OBJECTIVES: This study evaluates the correlation between clinical outcomes and reimbursement decisions across health technology assessment (HTA) agencies in Ulcerative Colitis.

METHODS: HTA reports from July 2012 to August 2020 were collected. HTA reports from G-BA, IQWiG (Germany), HAS (France), HIRA (South Korea), NICE (United Kingdom), PBAC (Australia), CADTH, INESSS (Canada), and TLV (Sweden) were reviewed for six drugs, i.e., adalimumab, golimumab, infliximab, tofacitinib, ustekinumab, and vedolizumab, approved for treatment of Ulcerative Colitis. Abbreviated submissions, non-submissions, reviews without details, reviews of biosimilars, and reviews without a decision were excluded. Relevant data regarding the role of clinical outcomes were then gathered. A chi-squared test was performed to measure significance.

RESULTS: A total of 94 reviews with 459 outcomes were assessed in the final sample, of which 85% of decisions were positive. Results from the chi-squared test showed that the two key clinical outcomes, response and remission, have a significant correlation with HTA decisions (p = 0.02 and 0.0004, respectively). Seventy-three percent (51/70) of response outcomes and 79% (81/102) of remission outcomes had clinically significant differences, while 51% (19 of 37) of response outcomes and 49% (17/35) of remission outcomes with clinically non-significant differences were reported for the positive decisions. The clinical outcomes for efficacy, healing, and quality of life showed no significant correlation with the HTA decisions (p = 0.72, 0.36, and 0.69, respectively). The reimbursement decisions were recommended for the HTAs with stool frequency and rectal bleeding outcomes.

CONCLUSIONS: From this study, it was observed that the key clinical outcomes (response and remission) are significantly correlated with a positive recommendation for the intervention. Further studies are needed to better understand this relationship.