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)