A Systematic Review of the Economic and Health-Related Quality of Life Impact of Advanced Therapies Used to Treat Moderate-to-Severe Ulcerative Colitis

IntroductionThe clinical benefits of advanced therapies (i.e., biologics and small-molecule drugs) in the treatment of moderate-to-severe ulcerative colitis (UC) have been demonstrated; however, there is less clarity regarding the economic and health-related quality of life (HRQoL) impact of these treatments. We conducted a systematic literature review to synthesize data on cost, healthcare resource utilization (HCRU), and HRQoL for patients who received approved advanced therapies for moderate-to-severe UC in the United States and Europe.MethodsDatabases including MEDLINE, Embase, the Database of Abstracts of Reviews of Effects (DARE), the National Health Service Economic Evaluation Database (NHS EED), and EconLit were searched systematically to identify observational studies published between January 1, 2010 and October 14, 2021 that assessed the impact of advanced therapies on cost, HCRU, and/or HRQoL in adults with moderate-to-severe UC. Supplementary gray literature searches of conference proceedings from the past 4 years (January 2018 to October 2021) were also performed.Results47 publications of 40 unique cost/HCRU studies and 13 publications of nine unique HRQoL studies were included. Findings demonstrated that biologics have a positive impact on indirect costs (i.e., productivity, presenteeism, and absenteeism) and HRQoL. High costs of biologics were not always fully offset by reductions in cost and HCRU associated with disease management. For many patients, treatment switching and dose escalations were required, thus increasing drug costs, particularly when switching across treatment classes.ConclusionThese findings highlight a high unmet need for therapies for moderate-to-severe UC that can reduce the healthcare burden and impact on society. Further research is warranted, as the reported evidence was limited by the small sample sizes of some treatment groups within a study. Plain Language SummaryAlthough advanced therapies, such as biologics and small-molecule drugs, have shown clinical benefit in treating moderate-to-severe ulcerative colitis, their economic impact and effect on patients' quality of life is less clear. This study comprehensively reviewed the cost and use of healthcare resources associated with starting treatment with advanced therapies for ulcerative colitis, as well as the impact of these treatments on quality of life. We found that while biologics have a benefit on work productivity, work attendance, work absence, and quality of life, the high costs of biologics were not always fully met by reductions in disease management costs and healthcare resources. Many patients needed to switch treatments or required dose increases, which were expensive. There is a high unmet need for therapies for moderate-to-severe ulcerative colitis that can reduce healthcare costs, use of healthcare resources, and effect on society.