Objectives: The aim of this study was to assess incidence, time frame, and outcome of “Coverage with Evidence Development” (CED) decisions in the Swiss Basic Health Insurance scheme.

Methods: Analysis of all controversial medical technologies submitted to review by the Swiss Federal Office of Public Health (FOPH) from 1996 to 2012 with focus on decisions with constraints. Description of types of technology, type of initial decision, duration of evaluation period, final decision, and search for potential factors associated with changes over time.

Results: Forty-five (37.5 percent) of 120 controversial health technologies were classified as “yes, in evaluation, reimbursed” for a certain period of time and thirty-five (29.2 percent) as “no, in evaluation, not reimbursed” by the Federal Department of Home Affairs from 1996 to 2012. The rate of CED decisions ranged between zero and nine per year and was influenced by type of technology and calendar year. Forty-four of forty-five decisions were subject to further restrictions, to a “center or a specialist” (76 percent), “indications” (49 percent), “registry” (31 percent), or “other” (49 percent). The time to a final decision ranged from 1.5 to 11 years (median, 6 years). No factors associated with initial decision and final outcome could be identified.

Conclusions: CED as a reality in Switzerland might have enabled patients to obtain access to promising technologies early in their life cycle. CED might have acted as a trigger to a successful implementation of a comprehensive national registry. The lack of qualitative data stresses the urgent need for evaluation of the HTA decisions and their impact on patient outcome and costs.

Background: Generation of additional evidence may be necessary to access new promising technologies (marketing approval or coverage). Access with evidence generation (AEG) is a more recent concept with regard to coverage than to marketing approval.

Objectives: One aim of Work Package 7 (WP7) Strand A of the European network for Health Technology Assessment (EUnetHTA) was to provide an overview of national AEG mechanisms associated with marketing approvals and funding or coverage decisions.

Methods: A systematic literature review, surveys of WP7 Partners, and consultation of key people were used to obtain information on the AEG mechanisms used by twenty-three countries (twenty European countries, United States, Canada [Ontario], and Australia).

Results: Interest in the implementation of AEG policies, particularly at the coverage decision stage, is growing. An overview of national experiences was used to draw up a generally applicable five-step policy framework for AEG mechanisms that comprised (i) a first assessment identifying knowledge gaps; (ii) a decision conditional to evidence generation; (iii) generation of the evidence requested; (iv) re-assessment integrating the new evidence; (v) a revised decision. The critical factors for success that were identified were coordination, methodological guidance, funding, and a regulatory framework. Countries were categorized on the basis of current implementation of the proposed policy framework.

Conclusions: International collaboration is necessary to gather a critical mass of high-quality data quickly and to ensure timely access to new promising technologies. The overview produced by WP7A has led to development of tools to facilitate collaboration on evidence generation.