Principles of Design of Access with Evidence Development Approaches

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CONSENSUS STATEMENT

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Principles of Design of Access with Evidence Development Approaches A Consensus Statement from the Banff Summit Devidas Menon,1 Christopher J. McCabe,2 Tania Stafinski1 and Richard Edlin,2 on behalf of the signatories to the Consensus Statement 1 Department of Public Health Sciences, University of Alberta, Edmonton, Alberta, Canada 2 Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK

Healthcare payers are increasingly entering into innovative reimbursement agreements to manage the tension between funding new but expensive treatments, and obtaining value (measured in terms of clinical effectiveness, improved quality of care, health-related quality of life [HR-QOL], etc.) for money. These often commit substantial resources, and thus impose a significant opportunity cost on healthcare systems. Commentators and stakeholders are increasingly concerned that not all such approaches represent good value for money.[1,2] However, there is little if any literature providing guidance on their design or evaluation. These reimbursement mechanisms have been given many names, such as ‘risk sharing’, ‘coverage with evidence development’, ‘field evaluations’ and ‘health impact guarantees’. We used the umbrella term ‘access with evidence development’ approaches (AEDs) to ensure discussions focussed upon the substantial issues common to all of these rather than their differences. The purpose of the Banff Summit (Alberta, Canada; 22–23 February 2009) was to bring together experts from around the world with direct experience of designing and implementing approaches to access with the aim of identifying principles to inform their design. The programme consisted of a presentation of findings from a review of the published literature and, drawing on that literature, a proposed checklist to describe and potentially evaluate such schemes. Participants from the US, the UK, Australia and

Canadian provinces (British Columbia, Ontario and Alberta) gave presentations on their experience of AED approaches. Each talk was followed by an open discussion of the lessons that could be drawn from this experience. The final session considered whether it was possible to identify principles of good design in AED schemes. The Summit organizers were charged with producing a written statement of these principles for circulation to all participants. Each individual was then invited to sign up to the statement. We provide here the consensus statement from the summit. This is followed by the literature review[3] completed in preparation for the meeting, a paper that outlines the descriptive framework (which was developed for the Summit) and an evaluation of an AED model implemented in the UK NHS using this framework.[4] In addition, experts from the US and the UK write about the future development of AEDs in their respective healthcare systems and consider how adherence to the principles set out in the consensus statement would improve