title: A common policy framework for evidence generation on promising health technologies.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: French National Authority for Health, Saint-Denis La Plaine CEDEX, F-93218, France. c.carbonneil@has-sante.fr
authors.forename: Cédric
authors.initials: C
authors.lastname: Carbonneil
authors.forename: Fabienne
authors.initials: F
authors.lastname: Quentin
authors.forename: Sun Hae
authors.initials: SH
authors.lastname: Lee-Robin
mesh_terms: D001315:Australia; D020811:Biomedical Technology; D003657:Decision Making; D005060:Europe; D019317:Evidence-Based Medicine / Q000458:organization & administration*; D009864:Ontario; D011050:Policy Making; D014481:United States