Program Content Outline

  1. Introduction to HTA

    1. 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, the public and patients
      • Other key terminology in HTA
    2. 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
    3. 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
      • Patient and citizen involvement
      • Transparency of process, confidentiality and conflict of interest
      • Data transparency, sharing and collaboration between HTA bodies and industry
    4. 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
    5. Local considerations for HTA
      • Results of course participant survey
      • Reflections on current and future use of HTA
      • Flexible content to fit to the context of the course e.g. a roundtable with regional stakeholders
    6. 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
      • Exercise: creating a question
      • Feasibility of evidence collection and potential risk to payers from decisions based on different types of evidence
  2. Conduct of HTA

    1. Developing protocols for primary evidence collection
      • Defining the need for primary evidence collection
      • What type of information contributes to a better understanding of clinical outcome (e.g., observational vs. experimental; quasi-experimental)
      • Differences in clinical information requirements for patients, payers, and regulators
      • Strengths and limitations of different study designs for clinical, economic, and psycho-social (including HRQL) impact of technology
    2. 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 PubMeb and NHS CRD
    3. 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)
      • 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
      • Exercise: Using the ISPOR Assessing Observational/Modeling Studies for Health Care Decisions Task Force Report
    4. 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
      • Exercises: Appraising economic studies; Conducting and transferring economic evaluation
    5. Budget Impact Analysis
      • 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
      • Exercise: Implementing economic evaluation
    6. 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
      • How do these forms of evidence overlap with clinical and economic evidence and evidence from patients?
    7. 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)