A review of technology appraisal guidances and health technology assessment by the National Institute for Health and Clinical Excellence in the UK

Abstract

The National Institute for Health and Clinical Excellence （NICE）, established in the UK in 1999, marks its 10th anniversary this year. NICE, which publishes guidances on technology appraisals, has attracted widespread international attention for its evaluations of medications and interventions based on safety and efficacy information and cost-effectiveness. We surveyed the current climate of NICE and changes in its technology appraisal policies over the past 10 years using literature reviews and interviews with regulatory agencies and pharmaceutical companies in the UK. In addition, we analyzed 169 technology appraisal guidances published by NICE between 2000 and the end of March 2009 to examine changes in the organization’s decision making over time.
In this paper, we describe changes in NICE’s technology appraisal guidances over the past 10 years and discuss several controversies that have emerged from these guidances. NICE has used economic evaluations to determine whether a technology is recommended to the National Health Service （NHS）. However, as a result of the 2009 Pharmaceutical Price Regulation Scheme （PPRS）reform, NICE will soon begin to use such evaluations to adjust drug reimbursement prices as well. We demonstrate that economic evaluations have been more influential in recent NICE guidances. Although PPRS in the UK is based primarily on the free pricing system, it has been criticized for not reflecting the actual value of medications in drug prices （i.e., PPRS is not a “value-based” pricing system）. Economic evaluation is a method used to assess the relationship between the value of a medication and its price, and the UK is currently attempting to utilize economic evaluation to achieve the goal of “value-based pricing.” As of September 2009, the new drug pricing system in Japan is deliberated by the Central Social Insurance Medical Council to reflect the value of innovative medications. We believe that the application of health technology assessment, including economic evaluation, should be discussed more seriously in order to shift the drug pricing system in Japan to a more “valuebased” system.