Introduction to HTA

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

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

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

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

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

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

Conduct of HTA

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

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

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

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

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

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?

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)