Study title

Qualitative methods using a combination of non participatory observation,informal interviews and documentary analysis. The study set out to explore and describe the various aspects of uncertainty faced by the NICE appraisal committee, the social mechanisms applied for coping with these and the influence of these processes on the outcomes of decisions. These aims were explored through an ethnographic study that was based on primary data collected using a prospective design to follow three distinctly different pharmaceutical products through the single technology appraisal process (STA) involving three different NICE technological appraisal committees This involved documentary analysis, observation of the open and closed sessions of the committee (9 observational sessions) and interviews (N=41) with committee members = 23, analysts from the NICE project teams =3, drug manufacturers representatives = 5, patient organisations =3, members of the assessment group = 4 and clinical experts = 3. Telephone interviews (N=26) were used in tandem with face-to-face interviews (N=15).These data were collected between 2012-2014.The National Institute for Health and Clinical Excellence is emblematic of the 'neutral' and 'objective' approach of modern regulatory institutions. Through systematic appraisals of the cost-effectiveness of drugs for the NHS, it aims to overcome the inconsistencies of the previously discretionary decisions of medical professionals. Cost-effectiveness recommendations ensure a more standardised access to medication across the NHS, as well as regulating the imperfections of the market in terms of over-priced medication. These regulatory roles have important ethical implications for access and resource use, yet the neutrality and objectivity referred to is not straightforward. The volume, contestability and complexity of information which is processed within these appraisals means that a number of decision mechanisms for coping with uncertainty are...