Table 1.

phases of CED schemes

Assessing the desirability of a scheme

This initial phase relates to the way candidate technologies for CED schemes are identified and selected. It also concerns the criteria used to assess whether a scheme is a good policy option, compared with other available options such as, for example, fully adopting the technology despite the residual uncertainties; refusing to adopt the technology until better evidence becomes available; or negotiating/mandating a lower price for the technology.

Designing the scheme

This phase is about deciding on the specific features of the scheme design. These include, for example, the categories of patients who will have access to the technology during the scheme (e.g., Only in Research or Only With Research schemes), and the characteristics of the data collection plan, such as the study design (e.g., registry-based studies versus randomized controlled studies), the duration of the data collection, and the types of outcomes to be measured.

Implementing the scheme

Reflecting the previous design phase, this phase is about the different ways schemes are operated and how roles and responsibilities are distributed among the stakeholders involved (e.g., the national/regional HTA agencies, the manufacturers, or the providers collecting the data). Relevant aspects are, for example, who will initially design the study protocol, who will coordinate and/or perform the data collection, monitoring and analysis, and who will fund the provision of care and the extra costs of collecting the new evidence.

Evaluating the scheme

This phase relates to the types of decisions/policy updates that are made at the end of the scheme once the data collection is concluded and the new evidence has been assessed along with other evidence that has become available. It also concerns the way data collection is monitored during the scheme and the definition of any stopping rule or intermediate assessment of the evidence being collected