A common policy framework for evidence generation on promising health technologies.

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.