TY - JOUR

T1 - The Type and Impact of Evidence Review Group Exploratory Analyses in the NICE Single Technology Appraisal Process

AU - Carroll, Christopher

AU - Kaltenthaler, Eva

AU - Hill-McManus, Daniel

AU - Scope, Alison

AU - Holmes, Michael

AU - Rice, Stephen

AU - Rose, Micah

AU - Tappenden, Paul

AU - Woolacott, Nerys

PY - 2017/6

Y1 - 2017/6

N2 - Background As part of the UK National Institute for Health and Care Excellence (NICE) single technology appraisal process, independent evidence review groups (ERGs) critically appraise a company's submission relating to a specific technology and indication. Objectives To explore the type of additional exploratory analyses conducted by ERGs and their impact on the recommendations made by NICE. Methods The 100 most recently completed single technology appraisals with published guidance were selected for inclusion. A content analysis of relevant documents was undertaken to identify and extract relevant data, and narrative synthesis was used to rationalize and present these data. Results The types of exploratory analysis conducted in relation to companies’ models were fixing errors, addressing violations, addressing matters of judgment, and the provision of a new, ERG-preferred base case. Ninety-three of the 100 ERG reports contained at least one of these analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category “Matters of judgment,” which was reported in 83 reports (89%). At least one of the exploratory analyses conducted and reported by an ERG is mentioned in 97% of NICE appraisal consultation documents and 94% of NICE final appraisal determinations, and had a clear influence on recommendations in 72% of appraisal consultation documents and 47% of final appraisal determinations. Conclusions These results suggest that the additional analyses undertaken by ERGs in the appraisal of company submissions are highly influential in the policy-making and decision-making process.

AB - Background As part of the UK National Institute for Health and Care Excellence (NICE) single technology appraisal process, independent evidence review groups (ERGs) critically appraise a company's submission relating to a specific technology and indication. Objectives To explore the type of additional exploratory analyses conducted by ERGs and their impact on the recommendations made by NICE. Methods The 100 most recently completed single technology appraisals with published guidance were selected for inclusion. A content analysis of relevant documents was undertaken to identify and extract relevant data, and narrative synthesis was used to rationalize and present these data. Results The types of exploratory analysis conducted in relation to companies’ models were fixing errors, addressing violations, addressing matters of judgment, and the provision of a new, ERG-preferred base case. Ninety-three of the 100 ERG reports contained at least one of these analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category “Matters of judgment,” which was reported in 83 reports (89%). At least one of the exploratory analyses conducted and reported by an ERG is mentioned in 97% of NICE appraisal consultation documents and 94% of NICE final appraisal determinations, and had a clear influence on recommendations in 72% of appraisal consultation documents and 47% of final appraisal determinations. Conclusions These results suggest that the additional analyses undertaken by ERGs in the appraisal of company submissions are highly influential in the policy-making and decision-making process.

KW - National Institute for Health and Care Excellence

KW - evidence review groups (ERGs)

KW - health policy

KW - single technology appraisal (STA)

U2 - 10.1016/j.jval.2016.08.729

DO - 10.1016/j.jval.2016.08.729

M3 - Article

VL - 20

SP - 785

EP - 791

JO - Value in Health

JF - Value in Health

SN - 1098-3015

IS - 6

ER -