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.

中文翻译：

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评估成本对慢性特发性便秘治疗算法的影响：成本效益分析。

简介 慢性特发性便秘（CIC）是一种常见且造成负担的疾病。我们对美国食品和药物管理局批准的 CIC 药物进行了成本效益分析，从保险公司和患者的角度评估和量化与常规护理相比的治疗偏好。方法 我们评估了 CIC 患者的子集，并记录了非处方 (OTC) 渗透性或散装泻药的失败情况。由 8 名神经胃肠病学家组成的兰德/加州大学洛杉矶分校共识小组为模型设计提供了信息。使用注册临床试验和美国医疗保险和医疗补助服务中心支持的成本数据库的综合分析来确定治疗结果和成本。质量调整生命年（QALY）是使用临床试验得出的健康实用程序计算的。使用 12 周的时间范围。结果 继续使用 OTC 泻药，从保险公司角度来看，CIC 相关费用为 569 美元，而从患者角度来看，CIC 相关费用为 3,154 美元（考虑到工资损失和自付费用）。CIC 处方药使保险公司费用增加了 618 美元至 1,015 美元，但患者费用减少了 327 美元至 1,117 美元。CIC 药物的疗效相似（每 12 周增加 0.02 QALY，或每年增加约 7 个健康天）。从保险公司的角度来看，处方药（利那洛肽、普卡必利和普卡那肽）的成本效益似乎低于持续使用非处方泻药（增量成本效益比 > 150,000 美元/获得的 QALY）。从患者的角度来看，具有成本效益的算法从普卡那肽开始，然后从 145 μg 剂量开始在普卡必利和利那洛肽之间进行选择（对于疾病影响工作效率的患者，倾向于选择普卡必利）。患者的观点是由药物耐受性和治疗对生活质量的影响决定的。讨论 在政策层面解决成本问题有可能使患者和临床医生摆脱治疗获取障碍，真正优化治疗选择。