Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR)

Abstract

Hunter (2020) Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real

Evaluating the Impact of Cost on the Treatment Algorithm for Chronic Idiopathic Constipation: Cost-Effectiveness Analysis

“…In addition, identifying patient subgroups in future studies in whom prescription drug therapy results in decreased healthcare utilization would also affect insurer treatment preferences, noting growing evidence of an association between treatment response and healthcare utilization in CIC (47). Our model suggests that insurers would have increasing preference toward drug therapy among subgroups of patients with greater healthcare utilization such as those typically referred to gastroenterology, contingent on the assumption that effective disease management (regardless of treatment specifics) might actually reduce healthcare utilization (7,34). We also found that clinicians should guide the choice between prucalopride and linaclotide and that an algorithmic approach to insurance coverage determinations is suboptimal, given variation in treatment preferences in sensitivity analysis.…”

“…We tested an assumption that effective treatment of any kind (including OTC laxatives and not specific to prescription drugs) might result in fewer diagnostic tests, procedures, and healthcare visits, specifically to evaluate whether drug prices could even be supported on this basis (34,38,39). All costs were inflation adjusted to November 2020 using the US Bureau of Labor Statistics Consumer Price Index for healthcare and rounded to the nearest whole US dollar (40).…”

“…Average wholesale drug prices at retail pharmacies were derived from the US Centers for Medicare and Medicaid Services' National Average Drug Acquisition Cost index (34). CIC-associated healthcare costs from both patient and insurer perspectives were extracted from the “Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform,” a recent nationwide, prospective observational cohort study of insured patients with CIC, containing patient-reported outcomes data link to medical and pharmacy claims information with comparable demographics with our base-case and clinical trial populations with CIC (34). CIC-related direct healthcare costs (from an insurer perspective) and co-pays/out-of-pocket healthcare costs, work productivity/wage losses because of CIC, and childcare/transportation costs to attend healthcare appointments (from a patient perspective) accumulated when treatment was not efficacious or when patients were not receiving prescription drug therapy (34–37).…”

Recognizing and Defining Occasional Constipation: Expert Consensus Recommendations

“…Focusing on stool frequency fails to recognize that most constipated individuals are bothered not by infrequent bowel movements but by symptoms suggestive of defecation difficulties, e.g. straining, need for manual maneuvers, passage of hard stools, and/or a sense of incomplete evacuation (4)(5)(6)(7)(8)(9). Thus, the subjective perception/ experience of what constitutes a normal bowel habit varies widely.…”

Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials

“…Owing to its heterogeneous pathogenesis, there is no single effective therapy for IBS, and patients with similar symptoms can respond differently to the same treatment (7). Patients are likely to suffer from chronic symptoms; many patients have complex treatment histories spanning many years and have tried multiple different interventions (8).…”