraisal-committee. Accessed September 7, 2021. 5. Angelis A, Kanavos P. Value-Based Assessment of New Medical Technologies: Towards a Robust Methodological Framework for the Application of Multiple Criteria Decision Analysis in the Context of Health Technology Assessment. Pharmacoeconomics. 2016;34(5):435-446. doi:10.1007/s40273-015-0370-z. 6. NICE. Selecting technologies | Guide to the processes of technology appraisal | Guidance | NICE. https://www.nice.org. uk/process/pmg19/chapter/selecting-technologies. Accessed September 7, 2021. 7. NICE. Topic identification, prioritisation and selection | Evidence summaries: process guide | Guidance | NICE. https:// www.nice.org.uk/process/pmg31/chapter/topic-identification-prioritisation-and-selection. Accessed September 7, 2021. 8. Oortwijn, W. et al. (2018) ‘How can health systems prepare for new and emerging health technologies? The role of horizon scanning revisited’, International Journal of Technology Assessment in Health Care. Cambridge University Press, 34(3), pp. 254–258. doi: 10.1017/S0266462318000363. 9. Ken Bond. 2020 HTAi Global Policy Forum. Background paper. Deliberative Processes in Health Technology Assessment: Prospects, Problems, and Policy Proposals. January 2020. Available on: https://htai.org/wp-content/ uploads/2020/02/HTAi_GPF-newOrleans_program_background-paper.pdf. . Accessed September 7, 2021. 46

HTAi 2021 Foro de Políticas en Background Paper | Documento de Antecedentes Evaluación de Tecnologías Sanitarias en Latinoamérica Documento de Antecedentes Procesos deliberativos para la toma de decisión informada por la evaluación de tecnologías sanitarias Foro Virtual octubre de 2021 47

Background Paper | Documento de Antecedentes Contenidos Introducción Antecedentes y Metodología Procesos deliberativos en evaluación de tecnologías sanitarias Referencias Experiencias internacionales Australia Canadá Escocia Reino Unido Este documento ha sido elaborado por: Andres Pichon-Riviere, Federico Augustovski, Verónica Alfie, Sebastián García Martí y Andrea Alcaraz. Instituto de Efectividad Clínica y Sanitaria (IECS) Buenos Aires. Argentina. Agradecemos a Héctor Castro, Presidente del Latin American Policy Forum 2021 de HTAi y a los integrantes del comité organizador: Adriana María Robayo (Colombia) - Instituto de Evaluación Tecnológica en Salud; Alicia Granados (España) - Sanofi; Dino Sepúlveda Viveros (Chile) - Ministerio de Salud Gobierno de Chile; Fernanda Laranjeira (Brasil) - Janssen-Cilag Farmacêutica Ltda.; Francisco Tellechea (Argentina) - Productos Roche SAQeI; Graciela Fernandez (Uruguay) - Fondo Nacional de Recursos; Homero Monsanto (Estados Unidos) Merck & Co.; Vania Cristina Canuto Santos (Brasil) - CONITEC, Ministerio de Salud por sus comentarios y sugerencias en la realización de este documento. 48