THE UK NICE SINGLE TECHNOLOGY APPRAISAL PROCESS- A QUALITATIVE STUDY BASED ON MANUFACTURERS' SUBMISSIONS

Author(s)

Kaltenthaler EUniversity of Sheffield, Sheffield, United Kingdom

OBJECTIVES: International health technology assessment is increasingly interested in the rapid review of technologies.  In the UK NICE  Single Technology Appraisal (STA) process, manufacturers present the clinical and cost effectiveness of new technologies in their evidence submissions.  These submissions are critically appraised by Evidence Review Groups (ERGs) who produce a report which forms part of the evidence considered by the Appraisal Committees.  Early on in the process the ERG requests more information from the manufacturer via a clarification letter.  The purpose of this research was to analyse ERG reports and clarification letters in order to develop guidance for manufacturers based on common problems or issues identified in manufacturer submissions (MS). METHODS: A thematic analysis of the first 30 completed ERG reports was undertaken using a framework approach.  Twenty one of the available associated clarification letters were analysed using a set of open codes to analyse data.  Both sources of evidence were used to identify common issues and concerns. RESULTS: Inadequate reporting of processes was identified in 90% of reports; criticisms of data used, especially in the model was mentioned for 67% of the reports and issues with the conduct of the systematic review in 57%.  The population and comparator represented the key items in the decision problem assessed by the ERGs as being inadequately addressed by manufacturers.  The majority of clarification points related to the economic data analysis.  Issues identified included clarification of data sources and selection, queries about modelling decisions and requests for additional analyses.  Internal inconsistencies between the clinical and economic sections of the MS and inconsistencies within the economic section of the MS were also identified as particular problems.  This analysis was used as the basis for the development of 12 recommendations for manufacturers. CONCLUSIONS: These recommendations may help to improve the quality of manufacturers’ submissions.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

NI1

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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