Proposals for the Evolution of CED Policy
Before the role of CED can be fully determined and embraced there are a number of significant policy issues that will need to be resolved. The first step in resolving these issues is for decision makers to move beyond regarding CED as a set of discrete ad-hoc decisions and to commit themselves to seeing this as a policy worth developing in a systematic way. To a certain extent the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom and the Centers for Medicare and Medicaid Services (CMS) in the United States have already done this but these organizations are largely restricted to making recommendations that a drug should undergo CED without having the power to act on those recommendations. Specifically, they do not have the resources or the authority to dictate the terms of the studies that drugs should be subject to and they do not have the funds to commission CED projects.
Separating the ability to make recommendations without the means to implement them is a recipe for policy failure. Either organizations need to be given the necessary power or there needs to be formal collaboration established between them and those who do have the power, for example between NICE and the National Health Service in the UK. Once this step has been taken then there are other measures that can be considered.
As an example, one possibility is to build in a policy analysis component into new CED projects. Not only would the studies generate new information about the drug being examined but at the same time policy issues could be studied. For instance, if different CED projects adopted different data collection and management strategies these could be compared; interviews could be undertaken with pharmaceutical companies to see if CED altered their research and development priorities; part of process of recruiting patients could involve exploring the ethical issues with them; decision makers could also be queried about their rationale for undertaking particular CED projects. CED for pharmaceuticals offers a way to help ensure appropriate use of medications while at the same time helping to control costs, however at present it is only a policy in the early stages of development and whether it will mature is uncertain.
Special thanks to Dr. Joel Lexchin, Professor in the School of Health Policy and Management, York University, Toronto, Canada for writing this post.