Dorsal root ganglion stimulation (DRG-s) for potential resolution of restless leg syndrome symptoms and increased cost savings for patients: A case study.

INTRODUCTION: We report successful use of dorsal root ganglion stimulation (DRG-s) to treat a patient with persistent symptoms of restless leg syndrome (RLS). METHODS: The treatment involved the placement of a small device millimeters away from the patient's DRG, which are nerves near the spinal cord that carry sensory information from the periphery of the body to the brain. The device automatically delivers electrical impulse to the DRG to alter and decrease pain perception in the brain. RESULTS: Our case report elucidates the use of this procedure as a targeted therapy for RLS, with a nearly 90% reduction in reported symptoms in our patient, thus potentially reducing morbidity associated with this condition. Furthermore, we report a 10-year cost savings of nearly $90,000 following DRG-s for our patient. CONCLUSION: This case study aims to demonstrate the effectiveness of DRG-s neuromodulation in managing RLS, a condition that is often difficult and costly to treat.

Cost-effectiveness of TOMAC therapy for medication-refractory restless legs syndrome: an updated analysis based on Extension study data.

AIMS: Patients with medication-refractory restless legs syndrome (RLS) have limited therapeutic options available for symptom relief. Tonic motor activation (TOMAC) presents a novel, non-invasive therapy for this patient population. The aim of this study was to conduct an updated cost-effectiveness analysis of TOMAC therapy based on recently available longer-term follow-up data. MATERIALS AND METHODS: A previously published decision-analytic Markov model was utilized to project strategy-specific costs and outcomes over three-years and lifetime for TOMAC compared to status quo treatment (control). Cohort characteristics were based on 24-week clinical data from the extension cohort of the RESTFUL study, which included longer-term follow-up of RESTFUL completers who were assigned to continue or discontinue TOMAC use (TOMAC and control, respectively). The primary analysis outcome was the incremental cost-effectiveness ratio (ICER) in $ per quality-adjusted life year (QALY) gained, calculated using change in International RLS Study Group Rating Scale (IRLS) score as the effect measure. Extensive sensitivity analyses were performed. RESULTS: TOMAC treatment improved IRLS by 5.9 versus control, resulting in estimated utility improvement of +0.05. Over three-years and lifetime, TOMAC added 0.14 and 0.73 QALYs, at incremental costs of $6,751 and $27,440, resulting in projected ICERs of $47,609 and $37,823 per QALY gained, respectively. TOMAC was found to be cost-effective across all tested sensitivity analyses. LIMITATIONS AND CONCLUSION: The inclusion of longer follow-up data in the current analysis confirms earlier exploratory cost-effectiveness findings and suggest TOMAC therapy may provide a high-value treatment option for patients with medication-refractory RLS.

Restless Legs Syndrome (RLS) is a is a neurological disorder, usually chronic, that causes an overwhelming urge to move one's legs, with pronounced implications for patients' quality of life. While pharmaceutical treatment options exist, a substantial proportion of patients are considered refractory to drug treatment. Tonic motor activation (TOMAC) therapy is a novel non-invasive neurostimulation approach that was recently cleared for market in the United States. This study sought to provide an updated economic analysis based on recently available data with longer follow-up. The findings of this study, based on data from the RESTFUL Extension study, suggest TOMAC therapy can be a high-value treatment alternative for refractory patients, providing meaningful quality of life improvement at costs that render it cost-effective in the United States. Future data with further extended follow-up will be useful to further broaden the evidence base underpinning these findings.

Health care resource utilization and costs associated with restless legs syndrome among managed care enrollees treated with dopamine agonists.

PURPOSE: This study assessed the direct economic burden of restless legs syndrome (RLS) among patients treated with dopamine agonists (DAs) using a large United States managed care database. DESIGN: Retrospective database analysis. METHODOLOGY: Patients were required to have > or =1 prescriptions for a DA (i.e., pergolide, pramipexole, ropinirole) between 1/1/2005 and 12/31/2007 (date of first DA, or "index"); continuous enrollment for > or =6 months before and > or =12 months after index; > or =1 diagnosis of RLS, before and after index; and no diagnosis of Parkinson's disease. Study measures included annual all-cause and RLS-related costs by care setting (hospitalizations, emergency room, office, pharmacy, other, total) and treatment-pattern events (discontinuations, switches, adjunctive treatments, titrations). PRINCIPAL FINDINGS: A total of 7,796 patients met the inclusion criteria. About 70% of patients received ropinirole, and 30% received pramipexole at index. Approximately 91% had >1 RLS-related office visits, and patients filled an average of 6.5 RLS-related prescriptions (DAs, gabapentin, carbidopa/levodopa) during the 1-year follow-up period. Mean (SD) all-cause health care costs were $11,485 ($21,362) per patient, mostly due to multiple medical conditions occurring with RLS. RLS-related costs were 6.7% of total all-cause costs (mean [SD] $774 [$1,504]), consisting of office visits (16%), pharmacy (63%), and other costs (20%). Approximately 58% had a treatment-pattern event suggesting a dopamine-related side effect. Opioids were the most commonly used adjunctive therapy (13% of patients). CONCLUSION: We found relatively low costs associated with RLS treatment. These findings should encourage expanding the coverage of treatment to reduce the suffering and costs associated with RLS.

Prevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United States.

To assess prevalence, disease burden, and costs of primary Restless Legs Syndrome (RLS) in the US. In 2007, 61,792 (20%) of 313,000 subjects from a representative US panel completed an online "global opinions" survey identifying respondents reporting all four diagnostic features of RLS. 4,484 met all criteria. 1,400 were randomly selected to complete a questionnaire to exclude those with diagnoses indicating possible secondary RLS. Those that did not have diagnoses associated with secondary RLS were asked to complete the Cambridge-Hopkins RLS questionnaire to exclude RLS mimics. Prevalence was estimated for the following groups: (1) RLS symptomatic, (2) primary RLS, and (3) primary RLS sufferers (symptoms ≥2/wk with moderate-to-severe distress). The primary RLS completed a larger online survey including the IRLS, EuroQol, Work Productivity and Activity Impairment questionnaire, and questions about healthcare resource use. The validated diagnostic tools and exclusion of medical conditions likely to cause RLS provide a very conservative estimate of US census-weighted prevalence of 2.4% for primary RLS and 1.5% for primary RLS sufferers. About 33% of respondents had a physician diagnosis of RLS. Primary RLS sufferers had a mean productivity loss of 1 day/wk. All RLS-related costs increased with RLS symptom severity, with increasingly significant decrements in health status, sleep disturbance, and work productivity. Even this very conservative approach finds RLS in this cohort to be common, under-diagnosed, and carried a significant personal and social burden.

Economic and human costs of restless legs syndrome.

Restless legs syndrome (RLS) is a common and often underestimated neurological disorder, with a prevalence ranging from approximately 2.5% to 10% in Western industrialized countries. The aim of the present study was to summarize the research findings on the human and economic costs associated with RLS in populations without any co-morbidities or potentially confounding health conditions. A further objective was to identify studies on the cost effectiveness of RLS treatments. A systematic literature search was performed. Two researchers independently assessed the relevance of each publication. Studies published before August 2008 were included if they assessed quality of life in patients suffering from RLS, determined total or patient-related costs attributable to RLS, and/or evaluated the cost effectiveness of treatment options for RLS. A total of 725 references were identified, including 100 full-text articles. Fifteen of these publications met all of the selection criteria and were included in the present review. Seven abstracts that focused on the economic burden of RLS and/or the cost effectiveness of different treatment strategies in RLS patients were also included. RLS was associated, in the included studies, with reductions in quality of life similar to those seen in patients with other chronic conditions. The cost-of-illness studies were heterogeneous but indicated that RLS was associated with a substantial economic burden, resulting in high direct and indirect costs to society. Although effective and cost-effective treatments appear to be available, further research is warranted, especially regarding the economic burden of RLS and the cost effectiveness of available treatment options.

Allocating provider resources to diagnose and treat restless legs syndrome: a cost-utility analysis.

OBJECTIVES: Restless legs syndrome (RLS) is a neurological disorder that is frequently misdiagnosed, resulting in delays in proper treatment. The objective of this study was to analyze the cost-utility of training primary care providers (PCP) in early and accurate diagnosis of RLS. METHODS: We used a Markov model to compare two strategies: one where PCPs received training to diagnose RLS (informed care) and one where PCPs did not receive training (standard care). This analysis was conducted from the US societal and health sector perspectives over one-year, five-year, and lifetime (50-year) horizons. Costs were adjusted to 2016 USD, utilities measured as quality-adjusted life-years (QALYs), and both measures were discounted annually at 3%. Cost, utilities, and probabilities for the model were obtained through a comprehensive review of literature. An incremental cost-effectiveness ratio (ICER) was calculated to interpret our findings at a willingness-to-pay threshold of $100,000/QALY. Univariate and multivariate analyses were conducted to test model uncertainty, in addition to calculating the expected value of perfect information. RESULTS: Providing training to PCPs to correctly diagnose RLS was cost-effective since it cost $2021 more and gained 0.44 QALYs per patient over the course of a lifetime, resulting in an ICER of $4593/QALY. The model was sensitive to the utility for treated and untreated RLS. The probabilistic sensitivity analysis revealed that at $100,000/QALY, informed care had a 65.5% probability of being cost-effective. CONCLUSION: A program to train PCPs to better diagnose RLS appears to be a cost-effective strategy for improving outcomes for RLS patients.

The Humanistic and Economic Burden of Restless Legs Syndrome.

UNLABELLED: RLSOBJECTIVES: To evaluate the humanistic and economic burden of a restless legs syndrome (RLS) diagnosis with regard to health-related quality of life, work productivity loss, healthcare resource use, and direct and indirect costs. STUDY DESIGN: Self-reported data came from the 2012 National Health and Wellness Survey (NHWS), a large, annual, nationally representative cross-sectional general health survey of US adults. METHODS: RLS patients (n = 2,392) were matched on demographic and health characteristics to Non-RLS respondents via propensity score matching differences between groups were tested with Bivariate and multivariable analyses. RESULTS: RLS patients had significantly lower health-related quality of life scores: Mental Component Summary (44.60 vs. 48.92, p<.001), Physical Component Summary (40.57 vs. 46.78, p<.001), Health Utilities (.63 vs. .71, p<.001) and higher levels of work productivity loss in the past seven days including absenteeism (8.1% vs. 3.9%, p<.001), presenteeism (26.5% vs. 15.8%, p<.001), and overall productivity loss (30.1% vs. 18.1%, p<.001) as well as general activity impairment (46.1% vs. 29.7%, p<.001) [corrected]. RLS patients had significantly higher healthcare resource use in the past 6 months than non-RLS patients: healthcare provider visits (7.46 vs. 4.42%, p<.001), ER visits (0.45 vs. 0.24, p<.001), and hospitalizations (0.24 vs. 0.15, p<.001). RLS patients also had higher estimated direct and indirect costs than non-RLS patients. Finally, it was found that across outcomes increasing severity is associated with increased economic and humanistic burden for RLS patients. CONCLUSIONS: RLS patients suffer a greater humanistic and economic burden than those without RLS. Moreover as severity increases so does the burden of RLS.

The real burden of restless legs syndrome: clinical and economic outcomes.

Restless legs syndrome (RLS) is a highly prevalent and substantially underdiagnosed sensorimotor disorder. Only relatively recently have the large impact on patient quality of life (QoL) and the economic burden associated with RLS become more widely recognized. QoL in patients with RLS has been shown to be worse than that of many other chronic conditions, including type 2 diabetes, clinical depression, and osteoarthritis. Sleep disturbance, a cardinal feature of RLS, is the most common and most destructive of its symptoms. More than two-thirds of RLS patients experience serious insomnia, and waking up several times per night is typical for this patient population. Moreover, RLS disrupts rest during waking hours, such as when the patient is sitting or relaxing. Thus, whether awake or asleep, the RLS patient finds little opportunity for the general restorative behaviors necessary for healthy human functioning, resulting in high rates of comorbidities including depression, anxiety, and hypertension. The direct and indirect costs related to RLS have been evaluated in a few studies. Although the cost studies are associated with certain limitations (eg, use of questionnaires), the results show that costs related to RLS are substantial. Healthcare utilization, primarily in the form of doctor visits, constitutes the largest proportion of direct expenditures for RLS in the United States. Indirect costs are also large, primarily due to productivity losses, which are as high as 20% in RLS patients. Effective treatment of RLS is necessary to limit the negative effects of RLS on QoL and to reduce costs associated with the condition.

Health economic burden of patients with restless legs syndrome in a German ambulatory setting.

The primary characteristics of restless legs syndrome (RLS), including severe sleep disorders, restlessness in the evening and discomfort while at rest, have substantial impact on normal daily activities. Because of the high prevalence of RLS in the general population, it is necessary to evaluate the economic impact of RLS. To determine the health economic burden of patients with RLS in Germany. A total of 519 RLS patients (mean age: 65.2 +/- 11.1 years) in different stages of disease were recruited in five health centres (university hospitals, district hospitals and office-based neurologists) by applying the diagnostic criteria of the International Restless Legs Syndrome Study Group. A questionnaire was administered that assessed healthcare resource consumption as well as socioeconomic, demographic, clinical and health status. In addition, the International RLS severity scale (IRLS), Epworth Sleepiness Scale (ESS), EQ-5D and Beck Depression Inventory (BDI) were addressed in the assessment. Direct and indirect costs (euro, year 2006 values) were derived from various German economic resources and calculated from the perspective of the healthcare and transfer payment providers. We calculated average total costs over the 3-month observation period. It was determined that average total costs were euro2090 for this period. The average direct medical and non-medical costs from the perspective of the health insurance provider were determined to be euro780, with euro300 attributed to drug costs and euro354 to hospitalization costs. Average total indirect costs amounted to euro1308 and were calculated based on productivity loss, using the human capital approach. As cost-driving factors we identified disease severity according to the IRLS (p < 0.01) and ESS (p < 0.04). Health-related quality of life was determined to be substantially affected by RLS; the mean EQ-5D visual analogue scale (VAS) was 55.6, considerably lower than that of the age-matched general population. RLS places a notable financial burden on society as well as on patients and their families. More detailed studies are needed to evaluate the health economic impact of this disorder.

[Socioeconomic relevance of the idiopathic restless legs syndrome (RLS) in Germany: cost-of-illness study]. / Sozioökonomische Bedeutung des idiopathischen Restless-Legs-Syndroms (RLS) für Deutschland: Krankheitskostenanalyse.

BACKGROUND AND PURPOSE: 1.3% of German adults suffer from clinically relevant restless legs syndrome (RLS). A cost-of-illness study was conducted to evaluate the costs for diagnosis and therapy of the idiopathic RLS. METHODS: A clinical pathway based on expert guidelines was developed. The costs for the 1st year of treatment in idiopathic RLS were calculated with the Markov Model. Relevant published clinical study data were used for the model as well as questioning of physicians. RESULTS: Costs per patient with approved drug treatment are 989.80 Euro for sickness funds and 1,285.26 Euro from the societal perspective. Drug costs are the main cost components for sickness funds and the society with 69% and 61%, respectively. Less than half of the patients continue an L-dopa therapy longer than 1 year. About one quarter of all RLS patients need off-label therapy after the 1st year of treatment. CONCLUSION: The costs for a guideline-oriented therapy for all patients with clinically relevant RLS in Germany are about 1,135 billion Euro, representing 0.5% of all health-related costs in Germany. Further controlled clinical trials are required to provide evidence for the efficacy of different treatment options including drugs without an approval for RLS and long-term use. Health services research is required for cost-utility analysis, to evaluate the costs of inadequate treatment, and to obtain additional information to improve the resource allocation in RLS treatment.

Cost-effectiveness of licensed treatment options for restless legs syndrome in the UK and Sweden.

OBJECTIVE: To estimate the cost-effectiveness of pramipexole versus no treatment and ropinirole in moderate to very severe idiopathic restless legs syndrome (RLS) in the UK and Sweden. METHODS: A Markov model was developed using clinical trial data for pramipexole and ropinirole. Model health states were based on the International RLS Study Group Rating Scale (IRLS) scores. Health states were: no (IRLS 0), mild (IRLS 1-14), moderate (IRLS 15-24), severe (IRLS 25-34), very severe RLS (IRLS 35-40) and death. Patients entered the model with an IRLS score > 15 matching the trial inclusion criteria of the pramipexole trials. Resource use and utilities were based on trial data, literature, a patient survey and a panel of physicians from the UK and Sweden in the absence of published information. A healthcare sector perspective was taken for the UK and a societal perspective for Sweden using 2004-2005 unit costs. The base case analysis took a 1-year timeframe. RESULTS: In the UK the incremental cost per quality-adjusted life year (QALY) for pramipexole was 3349 pounds sterling versus no treatment and a cost-saving of 92 pounds sterling against ropinirole. In Sweden, pramipexole produced cost-savings of Swedish Krona (SEK) 2381 (176 pounds sterling) versus no treatment and SEK 3564 (264 pounds sterling) against ropinirole. QALY gains in both countries were 0.095 versus no treatment and 0.007 versus ropinirole. Results compare well with UK cost-effectiveness thresholds of 20,000 pounds sterling/30,000 pounds sterling per QALY and are cost-saving for Sweden. One-way and probabilistic sensitivity analyses showed results to be robust. CONCLUSIONS: Pramipexole is cost-effective compared to no treatment and ropinirole for patients with moderate to very severe RLS.