PRIORITISING PRE-SUBMISSION INVESTMENT: ASSOCIATIONS BETWEEN HEALTH ECONOMIC MODEL CHARACTERISTICS AND NICE TA CRITIQUE BURDEN AND RECOMMENDATION OUTCOMES

Author(s)

Gareth Wynne-McHardy, MBChB, Amanda Hansson Hedblom, MSc, Anna Louise McCormick, DPhil, Gerdi Strydom, MBA, PharmD.
Valid Insight, Macclesfield, United Kingdom.
OBJECTIVES: To quantify associations between appraisal structural characteristics and the presence, direction, and decision-relevance of explicitly documented methodological critique in NICE technology appraisals.
METHODS: All publicly available NICE technology appraisal committee papers published between 01/01/2025 and 31/12/2025 were reviewed using a structured AI-assisted extraction protocol. For each paper, metadata and ten pre-specified binary critique domains were extracted. This yielded 114 appraisals. The primary analysis was restricted to first submissions (n=46) to preserve independence. Domains demonstrating near-universal results was excluded, and a Core Issues Score (sum of remaining domains) was used as the primary continuous outcome. Associations were assessed using χ²/Fisher’s tests with bias-corrected Cramér’s V and Mann-Whitney/Kruskal-Wallis tests with effect sizes. Odds ratios were estimated for each critique domain versus recommendation outcome to assess directionality. False discovery rate correction and minimum effect-size thresholds were applied. A supplementary analysis evaluated whether model-type composition influenced observed associations.
RESULTS: Eighteen significant associations (q<0.05, effect ≥ threshold) were identified and directionally replicated in the full dataset. Appraisal type and model type were co-determined (V=0.545). Issues in comparative treatment effect estimation across studies showed the strongest associations with overall critique burden (rank-biserial r=0.956 and 0.763) and were associated with reduced odds of recommendation. While utility and model structure critique were strongly associated with recommendation outcomes in univariable analyses (V=0.663-0.688), supplementary analyses demonstrated that these effects were largely driven by cost-comparison models, which exhibited higher recommendation rates and fewer recorded utility and structural issues due to model simplicity.
CONCLUSIONS: Methodological critique in NICE appraisals in 2025 is systematically structured and reflects both underlying model complexity and appraisal context. Evidence synthesis complexity, particularly indirect comparisons (ITCs), is a key driver of critique burden and reduced recommendation likelihood. These findings identify ITC and evidence synthesis quality as the highest-priority targets for pre-submission investment.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

HTA55

Topic

Economic Evaluation, Health Technology Assessment, Methodological & Statistical Research

Topic Subcategory

Decision & Deliberative Processes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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