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The Health Technology Assessment Process
In addition to the first step of defining the HTA process, the steps to conducting a thorough health technology assessment include:
The following featured HTA resources are organized by the key steps for conducting an HTA. This icon 
indicates ISPOR created content.
DEFINING THE HTA PROCESS
Defining the HTA Process: Structure/Governance/Organizational Aspects of HTA
- A Framework for Good Governance in the Pharmaceutical Sector. The Hashemite Kingdom of Jordan
- Governance for sustainable human development: a UNDP policy document. New York: United Nations Development Programme; 1997.
- Governance indicators: where are we, where should we be going? The World Bank; 2007 Oct p. 1. Report No.: WPS4370.
- Handbook on HTA Capacity Building (EUnetHTA)
- HTA country survey of National Authorities (World Health Organization [WHO]).
- Policy for the HTA Core Model® and core HTA information (EUnetHTA)
- Strengthening health system governance: better policies, stronger performance. Maidenhead, Berkshire, England: Open University Press; 2016.
- The world health report 2000 – Health systems: improving performance (WHO)
Defining the HTA Process: Framework/Principles for the HTA Process
- Accountability for reasonableness.
- A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
- Assessing the Added Value of Health Technologies: Reconciling Different Perspectives.
- Can we reliably benchmark health technology assessment organizations?
- Enhancing Fairness and Legitimacy.
- Guiding principles for good practices in hospital-based health technology assessment units.
- Health technology assessment agencies: an international overview of organizational aspects.
- Health technology assessment, deliberative process, and ethically contested issues.
- Health technology assessment for resource allocation decisions: are key principles relevant for Latin America?
- Health technology assessment toolkit (iDSI)
- Key principles for the improved conduct of health technology assessments for resource allocation decisions.
- Mapping of health technology assessment in selected countries.
- The impact of culture, values, and institutional context on the methods and use of economic evaluation.
- The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries.
- Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries.
- Toward international good practices in health technology assessment.
Defining the HTA Process: Priority Setting Process
- AHRQ series paper 3: identifying, selecting, and refining topics for comparative effectiveness systematic reviews: AHRQ and the effective health-care program.
- Choosing health technology assessment and systematic review topics: the development of priority-setting criteria for patients’ and consumers’ interests.
- Emerging health technologies: informing and supporting health policy early.
- How to choose health technologies to be assessed by HTA? A review of criteria for priority setting.
- Priority setting for health technology assessment. Theoretical considerations and practical approaches. Priority setting Subgroup of the EUR-ASSESS Project.
- Priority setting for health technology assessment at CADTH.
- Priority setting for health technology assessments: a systematic review of current practical approaches.
- The health systems’ priority setting criteria for selecting health technologies: A systematic review of the current evidence.
- The Refinement of Topics for Systematic Reviews: Lessons and Recommendations From the Effective Health Care Program. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013.
Defining the HTA Process: Framing and Scoping
- An integrated perspective on the assessment of technologies: Integrate-HTA.
- Formulating questions and locating primary studies for inclusion in systematic reviews.
- Guidance for conducting systematic scoping reviews.
- Health technology assessment handbook. Copenhagen: Danish Centre for Health Technology Assessment; 2001
- HTA Core Model® (EUnetHTA)
- Lay and professional stakeholder involvement in scoping palliative care issues: Methods used in seven European countries.
- Technology appraisal guidance (NICE)
- Using scoping literature reviews as a means of understanding and interpreting existing literature.
ASSESSMENT
Assessment: Identifying and Interpreting Individual Studies
- A Checklist for Medication Compliance and Persistence Studies Using Retrospective Databases
- A Checklist for Retrospective Database Studies
- Analytic Methods to Improve Causal Inference From Non-Randomized Studies of Treatment Effects Using Secondary Databases
- An integrated perspective on the assessment of technologies: INTEGRATE-HTA.
- Approaches to Mitigate Bias and Confounding in the Design of Non-Randomized Studies of Treatment Effects Using Secondary Databases
- A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Healthcare Decision Making
- Best Practices for Conducting Economic Evaluations in Health Care: A Systematic Review of Quality Assessment Tools. Rockville, MD: Agency for Healthcare Research and Quality (US); 2012.
- Cochrane Qualitative and Implementation Methods Group guidance series—paper 1: introduction.
- Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis
- Cochrane Qualitative and Implementation Methods Group guidance paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings.
- Cochrane Qualitative and Implementation Methods Group guidance paper 4: methods for assessing evidence on intervention implementation.
- Cochrane Qualitative and Implementation Methods Group guidance paper 5: methods for integrating qualitative and implementation evidence within intervention effectiveness reviews.
- Cochrane Qualitative and Implementation Methods Group guidance paper 6: reporting guidelines for qualitative, implementation, and process evaluation evidence syntheses.
- Complex health care interventions: characteristics relevant for ethical analysis in health technology assessment.
- Complexity of the paradigms present in quality criteria of qualitative research grids.
- Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute.
- Conjoint Analysis Applications in Health—A Checklist
- Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.
- Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Resources
- Constructing Experimental Designs for Discrete-Choice Experiments
- Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes Instruments for Medical Product Evaluation—Assessing Respondent Understanding
- Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation—Eliciting Concepts for a New PRO Instrument
- Cost-Effectiveness Analysis Alongside Clinical Trials II
- Cost-Effectiveness in Health and Medicine. 02 edition. Oxford; New York: Oxford University Press; 2016.
- Coverage with Evidence Development, Only in Research, Risk Sharing, or Patient Access Scheme? A Framework for Coverage Decisions.
- Coverage with evidence development: the Ontario experience.
- Criteria list for assessment of methodological quality of economic evaluations: consensus on health economic criteria.
- Current state of ethics literature synthesis: a systematic review of reviews.
- Defining, Reporting, and Interpreting Non-Randomized Studies of Treatment Effects Using Secondary Databases
- Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide. Rockville, MD: Agency for Healthcare Research and Quality (US); 2013.
- Different methods for ethical analysis in health technology assessment: an empirical study.
- Economic modelling of diagnostic and treatment pathways in National Institute for Health and Care Excellence clinical guidelines: the Modelling Algorithm Pathways in Guidelines (MAPGuide) project.
- Enhancing the QUAlity and Transparency Of Health Research.
- Enhancing transparency in reporting the synthesis of qualitative research: ENTREQ.
- Ethical analysis to improve decision-making on health technologies.
- Ethics and health technology assessment: handmaiden and/or critic?
- Ethics expertise for health technology assessment: a Canadian national survey
- Evidence Synthesis TSD series (NICE Decision Support Unit)
- Examining the value and quality of health economic analyses: implications of utilizing the QHES
- Exploring qualitative research synthesis: the role of patients’ perspectives in health policy design and decision-making.
- Framework for systematic identification of ethical aspects of healthcare technologies: the SBU approach.
- Future challenges for the economic evaluation of healthcare: patient preferences, risk attitudes and beyond.
- General Methods (benefit assessment) (The Institute for Quality and Efficiency in Healthcare)
- Good Practice for Budget Impact Analysis I
- Guidance for considering ethical, legal, and social issues in health technology assessment: application to genetic screening
- Guidance for developers of health research reporting guidelines.
- Healthcare technology assessment. In: Have H ten, editor. Encyclopedia of Global Bioethics. New York: Springer; 2015.
- HTA Adaptation Toolkit (EUnetHTA)
- INTEGRATE-HTA: adopting and implementing an integrated perspective on complex interventions.
- Integrating ethics in health technology assessment: many ways to Rome.
- Integration of Existing Systematic Reviews. Rockville, MD: Agency for Healthcare Research and Quality (US); 2014.
- Internal validity of non-randomised studies (NRS) on interventions guidelines (EUnetHTA)
- Is there a European view on health economic evaluations? Results from a synopsis of methodological guidelines used in the EUnetHTA partner countries
- Keeping up to date with information retrieval research: Summarized Research in Information Retrieval (SuRe Info)
- Key recommendations from the MedtecHTA project.
- Mapping the integration of social and ethical issues in health technology assessment.
- Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures
- Measuring Drug Costs in Cost-Effectiveness Analyses: A Managed Care Perspective
- Measuring Drug Costs in Cost-Effectiveness Analyses: An Industry Perspective
- Measuring Drug Costs in Cost-Effectiveness Analyses: An International Perspective
- Measuring Drug Costs in Cost-Effectiveness Analyses: A Societal Perspective
- Measuring Drug Costs in Cost-Effectiveness Analyses: Issues and Recommendations
- Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid, and Other United States Government Payers’ Perspectives
- Medication Compliance and Persistence: Terminology and Definitions
- Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review.
- Methodology Guidelines (EUnetHTA)
- Methods for the Economic Evaluation of Health Care Programmes. Oxford: Oxford University Press; 2015.
- Methods for Integrating Medication Compliance and Persistence in Pharmacoeconomic Evaluations
- Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008.
- Methods of international health technology assessment agencies for economic evaluations comparative analysis.
- Methods of synthesizing qualitative research studies for health technology assessment.
- Modeling and Simulation in the Context of Health Technology Assessment: Review of Existing Guidance, Future Research Needs, and Validity Assessment Rockville (MD): Agency for Healthcare Research and Quality (US); 2017.
- Modeling good research practices-overview
- Modelling methods for pharmacoeconomics and health technology assessment: an overview and guide.
- Multinational Trials—Recommendations on the Translations, Required Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data
- Observational Data TSD (NICE Decision Support Unit)
- Observational Evidence and Strength of Evidence Domains: Case Examples. Rockville, MD: Agency for Healthcare Research and Quality (US); 2014.
- Patient-centric HTA: different strokes for different folks.
- Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials
- Patient-Reported Outcome Data Collection in Clinical Trials Using Mixed Modes
- PBAC Guidelines (Australian Pharmaceutical Benefits Advisory Committee)
- Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling
- Pharmacoeconomic Guidelines Around the World
- Principles of Good Practice for Budget Impact Analysis II
- Q-SEAda tool for quality assessment of ethics analyses conducted as part of health technology assessments.
- Qualitative and mixed methods provide unique contributions to outcomes research.
- Qualitative methods in patient-centered outcomes research.
- Questionnaire to Assess Relevance and Credibility of Modeling Studies for Informing Healthcare Decision Making
- Revealing and acknowledging value judgments in health technology assessment.
- Reviewing model parameters TSD (NICE Decision Support Unit)
- Risk of Bias 2 Tool
- ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions.
- Statistical Methods for the Analysis of Discrete-Choice Experiments
- STRengthening Analytical Thinking for Observational Studies. Stratos Initiative.
- Survival analysis TSD (NICE Decision Support Unit)
- Systematic Reviews of Economic Evaluations: Utility or Futility?
- Technology appraisal guidance (NICE)
- The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials.
- The EQUATOR Network and reporting guidelines: Helping to achieve high standards in reporting health research studies.
- Transferability of Economic Evaluations Across Jurisdictions
- Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures
- Use of Existing Patient-Reported Outcome Instruments and Their Modification
- Using expert opinion in health technology assessment: a guideline review.
- Validation of Electronic Systems to Collect Patient-Reported Outcome Data—Recommendations for Clinical Trial Teams
Assessment: Interpreting Bodies of Evidence
- Advances in the GRADE approach to rate the certainty in estimates from a network meta-analysis.
- A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis.
- Assessing the Quality of Mixed Methods Research: Toward a Comprehensive Framework. In: SAGE Handbook of Mixed Methods in Social & Behavioral Research. Thousand Oaks, CA: Sage Inc.; 2010
- Conducting Indirect Treatment Comparison and Network Meta-Analysis Studies
- Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews.
- Indirect Treatment Comparison/Network Meta-Analysis Study Questionnaire to Assess Relevance and Credibility to Inform Healthcare Decision Making
- Integration of Existing Systematic Reviews. Rockville, MD: Agency for Healthcare Research and Quality (US); 2014.
- International comparison of the definition and the practical application of health technology assessment
- Interpreting Indirect Treatment Comparisons and Network Meta-Analysis for Healthcare Decision Making
- Methods for Meta-Analysis in Medical Research.
- Protocol-developing meta-ethnography reporting guidelines (eMERGe).
- RAMESES publication standards: meta-narrative reviews
- RAMESES publication standards: realist syntheses.
- The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations
- The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.
- Using qualitative evidence in decision-making for health and social interventions: an approach to assess confidence in findings from qualitative evidence syntheses (GRADE-CERQual).
CONTEXTUALIZATION
Contextualization: Deliberative Processes
- Conceptualizing and Combining Evidence for Health System Guidance. Ottawa, ON: Canadian Health Services Research Foundation; 2005.
- Deliberation as discussion. In: Elster J, editor. Deliberative Democracy. Cambridge: Cambridge University Press; 1998.
- Deliberative processes and evidence-informed decision making in healthcare: do they work and how might we know?
- Deliberative Processes in Decisions About Health Care Technologies: Combining Different Types of Evidence, Values, Algorithms and People. London: Office of Health Economics; 2009.
- Designing and Implementing Deliberative Processes for Health Technology Assessment: Joint HTAi/ISPOR Task Force Report
- Evidence-informed deliberative processes. A practical guide for HTA agencies to enhance legitimate decision-making. Version 1.0. Nijmegen, Radboud university medical centre, Radboud Institute for Health Sciences, 2019.
- Value assessment frameworks for HTA agencies: the organization of evidence-informed deliberative processes.
Contextualization: Patient Engagement and Patient Preferences
- Bringing “the public” into health technology assessment and coverage policy decisions: from principles to practice.
- Clinical Outcome Assessments: Conceptual Foundation
- Clinician-Reported Outcome Assessments of Treatment Benefit
- Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute.
- Exploring qualitative research synthesis: the role of patients’ perspectives in health policy design and decision-making.
- Guidance for patient involvement in HTA. (EUPATI)
- Incorporating the Patient's Perspective into Drug Development and Communication
- Patient and Public Involvement Policy (NICE)
- Patient-based health technology assessment: a vision of the future.
- Patient-centric HTA: different strokes for different folks.
- Patients’ perspectives in health technology assessment: a route to robust evidence and fair deliberation.
- Value to whom? The patient voice in the value discussion.
Contextualization: Weighted Stakeholder Preferences and Multi-Criteria Decision Analysis
- Advancing MCDA and HTA into Coverage Decision-Making. In: Multi-Criteria Decision Analysis to Support Healthcare Decisions. Cham, Switzerland: Springer; 2017.
- Bridging health technology assessment (HTA) with multicriteria decision analyses (MCDA): field testing of the EVIDEM framework for coverage decisions by a public payer in Canada.
- Implementation of EUnetHTA core Model® in Lombardia: the VTS framework.
- Integrating patients’ views into health technology assessment: Analytic hierarchy process (AHP) as a method to elicit patient preferences.
- Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures
- Multi-Criteria Decision Analysis to Support Healthcare Decisions. New York: Springer; 2017.
- Multicriteria decision analysis for including health interventions in the universal health coverage benefit package in Thailand.
- Multiple Criteria Decision Analysis for Healthcare Decision Making—An Introduction: Report 1
- Multiple Criteria Decision Analysis for Healthcare Decision Making: Report 2
- Priority setting for health technology assessment at CADTH.
- Statistical Methods for the Analysis of Discrete-Choice Experiments
- Use of Existing Patient-Reported Outcome Instruments and Their Modification
- Which health technologies should be funded? A prioritization framework based explicitly on value for money.
Contextualization: Use of Thresholds
- Country-Level Cost-Effectiveness Thresholds: Initial Estimates and the Need for Further Research.
- Extended cost-effectiveness analysis for health policy assessment: a tutorial.
- Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold.
- Performance-Based Risk-Sharing Arrangements—Good Practices for Design, Implementation, and Evaluation
- Systematic overview of cost-effectiveness thresholds in ten countries across four continents.
- The NICE cost-effectiveness threshold: what it is and what that means.
Contextualization: Interpreting or Adapting HTAs from Other Jurisdictions
- Challenges faced in transferring economic evaluations to middle income countries.
- EUnetHTA information management system: development and lessons learned.
- HTA Adaptation Toolkit (EUnetHTA)
- Transferability of Economic Evaluations Across Jurisdictions
- Variability of cost-effectiveness estimates for pharmaceuticals in Western Europe: lessons for inferring generalizability.
- What do international pharmacoeconomic guidelines say about economic data transferability?
Contextualization: Use of Budget Impact Analysis
IMPLEMENTATION
Implementation: Implementing HTA
- Health Systems Evidence (McMaster University)
- How can research organizations more effectively transfer research knowledge to decision makers?
- HTA Implementation Roadmap in Central and Eastern European Countries.
- Submission template for Pharmaceuticals and Submission template for Medical Devices (EUnetHTA)
- SUPPORT Tools for evidence informed health Policymaking (STP).
- Format for formulary submissions (AMCP)
- The Pharmaceutical Price Regulation Scheme. 02/07. London: Office of Fair Trading; 2007.
Implementation: Measuring HTA Impact
- Assessing the impact of health technology assessment.
- Assessing the impact of health technology assessment on the Austrian healthcare system.
- Influence Of Health Technology Assessment And Its Measurement.
- Models and applications for measuring the impact of health research: update of a systematic review for the Health Technology Assessment programme.
- Research impact: a narrative review.
- Returns on Research Funded Under the NIHR Health Technology Assessment (HTA) Programme: Economic Analysis and Case Studies.
- The impact of health technology assessment reports on decision making in Austria.
- The impact of HTA and procurement practices on the selection and prices of medical devices.
- The impact of HTA reports on health policy: a systematic review.
- What are the effects of HTA reports on the health system? Evidence from the research literature. In: Health technology assessment and health policy-making in Europe. 2008.