Cost and burden of gastroesophageal reflux disease among patients with persistent symptoms despite proton pump inhibitor therapy: an observational study in France.

BACKGROUND: Gastrointestinal reflux disease (GERD) is a common disorder that negatively impacts health-related quality of life (HRQL) and work productivity. Many patients have only a partial response to proton pump inhibitor (PPI) therapy and continue to experience GERD symptoms despite optimized treatment. This observational study aimed to provide information on symptoms, HRQL, resource usage, costs and treatment pathways associated with partial response to PPI therapy in French patients with GERD. METHODS: Patients with partial response to PPI therapy, defined as persistent GERD symptoms ≥3 days/week despite optimized treatment with a PPI, were recruited for this 12-month observational study. GERD symptoms, HRQL, work productivity and resource use were assessed by patient surveys. Costs were calculated based on lost work productivity and resource use. RESULTS: The patient population (n=262; mean age, 54 years; 40% men) carried a significant symptom burden, with 98% of patients having moderate-to-severe GERD symptoms and 65% of patients experiencing daily symptoms at baseline. HRQL and work productivity were significantly impaired, with a greater degree of impairment in patients with higher symptom burden. The mean total cost per patient over the 12-month follow-up period was €5237, of which €4674 (89%) was due to lost work productivity. CONCLUSIONS: Partial response to PPI therapy for GERD is associated with a high symptom burden, significant impairment of HRQL and work productivity, and substantial GERD-related costs.

The burden of disrupting gastro-oesophageal reflux disease: a database study in US and European cohorts.

BACKGROUND: Recent data indicate that among patients with gastro-oesophageal reflux disease (GORD) there is a subgroup with a higher disrupting burden of illness in terms of symptom frequency and overall impact. OBJECTIVE: The aim of this study was to evaluate the burden of disrupting versus non-disrupting GORD on individuals, healthcare providers and society. METHODS: Data were obtained from European (France, Germany, Italy, Spain and the UK) and US respondents in the 2007 National Health and Wellness Survey (NHWS). Respondents with GORD were classified as having disrupting or non-disrupting GORD based on self-reported symptom frequency, presence of night-time symptoms and medication usage. Disrupting GORD was defined as the presence of GORD symptoms on at least 2 days/week in addition to either night-time symptoms or use of prescribed/over-the-counter medication at least twice a week during the past month. RESULTS: Of 116 536 respondents included in the 2007 NHWS, 23% reported GORD symptoms; 39% of these were acknowledged as having disrupting GORD. These patients had higher healthcare resource utilization than those with non-disrupting disease. Respondents with disrupting GORD also had poorer health-related quality of life, greater impairments in health-related work productivity and absenteeism (all p < 0.05 vs non-disrupting GORD), and higher associated total medical costs. Overall, patients with physician-diagnosed GORD also had significantly lower health-related quality of life than self-diagnosed respondents (p < 0.05). CONCLUSIONS: GORD is a common disease that places a substantial burden on affected individuals and society. A high proportion of patients have disrupting GORD, which has significant adverse potential from both a clinical and an economic perspective.

Objective measurement of work absence and on-the-job productivity: a case-control study of US employees with and without gastroesophageal reflux disease.

OBJECTIVE: To establish an association between gastroesophageal reflux disease (GERD) and increased work absence, as well as reduced productivity while at work, by using objective productivity measurements. METHODS: Retrospective case-control analysis of a database containing US employees' administrative health care and payroll data for employees (N = 11,653 with GERD; N = 255,616 without GERD) who were enrolled for at least one year in an employer-sponsored health insurance plan. RESULTS: Employees with GERD had 41% more sick leave days (P < 0.0001), 59% more short-term disability days (P < 0.0001), 39% more long-term disability days (P = 0.1910), 48% more workers' compensation days (P < 0.0001), 4.4% lower objective productivity per hour worked (P = 0.0481), and 6.0% lower annual objective productivity (P = 0.0391) than the employees without GERD. CONCLUSIONS: GERD is associated with a significant impact on employees' work absence and productivity while at work as measured using objective data.

Cost-effectiveness of Simple Insulin Infusion Devices Compared to Multiple Daily Injections in Uncontrolled Type 2 Diabetics in the United States Based on a Simulation Model.

BACKGROUND: As type 2 diabetes (T2D) progresses, administering basal and bolus insulin through multiple daily injections (MDI) is often required to achieve target control, although many people fail to achieve target levels. Continuous subcutaneous insulin infusion (CSII) treatment with traditional pumps has proven effective in this population, but use remains limited in T2D due to CSII cost and complexity. A new class of simple insulin infusion devices have been developed which are simpler to use and less expensive. This paper assesses at what price one such simple insulin infusion device, PAQ® (Cequr SA, Switzerland), may be cost-effective compared to MDI in people with T2D not in glycemic control in the United States. METHODS: Published equations were used in a simulation model to project long-term cost-effectiveness over 40 years, combined with data from the recent OpT2mise study, assuming similar efficacy of CSII and simple insulin infusion. Cost-effectiveness was pre-defined in relation to per capita gross domestic product (GDP), where incremental cost-effectiveness ratios below 1X the per capita GDP per quality-adjusted life year (QALY) gained were defined as "highly cost-effective" and below 3X GDP per capita as "cost-effective." RESULTS: Simple insulin infusion resulted in 0.17 QALYs gained per patient compared to MDI, along with lifetime cost-savings of USD 66 883 per person due to reduced insulin use and less complications. Analyses on price sensitivity of simple insulin infusion indicated that a device such as the PAQ is cost-effective compared with MDI up to price points of around USD 17 per day. CONCLUSIONS: For people with T2D not in glycemic control on MDI, simple insulin infusion devices such as PAQ have the potential to be highly cost-effective in the United States.

The Work Productivity and Activity Impairment Questionnaire for Patients with Gastroesophageal Reflux Disease (WPAI-GERD): responsiveness to change and English language validation.

BACKGROUND: A validated productivity questionnaire, the Work Productivity and Activity Impairment questionnaire for Gastroesophageal Reflux Disease (WPAI-GERD), exists for Swedish patients with GERD. OBJECTIVE: To assess responsiveness to change of the WPAI-GERD and construct validity of the English language version. METHODS: We used the WPAI-GERD in a before-after treatment clinical study of Canadian GERD patients with moderate or severe symptoms treated with esomeprazole 40 mg once daily for 4 weeks. We measured productivity variables including GERD-specific absence from work, reduced productivity while at work and reduced productivity while carrying out regular daily activities other than work during the preceding week. RESULTS: The analysis included 217 patients, of whom 71% (n = 153) were employed. Before treatment, employed patients reported an average 0.9 hours of absence from work due to GERD and 14.0% reduced work productivity (5.8 hours equivalent) in the previous week, as well as 21.0% reduced productivity in daily activities (all patients). After treatment, the corresponding figures decreased to 0.3 hours, 3.0% (1.1 hours equivalent) and 4.9%, respectively. Thus, the improvement (difference from start of treatment) in productivity was 0.6 hours (p = 0.011) for absence from work and 11.0% units (p < 0.001) for reduced work productivity (4.7 hours equivalent, p < 0.001). This translated into an avoided loss of work productivity of 5.3 hours in total on a weekly basis per employed patient. In addition, a 16.1% unit (p < 0.001) improvement for reduced productivity in activities was observed. Cross-sectional correlation coefficients of WPAI variables with symptoms (range 0.04-0.63) and health-related quality of life (HR-QOL; range 0.02-0.65) supported cross-sectional construct validity. Corresponding change score correlations between WPAI variables and HR-QOL (range 0.05-0.56) supported longitudinal construct validity of the WPAI-GERD while low change score correlations between productivity variables and relevant symptoms (range 0.06-0.34) did not. CONCLUSION: The English version of the WPAI-GERD showed good cross-sectional construct validity, and results indicated that the WPAI-GERD is responsive to change. Although the results also indicated that longitudinal construct validity may be poor, the overall findings suggest that further study of the instrument remains warranted.

The impact of illness in patients with moderate to severe gastro-esophageal reflux disease.

BACKGROUND: Gastro-esophageal reflux disease (GERD) is a common disease. It impairs health related quality of life (HRQL). However, the impact on utility scores and work productivity in patients with moderate to severe GERD is not well known. METHODS: We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7) across 17 Canadian centers. Patients completed three utility instruments--the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3)--and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks. RESULTS: The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired. CONCLUSION: GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL.

Impact of once-daily extended-release quetiapine fumarate on hospitalization length in patients with acute bipolar mania.

AIMS: Evaluate the impact of quetiapine extended release (XR) versus quetiapine immediate release (IR) on hospitalization length in acute bipolar mania using Truven Health Analytics MarketScan Hospital Drug Database. PATIENTS & METHODS: Generalized linear model analyses were used, adjusting for patient and hospital characteristics. RESULTS: Using data from 3088 discharges, quetiapine XR reduced hospitalization length by 6.7% versus quetiapine IR (p = 0.11; no statistically significant differences between groups), corresponding to 0.6 fewer days in hospital. Excluding the outlier, quetiapine XR significantly reduced hospitalization length by 9.6% versus quetiapine IR (p = 0.02), corresponding to 0.9 days. CONCLUSION: Inpatient use of quetiapine XR in acute bipolar mania may be associated with reduced hospitalization length (7-10%), possibly owing to the faster titration schedule versus quetiapine IR.

Cost effectiveness of esomeprazole compared with omeprazole in the acute treatment of patients with reflux oesophagitis in the UK.

BACKGROUND: Clinical studies have demonstrated that esomeprazole is superior to omeprazole for the acute treatment of reflux oesophagitis. OBJECTIVE: To compare the cost effectiveness of esomeprazole 40mg once daily with omeprazole 20mg once daily in patients with reflux oesophagitis. METHODS: Pooled data were used from three 8-week clinical trials comparing the efficacy and safety of esomeprazole 40mg once daily and omeprazole 20mg once daily for the acute treatment of reflux oesophagitis. A simple decision analysis model, using UK direct medical costs, compared the cost effectiveness of the two treatments. Healing probabilities derived from the clinical studies using the Life Table method were used to estimate the effectiveness and cost of treating 100 patients with reflux oesophagitis. Patient management assumptions were based on a clinical management survey involving 25 UK physicians. PERSPECTIVE: UK National Health Service. RESULTS: After 4 weeks' therapy, the Life Table estimated the oesophageal healing rate to be 77.7% in esomeprazole 40mg once-daily recipients (n = 2446), compared with 67.6% in omeprazole 20mg once-daily recipients (n = 2431; p < 0.001). The corresponding values after 8 weeks' treatment were 93.4% and 86.2%, respectively (p < 0.001). The model predicted that when considering healing probabilities over 8 weeks, esomeprazole 40mg once daily produced total direct cost savings of pound1290 (14%) when compared with omeprazole 20mg once daily. When considering the cost of treating patients who had failed treatment (defined as patient not healed as assessed by endoscopy) after 8 weeks, the cost advantage for esomeprazole was even greater. CONCLUSION: Esomeprazole 40mg once daily is cost effective compared with omeprazole 20mg once daily in the acute treatment of patients with reflux oesophagitis; esomeprazole provides greater effectiveness at a lower cost.

Cost effectiveness of proton pump inhibitors in gastro-oesophageal reflux disease without oesophagitis: comparison of on-demand esomeprazole with conventional omeprazole strategies.

OBJECTIVES: To evaluate the cost effectiveness of on-demand treatment with esomeprazole 20mg compared with two alternative omeprazole treatment strategies for the long-term management of patients with gastro-oesophageal reflux disease (GORD) without oesophagitis. DESIGN: A simple Markov model was designed to compare the cost effectiveness of on-demand esomeprazole 20mg therapy for 6 months with a strategy consisting of intermittent 4-week acute treatment courses of omeprazole 20mg once daily or a strategy consisting of continuous omeprazole treatment (20mg once daily) following acute treatment of first relapse while on no drug treatment (a commonly used conventional care strategy). Relapse probabilities were based on pooled results from two 6-month placebo-controlled clinical studies of on-demand esomeprazole 20mg treatment in patients with GORD without oesophagitis and on results from a GORD study with a 6-month untreated follow-up. The expected number of relapses per patient was used as the effectiveness measure. SETTING AND PERSPECTIVE: Patient management assumptions were based on a UK physician survey. The cost-effectiveness analysis considered UK direct medical costs from the perspective of the National Health Service. RESULTS: The pooled analysis showed that after 6 months treatment, 90% of patients could control symptoms effectively with on-demand esomeprazole 20mg. The expected number of relapses per patient was estimated at 0.10 for on-demand esomeprazole, 0.57 to 1.12 for intermittent omeprazole and 0.47 to 0.75 for conventional omeprazole treatment. The esomeprazole strategy incurred considerably lower direct medical costs (16 to 61%) than either omeprazole strategy. CONCLUSION: On-demand treatment with esomeprazole 20mg is cost effective compared with two alternative omeprazole treatment strategies in patients with GORD without oesophagitis.

A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective.

Health impairment often leads to work impairment in the form of both absenteeism and presenteeism (i.e. reduced productivity while at work). Several self-report productivity instruments have been designed over the past few years to measure the impact of illness on productivity at work and/or in non-work activities. In a review of the literature we identified six generic subjective instruments - the Endicott Work Productivity Scale, Health and Labor Questionnaire, Health and Work Questionnaire, Health and Work Performance Questionnaire, Work Limitations Questionnaire (WLQ) and the Work Productivity and Activity Impairment Questionnaire (WPAI) - that could theoretically be used in any working population. These instruments were usually validated against other subjective measures (such as health-related QOL). Each productivity instrument has benefits in certain research settings, but the psychometric properties of the WPAI have been assessed most extensively. It was the most frequently used instrument and has also been modified to measure productivity reductions associated with specific diseases (e.g. allergic rhinitis, gastro-oesophageal reflux disease, chronic hand dermatitis). The WLQ has also been tested extensively to measure the general health impact and impact of specific conditions. Two migraine-specific subjective instruments were also identified: the Migraine Disability Assessment questionnaire and the Migraine Work and Productivity Loss Questionnaire, of which the latter was found to have better psychometric properties. Productivity outcomes are useful in that they characterise the impact of an illness in the workplace and show the effect of treatment on productivity. Evidence of psychometric properties and generalisability of different instruments was found to a varying degree. Thus, further research is needed to assess the accuracy and usefulness of individual instruments in certain research settings. Health-related productivity has been increasingly recognised as an important component of the burden of illness associated with a given disease; without it, one cannot reliably assess this burden.

Impact of extended-release quetiapine fumarate on hospitalization length and cost in schizophrenia and bipolar disorder patients: a retrospective, hospital-based, US-cohort analysis.

AIM: The aim was to evaluate the impact of quetiapine extended release (XR) on hospitalization length and cost in schizophrenia or bipolar disorder, versus quetiapine immediate release (IR), using Premier Perspective™ inpatient hospital database data. METHODS: Inpatient discharges classified within diagnosis-related group 430 (psychoses), prescribed quetiapine XR or IR, were identified. Patients had International Classification of Disease-9 diagnosis of schizophrenia or bipolar disorder. The impact of the XR formulation on hospitalization length and costs was assessed using generalized linear model analyses. RESULTS: A total of 30,429 discharges between 1 January 2008 and 30 June 2009 were analyzed. Patients who received quetiapine XR had significantly reduced hospitalization length (10.73% estimated reduction; p = 0.001) and cost (9.52% estimated reduction; p < 0.001), versus IR. This corresponds to a 1.0-day reduction in hospitalization (10.73% of 9.2 days) and US$532 reduction in hospitalization cost (9.52% of US$5588) per patient, based on least squares mean estimations. Evaluation of patient subpopulations suggested the reduction in length of hospitalization for quetiapine XR versus IR was driven mainly by patients with bipolar disorder, whereas cost reduction was driven mainly by patients with schizophrenia. CONCLUSION: Inpatient use of quetiapine XR in schizophrenia or bipolar disorder is associated with reduced hospitalization length and cost, possibly due to the faster titration schedule versus quetiapine IR.

Partial response to proton pump inhibitor therapy for GERD: observational study of patient characteristics, burden of disease, and costs in the USA.

BACKGROUND: Disease burden and associated costs are not well understood among patients with gastroesophageal reflux disease (GERD) who have persistent symptoms despite optimized proton pump inhibitor (PPI) therapy. The aim of this study was to investigate disease burden and costs of GERD in partial responders to PPI therapy. METHODS: The Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US (REMAIN US) study was a 12-month, multicenter, noninterventional, observational study of 552 partial PPI responders in the USA. Participating sites were comprised of family practice (n = 30), internal medicine (n = 8), and specialist (gastroenterologist) centers (n = 15). GERD symptoms, health-related quality of life (HRQL), and impact on productivity were evaluated from patient-reported outcome instruments. Resource utilization data were also collected. RESULTS: Patients had a high symptom burden, impaired HRQL, and reduced productivity while at work and in daily activities, despite optimized PPI therapy. Mean annual GERD-related costs were US$9944 per patient, comprising total direct costs and mean productivity loss costs of US$4068 and US$5876 per patient, respectively. CONCLUSION: Patients with GERD and a partial response to PPI therapy have considerable direct and indirect costs, along with substantial impairments in HRQL and productivity.

Validity of a Work Productivity and Activity Impairment questionnaire for patients with symptoms of gastro-esophageal reflux disease (WPAI-GERD)--results from a cross-sectional study.

OBJECTIVES: To validate a Work Productivity and Activity Impairment questionnaire (WPAI-GERD) developed to measure lost productivity due to symptoms of gastro-esophageal reflux disease (GERD). METHODS AND DATA: The WPAI-GERD was administered along with two quality-of-life questionnaires, Quality of Life in Reflux and Dyspepsia (QOLRAD) and Short Form 36 (SF-36), to a Swedish working population (N = 136) visiting a general practitioner for symptoms attributed to GERD. Correlation coefficients were calculated between each productivity variable derived from the WPAI-GERD and symptom severity, symptom frequency, quality of life dimensions, age, and gender. Statistical tests were carried out to determine the relationship between each productivity variable and the severity of heartburn. RESULTS: High correlations (range: 0.30-0.75) were found between productivity and symptom severity as well as between productivity and quality-of-life dimensions related to work and daily activities. The results demonstrated the ability of the questionnaire to discriminate between different grades of heartburn severity. On average, patients with heartburn reported 2.5 hours absence from work, 23% reduced productivity while at work, and 30% reduced productivity while doing regular daily activities during the week preceding the consultation. The SF-36 scores implied that patients, especially those with moderate-to-severe heartburn, had a poor quality of life compared with a normal population. CONCLUSION: The results indicate a high convergent and discriminant validity of the WPAI-GERD questionnaire and also show that patients consulting a physician because of symptoms attributed to GERD report substantial impairment in both productivity and health-related quality of life.