The use of exploratory analyses within the National Institute for Health and Care Excellence single technology appraisal process: an evaluation and qualitative analysis
- 1 April 2016
- journal article
- research article
- Published by National Institute for Health and Care Research in Health Technology Assessment
- Vol. 20 (26), 1-48
- https://doi.org/10.3310/hta20260
Abstract
Background: As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal (STA) process, independent Evidence Review Groups (ERGs) critically appraise the company submission. During the critical appraisal process the ERG may undertake analyses to explore uncertainties around the company's model and their implications for decision-making. The ERG reports are a central component of the evidence considered by the NICE Technology Appraisal Committees (ACs) in their deliberations. Objective: The aim of this research was to develop an understanding of the number and type of exploratory analyses undertaken by the ERGs within the STA process and to understand how these analyses are used by the NICE ACs in their decision-making. Methods: The 100 most recently completed STAs with published guidance were selected for inclusion in the analysis. The documents considered were ERG reports, clarification letters, the first appraisal consultation document and the final appraisal determination. Over 400 documents were assessed in this study. The categories of types of exploratory analyses included fixing errors, fixing violations, addressing matters of judgement and the ERG-preferred base case. A content analysis of documents (documentary analysis) was undertaken to identify and extract relevant data, and narrative synthesis was then used to rationalise and present these data. Results: The level and type of detail in ERG reports and clarification letters varied considerably. The vast majority (93%) of ERG reports reported one or more exploratory analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category 'matters of judgement', which was reported in 83 (89%) reports. The category 'ERG base-case/preferred analysis' was reported in 45 (48%) reports, the category 'fixing errors' was reported in 33 (35%) reports and the category 'fixing violations' was reported in 17 (18%) reports. The exploratory analyses performed were the result of issues raised by an ERG in its critique of the submitted economic evidence. These analyses had more influence on recommendations earlier in the STA process than later on in the process. Limitations: The descriptions of analyses undertaken were often highly specific to a particular STA and could be inconsistent across ERG reports and thus difficult to interpret. Conclusions: Evidence Review Groups frequently conduct exploratory analyses to test or improve the economic evaluations submitted by companies as part of the STA process. ERG exploratory analyses often have an influence on the recommendations produced by the ACs. Future work: More in-depth analysis is needed to understand how ERGs make decisions regarding which exploratory analyses should be undertaken. More research is also needed to fully understand which types of exploratory analyses are most useful to ACs in their decision-making.Keywords
Funding Information
- Health Technology Assessment Programme (14/151/04)
This publication has 13 references indexed in Scilit:
- ASSESSING SEARCHES IN NICE SINGLE TECHNOLOGY APPRAISALS: PRACTICE AND CHECKLISTInternational Journal of Technology Assessment in Health Care, 2013
- How long has NICE taken to produce Technology Appraisal guidance? A retrospective study to estimate predictors of time to guidanceBMJ Open, 2013
- When Does NICE Recommend the Use of Health Technologies Within a Programme of Evidence Development?PharmacoEconomics, 2013
- NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines ConsortiumBMJ Open, 2012
- A qualitative study of manufacturers' submissions to the UK NICE single technology appraisal processBMJ Open, 2011
- The National Institute for Health and Clinical Excellence Single Technology Appraisal Process: Lessons from the First 4 YearsValue in Health, 2011
- A thematic analysis of the strengths and weaknesses of manufacturers’ submissions to the NICE Single Technology Assessment (STA) processHealth Policy, 2011
- Evidence review group approaches to the critical appraisal of manufacturer submissions for the NICE STA process: a mapping study and thematic analysisHealth Technology Assessment, 2011
- Comparing methods for full versus single technology appraisal: A case study of docetaxel and paclitaxel for early breast cancerHealth Policy, 2008
- Single Technology Appraisals by NICEPharmacoEconomics, 2008