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BACKGROUND: Because health plans each issue their own policies, drug coverage can vary. This variation can result in patients having unequal access to treatment. In this study, we evaluate commercial health plans' coverage policies for erythropoiesis-stimulating agents (ESAs) for patients with anemia resulting from chronic kidney disease (CKD). OBJECTIVES: To assess how a set of US commercial health plans cover ESAs for patients with anemia due to CKD. Our second objective was to examine the evidence that the plans reviewed when formulating their coverage policies. METHODS: We used the Tufts Medical Center Specialty Drug and Evidence and Coverage Database to identify coverage policies issued by 17 of the largest US commercial health plans for ESAs. The following drugs were indicated for anemia due to CKD: darbepoetin alfa, methoxy polyethylene glycol-epoetin beta, epoetin alfa (available as two brands), and epoetin alfa-epbx. Coverage policies were current as of May 2019. We determined whether the health plans applied any restrictions, such as step therapy protocols or patient subgroup restrictions, in their coverage policies. We categorized the evidence that plans cited to support their policies into seven categories: randomized controlled trials (RCTs), real-world evidence (RWE) studies (studies based on data collected in a real-world setting), other clinical studies (eg, single arm trials), systematic reviews and/or meta-analyses, clinical or treatment guidelines, health technology assessments, and economic evaluations. RESULTS: We categorized 72.5% of coverage policies (58/80 policies) as equivalent to the FDA label and 27.5% (22/80 policies) as more restrictive. In restricted policies, plans most often applied step therapy protocols (18/22 policies), followed by prescriber requirements (4/22 policies), and patient subgroup restrictions (3/22 policies). Five health plans applied restrictions in at least half of their coverage policies; seven plans did not apply restrictions in any policy. Plans that cited evidence reviewed an average of 10 citations across their ESA coverage policies, ranging from one to 29 studies. Plans varied with respect to the types of cited studies: at least 50% of evidence cited by five health plans was RCTs, while half or more of the evidence cited by four health plans was clinical or treatment guidelines. CONCLUSIONS: Health plans varied in how they covered ESAs for patients with anemia due to CKD and in the evidence cited in their coverage policies. Inconsistencies in plans' coverage policies may have implications for patients' access to ESAs. DISCLOSURES: This study was funded by Otsuka Pharmaceutical Development and Commercialization. Sanon, Redmond, and Mogahadam are employed by Otsuka Pharmaceutical. Michalopoulos was employed by Otsuka Pharmaceutical at the time of this study. Margaretos, Panzer, and Chambers are employed by Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health. Lai was with Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health at the time of this study.

Objectives To describe characteristics and compare clinical outcomes including falls, fractures, infections, and neuropsychiatric symptoms (NPS) among long-term care residents with dementia with and without agitation. Methods A cross-sectional secondary analysis of administrative healthcare data was conducted whereby residents with dementia residing in a long-term care facility for ≥12 months were identified from the AnalytiCare LLC database (10/2010-06/2014) and were classified into mutually exclusive cohorts (Agitation Cohort or No-Agitation Cohort) based on available agitation-related symptoms. Entropy balancing was used to balance demographic and clinical characteristics between the two cohorts. The impact of agitation on clinical outcomes was compared between balanced cohorts using weighted logistic regression models. Results The study included 6,265 long-term care residents with dementia among whom, 3,313 were included in the Agitation Cohort and 2,952 in the No-Agitation Cohort. Prior to balancing, residents in the Agitation Cohort had greater dementia-related cognitive impairment and clinical manifestations compared to the No-Agitation Cohort. After balancing, residents with and without agitation, respectively, received a median of five and four distinct types of medications (including antipsychotics). Further, compared to residents without agitation, those with agitation were significantly more likely to have a recorded fall (OR = 1.58), fracture (OR = 1.29), infection (OR = 1.18), and other NPS (OR = 2.11). Conclusions Agitation in long-term care residents with dementia was associated with numerically higher medication use and an increased likelihood of experiencing falls, fractures, infections, and additional NPS compared to residents without agitation, highlighting the unmet need for effective management of agitation symptoms in this population.

Myrlene Sanon Aigbogun,1 Dorothee Oberdhan,1 Michael J Doane,2 Jillian Rooney,2 Brian C Inyart,2 Christina S Pao,1 Alexis H Denny3 1Health Outcomes, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Health Outcomes Research, New York, NY, USA; 3Government Affairs, Polycystic Kidney Disease (PKD) Foundation, Kansas City, MO, USACorrespondence: Dorothee OberdhanHealth Outcomes, Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Boulevard, Rockville, MD, 20850, USATel +1 240-683-3517Fax +1 301-721-7517Email dorothee.oberdhan@otsuka-us.comBackground: Autosomal dominant polycystic kidney disease (ADPKD) is a rare inherited kidney disorder with considerable symptom burden and negative effects even in early-stage disease. Patients’ reporting of ADPKD symptom burden may differ from physicians’ impressions. In this quantitative, cross-section survey study, we evaluated patient and physician assessments of symptom burden at early- and late-stage ADPKD.Methods: In the United States, 300 patients with ADPKD and 155 physicians treating patients with ADPKD completed online surveys administered by Kantar. Disease stage was categorized as early (chronic kidney disease [CKD] stages 1– 3) or late (stages 4– 5). Patients completed the Work Productivity and Activity Impairment Questionnaire and reported current disease symptoms. Patients and physicians assessed impacts of ADPKD on daily life and burden of specific symptoms. Statistical analyses compared patient versus physician responses stratified by early- versus late-stage ADPKD.Results: We found that impairment in work productivity was statistically greater in late- versus early-stage CKD. Compared with physicians’ impressions, patients were more likely at early stages and less likely at later stages to report a moderate/strong impact of ADPKD on daily life. Among patients, 74% with early- and 88% with late-stage disease reported that ADPKD caused them to modify their daily lives. In early-stage disease, patients reported a statistically greater burden from feeling exhausted and less burden from dull kidney pain, cardiovascular problems, high blood pressure, and liver cysts than physicians assumed. At later stages, patients reported feeling exhausted and skeletal/joint pain as more burdensome, and frequent urination, high blood pressure, liver cysts, and hematuria as less burdensome, compared with physicians’ impressions.Conclusion: The results of this survey study demonstrate a disconnect between patients’ experiences and physicians’ awareness of the burden of ADPKD and highlight the need for more patient/physician discussion of symptoms and disease management.Keywords: autosomal dominant polycystic kidney disease, ADPKD, symptom burden, patient reports, physician views, survey

Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%) were initiated within 3 months of the onset of their studied agitation episode, and 62.8% experienced multiple agitation episodes before initiation. While non-pharmacological therapies are recommended first-line approach for agitation in dementia, use of non-pharmacological therapy before initiation of antipsychotics was reported for only 37.8% of patients in residential care and 21.3% in community-based settings. Conclusion: Most patients were initiated on an antipsychotic treatment after multiple episodes of agitation and largely without initial non-pharmacological therapy, suggesting that current treatment guideline recommendations for first-line non-pharmacological intervention may not be adequately followed in clinical practice. Understanding the clinical burden and treatment patterns among dementia patients with agitation is imperative for effective disease management.

Background Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common inherited kidney diseases characterized by progressive development of renal cysts and numerous extra-renal manifestations, eventually leading to kidney failure. Given its chronic and progressive nature, ADPKD is expected to carry a substantial economic burden over the course of the disease. However, there is a paucity of evidence on the impact of ADPKD from a societal perspective. This study aimed to estimate the direct and indirect costs associated with ADPKD in the United States (US). Methods A prevalence-based approach using data from scientific literature, and governmental and non-governmental organizations was employed to estimate direct healthcare costs (i.e., medical services, prescription drugs), direct non-healthcare costs (i.e., research and advocacy, donors/recipients matching for kidney transplants, transportation to/from dialysis centers), and indirect costs (i.e., patient productivity loss from unemployment, reduced work productivity, and premature mortality, caregivers’ productivity loss and healthcare costs). The incremental costs associated with ADPKD were calculated as the difference between costs incurred over a one-year period by individuals with ADPKD and the US population. Sensitivity analyses using different sources and assumptions were performed to assess robustness of estimates and account for variability in published estimates. Results The estimated total annual costs attributed to ADPKD in 2018 ranged from $7.3 to $9.6 billion in sensitivity analyses, equivalent to $51,970 to $68,091 per individual with ADPKD. In the base scenario, direct healthcare costs accounted for $5.7 billion (78.6%) of the total $7.3 billion costs, mostly driven by patients requiring renal replacement therapy ($3.2 billion; 43.3%). Indirect costs accounted for $1.4 billion (19.7%), mostly driven by productivity loss due to unemployment ($784 million; 10.7%) and reduced productivity at work ($390 million; 5.3%). Total excess direct non-healthcare costs were estimated at $125 million (1.7%). Conclusions ADPKD carries a considerable economic burden, predominantly attributed to direct healthcare costs, the majority of which are incurred by public and private healthcare payers. Effective and timely interventions to slow down the progression of ADPKD could substantially reduce the economic burden of ADPKD.

Background The cost and health-related quality of life (HRQoL) burden associated with treatments for anaemia of chronic kidney disease (CKD) is not well characterized among non-dialysis-dependent (NDD) patients. Objective Our objective was to review the literature on costs and HRQoL associated with current treatments for anaemia of CKD among NDD patients. Methods The Cochrane Library, MEDLINE, Embase, NHS EED, and NHS HTA databases were searched for original studies published in English between 1 January 2000 and 17 March 2017. The following inclusion criteria were applied: adult population; primary focus was anaemia of CKD; patients received iron supplementation, red blood cell transfusion, or erythropoiesis-stimulating agents (ESAs); and reported results on HRQoL and/or costs. Studies that included NDD patients, did not compare different treatments, and had relevant designs were retained. HRQoL and cost outcomes were summarized in a narrative synthesis. Results In total, 16 studies met the inclusion criteria: six randomized controlled trials, four prospective single-arm trials, three retrospective studies, one prospective observational study, one simulation study, and one cross-sectional survey. All included ESAs. Treatment of anaemia (compared with no treatment) was associated with HRQoL improvements in five of six studies and lower costs in four of four studies. Treatment aiming for higher haemoglobin targets (compared with lower targets) resulted in modest HRQoL improvements, higher healthcare resource utilization (HRU), and higher costs. Conclusions In NDD patients, untreated anaemia of CKD leads to higher costs, higher HRU, and lower HRQoL compared with initiating anaemia treatment. Relative to aiming for lower haemoglobin targets with ESAs, higher targets conferred modest HRQoL improvements and were associated with higher HRU.

Objectives:More than 90% of individuals with Alzheimer’s disease (AD) experience behavioral and neuropsychiatric symptoms (NPS), such as agitation. However, little is known regarding the specific burden of agitation for Alzheimer’s patients.Design:A global systematic literature review was conducted in MEDLINE and Embase for studies of clinical, humanistic, and economic burden of agitation in AD/dementia published from 2006–2016. References of identified papers and related literature reviews were examined. Studies meeting predetermined inclusion criteria for burden of agitation/NPS were summarized.Results:Eighty papers met the inclusion criteria for burden of agitation in dementia. Wide ranges of agitation prevalence were reported, but few papers provided information on incidence. The association of agitation with AD severity was presented in multiple studies; a few suggested positive association of agitation with mortality.Conclusions:High prevalence of agitation is consistent with earlier reports, but several gaps in understanding of agitation in AD need further exploration.

Introduction Agitation in individuals with Alzheimer's disease (AD) may predict institutionalization. This study assessed the incremental risk and costs associated with agitation in individuals with AD. Methods A retrospective analysis of the National Alzheimer's Coordinating Center Uniform Data Set (June 2005–February 2018) was conducted. Incremental risk of institutionalization associated with agitation was estimated and used with the number of institutionalized individuals with AD and agitation and costs of living by residential setting in the United States (literature-based), to estimate incremental institutionalization costs. Results The analysis included 11,348 individuals with AD: 6603 (58.2%) with and 4745 (41.8%) without agitation. Compared with individuals without agitation, those with agitation were 20% more likely to be institutionalized (odds ratio = 1.20; 95% CI = 1.08–1.33). Total incremental cost of institutionalization associated with agitation was $4.3 billion ($50,588/individual). Discussion Agitation is associated with a higher risk of institutionalization among patients with AD, which translates into a substantial economic burden., Highlights • Agitation in Alzheimer's disease portends higher risk of institutionalization. • Higher institutionalization risk translates into a substantial economic burden. • Agitation-related institutionalization cost was ∼$4.3 billion in the United States.

Background Agitation is a common neuropsychiatric symptom of Alzheimer disease (AD). Data are scarce regarding agitation prevalence among community-dwelling patients with AD. Objective To estimate agitation prevalence in a sample of US patients with AD/dementia overall and by AD/dementia disease severity, using data from electronic health records (EHR). Methods This retrospective database study examined community-dwelling patients with ≥1 EHR record indicating AD/dementia from January 2008 to June 2015 and no evidence of non-Alzheimer dementia during the 12-month preindex and postindex periods. Agitation was identified using diagnosis codes for dementia with behavioral disturbance and EHR abstracted notes records indicating agitation symptoms compiled from the International Psychogeriatric Association provisional consensus definition. Results Of 320 886 eligible patients (mean age, 76.4 y, 64.7% female), 143 160 (44.6%) had evidence of agitation during the observation period. Less than 5% of patients with agitation had a diagnosis code for behavioral disturbance. The most prevalent symptom categories among patients with agitation, preindex and postindex, were agitation (31.4% and 41.3%), falling (22.6% and 21.7%), and restlessness (18.3% and 23.3%). Among the 78 827 patients (24.6%) with known AD/dementia severity, agitation prevalence was 61.3%. Agitation during the observation period was most prevalent for moderate-to-severe and severe AD/dementia (74.6% and 68.3%, respectively) and lowest for mild AD/dementia (56.4%). Conclusions Agitation prevalence was 44.6% overall and 61.3% among patients with staged AD/dementia. Behavioral disturbance appeared to be underdiagnosed. While agitation has previously been shown to be highly prevalent in the long-term care setting, this study indicates that it is also common among community-dwelling patients.

Myrlene Sanon Aigbogun,1 Robert A Stellhorn,1 Christina S Pao,1 Stephen L Seliger2 1Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 2University of Maryland School of Medicine, Baltimore, MD, USACorrespondence: Stephen L SeligerUniversity of Maryland School of Medicine, 10 N. Greene Street, Baltimore, MD, 21201, USATel +410 605-7000 x5231Fax +410 328-5685Email sseliger@som.umaryland.eduBackground: Progression of autosomal dominant polycystic kidney disease (ADPKD) is highly variable, with some patients progressing rapidly to end-stage renal disease (ESRD). Abdominal imaging is an important modality for verifying diagnosis in patients at risk for rapidly progressing ADPKD, targeting them for early treatment that could slow onset of ESRD. Published literature is limited on the real-world abdominal imaging utilization patterns in ADPKD.Methods: A retrospective healthcare administrative claims analysis examining abdominal imaging scans occurring from January 1, 2014, through June 30, 2017, was conducted using the IBM MarketScan® commercial and Medicare supplemental databases. Patients in the United States who were at least 18 years old and had at least 1 inpatient claim or 2 outpatient claims (with different dates of service) with an ADPKD diagnosis code, as defined by the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM codes 753.12 [polycystic kidney, unspecified type] and 753.13 [polycystic kidney, autosomal dominant] and/or Tenth Revision (ICD-10-CM codes Q61.2 [polycystic kidney, adult type] and Q61.3 [polycystic kidney, unspecified]) were included.Results: Of the 4637 patients with ADPKD (mean age, 51.2 years [SD = 15.52]), 59% had ≥ 1 abdominal imaging scan. Of these patients, 46% had ≥ 1 computed tomography (CT) scan, 25% had ≥ 1 ultrasound, 10% had ≥ 1 magnetic resonance imaging scan. Among the 1754 patients (38%) with chronic kidney disease (CKD) stage information, CT imaging was more frequent in later stages (31% stage 1 versus 68% stage 5). The proportion of patients undergoing at least 1 CT or MRI scan increased with disease severity (37% in stage 1, 42% in stage 2, 48% in stage 3, 56% in stage 4, and 71% in stage 5).Conclusion: Results of this analysis support the need for further investigation into abdominal imaging utilization in managing patients with ADPKD. Future research could clarify barriers and increase access to imaging, which has the potential to inform risk stratification, help patients delay dialysis or transplantation associated with ESRD, and help health systems avoid the costs associated with ESRD.Keywords: polycystic kidney, autosomal dominant, kidney diseases, cystic, MRI, CT scan, ultrasound

To evaluate geographic variation in the prevalence of autosomal dominant polycystic kidney disease (ADPKD) in the US, including ADPKD at risk of rapid progression. Claims data from the IBM MarketScan Commercial and Medicare Supplemental databases (01/16/2016–12/31/2017) were used to estimate the 2017 annual and 2016–2017 two-year prevalence of diagnosed ADPKD and ADPKD at risk of rapid progression in the US overall, and stratified by census regions and states. Risk of rapid progression was identified based on either: hypertension r = .34, one-sided p = .026). In 2017, 37.5% of patients were identified as being at risk for rapid progression, and this proportion was larger among patients in the South (42.1%, p This estimate for ADPKD prevalence is consistent with previously reported national estimates, with regional variation suggesting that ADPKD might be under-diagnosed in rural areas with more limited access to care. More than one-third of ADPKD patients presented risk factors associated with rapid progression, highlighting the need for timely identification, as disease-modifying therapy may delay progression to end-stage renal disease.

To build upon previous outdated studies by comprehensively assessing the direct healthcare burden of autosomal dominant polycystic kidney disease (ADPKD). Patients with ≥2 diagnoses for ADPKD (ADPKD cohort) were identified in the US fee-for-use IBM Truven Health Analytics MarketScan Commercial Claims and Encounters and IBM Truven Health Analytics MarketScan Medicare Supplemental databases (01 January 2015–31 December 2017) and matched (1:3) to controls without ADPKD (non-ADPKD cohort). The index date was the last calendar date followed by 12 months continuous enrollment (study period). Patients with ADPKD were stratified into one of seven mutually exclusive groups based on chronic kidney disease (CKD) stages (I–V), end-stage renal disease requiring renal replacement therapy (ESRD-RRT), and unknown stage. During the 12-month study period, patients with ADPKD incurred significantly higher total healthcare costs than those without ADPKD (mean cost difference = $22,879 per patient per year [PPPY]; p p Results may not be representative of the overall ADPKD US population; CKD stage was based on diagnosis and procedure codes; criteria used to identify ADPKD at risk of rapid progression did not rely on laboratory values; there may be billing inaccuracies and omissions in health insurance claims data. This study demonstrated the substantial healthcare costs associated with ADPKD, which increased as patients progressed through more severe CKD stages.

Importance Atypical antipsychotics (AAPs) are often used off-label to manage dementia-associated neuropsychiatric symptoms. In 2005, the US Food and Drug Administration (FDA) issued a boxed warning for the use of AAPs in elderly patients. The long-term association of this warning with health outcomes is unknown to date. Objective To assess the long-term association of the 2005 FDA boxed warning on AAPs with psychiatric medication and opioid use, health events, and quality of life among elderly individuals with dementia. Design, Setting, and Participants For this cross-sectional study, data were analyzed from the household component of the Medical Expenditure Panel Survey (MEPS), the National Ambulatory Medical Care Survey (NAMCS), and the National Hospital Ambulatory Medical Care Survey (NHAMCS) fielded between January 1, 1996, and December 31, 2014. This interrupted time-series analysis applied to 3-year moving means derived from the 1996-2014 MEPS, NAMCS, and NHAMCS. All survey respondents included in this analysis were 65 years or older and had dementia. Data analysis was performed from December 1, 2017, to March 15, 2018. Exposures The 2005 FDA boxed warning on AAPs. Main Outcomes and Measures Use of psychiatric medications and opioids, prevalence of cerebrovascular and cardiovascular events, prevalence of falls and/or fractures, 2-year mortality, and health-related quality of life assessed by the Medical Outcomes Study 12-Item Short-Form Health Survey scores. Results A total of 2430 (MEPS) and 5490 (NAMCS and NHAMCS) respondents were identified, corresponding to weighted populations of 22 996 526 (MEPS) and 65 502 344 (NAMCS and NHAMCS) noninstitutionalized elderly individuals with dementia (mean [SD] age, 81.06 [1.13] years; 63.1% female). In the MEPS sample, compared with before 2005, AAP use (from an annual slope of 0.99 to −0.18 percentage points), cerebrovascular events (0.75 to −0.50 percentage points), and falls and/or fractures (−1.72 to −0.40 percentage points) decreased and opioid use (0.04 to 1.29 percentage points), antiepileptic use (−0.42 to 1.21 percentage points), cardiovascular events (−0.13 to 1.30 percentage points), and 2-year mortality risk (−0.68 to 0.18 percentage points) increased. Health-related quality of life remained relatively unchanged. The NAMCS and NHAMCS sample yielded similar findings. Conclusions and Relevance These data suggest that the 2005 FDA boxed warning was associated with some unintended negative patient outcomes.

Introduction This study aims to evaluate the conceptual relevance of four measures of disease activity in patients with mild/mild-moderate Alzheimer's disease (AD): (1) the Alzheimer's Disease Assessment Scale–Cognitive Subscale; (2) the Alzheimer's Disease Cooperative Study–Activities of Daily Living Inventory; (3) the Neuropsychiatry Inventory; and (4) the Dependence Scale. Methods A conceptual model depicting patient experience of mild AD was developed via literature review; concepts were compared with the items of the four measures. Relevance of the concepts included in the four measures was evaluated by patients with mild AD in a survey and follow-up interviews. Results The four measures assessed few of the symptoms/impacts of mild AD identified within the literature. Measured items addressing emotional impacts were deemed most relevant by participants but were included in the measures only superficially. Discussion The four assessment measures do not appear to capture the concepts most relevant to/important to patients with mild/mild-moderate AD., Highlights • Many impacts associated with mild Alzheimer's disease were reported by patients. • The included outcome measures assessed did not provide high conceptual coverage. • These four measures appeared more suitable for more severe Alzheimer's disease. • Completion of patient reported outcomes should be possible in this patient population. • These may be currently used in addition to clinician- and observer-reported outcomes.

Introduction Alzheimer’s disease (AD) is the most common neurodegenerative form of dementia. Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and memantine, have been available in the USA since 2000. Over the past decade, few studies have analyzed real-world anti-dementia treatment patterns in the USA. This study evaluated monotherapy AChEIs and memantine treatment patterns among newly diagnosed AD patients. Methods A retrospective cohort study was conducted using Medicare data and the Minimum Data Set from 2008 to 2012. Patients aged 65–100 years with newly diagnosed AD (ICD-9 code: 331.0) and monotherapy AChEI or memantine treatment initiated after diagnosis were included. Descriptive treatment pattern analyses, including discontinuation and switch, were undertaken. Kaplan–Meier curves were developed to examine the treatment duration. Results A total of 9812 newly diagnosed AD patients were identified, with 56.7% (n = 5567) first receiving anti-dementia treatment after the initial AD diagnosis. Among patients initiating monotherapy AChEIs or memantine after AD diagnosis (N = 5200), 51.6% continued index treatment during the entire follow-up period (mean follow-up: 659.7 days) and 21.7% discontinued treatment. Of those who initiated monotherapy treatment with an AChEI, 11.1% received adjunct therapy with memantine. Among patients with ≥1 year of continuous treatment (mean follow-up: 834 days), 75.6% remained on the index drug, 10.2% discontinued during the remaining follow-up period, and 9.5% of the AD patients initiating AChEIs received adjunct memantine therapy during the remaining follow-up period. Conclusion In the USA Medicare population, about 50% of the patients who initiated treatment with AChEI or memantine after diagnosis continued the index treatment, and more than 20% discontinued and were untreated afterwards over the observation period. AD patients initiating AChEIs or memantine were more likely to remain on their treatment if they were persistently treated for the first year. Electronic supplementary material The online version of this article (doi:10.1007/s40120-017-0067-7) contains supplementary material, which is available to authorized users.

Introduction Dementia is a prevalent condition in older adults associated with decline in cognitive and functional abilities and substantial burden. This study assessed the prevalence and impact of subjective memory impairment in the United States. Methods The 2011 to 2014 National Health and Nutrition Examination Survey, a population‐based, nationally representative survey, was analyzed. Data included medical examinations, self‐reported cognitive and functional limitations, and health care utilization over 1 year. Participants were aged ≥65 years and completed both interview and medical examination components. Descriptive analyses of patient characteristics were performed, and complex survey regression models were used to test associations. Results Of 2431 survey participants included, 53.1% had no memory impairment, 40.1% had early‐stage memory impairment, and 6.6% had late‐stage memory impairment. In adjusted analyses, late‐stage versus no impairment was associated with more functional limitations (odds ratio [OR] = 7.26, P

Background: In people with dementia, neuropsychiatric symptoms (NPSs), especially agitation, are associated with worse quality of life and caregiver burden. As NPSs may vary with illness severity, knowledge of how people with dementia and their caregivers describe and rate the importance of agitation symptoms can improve the understanding of the clinical meaningfulness of the manifestations of agitation. The internet provides new opportunities to better understand patient experiences, as patients and caregivers increasingly look to Web-based platforms as a means of managing symptoms. Objective: The aim of this study was to examine Web-based reports from a dementia symptom website to better understand the symptoms of agitation and explore how they are being targeted for monitoring by caregivers of people with dementia. Methods: The Dementia Guide website hosts a Web-based database used by caregivers (97%) and people with dementia (3%). From its 61 dementia symptoms, users can select relevant symptoms that they deem important to monitor or track the effects of treatment. We employed a staging algorithm to determine if individuals had mild cognitive impairment (MCI) or mild, moderate, or severe dementia. Agitation was defined using terms consistent with the International Psychogeriatrics Association’s provisional consensus definition. We compared the proportion of people with NPSs and agitation across stages of dementia severity and studied how many agitation-defining descriptors were selected, and how often they occurred, by stage. Results: As of March 2017, 4121 people had used the tracking tool, of whom 2577 provided sufficient data to allow disease severity staging. NPSs were tracked by 2127/2577 (82.54%) and agitation by 1898/2577 (73.65%). The proportion in whom agitation was tracked increased with increasing cognitive impairment: 68.5% (491/717) in people with MCI, and 72.50% (754/1040), 73.3% (378/516), and 90.5% (275/304) in mild, moderate, and severe dementia, respectively (χ23=54.9; P

Alzheimer’s disease or dementia can impose a significant burden on family and other informal caregivers. This study investigated how the inclusion of family/informal caregiver spillover effects in a cost-utility analysis may influence the reported value of Alzheimer’s disease/dementia interventions. We used PubMed to identify Alzheimer’s disease or dementia cost-utility analyses published from 1 January, 2000 to 31 March, 2018. We reviewed and abstracted information from each study using a two-reader consensus process. We investigated the frequency and methods in which family/caregiver spillover costs and health effects were incorporated into cost-utility analyses, and examined how their inclusion may influence the reported incremental cost-effectiveness ratios. Of 63 Alzheimer’s disease/dementia cost-utility analyses meeting inclusion criteria, 44 (70%) considered at least some family/caregiver spillover costs or health effects. Thirty-two studies incorporated spillover costs only, two incorporated spillover health effects only, and ten incorporated both. The most common approach for accounting for spillover was adding informal caregiving time costs to patient costs (n = 36) and adding informal caregiver quality-adjusted life-years to patient values (n = 7). In a subset of 33 incremental cost-effectiveness ratio pairs from 19 studies, incorporating spillover outcomes made incremental cost-effectiveness ratios more favorable (n = 15; 45%) or kept the intervention cost saving (n = 13; 39%) in most cases. In fewer cases, including spillover increased incremental cost-effectiveness ratios (n = 2; 6%), kept the intervention dominated [more costs/less quality-adjusted life-years] (n = 2; 6%), or changed incremental cost-effectiveness ratio from dominated to less cost/less quality-adjusted life-years (n = 1; 3%). In 11 cases (33%), adding spillover effects into analyses resulted in a lower incremental cost-effectiveness ratio that crossed a common cost-effectiveness threshold, which could have downstream implications for programs or policies that are adopted based on cost-effectiveness analysis results. Most Alzheimer’s disease/dementia cost-utility analyses incorporated spillover costs, often as caregiver time costs, but considered spillover health impacts less often. In about 85% of the analyses, including Alzheimer’s disease/dementia spillover cost or health effects decreased incremental cost-effectiveness ratios or kept the intervention cost saving. The broader value of an Alzheimer’s disease/dementia intervention to society may in some cases be underestimated without considering these spillover effects on family and informal caregivers.

Aims: The overall cost and health-related quality of life (HRQoL) associated with current treatments for chronic kidney disease (CKD)-related anemia are not well characterized. A systematic literature review (SLR) was conducted on the costs and HRQoL associated with current treatments for CKD-related anemia among dialysis-dependent (DD) patients. Materials and methods: The authors searched the Cochrane Library, MEDLINE, EMBASE, NHS EED, and NHS HTA for English-language publications. Original studies published between January 1, 2000 and March 17, 2017 meeting the following criteria were included: adult population; study focus was CKD-related anemia; included results on patients receiving iron supplementation, red blood cell transfusion, or erythropoiesis stimulating agents (ESAs); reported results on HRQoL and/or costs. Studies which included patients with DD-CKD, did not directly compare different treatments, and had designs relevant to the objective were retained. HRQoL and cost outcomes, including healthcare resource utilization (HRU), were extracted and summarized in a narrative synthesis. Results: A total of 1,625 publications were retrieved, 15 of which met all inclusion criteria. All identified studies included ESAs as a treatment of interest. Two randomized controlled trials reported that ESA treatment improves HRQoL relative to placebo. Across eight studies comparing HRQoL of patients achieving high vs low hemoglobin (Hb) targets, aiming for higher Hb targets with ESAs generally led to modest HRQoL improvements. Two studies reported that ESA-treated patients had lower costs and HRU compared to untreated patients. One study found that aiming for higher vs lower Hb targets led to reduced HRU, while two other reported that this led to a reduction in cost-effectiveness. Limitations: Heterogeneity of study designs and outcomes; a meta-analysis could not be performed. Conclusions: ESA-treated patients undergoing dialysis incurred lower costs, lower HRU, and had better HRQoL relative to ESA-untreated patients. However, treatment to higher Hb targets led to modest HRQoL improvements compared to lower Hb targets.

Background Although patients with dementia frequently experience neuropsychological symptoms (NPS) such as agitation, which profoundly impacts patients, caregivers, and the healthcare system, few studies have evaluated the associated burden of agitation or agitation-related symptoms in dementia. Methods This retrospective analysis of claims data from the Truven Health MarketScan® database (2012–2015) compared clinical characteristics, treatment patterns, healthcare resource utilization, and costs among patients with dementia with behavioral disturbances (BD) versus patients with dementia without BD. Existing BD diagnosis codes 294.11 or 294.21 were used as a means to identify patients with agitation/agitation-related symptoms. Results From a starting sample of 6.4 million beneficiaries, 103,402 patients with dementia were identified, of whom 16,440 (16%) had BD during an average of 17 months of follow-up. Patients with BD had significantly more medical and psychiatric comorbidities and greater comedication use (i.e., antidementia drugs, antidepressants, and antipsychotics; all values, P

Nephrology nurses face health and wellness challenges due to significant work-related stressors. This survey, conducted online between July 24 and August 17, 2020, assessed the psychological well-being of nephrology nurses in the United States during the COVID-19 pandemic (n = 393). Respondents reported feeling burned out from work (62%), symptoms of anxiety (47% with Generalized Anxiety Disorder-7 [GAD-7] scores ≥ 5), and major depressive episodes (16% with Patient Health Questionnaire-2 [PHQ-2] scores ≥ 3). Fifty-six percent (56%) of survey respondents reported caring for COVID-19 patients, and 62% were somewhat or very worried about COVID-19. Factors, including high workload, age, race, and the COVID-19 pandemic, may partially explain the high proportion of nephrology nurses who reported symptoms of burnout, anxiety, and depression.

Objective The objective of this study was to estimate the US societal economic burden of schizophrenia and update the 2002 reported costs of $62.7 billion given the disease management and health care structural changes of the last decade. Methods A prevalence-based approach was used to assess direct health care costs, direct non-health care costs, and indirect costs associated with schizophrenia (ICD-9 codes 295.xx) for 2013, with cost adjustments where necessary. Direct health care costs were estimated using a retrospective matched cohort design using the Truven Health Analytics MarketScan Commercial Claims and Encounters, Medicare Supplemental, and Medicaid Multistate databases. Direct non-health care costs were estimated for law enforcement, homeless shelters, and research and training. Indirect costs were estimated for productivity loss from unemployment, reduced work productivity among the employed, premature mortality (ie, suicide), and caregiving. Results The economic burden of schizophrenia was estimated at $155.7 billion ($134.4 billion-$174.3 billion based on sensitivity analyses) for 2013 and included excess direct health care costs of $37.7 billion (24%), direct non-health care costs of $9.3 billion (6%), and indirect costs of $117.3 billion (76%) compared to individuals without schizophrenia. The largest components were excess costs associated with unemployment (38%), productivity loss due to caregiving (34%), and direct health care costs (24%). Conclusions Schizophrenia is associated with a significant economic burden where, in addition to direct health care costs, indirect and non-health care costs are strong contributors, suggesting that therapies should aim at improving not only symptom control but also cognition and functional performance, which are associated with substantial non-health care and indirect costs.

Myrlene S Aigbogun,1 Sizhu Liu,2 Siddhesh A Kamat,1 Christophe Sapin,3 Amy M Duhig,2 Leslie Citrome4 1Health Economics and Outcomes Research, Otsuka Pharmaceutical Development and Commercialization, Inc, Princeton, NJ, USA; 2Global Health Economics and Outcomes Research, Xcenda, Palm Harbor, FL, USA; 3Global Analytics, Lundbeck, Paris, France; 4Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA Objective: This study used a decision-analytic framework to assess the cost-effectiveness of brexpiprazole vs comparator branded therapies for reducing relapses and hospitalizations among adults with schizophrenia from a US payer perspective.Methods: An economic model was developed to assess patients with stable schizophrenia initiating treatment with brexpiprazole (1–4 mg), cariprazine (1–6 mg), or lurasidone (40–80 mg) over a 1-year period. After 6 months, patients remained on treatment or discontinued due to relapse, adverse events, or other reasons. Patients who discontinued due to relapse or adverse events were assumed to have switched to other therapy, and those who discontinued due to other reasons were assumed to have received no therapy. Primary outcomes were incremental cost per relapse avoided and hospitalization avoided, and the secondary outcome was cost per quality-adjusted life-year (QALY) gained. Sensitivity and scenario analyses were also conducted.Results: Brexpiprazole was associated with the highest per-patient clinical effectiveness (avoided relapses 0.637, avoided hospitalizations 0.719, QALYs 0.707) among comparators, followed by cariprazine (avoided relapses 0.590, avoided hospitalizations 0.683, QALYs 0.683) and lurasidone (avoided relapses 0.400, avoided hospitalizations 0.536, QALYs 0.623). Annual per-patient health-care costs were lowest for brexpiprazole ($20,510), followed by cariprazine ($22,282) and lurasidone ($25,510). Brexpiprazole was the least costly and most effective treatment strategy for all outcomes. Results were sensitive to relapse rates and daily cost of brexpiprazole. Limitations include data principally obtained from drug-specific randomized withdrawal studies and lack of direct-comparison trials.Conclusion: This analysis evaluated brexpiprazole treatment for the reduction of schizophrenia relapses and hospitalizations over a 1-year period compared to other recently available branded antipsychotics, and excluded generic antipsychotic treatments. Brexpiprazole treatment may lead to clinical benefits and medical cost savings, and provides a cost-effective treatment option for patients relatively to other branded second-generation antipsychotics. Keywords: schizophrenia, cost-effectiveness, relapse prevention, cost-benefit, indirect analysis, event avoided, hospitalization avoided, brexpiprazole

Introduction Agitation is among the most common behavioral symptoms of dementia and poses a major challenge for the treatment and management of individuals with dementia. A few studies have shown agitation may be an important predictor of institutionalization; however, these studies were limited to very small sample sizes and focused on behavioral symptoms in general. This study aimed to assess the rate of institutionalization by agitation severity level in patients with dementia. Methods A retrospective cohort analysis was undertaken using the National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS), comprising data from 39 past and present Alzheimer's Disease Centers across the United States supported by the National Institute on Aging/National Institute of Health. Eligible individuals had dementia due to Alzheimer's disease, were not institutionalized as of the index date, and had known information on key variables (including residence status) as of the index date and the following annual visit. Agitation severity level was assessed using reported scores per the Neuropsychiatric Inventory Questionnaire (NPI-Q), a behavioral assessment scale. More specifically, agitation was defined per the NPI-Q agitation/aggression scale, where 1=mild (noticeable, but not a significant change), 2= moderate (significant, but not a dramatic change), and 3=severe (very marked or prominent; a dramatic change). Patients with no agitation at any time were included in the “No agitation cohort”. For each patient in the “No agitation cohort”, one visit was randomly selected among all of the patient's visits during which a score on the NPI-Q for the agitation domain was recorded, and the date of the selected visit was defined as the index date. Patients with at least one visit with a score greater than 0 on the agitation domain of the NPI-Q at any time were included in the “Agitation cohort” and classified in the Mild, Moderate, or Severe cohort based on their score on the agitation domain of the NPI-Q as of their index date. For each patient, one visit was randomly selected among all of the patient's visits where a score greater than 0 on the NPI-Q for the agitation domain was recorded, and the date of the selected visit was defined as the index date. Entropy balancing was used to reweight baseline characteristics of individuals included in the “Agitation cohort” and those in the “No agitation cohort” based on age; gender; race; ethnicity; education; primary language; marital status; blood pressure (systolic and diastolic); resting heart rate; active depression; and Clinical Dementia Rating, Geriatric Depression Scale, Modified Hachinski Ischemia Scale, and Functional Activities Questionnaire scores. Institutionalization rates were assessed among balanced cohorts at the first annual visit following the index date. Results A total of 4,344 individuals met the sample selection criteria for the study, of whom 2,798 (64%) were classified as having agitation per the NPI-Q agitation/aggression scale and 1,546 (36%) were in the “No agitation cohort”. Among patients in the balance cohort, 50% were female, 82% were white, and the mean age was 75.2 years ± 9.7. The proportion of patients by agitation severity level at index was 62.2% with mild agitation, 29.5% with moderate agitation, and 8.3% with severe agitation. The risk of transitioning to long-term care over a 12-month period was 4.78% for no agitation, 7.84% for mild agitation, 8.19% for moderate agitation, and 10.13% for severe agitation. Conclusions Study findings support increasing rates of long-term residential placement as agitation progresses which is interlinked with the natural disease progression. To our knowledge, this is one of the few studies reporting rates of institutionalization by agitation severity level, underscoring a need for research and innovation in a prevalent yet underserved condition. This research was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. Lundbeck LLC

Introduction Agitation is among the most common behavioral symptoms of dementia and poses a major challenge for the treatment and management of individuals with dementia. Very few studies report patients’ dependence levels by agitation severity. This study aims to assess the level of care dependency including patients’ functional status. Methods A retrospective cohort analysis was undertaken using the National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS), comprising data from 39 past and present Alzheimer's Disease Centers across the United States supported by the National Institute on Aging/National Institute of Health. Eligible individuals had dementia due to Alzheimer's disease and known information on key variables. Agitation severity level was assessed using reported scores per the Neuropsychiatric Inventory Questionnaire (NPI-Q), a behavioral assessment scale. More specifically, agitation was defined per the NPI-Q agitation/aggression scale, where 1=mild (noticeable, but not a significant change), 2= moderate (significant, but not a dramatic change), and 3=severe (very marked or prominent; a dramatic change). Functional status was based on scores reported from the Functional Activities Questionnaire (FAQ) scale ranging 0 to 30, where a score higher than 9 indicates impaired function and possible cognitive impairment. Dependence status was assessed per the question assessing level of dependence and response options included: 1) able to live independently, 2) requires some assistance with complex activities, 3) requires some assistance with basic activities, 4) completely dependent, and 5) unknown. Patients were classified as having agitation if they were reported to have agitation based on the NPI-Q scale for at least one visit. The index date was randomly selected among all visits with agitation, and the severity of agitation was based on the NPI-Q scale as of the index date. For patients without agitation, the index date was randomly selected among all visits. Outcomes were assessed during the 12-month period following the index date (or the next visit if there were no other visits within 12 months). Results A total of 11,346 individuals met the sample selection criteria for the study, of whom 4,745 (42%) were classified as having no agitation per the NPI-Q agitation/aggression scale, 3,861 (34%) with mild agitation, 2,084 (18%) with moderate agitation, and 656 (6%) with severe agitation. The proportion by severity level who reported being “completely dependent” were as follows: 10.2% for no agitation, 21.8% for mild agitation, 29.0% for moderate agitation, and 35.4% for severe agitation. Mean FAQ scores were 14.5 for no agitation, 18.0 for mild agitation, 20.6 for moderate agitation, and 21.9 for severe agitation. Conclusions Study findings show greater dependency and higher functional impairment with progressing agitation. To our knowledge, this is one of the few studies reporting rates of care dependency by agitation severity level, underscoring a need for research and innovation in a prevalent yet underserved condition. This research was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. Lundbeck LLC