국내 신의료기술평가 현황과 평가 결과에 연관성을 보이는 요인 연구 국내 신보건의료기술평가 현황 및 평가결과에 영향을 미치는 요인에 관한 조사

Abstract

Background: This study aims to evaluate factors influencing assessment results in the new Health Technology Assessment (nHTA) in Korea. Methods: We analyzed publicly available nHTA reports obtained from the program’s website. A total of 258 reports, encompassing 305 technologies, were included. Reported details were categorized into three main areas: technical characteristics, evaluation methods, and publication types. To investigate differences in evidence level (high, medium, or low) and assessment results (pass or fail) according to these categories, we employed a chi-squared test. Univariate and multivariate logistic regression analyses were further conducted to identify factors associated with evidence level and assessment results. Results: nHTA reports employing meta-analysis and included randomized trials for evidence synthesis exhibited a higher likelihood of achieving high evidence level (odds ratio [OR], 5.008; 95% confidence interval [CI], 1.265- 18.826 and OR, 27.052; 95% CI, 7.802-103.330, respectively). Increasing evidence level was significantly associated with a higher possibility of passing the assessment (OR 2.789; 95% CI, 1.284-6.057). However, in univariate analysis, neither performing meta-analysis nor including randomized trials, both of which were associated with evidence level, demonstrated a statistically significant association with assessment results. Conclusion: This study represents the first systematic analysis of factors influencing nHTA assessment results in Korea. While increased evidence level was associated with positive assessment outcomes, factors affecting the evidence level itself did not directly influence assessment results. This suggests the need for further efforts to effectively integrate high-level evidence into assessment decisions within the nHTA program.