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

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.

Evaluation and Comparison of Daiokanzoto and Lubiprostone for Constipation: A Retrospective Cohort Study.

Daiokanzoto (DKT) and lubiprostone (LPS) are drugs used for constipation, but few studies have compared them. This study examined the effectiveness, adverse events, and medical economic efficiency of DKT and LPS for constipation. Patients who received DKT (DKT group) and those who received LPS (LPS group) during admission to Ogaki Municipal Hospital between November 2012 and May 2016 were enrolled. Drug efficacy was evaluated based on the median value of bowel movement frequency over 1 week before and after drug administration, and their safety was evaluated by the presence or absence of diarrhea, abdominal pain, nausea, and vomiting. To assess medical economic efficiency, drug costs for constipation per week were calculated. The median values (quartile ranges) of bowel movement frequency at 1 week after drug administration were 8.5 (6.0-12.0) in the DKT group and 5 (3.0-7.0) in the LPS group, which was significantly different (p < 0.01). Diarrhea occurred significantly less often in the DKT group (4 cases) than in the LPS group (17 cases) (p < 0.01). The median cost of drugs administered for constipation for 1 week was significantly lower in the DKT group (631 [quartile range, 513-653] yen) than in the LPS group (1431 [1135-2344] yen) (p < 0.01). DKT had a higher immediate effect on constipation and was associated with more frequent bowel movement and fewer adverse events of diarrhea than LPS, suggesting that it may be effective and safe for treating constipation, and DKT is inexpensive.

$850 Per Bowel Movement?! Hard To Justify That Cost.

Constipation can be a serious and painful problem, and we shouldn't dismiss other people's suffering. On the other hand there's a danger when new medications are compared against placebo rather than against over-the-counter products with a history of effectiveness.

Abdominal massage in the management of chronic constipation for children with disability.

A service development initiative was conducted to assess the impact of abdominal massage on chronic constipation in children with physical disabilities and learning needs. Twenty-five parents engaged in an abdominal massage training programme led by a specialist health visiting team (children's disability). Participants were asked to carry out abdominal massage for a total of 20 minutes per day. Quality of life indicators, descriptions of bowel movements, use of laxative medication and contact with health care services were recorded by parents. Costs and professional contact time with families was calculated. Results reported a wide range of quality of Life improvements including relief in symptoms of constipation (87.5%), reduction in laxative medication (58%) and improved dietary intake (41%). Qualitative data indicated positive experiences described by parents which included enhanced parent-child relationships.

Analysis of the economic burden of docusate sodium at a United States tertiary care center.

OBJECTIVES: The primary objective was to determine the financial resources allocated to docusate at a representative U.S. tertiary care center. Secondary objectives included comparing docusate utilization between two tertiary care centers, and exploring alternative uses for the funds spent on docusate. METHODS: The study population included all patients 18 years and older admitted to University Hospital in Newark, New Jersey. Every scheduled docusate prescription for the study population between January 1st, 2015 and December 31st, 2019 was collected. The annual total cost associated with docusate use per year was calculated. The 2015 data from this study and a 2015 McGill University Health Centre study were compared. Also, alternative uses for the money utilized on docusate were assessed. RESULTS: Over the study period, 37,034 docusate prescriptions and 265,123 docusate doses were recorded. The average cost of prescribing docusate was $25,624.14 per year and $49.37 per hospital bed per year. A comparison between the 2015 data of University Hospital and McGill showed that McGill prescribed 107 doses and spent $10.09 more per hospital bed than University Hospital. Finally, alternative uses for the average yearly spending on docusate equated to 0.35 the salary of a nurse, 0.51 the salary of a secretary, 20.66 colonoscopies, 27.00 upper endoscopies, 186.71 mammograms, 1,399.37 doses of polyethylene glycol 3350, 3,826.57 doses of lactulose, or 4,583.80 doses of psyllium. CONCLUSION: A single average size tertiary care hospital spent about $25,000 yearly on docusate despite its lack of clinical effectiveness. While this amount is small compared to an overall hospital budget, when considering likely comparable docusate use at the U.S's 6,090 hospitals, the economic burden of docusate becomes significant. The funds currently being used on docusate could be redirected to alternative, more cost-effective purposes.

Magnesium Oxide in Constipation.

Magnesium oxide has been widely used as a laxative for many years in East Asia, yet its prescription has largely been based on empirical knowledge. In recent years, several new laxatives have been developed, which has led to a resurgence in interest and increased scientific evidence surrounding the use of magnesium oxide, which is convenient to administer, of low cost, and safe. Despite these advantages, emerging clinical evidence indicates that the use of magnesium oxide should take account of the most appropriate dose, the serum concentration, drug-drug interactions, and the potential for side effects, especially in the elderly and in patients with renal impairment. The aim of this review is to evaluate the evidence base for the clinical use of magnesium oxide for treating constipation and provide a pragmatic guide to its advantages and disadvantages.

Abdominal massage for people with constipation: a cost utility analysis.

AIM: This paper is a report of a study conducted to evaluate change in health-related quality of life for people with constipation receiving abdominal massage and to estimate the cost-effectiveness of two alternative scenarios developed from the original trial. BACKGROUND: Constipation is a common problem and is associated with decrease in quality of life. Abdominal massage appears to decrease the severity of gastrointestinal symptoms, but its impact on health-related quality of life has not been assessed. METHODS: A randomized controlled trial including 60 participants was conducted in Sweden between 2005 and 2007. The control group continued using laxatives as before and the intervention group received additional abdominal massage. Health-related quality of life was assessed using the EQ-5D and analyzed with linear regression. Two scenarios were outlined to conduct a cost utility analysis. In the self-massage scenario patients learned to give self-massage, and in the professional massage scenario patients in hospital received abdominal massage from an Enrolled Nurse. RESULTS: Linear regression analysis showed that health-related quality of life was statistically significantly increased after 8 weeks of abdominal massage. About 40% were estimated to receive good effect. For 'self-massage', the cost per quality adjusted life year was euro75,000 for the first 16 weeks. For every additional week of abdominal massage, the average dropped and eventually approached euro8300. For 'professional massage', the cost per quality adjusted life year was euro60,000 and eventually dropped to euro28,000. CONCLUSION: Abdominal massage may be cost-effective in the long-term and it is relevant to consider it when managing constipation. A crucial aspect will be to identify those who will benefit.

Health utilization and cost impact of childhood constipation in the United States.

OBJECTIVE: To estimate the total health care utilization and costs for children with constipation in the United States. STUDY DESIGN: We analyzed data from 2 consecutive years (2003 and 2004) of the Medical Expenditure Panel Survey (MEPS), a nationally representative household survey. We identified children who either had been reported as constipated by their parents or had received a prescription for laxatives in a given year. Outcome measures were service utilization and expenditures. RESULTS: The MEPS database included a total of 21 778 children age 0 to 18 years, representing 158 million children nationally. An estimated 1.7 million US children (1.1%) reported constipation in the 2-year period. No differences with respect to age, sex, race, and socioeconomic status were found between the children with constipation and those without constipation. The children with constipation used more health services than children without constipation, resulting in significantly higher costs: $3430/year vs $1099/year. This amounts to an additional cost for children with constipation of $3.9 billion/year. CONCLUSIONS: This study demonstrates that childhood constipation has a significant impact on the use and cost of medical care services. The estimated cost per year is 3 times than that in children without constipation, which likely is an underestimate of the actual burden of childhood constipation.

Prucalopride for the treatment of constipation: a view from 2015 and beyond.

INTRODUCTION: Prucalopride is a prokinetic drug, that has been commercially available in recent years for the treatment of chronically constipated patients. In this update of a previous 2016 article, we reviewed the more recent data supporting its role in the treatment of constipation and constipation-associated conditions. Areas covered: We carried out an extensive literature review on the effects of prucalopride for the years 2012-2018 by means of scientific databases and manual research. More evidence was found on its possible therapeutic role in conditions in which constipation plays a role as an associated symptom, such as opioid-induced constipation, constipation-predominant irritable bowel syndrome, post-operative ileus, colonic diverticular disease, drug-related constipation, and chronic intestinal pseudo-obstruction. Expert opinion: Based on the added literature evidence, we feel that prucalopride is an effective, although expensive, drug for the treatment of primary and secondary forms of constipation, and of other clinical conditions associated with constipation.

Stepped treatment of older adults on laxatives. The STOOL trial.

OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of bulk-forming, stimulant and osmotic laxatives, and also of adding a second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent. Additionally, to define the meaning of constipation in older people from the perspective of GPs and older patients, and to investigate the use of prescribed and non-prescribed treatments for constipation in older people together with their adherence to prescribed treatments. DESIGN: A multicentre pragmatic, factorial randomised controlled trial with economic evaluation and qualitative study using in-depth interviews and focus groups with older people, GPs and community nurses. SETTING: General practices in north-east England. PARTICIPANTS: People aged 55 years or over with chronic constipation living in private households. INTERVENTIONS: Six stepped-treatment strategies using three classes of laxatives: bulk, stimulant and osmotic preparations, singly and in combination. MAIN OUTCOME MEASURES: The primary outcome was the constipation-specific Patient Assessment of Constipation--Symptoms/Patient Assessment of Constipation--Quality of Life. Secondary outcomes included EuroQoL 5 Dimensions, reported number of bowel movements per week, the presence/absence of the other Rome II criteria for constipation, adverse effects of treatment and relapse rates. RESULTS: Recruitment to the trial was difficult and the trial was closed after recruiting 19 participants. GP participants provided patient-centred definitions that focused on the idea of a change from the norm as defined by the individual patient and 'textbook definitions' that focused on reduced frequency of defecation associated with a range of unpleasant sensations and other clinical symptoms. Nurses' definitions of constipation included both a patient-centred perspective and the description of particular symptoms associated with constipation. Older participants defined constipation in terms of frequency of bowel movements and changes in normal bowel routine. Older participants perceived constipation as follows: linked to specific diseases, medical conditions or health problems; caused by the consumption of specific medications or surgical procedures; caused by diet or eating habits; part of the ageing process; due to not going to the toilet when having the urge to defecate; hereditary; caused by stress or worry; and caused by environmental exposure. GP participants suggested that constipation is due to changes in diet and lifestyle; the physiology and degenerative processes of ageing; and the iatrogenic impact of opiate medications. Nurse participants identified that constipation is linked to decreased mobility, decreased food intake, decreased fluid intake and consumption of certain medications. For many older people their constipation emerged as a problem over a period of time; for some the 'condition' had existed for many years. Self-management of constipation had typically been their first response to the symptoms and continued once professional help had been sought. Older participants had a wide experience of different management strategies and treatments for constipation, and at the time of the study had firm preferences about the laxatives they would use. GP participants recognised the experience and use of laxatives of their patients. They exhibited strong personal preferences for different laxatives, often prescribing them in combination. Nurses were more likely than GPs to treat and prevent constipation using non-laxative measures; these included providing advice on appropriate dietary changes, increasing fluid intake and, if possible, encouraging exercise and mobility. CONCLUSIONS: There is little shared understanding between patients and professionals about 'normal' bowel function with little consensus in general practice of the optimum management strategies for chronic constipation and the most effective strategies to use. Chronic constipation is seen as less important than other conditions prevalent in general practice (e.g. diabetes) because it is not an agreed management target within national frameworks. Consequently, practitioners had little interest in constipation as a research topic. Patient preferences and the absence of patient equipoise formed an enormous barrier to the recruitment of patients in the implementation of this trial. Studies are needed to investigate different methods of recruitment within the constraints of current ethical guidelines on 'opting in' and to identify barriers and facilitators to recruitment to complex trials in general. Patient preference trials and natural cohort observational studies are also needed to investigate the effectiveness or cost-effectiveness of different laxatives and treatment strategies in the management of chronic constipation.

A comparative review of common laxatives in the treatment of constipation.

INTRODUCTION: Constipation is a common condition that affects people all over the world. A frequently sought out solution to this problem consists of laxatives, especially since these medications are easily accessible over-the-counter in most pharmacies. This has led laxative spending in North America alone to be approximately $500 million per year. EVIDENCE ACQUISITION: Due to this large expenditure, a review of the available laxative data was completed and common laxative classes were evaluated and contrasted for the purposes of evaluating cost-effectiveness. EVIDENCE SYNTHESIS: Despite the wide use of laxatives, very little research has been done to evaluate their efficacy. Even less has been done to analyze these medications from a cost standpoint. CONCLUSIONS: Although laxatives are very commonly prescribed and used over-the-counter, more research attention should be granted on determining the efficacy and cost-effectiveness of laxative use.

Pharmacoeconomic study of chronic constipation in a secondary care centre.

OBJECTIVE: The aim of this study was to measure any incremental costs or savings within the health system associated with the introduction of the new technology, prucalopride, for the management of chronic constipation. METHODOLOGY: The study design was based on a budget impact analysis conducted by the National Institute of Clinical Excellence (NICE). To validate the findings of the NICE costing template, a case series audit capturing real world data was used to determine the financial impact of adopting prucalopride in 40 women suffering with chronic constipation. This facilitated the application of local unit costs to the resources used and determined whether the use of prucalopride, as an alternative treatment to laxatives, resulted in a reduction in the use of secondary care resources. RESULTS: Patients were treated with an average of 2.6 laxatives in the baseline (laxatives only) scenario. The total medication costs in the baseline (laxatives only) and the new treatment (prucalopride) scenario amounted to €17,440.84 and €18,417.62, respectively. There was a significant reduction in the number of investigations and procedures in the 12 months after commencing prucalopride, with cost savings of €41,923.28 (€1,048.08 per patient per year) demonstrated. Input cost variables were adjusted as part of sensitivity analysis. CONCLUSION: This study validated the findings of the NICE costing template and suggests that the use of prucalopride for the treatment of chronic constipation in women refractory to laxatives has the potential to reduce secondary care resource use and hence led to cost savings.

Role of polyethylene glycol in childhood constipation.

Constipation is a common and chronic problem in children worldwide. Long-term use of laxatives is necessary for successful treatment of chronic constipation. Commonly used laxatives in children include milk of magnesia, lactulose, mineral oil, and polyethylene glycol (PEG). Recent studies report the efficacy and safety of PEG for the long-term treatment of constipation in children. Because of its excellent patient acceptance, PEG is being used widely in children for constipation. In this commentary, we review the recently published pediatric literature on the efficacy, safety, and patient acceptance of PEG. We also assess the role of PEG in childhood constipation by comparing it with other laxatives in terms of efficacy, safety, patient acceptance, and cost.

Prucalopride for the treatment of women with chronic constipation in whom standard laxative regimens have failed to provide adequate relief.

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of prucalopride for the treatment of women with chronic constipation in whom standard laxative regimens have failed to provide adequate relief. The ERG report is based on the manufacturer's submission (MS) to the National Institute for Health and Clinical Excellence as part of the single technology appraisal process. In the submission, quality-of-life data [Patient Assessment of Constipation Quality of Life (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaires] from trials of prucalopride were extrapolated to EQ-5D (European Quality of Life-5 Dimensions) data and used to inform effectiveness in an economic model. Response rates to prucalopride were derived from observed response rates in trials, defined as the proportion of patients achieving an average of three or more spontaneous complete bowel movements over the 4- or 12-week trial periods. Adult (18-64 years) and elderly (≥ 65 years) patients were considered separately in the model. Cost-effectiveness was determined from estimated improvements in EQ-5D and anticipated response rates, adjusted for baseline severity of chronic constipation. The ERG considered that the patients participating in these trials were not representative of those in the licensed indication. They were not all refractory to laxatives, and baseline EQ-5D scores showed a large spread in quality of life, with many patients experiencing little baseline dissatisfaction. The mapping of quality-of-life data from trials (PAC-QOL and PAC-SYM data) to EQ-5D was unclear and invalidated. The assumption of the long-term effectiveness and safety of prucalopride to 1 year was considered unjustified. There was no justification or sources given for coefficients used to predict effectiveness in the economic model, and no costs other than the cost of prucalopride were incorporated into the model. Owing to the many areas of uncertainty, particularly the effectiveness of prucalopride in the licensed patient group and its long-term effectiveness and safety, it was considered that the MS provided no evidence for whether prucalopride is effective or not in women with laxative-refractory chronic constipation. Further subgroup analysis of the actual patient group of interest may have better guided decision-making. However, long-term efficacy data, with validated estimates of quality of life incorporated in a well-founded model, would be important for an evidence-based judgement to be made.

What role for prucalopride in constipation?

▾Prucalopride (Resolor - Shire Pharmaceuticals Ltd) is licensed, only in women, for symptomatic treatment of chronic constipation when laxatives fail to provide adequate relief. It is promoted as being "effective in helping to restore normal bowel movements and alleviating a broad range of constipation symptoms in women." Here we review the evidence for prucalopride and consider the drug's place as a treatment for chronic constipation.

The cost-effectiveness of macrogol 3350 compared to lactulose in the treatment of adults suffering from chronic constipation in the UK.

BACKGROUND: It is unknown whether macrogol 3350 (Movicol) affords the UK's National Health Service (NHS) a cost-effective addition to the current range of laxatives. AIM: To estimate the cost-effectiveness of macrogol 3350 compared with lactulose in the treatment of chronic constipation, from the perspective of the UK's NHS. METHODS: A decision model depicting the management of chronic constipation was constructed using clinical outcomes and resource use values derived from patients suffering from chronic constipation in The Health Independent Network (THIN) database. The model was used to estimate the cost-effectiveness of a GP prescribing macrogol 3350 instead of lactulose to treat adults > or =18 years of age suffering from chronic constipation. RESULTS: Sixty-eight percent of patients given macrogol 3350 were successfully treated within 6 months after starting treatment compared to 60% of patients given lactulose.Patients' health status at 6 months was estimated to be 0.458 and 0.454 quality-adjusted life years (QALYs) in the macrogol 3350 and lactulose groups respectively. The total 6-monthly NHS cost of initially treating patients with macrogol 3350 or lactulose was estimated to be pound420 (US $688) and pound419 (US $686) respectively. Hence, the cost per QALY gained with macrogol 3350 was estimated to be pound250 (US $410). CONCLUSION: Macrogol 3350 affords the NHS a cost-effective addition to the range of laxatives available for this potentially resource-intensive condition.