OBJECTIVES: The impact of clinical trials on European agencies’ economic modeling of drugs is unclear. This research aims to evaluate that impact in the United Kingdom (National Institute of Health and Care Excellence [NICE] and Scottish Medicines Consortium [SMC]) and France (Haute Autorité de Santé - Commission Évaluation Économique et de Santé Publique [HAS-CEESP]).

METHODS: Clinical trial and economic modeling data were assessed by reviewing a decade (2009 to 2018) of HTAs. NICE, SMC, and HAS-CEESP HTAs (n=1,491) were chosen because their assessments include both clinical and economic analyses. A comparison between reimbursement decisions and matching clinical and economic evaluations was done. A chi-squared test was performed to identify any significant differences between matched clinical and economic evaluations, and reimbursement decisions.

RESULTS: NICE had the highest similarity rate, with 59.87% (n=319) of their clinical trial data also being mentioned in their economic modeling data; they were followed by HAS-CEESP (46.43% [n=13]), then SMC (24.67% [n=205]). In most of the cases where the evidence was not the same, there was no clear study listed in either the clinical or economic evaluation (NICE, 58% [n=314] and SMC, 53% [n=625]). NICE had more positive decisions (234/436) when the clinical and economic studies matched and more negative decisions (112/197) when they did not match. SMC had more positive (375/540) and negative decisions (250/290) when the studies did not match. HAS-CEESP supports the clinical evaluations but does not make final decisions. This difference was statistically significant (p=1.32 x 10^-8).

CONCLUSIONS: The dissimilarity between clinical and economic evaluations may be partially explained by a lack of clarity in reporting; however, the remaining dissimilarities are an important factor in considering future evaluations. Since this difference in study use is associated with a difference in decisions, the underlying reasons should be explored in future research.