Barbara E. Lewis

The economic burden of treatment failure amongst patients with irritable bowel syndrome with constipation or chronic constipation: a retrospective analysis of a Medicaid population

Abstract Objective: To compare healthcare resource utilization (HRU) and costs between patients with irritable bowel syndrome with constipation (IBS-C) or chronic constipation (CC) with and without evidence of treatment failure. Methods: Claims data from the Missouri Medicaid program were used to identify adults with IBS-C or CC treated for constipation. IBS-C patients were required to have ≥2 constipation therapy claims, and the index date was defined as the date of the first constipation therapy claim within 12 months after an IBS diagnosis. For CC, the index date was defined as the date of the first constipation treatment claim followed by a second claim for constipation treatment or diagnosis between 60 days and 12 months later. Indicators of treatment failure were: switch/addition of constipation therapy, IBS- or constipation-related inpatient/emergency admission, megacolon/fecal impaction, constipation-related surgery/procedure, or aggressive prescription treatments. Annual incremental HRU and costs (public payer perspective) were compared between patients with and without treatment failure. Incidence rate ratios (IRRs) and cost differences are reported. Results: In total, 2830 patients with IBS-C and 8745 with CC were selected. Approximately 50% of patients had ≥1 indicator of treatment failure. After adjusting for confounding factors, patients with treatment failure experienced higher HRU, particularly in inpatient days (IRR = 1.75 for IBS-C; IRR = 1.54 for CC) and higher total healthcare costs of

Measuring the Symptoms of Pediatric Constipation and Irritable Bowel Syndrome with Constipation: Expert Commentary and Literature Review

4353 in IBS-C patients and

A Systematic Review of the Economic and Humanistic Burden of Illness in Irritable Bowel Syndrome and Chronic Constipation

2978 in CC patients. Medical service costs were the primary driver of the incremental costs associated with treatment failure, making up 71.3% and 67.0% of the total incremental healthcare costs of the IBS-C and CC samples, respectively. Limitations: Sample was limited to Medicaid patients in Missouri. Claims data were used to infer treatment failure. Conclusion: Treatment failure is frequent among IBS-C and CC patients, and sub-optimal treatment response with available IBS-C and CC therapies may lead to substantial HRU and healthcare costs.

Effect of Linaclotide on Quality of Life in Adults With Irritable Bowel Syndrome With Constipation: Pooled Results From Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials

BackgroundSymptom measurement in pediatric chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) trials requires appropriately developed clinical outcome assessments (COAs).MethodsLiterature was reviewed to identify symptom COAs meeting regulatory standards. Searches were conducted in Pubmed/Medline, EMBASE, and PsychINFO. Title/abstracts were reviewed to identify qualitative studies and those using COAs to measure pediatric CIC/IBS symptoms. Pediatric functional gastrointestinal experts provided input on relevant symptom-concepts to measure.ResultsReview of 1,105 abstracts identified 1 relevant qualitative article and 113 articles including COAs. Symptoms most frequently measured in CIC studies were frequency of bowel movements, fecal incontinence/encopresis, abdominal pain, stool consistency, and painful defecation. Symptoms most frequently measured in IBS were abdominal pain, abdominal distention/bloating, stool consistency, frequency of bowel movements, and gas. Evidence of development/validity of COAs was limited. Expert feedback was broadly consistent with the literature.ConclusionFindings demonstrate consistency in the literature on key CIC/IBS symptoms to measure in pediatric trials, but existing COAs do not meet regulatory standards.