Abstract
Abstract NICE was set up in 1999 and publishes guidance to the NHS in England and Wales. Although not specifically set up as a fourth hurdle in the drug and device approval process, NICE is centrally involved in informing reimbursement decisions for new and costly drugs including those in oncology. NICE has successfully addressed so called postcode prescribing variations, but has been challenged by the number and cost of new drug applications particularly in oncology. Since July 2016 the Cancer Drugs Fund has acted to provide short term access to promising drugs which have not achieved sufficient evidence to support their use although there is a reasonable prospect of this being achieved in the future. In this presentation I will describe the history and development of NICE and provide a synthesis of how it operates. The interplay between the regulators and NICE is particularly relevant, and the roles that both have adopted will be discussed. I will address the strengths and limitations of the current structure of the organisation, and consider what future changes may be appropriate. I will illustrate the talk with a range of relevant examples drawn from the literature and personal experience.
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