Presently, linaclotide is the only EMA-approved therapy indicated for the treatment of irritable bowel syndrome with constipation (IBS-C). This study sought to determine the cost-effectiveness of linaclotide compared to antidepressants for the treatment of adults with moderate to severe IBS-C who have previously received antispasmodics and/or laxatives. A Markov model was created to estimate costs and QALYs over a 5-year time horizon from the perspective of NHS Scotland. Health states were based on treatment satisfaction (satisfied, moderately satisfied, not satisfied) and mortality. Transition probabilities were based on satisfaction data from the linaclotide pivotal studies and Scottish general all-cause mortality statistics. Treatment costs were calculated from the British National Formulary. NHS resource use and disease-related costs for each health state were estimated from Scottish clinician interviews in combination with NHS Reference costs. Quality of life was based on EQ-5D data collected from the pivotal studies. Costs and QALYs were discounted at 3.5 % per annum. Uncertainty was explored through extensive deterministic and probabilistic sensitivity analyses. Over a 5-year time horizon, the additional costs and QALYs generated with linaclotide were £659 and 0.089, resulting in an incremental cost-effectiveness ratio of £7370 per QALY versus antidepressants. Based on the probabilistic sensitivity analysis, the likelihood that linaclotide was cost-effective at a willingness to pay of £20,000 per QALY was 73 %. Linaclotide can be a cost-effective treatment for adults with moderate-to-severe IBS-C who have previously received antispasmodics and/or laxatives in Scotland.
Keywords: Constipation; Cost-effectiveness analysis; Irritable bowel syndrome; Linaclotide.