Table 1 Specification of constructs and measurement models for SEM of coverage decision-making

Participation

Different stakeholder groups are involved at various stages of decision processes to ensure that their interests are not neglected [34, 35, 54, 55].

Number of different types of participating stakeholders (i.e. service provider(s), payer, government, patients/patient representative(s), industry)

Degree of participation reflected by number of types of stakeholders involved in the decision process. High diversity of stakeholders increases the possibility that particular interests of single stakeholders are balanced out.

Degree of stakeholder involvement (i.e. information provision, appeal, voting, one indicator per type of involvement)

Number of stakeholders involved at stages in decision process. More involvement opportunities result in stronger participation.

Transparency

Processes are considered transparent if relevant information is provided so that decisions can be retraced [36, 56]. More transparency improves the extent to which a decision can be controlled. Transparency is reflected by the degree of detail in the documentation of processes and decision outcomes [33, 56].

Amount of information published during or after decision process

Degree of transparency reflected by the amount of documents published for each decision.

Type of information provided

Degree of transparency reflected by the diversity of published information provided – i.e. whether it relates to the process or decision outcome or both.

Scientific rigour of assessment

Scientific rigour is defined by the methodological standards for generating evidence. The assessment of effectiveness may range from collecting expert opinions to quantitative meta-analyses of studies. Assessment of costs may go from rough estimates to comprehensive cost-effectiveness or budget impact analyses. Rigorous assessments are prerequisites to reasonable decisions that are evidence based and accepted by informed people [36, 56].

Scientific rigour in assessment of effectiveness

The degree of scientific rigour is positively reflected by the degree of methodological standards used for the assessment of effectiveness.

Scientific rigour in assessment of costs/cost-effectiveness

The degree of scientific rigour is positively reflected by the degree of methodological standards used for the assessment of costs/cost-effectiveness.

Reasonableness

Reasonableness is defined as the extent to which typically accepted criteria are considered in technology appraisal [1, 18, 32]. The higher their relevance and the number of criteria considered, the stronger the degree of reasonableness is reflected.

Relevance of criteria that contribute to reasonable appraisal (i.e. clinical (effectiveness: health benefit; effectiveness: other benefit (e.g. knowledge of diagnostic test result)), economic (cost-effectiveness, budget impact) and other ethical criteria (severity of the disease, equitable access to care), one indicator per criterion)

The higher the relevance of clinical, economic or other ethical criteria, the higher the degree of reasonableness of the decision.