Table 1 EVIDEM and EUnetHTA criteria correspondence
EVIDEM CRITERIA | EUnetHTA CRITERIA | |
|---|---|---|
NON-CONTEXTUAL CRITERIA | ||
Disease severity | • Effect of disease on life-expectancy • Effect of disease on morbidity (includes disability and function) • Effect of disease on patients’ quality of life • Effect of disease on caregivers’ quality of life | Methodology requirements for the clinical assessment compared to the HTA Core Model for REA - SEVERITY DEFINITION |
A description of the health problem and current use of technology are included in assessments | ||
Size of affected population | • Prevalence • Incidence | Methodology requirements for the clinical assessment compared to the HTA Core Model for REA - POPULATION |
A description of the health problem and current use of technology are included in assessments | ||
Unmet needs | • Unmet needs in efficacy • Unmet needs in safety • Unmet needs in patient reported outcomes • Patient demand | A description of the health problem and current use of technology are included in assessments |
Systematic search strategies applied to evidences (HEALTH PROBLEM - CURRENT TECHNOLOGY USE) | ||
Comparative effectiveness | • Magnitude of health gain • Percentage of the target population expected to achieve the anticipated health gain • Onset and duration of health gain • Sub-criteria for the measure of efficacy specific to the therapeutic area | The comparator is supported by evidence on its efficacy profile for the respective clinical indication/population |
Assessments analyze clinical effectiveness / efficacy (added therapeutic value) | ||
Systematic search strategies applied to evidences (EFFICACY-EFFECTIVENESS) | ||
Comparative safety/tolerability | • Adverse events • Serious adverse events • Fatal adverse events • Short-term safety • Long-term safety • Tolerability | The comparator is supported by evidence on its safety profile for the respective clinical indication/population |
Assessments analyze safety | ||
Systematic search strategies applied to evidences (SAFETY) | ||
Comparative patient-perceived health | • Improvement in health-related quality of life • Impact on autonomy • Impact on dignity • Convenience / ease of use / mode & setting of administration | QALYs applied |
Assessments analyze patient aspects | ||
Assessments include a separate ethical analysis | ||
Systematic search strategies applied to evidences (PATIENT ASPECTS) | ||
Type of preventive benefit | • Eradication, prevention, reduction in disease transmission, reduction in the prevalence of risk factors). Public health perspective. | Not available |
Type of therapeutic benefit | • Symptom relief, prolonging life, cure | Assessments include a description of the health problem and current use of technology |
Comparative cost consequences – cost of intervention | • Net cost of intervention • Acquisition cost • Implementation/ maintenance cost | Assessments analyze cost, budget impact or include economic evaluation |
Comparative cost consequences – other medical costs | • Impact on primary care expenditures • Impact on hospital care expenditures • Impact on long-term care expenditures | Assessments analyze cost, budget impact or include economic evaluation |
Comparative cost consequences – non-medical costs | • Impact on productivity • Financial impact on patients • Financial impact on caregivers • Costs to the wider social care system | Assessments analyze social aspects |
Quality of evidence | • Validity (study design, agreement among studies) • Relevance (population, disease stage, outcomes) • Completeness of reporting (uncertainty, conflicting results across studies, limited number of studies) • Type of evidence | Sources of evidence included as relevant clinical evidence for the clinical assessment (1- randomized controlled; 2- Nonrandomized prospective; 3- Other observational; 4- Expert Opinion). |
Methodology requirements for the clinical assessment compared to the HTA Core Model for REA | ||
Formal tools or algorithms for evidence grading applied | ||
The GRADE approach in routine use | ||
Plan for how evidence will be synthesized (e.g. evidence tables, meta-analysis, qualitative synthesis) | ||
Tables and forms are standardized for evidence synthesis and analysis | ||
Evidence analysis include surrogate endpoints, composite endpoints, PROs, HRQoL measures, indirect comparisons, meta-analysis, relevant group sub-population, key deficiencies in available data, transferability issues, summary of findings | ||
Sources of evidence on the technology: A. scientific journal publications, B. grey literature (e.g. published reports), C. unpublished data, D. register data, E. administrative data, F. manufacturer data | ||
Confidential data from manufacturers accepted | ||
Expert consensus/clinical practice guidelines | Current consensus of experts on what constitutes state-of-the-art practices (guidelines | Not available |
CONTEXTUAL CRITERIA | ||
Mandate and scope of the healthcare system | Alignment with healthcare plans/systems | Circumstances where HTA reports are provided |
Population priorities and access | • Current priorities of health system (e.g. low socioeconomic status; specific age groups) • Special populations (e.g. ethnicity) • Remote communities • Rare diseases • Specific therapeutic areas | Assessments analyze social aspects |
Common goal and specific interests | • Stakeholder pressures • Stakeholders barriers • Conflict of interest | Assessments analyze social aspects |
Environmental impact | • Environmental impact of production • Environmental impact of use • Environmental impact of implementation • Environmental impact of production • Environmental impact of use • Environmental impact of implementation | Not available |
System capacity and appropriate use of intervention | • Organizational requirements (e.g., process, premises, equipment) • Skill requirements • Legislative requirements • Surveillance requirements • Risk of inappropriate use • Institutional limitations to uptake | Assessments include a separate ethical analysis |
Assessments analyze legal aspects | ||
Assessments analyze organizational aspects | ||
Political/historical/cultural context | • Political priorities and context • Cultural acceptability • Precedence (congruence with previous and future decisions) • Impact on innovation & research • Impact on partnership & collaboration among healthcare stakeholders | Assessments include a separate ethical analysis |