Hotel Lutécia. Av. Frei Miguel Contreiras nº 52, , Lisbon, Portugal June 2016

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1 Hotel Lutécia Av. Frei Miguel Contreiras nº 52, , Lisbon, Portugal June 2016 This three and a half day training program brings together leading experts in HTA to teach good practices in the use and conduct HTA. The course is intended for both those who need to understand what HTA can do and what good HTA looks like, as well as those who would like to learn basic skills in conducting HTA. Course Agenda Sunday 26 June 7:45 & registration 8:30 8:45 Introduction to ISPOR and faculty Opening remarks 8:45 9:00 Overview of course, course objectives, and group introductions 9:00-10:00 What is Health Technology Assessment and why is it important? Describe what health technology, health technology assessment is and key definitions linked with this process Describe role of HTA in health care system; assessment process, appraisal process, and decision-making process Why HTA is important for health policy Other key terminology in HTA Discussion 10:00 10:30 BREAK 10:30 11:30 What are best practices in HTA? Outline the fundamentals of what a good HTA process looks like Identify principles applicable to structuring and governing HTA organizations How patients and other stakeholders can interact with an HTA process Key aspects of HTA: Clinical evidence, economic evaluation, budget impact and uncertainty Evidence Interpretation and Appraisal Importance of process and societal and stakeholder involvement Discussion

2 11:30 12:00 Current and future issues in HTA Different and evolving approaches to implement HTA Impact of HTA and barriers to impact Upstream/Constructive HTA Personalized medicine Transparency of process, confidentiality and conflict of interest Data transparency, sharing, and collaboration between HTA bodies and industry Discussion 12:00 1:20 LUNCH 1:20 1:30 Group Photo 1:30 2:30 Implementing HTA Formulary and benefits packages/tiering Managed entry agreements: risk-sharing/ performance-based, coverage with evidence development agreements Supporting disinvestment decisions Pricing and value-based pricing Evidence-based/strategic procurement Discussion 2:30 5:45 Local considerations for HTA Reflections on current and future use of HTA Break Flexible content to fit to the context of the course e.g. a roundtable with regional stakeholders Discussion 5:45 6:00 Summary and Q&A

3 Monday 27 June 8:40 9:00 Review of day 1 course, Q&A and overview of day 2 course and objectives 9:00-10:30 Framing and Scoping in HTA Differences between policy questions and HTA questions and how they are linked Depth of analysis needed in HTA (e.g., rapid, mini, or full HTA) What sources of information that can be used to answer questions (such as collecting new data or using existing data), the strengths and limitations of each approach 10:30 11:00 BREAK 11:00 11:30 Developing Protocols for HTA Projects and Primary Evidence Collection Feasibility of evidence collection and potential risk to payers from decisions based on different types of evidence 11:30 12:00 Summary, Discussion, and Evaluation 12:00 1:30 LUNCH 1:30 3:00 Literature searching: How to identify clinical/economic evidence from secondary sources Various secondary information sources available and how these can be identified through searching databases and other sources Strengths and limitations of using secondary sources of information (i.e., generalizability, dissemination bias) General search methods common across all health technology assessments EXERCISE Searching PubMed and NHS CRD 3:00 3:30 BREAK 3:30 4:15 Combining and interpreting clinical evidence Differences between efficacy and effectiveness How to use and interpret observational (i.e., real-world evidence), modeling studies and meta-analysis (including indirect treatment comparison) 4:15 5:00 Combining and interpreting clinical evidence How to interpret patient reported outcome measures including health-related quality of life instruments How clinical data can be combined with data on health-related quality of life 5:00 5:45 Combining and interpreting clinical evidence EXERCISE - Using the ISPOR Assessing Observational/Modeling Studies for Health Care Decisions Task Force 5:45 6:00 Summary and Q&A

4 Tuesday 28 June 8:40 9:00 Review of day 2 course, Q&A and overview of day 3 course and objectives 9:00 10:00 Economic evaluation, budget impact and uncertainty Differences between a budget impact analysis and economic evaluation How to conduct budget impact analysis How economic evaluation and budget impact analysis can be used to address policymaker uncertainty 10:00 11:30 Costing and economic evaluation EXERCISE Conducting and transferring economic evaluation 11:30 11:45 BREAK 11:45 12:45 Costing and economic evaluation EXERCISE Implementing economic evaluation 12:45 2:15 LUNCH 2:15 3:15 Costing and economic evaluation Introduction to economic evaluation Best practices in conducting and reporting economic evaluation Best practices and issues related to study-based economic evaluation Best practices and issues related to model-based economic evaluation 3:15 3:45 BREAK 3:45 5:15 Costing and economic evaluation EXERCISE Appraising economic studies 5:15 6:00 Summary and Q&A

5 Wednesday 29 June 8:40 9:00 Review of day 3 course, Q&A, and overview of day 4 course and objectives 9:00 10:00 Combining ethical, legal, social, cultural, and other forms of evidence in HTA Best practices in conducting and reporting research on ethical, legal, social and cultural impacts of technology 10:00 10:45 Evidence Appraisal - Methods for integrating societal and stakeholder values Principles of combining social value including patient perspectives into an appraisal of evidence Role and use of multi-criteria decision analysis and other approaches for combining perspectives Best practices in patient engagement Best practices in deliberative methods (processes) 10:45 11:00 BREAK 11:00 12:15 Evidence Appraisal - Methods for integrating societal and stakeholder values EXERCISE Evidence Appraisal 12:15 12:45 Summary and Q&A 12:45 Course evaluation and dismissal

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