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Access with Evidence Development

The US Experience

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Abstract

The concept of access with evidence development (AED), also known as ‘coverage with evidence development’ in the Medicare programme, has long been discussed as a policy option for ensuring more appropriate use of new technologies in the US. This article provides a comprehensive overview of more than 10 years of US experience with AED, both in the public and private healthcare sectors. Beginning with a discussion of the successes of private plans conditional coverage for high-density chemotherapy for autologous bone marrow transplants for metastatic breast cancer and Medicare’s conditional coverage of lung-volume-reduction surgery in the 1990s, the article moves on to describe how Medicare worked to codify AED as one of its coverage policy options in the early part of this decade. More recent private and public sector initiatives are also discussed, including an overview of barriers to implementing AED. Despite the complexity of political, financial and ethical issues faced in implementation, AED is now a permanent fixture of US coverage policy. Future initiatives within the Medicare programme and with private payers in the US are much more likely to succeed by relying upon the simple but consequential principles laid out at a Summit convened in Banff, Alberta, Canada in 2009 and presented in another article in this issue.

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Acknowledgements

No sources of funding were used to assist in the preparation of this article.

Penny Mohr and Sean Tunis have received grant support for policy development concerning coverage with evidence development. Dr Tunis also helped implement the CED programme in the US Medicare system. The authors have no other conflicts of interest that are directly relevant to the content of this article.

The authors thank Linda Bergthold, Wade Aubry and Seema Sonnad for their helpful comments on an earlier draft of this manuscript. All remaining errors or omissions are solely the responsibility of the authors.

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Authors and Affiliations

  1. Center for Medical Technology Policy, 401 East Pratt Street, Suite 831, Baltimore, Maryland, 21202, USA

    Penny E. Mohr (Vice President) & Sean R. Tunis

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  1. Penny E. Mohr
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  2. Sean R. Tunis
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Correspondence to Penny E. Mohr.

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Mohr, P.E., Tunis, S.R. Access with Evidence Development. Pharmacoeconomics 28, 153–162 (2010). https://doi.org/10.2165/11531050-000000000-00000

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