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

Abstract

INTRODUCTION: Chronic idiopathic constipation (CIC) is a common and burdensome illness. We performed a cost-effectiveness analysis of the US Food and Drug Administration–approved CIC drugs to evaluate and quantify treatment preferences compared with usual care from insurer and patient perspectives. METHODS: We evaluated the subset of patients with CIC and documented failure of over-the-counter (OTC) osmotic or bulk-forming laxatives. A RAND/UCLA consensus panel of 8 neurogastroenterologists informed model design. Treatment outcomes and costs were defined using integrated analyses of registered clinical trials and the US Centers for Medicare and Medicaid Services–supported cost databases. Quality-adjusted life years (QALYs) were calculated using health utilities derived from clinical trials. A 12-week time horizon was used. RESULTS: With continued OTC laxatives, CIC-related costs were $569 from an insurer perspective compared with $3,154 from a patient perspective (considering lost wages and out-of-pocket expenses). CIC prescription drugs increased insurer costs by $618–$1,015 but decreased patient costs by $327–$1,117. Effectiveness of CIC drugs was similar (0.02 QALY gained/12 weeks or ∼7 healthy days gained/year). From an insurer perspective, prescription drugs (linaclotide, prucalopride, and plecanatide) seemed less cost-effective than continued OTC laxatives (incremental cost-effectiveness ratio >$150,000/QALY gained). From a patient perspective, the cost-effective algorithm started with plecanatide, followed by choosing between prucalopride and linaclotide starting at the 145-μg dose (favoring prucalopride among patients whose disease affects their work productivity). The patient perspective was driven by drug tolerability and treatment effects on quality of life. DISCUSSION: Addressing costs at a policy level has the potential to enable patients and clinicians to move from navigating barriers in treatment access toward truly optimizing treatment choice.

Optimizing the Management Algorithm for Adults With Functional Constipation Failing a Fiber/Laxative Trial in General Gastroenterology: Cost-Effectiveness and Cost-Minimization Analysis

“…What is lost in this conversation is that both answers may be correct: (i) Cost is critical in general gastroenterology considering the large number of patients, and (ii) the paradigm and positioning of pelvic floor evaluation and management in general gastroenterology does not inherently need to match that of a handful of subspecialty motility centers that can safely continue to rigorously advocate extensive testing and intensive biofeedback for their subgroups of patients (35–37). Indeed, the reality that drug trials actually enrolled relatively treatment-naïve patients is frequently lost because the use of prescription drugs is sensibly restricted to truly treatment-refractory patients out of concern for costs in the minds of gastroenterologists that decline to prescribe expensive drugs to many millions of treatment-naïve patients (2,3). Therefore, our study is the first to support the robustness of this clinical decision support tool (15) that provides a way out for the many patients caught “in the middle” between evidence and cost—that is to say, the actual evidence base developed across clinical drug trials and our recent pelvic floor trial for patients that reach a general gastroenterologist, meet Rome IV criteria, and fail a low-cost OTC trial (11).…”

“…We adapted a recently published decision-analytic model that was developed to assess costs and outcomes among patients with chronic constipation (see Supplementary Figure 1, Supplementary Digital Content 1, http://links.lww.com/AJG/D45). The published model developed assumptions on treatment efficacy, tolerability, and safety using the RAND/UCLA appropriateness method that is previously described in detail (3). This study adhered to the Consolidated Health Economic Evaluation Reporting Standards checklist and methodologic guidance from the Second Panel on Cost-Effectiveness in Health and Medicine (13).…”

“…Recognizing our intention to evaluate overarching conceptual strategies to use PFPT or prescription drugs at all, we modeled the most cost-effective prescription drug strategies in primary analysis. Comparisons among individual drugs are reported previously for subsets of patients that prefer this approach (3). Sensitivity analyses were conducted across all model input, including to evaluate the capacity of anorectal function tests to influence cost-effectiveness from a patient perspective and cost savings from an insurer perspective.…”

“…Many gastroenterologists regard constipation as a benign disorder of slow intestinal transit, and so, the mainstay of specialty care management involves cycling over-the-counter (OTC) laxatives and reinforcing the need to increase water intake and dietary fiber (2). Over one-half of patients do not respond to these interventions yet face limited choices largely due to cost (3). Specifically, conflict arises among insurers that would pay for prescription drug treatments, patients who would pay out-of-pocket for additional OTC laxatives or dietary changes, and gastroenterologists that seek to minimize unnecessary testing (4).…”

Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation

“…Chronic constipation is one of the most common gastrointestinal (GI) disorders, affecting approximately 15% of the global population ( Bharucha and Lacy, 2020 ) and 37.7% of people over 80 years old ( Chu et al, 2014 ), and has a substantial impact on both patients and healthcare systems, resulting in an enormous healthcare resource burden ( Camilleri et al, 2017 ; Shah et al, 2021 ). Chronic constipation is usually characterized by the decreased spontaneous bowel movements (SBMs, <3 per week), difficulty in defecation, incomplete evacuation, excess straining and other accompanying symptoms ( Forootan et al, 2018 ).…”