Quality of Life and Caregiver Burden of Alzheimer's Disease Among Community Dwelling Patients in Europe: Variation by Disease Severity and Progression.

BACKGROUND: Alzheimer's disease (AD) is a significant burden on patients and caregivers. How this burden increases as disease progresses has not been well researched. OBJECTIVE: To assess the association of caregiver burden and quality of life with Alzheimer's disease severity and disease progression in community-dwelling patients in Germany, Spain, and the UK. METHODS: This was a prospective observational longitudinal study of mild-to-moderate AD patients (assessed by Mini-Mental State Examination, MMSE), and their caregivers. The humanistic burden was assessed using these instruments: [Rapid Assessment of Physical Activity (RAPA), EuroQoL-5-Dimension Level (EQ-5D-5L)] and caregiver-reported [Dependence Scale (DS), EQ-5D-5L, Zarit Burden Interview (ZBI)]. Caregiver-reported healthcare resource use was assessed using the Resource Use in Dementia (RUD) and ad-hoc questions. RESULTS: Of 616 patients recruited, 338 and 99 were followed-up at 12 and 18 months, respectively. The caregiver-reported EQ-5D-5L scores of patients' health-related quality of life (HRQoL) showed a negative trend over time (baseline: 0.76; 18 months: 0.67) while patient-reported HRQoL remained at 0.85. DS scores tended to worsen. Disease progression was an independent predictor of HRQoL and increased dependence.Mean ZBI score increased over time reflecting an increase in caregiver burden; MMSE being an independent predictor for caregiver burden. Patient resource utilization and caregiver time for caregiving tended to increase over time. CONCLUSION: We found significant association between disease progression and caregiver and patient burden. Independently, both disease-specific outcomes and disease burden measures increased over time, but as disease progresses, we also found incremental burden associated with it.

Impact of Dementia-Related Behavioral Symptoms on Healthcare Resource Use and Caregiver Burden: Real-World Data from Europe and the United States.

BACKGROUND: Dementia is commonly accompanied by neurobehavioral symptoms; however, the relationship between such symptoms and health-related outcomes is unclear. OBJECTIVE: To investigate the impact of specific neurobehavioral symptoms in dementia on healthcare resource use (HCRU), patient quality of life (QoL), and caregiver burden. METHODS: Data were taken from the 2015/16 Adelphi Real World Dementia Disease Specific Programme™, a point-in-time survey of physicians and their consulting dementia patients. Multiple regression analyses were used to examine associations between patient symptom groups and health-related outcomes. RESULTS: Each patient symptom group of interest (patients with agitation/aggression and related symptoms [AARS] with psychosis, patients with AARS without psychosis, and patients with other behavioral symptoms) had a positive association with HCRU variables (i.e., HCRU was greater), a negative association with proxy measures of patient QoL (i.e., QoL was decreased), and a positive association with caregiver burden (i.e., burden was greater) compared with patients with no behavioral symptoms (control group). The magnitude of effect was generally greatest in patients with AARS with psychosis. Regression analysis covariates that were found to be most often significantly related to the outcomes were dementia severity and the patients' living situation (i.e., whether they were in nursing homes or living in the community). CONCLUSION: Combinations of behavioral symptoms, particularly involving AARS plus psychosis, may have a detrimental impact on health-related outcomes such as HCRU, patient QoL, and caregiver burden in dementia. Our results have implications for intervention development in patients who report clusters of symptoms and caregivers, and for identifying at-risk individuals.

Assessing the Progression of Alzheimer's Disease in Real-World Settings in Three European Countries.

BACKGROUND: There exists considerable variation in disease progression rates among patients with Alzheimer's disease (AD). OBJECTIVE: The primary objective of this observational study is to assess the progression of AD by characterizing cognitive, functional, and behavioral changes during the follow-up period between 6 and 24 months. METHODS: A longitudinal prospective study with community-dwelling patients with an established clinical diagnosis of AD of mild to moderate severity was conducted in Germany, Spain and the UK. A sample of 616 patients from 69 sites was included. RESULTS: Patients had a mean of 1.9 years (SD = 1.9) since AD diagnosis at study inclusion. Cognitive symptoms were reported to have first occurred a mean of 1.1 years (SD = 1.7) prior to AD diagnosis and 1.4 (SD = 1.8) years prior to AD treatment. Patients initially diagnosed with mild and moderate AD spent a median (95%CI) of 3.7 (2.8; 4.4) and 11.1 (6.1, 'not reached') years until progression to moderate and severe AD, respectively, according to the Mini-Mental State Examination (MMSE) scores. A mixed model developed for cognitive, functional, and neuropsychiatric scores, obtained from study patients at baseline and during follow-up period, showed progressive deterioration of AD patients over time. CONCLUSION: The study showed a deterioration of cognitive, functional, and neuropsychiatric functions during the follow-up period. Cognitive deterioration was slightly faster in patients with moderate AD compared to mild AD. The duration of moderate AD can be overestimated due to the use of retrospective data, lack of availability of MMSE scores in clinical charts and exclusion of patients at time of institutionalization.

Multi-National, Cross-Sectional Survey of Healthcare Resource Utilization in Patients with All Stages of Cognitive Impairment, Analyzed by Disease Severity, Country, and Geographical Region.

BACKGROUND: Alzheimer's disease (AD) is one of the most disabling conditions worldwide and the disease burden increases with the aging global population. There are only a few prospective studies using real-world data to support effective healthcare resource utilization (HCRU) in AD. OBJECTIVE: To confirm the association between HCRU and AD severity in a real-world population, including patients with all cognitive impairment (CI) severities. METHODS: Data were drawn from a multi-national, cross-sectional survey of physicians and their consulted patients with all stages (very mild, mild, moderate, and severe) of CI including AD conducted in France, Germany, Italy, Spain, UK, US, and Canada. Elements of HCRU including medical consultations, professional caregiver hours, hospitalization, and institutionalization were compared between CI severity subgroups, and by country and region. RESULTS: 6,143 CI patients were included with very mild (n = 659), mild (n = 2,473), moderate (n = 2,603), and severe (n = 408) dementia. HCRU increased with increasing CI severity (p < 0.001) for the majority of elements measured. Further analyses of overall and regional populations also confirmed significant increases in most HCRU elements with increasing disease severity. The general trend toward increased HCRU with increased CI severity was also seen in individual countries. Individual country data appeared to indicate that earlier intervention decreased hospitalizations and full-time institutionalization at the later (more severe) disease stages. CONCLUSION: Our findings confirmed that HCRU increases with increasing CI severity. Effective intervention in early disease could therefore reduce or delay incurring greater HCRU costs associated with more severe disease. Further studies are needed to confirm this hypothesis.

Quantifying and Describing the Natural History and Costs of Alzheimer's Disease and Effects of Hypothetical Interventions.

BACKGROUND: A long-term horizon is necessary when the socioeconomic consequences and the potential effects of interventions in Alzheimer's disease (AD) are estimated. OBJECTIVES: To illustrate the potential societal costs of AD across the disease continuum and to illustrate the potential cost-effectiveness of a hypothetical intervention with disease modifying treatment (DMT). METHODS: Based on the Swedish dementia registry, a Markov model was used to simulate a virtual cohort of 100,000 people with mild cognitive impairment (MCI) due to AD (AD-MCI) in Sweden for 40 years starting at the age of 60. A simulated hypothetical intervention assumed a 25% reduction in progression rate during AD-MCI and mild AD-dementia. A comprehensive set of sensitivity analyses was included. RESULTS: The cumulative risk to develop dementia was 96%. The mean simulated survival was 19.0 years. The net present value for a person year with dementia was 252,843 SEK (about 29,500 US$). The cost effectiveness model illustrated how the hypothetical scenario of a 25% reduction in progression to AD-dementia would require 41 AD-MCI patients to be treated to prevent one case of AD-dementia (2,447 avoided AD-dementia cases of 100,000 with AD-MCI). Most scenarios illustrated hypothetical cost effectiveness (based on a willingness to pay level of 600,000 SEK (70,000 US$) per gained QALY), but not cost savings. DISCUSSION: Lifetime societal costs of AD are substantial. A future DMT may be potentially cost-effective given assumed treatment effects and costs, but cost savings are unlikely.

Quantifying the diagnostic pathway for patients with cognitive impairment: real-world data from Australia.

OBJECTIVES: Rapid diagnosis of dementia is essential to ensure optimum patient care. This study used real-world data to quantify the dementia diagnostic pathway in Australia. DESIGN: A real-world, cross-sectional survey of physicians and patients. SETTING: Clinical practice. PARTICIPANTS: Primary care or specialist physicians managing patients with cognitive impairment (CI). MEASUREMENTS: Descriptive analyses focused on key events in the diagnostic pathway. Regression modeling compared the duration between first consultation and formal diagnosis with various factors. RESULTS: Data for 600 patients were provided by 60 physicians. Mean time from initial symptoms to first consultation was 6.1 ± 4.4 months; 20% of patients had moderate or severe CI at first consultation. Mean time from first consultation to formal diagnosis was 4.0 ± 7.4 months (1.2 ± 3.6 months if not referred to a secondary physician, and 5.3 ± 8.3 months if referred). Time from first consultation to diagnosis was significantly associated with CI severity at first consultation; time was shorter with more severe CI. There was no association of disease severity and referral to a secondary physician; 69.5% of patients were referred, the majority (57.1%) to a geriatrician. The highest proportion of patients were diagnosed by geriatricians (47.4%). Some form of test or scale was used to aid diagnosis in 98.8% of patients. CONCLUSIONS: A substantial number of Australians experience cognitive decline and behavioral changes some time before consulting a physician or being diagnosed with dementia. Increasing public awareness of the importance of early diagnosis is essential to improve the proportion of patients receiving comprehensive support prior to disease progression.

The Diagnostic Pathway From Cognitive Impairment to Dementia in Japan: Quantification Using Real-World Data.

OBJECTIVE: This study aimed to quantify the diagnostic pathway from cognitive impairment (CI) to dementia in Japan. METHODS: This was a real-world, cross-sectional survey of patients with CI and their physicians. RESULTS: Data for 1107 patients were provided by 106 physicians. Mean time from initial symptoms to the first consultation was 7.4±6.9 months; 42% of patients had moderate/severe CI at first consultation. Mean time from the first consultation to formal diagnosis was 2.9±11.0 months (1.9±8.8 mo if not referred to a secondary physician, and 5.1±14.6 mo if referred). Time from the first consultation to diagnosis was shorter with more severe CI at first consultation (P=0.0072). The highest proportion of patients were diagnosed by neurologists (45.8%). Tests or scales were used to aid diagnosis in 81.2% of patients. There was no association of disease severity and referral to a secondary physician; 30.9% of patients were referred, the majority (57.7%) to a neurologist. CONCLUSIONS: A substantial proportion of patients with dementia in Japan experience CI for some time before consulting a physician. Government policy to increase public understanding and awareness of dementia, and a proposed dementia screening system, should increase the proportion of individuals consulting physicians before disease progression.

Non-professional caregiver burden is associated with the severity of patients' cognitive impairment.

BACKGROUND/OBJECTIVES: To analyse the relationship between caregiver burden and severity of patients' cognitive impairment. DESIGN: Data were drawn from the cross-sectional 2015/2016 Adelphi Real World Dementia Disease-Specific Programme. SETTING: This research was multi-national and studied physicians and their consulting patients with cognitive impairment. PARTICIPANTS: 1,201 caregivers completed self-assessment forms. MEASUREMENTS: Validated instruments of caregiver wellbeing and burden (EQ-5D-3L questionnaire, EQ-VAS, Zarit Burden Interview, and Work Productivity and Activity Impairment questionnaire) and number of caregiver hours were analysed by severity of patients' cognitive impairment, categorised according to the Mini-Mental State Examination. Data were analysed using Spearman's rank correlation coefficients and ordinary least squares regression models, to compare outcomes between caregivers of patients with prodromal, mild, moderate, and severe dementia. RESULTS: The majority of caregivers were female (69.1%), lived with the patient they cared for (75.8%), and only approximately one third (28.3%) were in part- or full-time employment. There were statistically significant (p<0.001) increases in caregiver time (36.9 versus 108.6 hours per week for prodromal versus severe dementia, respectively) and measures of caregiver burden and health status (EQ-5D-3L, EQ-VAS, and Zarit Burden Interview) and increases in measures of work productivity and activity impairment with increasing severity of patients' disease. CONCLUSION: This study of real-world data confirmed an association between increased caregiver burden and severity of patients' cognitive impairment by analysis of a wide range of validated measures of caregiver burden. These findings suggest that maintaining patients in the earliest stages of their disease for as long as possible may potentially help to protect caregiver wellbeing, although further research is required to confirm this hypothesis.

Real-World, Multinational, Retrospective Observational Survey of the ADAS-Cog and Associations with Healthcare Resource Utilization in Patients with Alzheimer's Disease.

BACKGROUND: Alzheimer's disease (AD) is one of the most costly conditions, both economically and regarding patient disability and dependency. The huge costs coupled with the predicted increase in prevalence worldwide are likely to challenge healthcare systems in the future. The classic version of the Alzheimer's Disease Assessment Scale-Cognition subscale (ADAS-Cog) is generally seen as the current gold standard primary outcome measure of cognitive symptom progression in dementia clinical trials. OBJECTIVE: This study evaluated the relationship between ADAS-Cog scores as a measure of clinical progression and the healthcare resource utilization (HCRU)-measured burden of cognitive impairment in patients with mild cognitive impairment, AD, or suspected AD in the real world. METHODS: A retrospective observational survey of physicians and their consulting patients with multiple ADAS-Cog scores. Regression models were constructed for HCRU variables (e.g., consultations, hospitalizations, caregiving requirements) with ADAS-Cog rate of change, baseline ADAS-Cog, and their interaction included as exposure variables. RESULTS: 651 patient records were completed by 154 physicians. Approximately 70% of patients had mild to moderate dementia. In 56.7% of patients, clinical progression was maintained/stable from baseline. Mean change in ADAS-Cog (adjusted to 12 months) was 2.8 points and change scores increased with increasing dementia severity. Most HCRU variables increased significantly (p < 0.05; joint test) with increasing ADAS-Cog scores (indexing clinical deterioration). CONCLUSION: The results suggest that further understanding the relationship between HCRU and ADAS-Cog changes in real-world clinical practice could potentially provide a baseline upon which the success of disease-modifying, as well as newer symptomatic, dementia therapies can be judged.

Analysis of Episodes of Care in Medicare Beneficiaries Newly Diagnosed with Alzheimer's Disease.

OBJECTIVES: To study transitions between healthcare settings and quantify the cost burdens associated with different combinations of transitions during a 6-month period before initial Alzheimer's disease (AD) diagnosis so as to investigate how using an episode-of-care approach to payment for specific disease states might apply in AD. DESIGN: A retrospective observational cohort study. SETTING: United States. PARTICIPANTS: A random sample of 8,995 individuals aged 65 to 100 with a diagnosis of AD (International Classification of Diseases, Ninth Revision, Clinical Modification code 331.0) were identified from the Medicare database between January 1, 2011, and June 30, 2014. This analysis identified individuals with AD diagnosed in inpatient (18%), skilled nursing facility (SNF) (1%), hospice (4%), and home and outpatient (77%) settings and analyzed episodes that began in the index setting (defined as the care setting in which the individual was first diagnosed with AD). MEASUREMENTS: Study outcomes included number of transitions between settings, primary discharge diagnoses, and total all-cause healthcare costs during the 6 months after the AD diagnosis. RESULTS: The average numbers of transitions between care settings were 2.8 originating from an inpatient setting, 2.4 from a SNF, 0.3 from a hospice setting and 0.7 from a home or outpatient setting during 6 months post-AD diagnosis. The overall cost burden during the 6 months after AD diagnosis (including costs incurred at the index setting) was high for individuals diagnosed in a nonambulatory setting (mean $41,468). Individuals diagnosed in an ambulatory setting incurred only $12,597 in costs during the same period. CONCLUSION: Episodes of care can be defined and studied in individuals with AD. An episode-of-care approach to payment could encourage providers to use the continuum of care needed for quality medical management in AD more efficiently.

Quantifying the Diagnostic Pathway for Patients with Cognitive Impairment: Real-World Data from Seven European and North American Countries.

To ensure that patients with dementia and their caregivers receive appropriate treatment and support, early diagnosis is essential but remains challenging. Real-world data from a multi-national, cross-sectional survey of physicians and their patients were analyzed to quantify the diagnostic pathway for dementia, including a focus on severity of patients' cognitive impairment (CI) at the time of symptom onset, referral and subsequent diagnosis. Data were collected for 7,620 patients with CI. Most patients saw a healthcare professional within 1 year of first symptoms and received a diagnosis within 3-7 months of initial consultation. However, only 20% of patients received a diagnosis before their disease progressed beyond the prodromal stage and 23.5% already had moderate CI at diagnosis. These findings show that the goal of identifying and diagnosing CI at the earliest stages of disease is, for many patients, not achieved. Efforts toward public awareness and proactive, earlier detection and intervention, must be maintained-indeed where possible invigorated.

Economic Burden, Mortality, and Institutionalization in Patients Newly Diagnosed with Alzheimer's Disease.

BACKGROUND: Current information is scarce regarding comorbid conditions, treatment, survival, institutionalization, and health care utilization for Alzheimer's disease (AD) patients. OBJECTIVES: Compare all-cause mortality, rate of institutionalization, and economic burden between treated and untreated newly-diagnosed AD patients. METHODS: Patients aged 65-100 years with ≥1 primary or ≥2 secondary AD diagnoses (ICD-9-CM:331.0] with continuous medical and pharmacy benefits for ≥12 months pre-index and ≥6 months post-index date (first AD diagnosis date) were identified from Medicare fee-for-service claims 01JAN2011-30JUN2014. Patients with AD treatment claims or AD/AD-related dementia diagnosis during the pre-index period were excluded. Patients were assigned to treated and untreated cohorts based on AD treatment received post-index date. Total 8,995 newly-diagnosed AD patients were identified; 4,037 (44.8%) were assigned to the treated cohort. Time-to-death and institutionalization were assessed using Cox regression. To compare health care costs and utilizations, 1 : 1 propensity score matching (PSM) was used. RESULTS: Untreated patients were older (83.85 versus 81.44 years; p < 0.0001), with more severe comorbidities (mean Charlson comorbidity index: 3.54 versus 3.22; p < 0.0001). After covariate adjustment, treated patients were less likely to die (hazard ratio[HR] = 0.69; p < 0.0001) and were associated with 20% lower risk of institutionalization (HR = 0.801; p = 0.0003). After PSM, treated AD patients were less likely to have hospice visits (3.25% versus 9.45%; p < 0.0001), and incurred lower annual all-cause costs ($25,828 versus $30,110; p = 0.0162). CONCLUSION: After controlling for comorbidities, treated AD patients have better survival, lower institutionalization, and sometimes fewer resource utilizations, suggesting that treatment and improved care management could be beneficial for newly-diagnosed AD patients from economic and clinical perspectives.

Impact of rheumatoid arthritis on quality of life, work productivity and resource utilisation: an observational, cross-sectional study in Brazil.

OBJECTIVES: Increasing severity in rheumatoid arthritis (RA) may result in poorer health-related quality of life (HRQoL), reduced work productivity and increased resource utilisation. This study investigated the impact of RA severity on HRQoL and healthcare resource utilisation among RA patients in Brazil. METHODS: Data were drawn from an observational cross-sectional study of consulting RA patients undertaken in November-December 2007. Rheumatologists (n=55) provided information for 526 RA patients, 521 of whom also completed patient self-completion (PSC) questionnaires. Physicians subjectively rated each patient's RA as mild, moderate or severe. The PSC included the Work Productivity and Activity Impairment questionnaire (WPAI), Health Assessment Questionnaire Disability Index (HAQ-DI) and HAQ-Pain score, EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Data on the number of hospitalisations and consultations to healthcare professionals in the past 12 months and RA drug therapy class received were also collected. RESULTS: Patients with severe RA had significantly impaired health and work status compared to those with mild/moderate disease. Overall work and activity impairment rose with increasing disease severity. Health status deteriorated as disease severity increased with worsening disability, pain, fatigue, quality of life and perceived general health status. Hospitalisation rate and frequency of physician consultations were also significantly greater among those with severe RA. CONCLUSIONS: In Brazil, moderate to severe RA is associated with significant functional disability and morbidity. Disease severity should be considered when treating patients with RA. More aggressive treatment strategies may be needed to effectively manage patients with moderate to severe RA.

The impact of uncontrolled asthma on absenteeism and health-related quality of life.

OBJECTIVE: To evaluate the impact of uncontrolled asthma on the absenteeism and health-related quality of life (HRQOL) of adults and children with asthma and the caregivers of pediatric patients. PATIENTS AND METHODS: Patient information was obtained from datasets maintained by National Jewish Health for this cross-sectional study. Participants in the study were 12 years of age or older. Participants younger than 18 years had their information provided by caregivers. Caregivers also provided 6 months of absenteeism and QOL data. Participants were classified as having uncontrolled asthma based on a treatment and symptom guideline-based algorithm. Absenteeism was assessed from the self-reported number of work or school days missed due to asthma during the previous 6 months. HRQOL among adults was measured using the validated Marks Asthma Quality of Life Questionnaire (Marks-AQLQ) and among caregivers using the validated Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ). To account for the positive skew in absenteeism data, a zero-inflated Poisson regression model was used to compare group differences. HRQOL was analyzed for adults and caregivers using the Wilcoxon-Mann-Whitney test. RESULTS: A total of 15,149 patients met the inclusion criteria for the study and were included in the analysis. Adults with uncontrolled asthma and caregivers of children with uncontrolled asthma reported significantly higher absenteeism than their controlled counterparts: 43% vs 24% adults reported missing days of work, with a median 6 days vs 3 days missed; 31% vs 16% of caregivers reported missing days of work, with 4 days vs 2 days missed; and caregivers reported that more than 70% vs 45% pediatric patients missed school, with a median of 6 days vs 4 days missed (uncontrolled vs controlled asthma, respectively). Adult uncontrolled asthmatics and caregivers of uncontrolled pediatric patients had significantly lower HRQOL as indicated by the Marks-AQLQ (scores 1.5 points higher, p < 0.001) and PACQLQ (scores < 0.5 points lower, p < 0.001), respectively. CONCLUSIONS: Uncontrolled asthma has far-reaching impact on the productivity and quality of life of asthma patients and their caregivers. Proper assessment, treatment, and disease management to improve asthma control may reduce the impact of uncontrolled asthma on asthmatic adults, children, and the caretakers of pediatric asthmatic patients.

Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebo-controlled trial.

RATIONALE: An efficacious medical therapy for idiopathic pulmonary fibrosis (IPF) remains elusive. OBJECTIVES: To explore the efficacy and safety of etanercept in the treatment of IPF. METHODS: This was a randomized, prospective, double-blind, placebo-controlled, multicenter exploratory trial in subjects with clinically progressive IPF. Primary endpoints included changes in the percentage of predicted FVC and lung diffusing capacity for carbon monoxide corrected for hemoglobin (Dl(CO(Hb))) and change in the alveolar to arterial oxygen pressure difference P(a-a)(O(2)) at rest from baseline over 48 weeks. MEASUREMENTS AND MAIN RESULTS: Eighty-eight subjects received subcutaneous etanercept (25 mg) or placebo twice weekly as their sole treatment for IPF. No differences in baseline demographics and disease status were detected between treatment groups; the mean time from first diagnosis was 13.6 months and mean FVC was 63.9% of predicted. At 48 weeks, no significant differences in efficacy endpoints were observed between the groups. A nonsignificant reduction in disease progression was seen in several physiologic, functional, and quality-of-life endpoints among subjects receiving etanercept. There was no difference in adverse events between treatment groups. CONCLUSIONS: In this exploratory study in patients with clinically progressive IPF, etanercept was well tolerated. Although there were no differences in the predefined endpoints, a decreased rate of disease progression was observed on several measures. Further evaluation of TNF antagonists in the treatment of IPF may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 00063869).

Pharmacy and medical costs associated with switching between venlafaxine and SSRI antidepressant therapy for the treatment of major depressive disorder.

BACKGROUND: While much has been published on utilization of antidepressants and associated resource use, surprisingly little information is available on the relationship between a change in antidepressant agent and health care utilization. Given that many patients will not respond to initial therapy (and therefore would be candidates for switching treatment) and the array of antidepressant medications on the market, information on the impact of switching would be beneficial to both providers and policymakers. OBJECTIVE: To explore patterns of antidepressant drug use and depression-related and all-cause medical costs for patients who switched therapy between 2 drug classes, selective serotonin reuptake inhibitors (SSRIs) and the selective norepinephrine reuptake inhibitor (SNRI) venlafaxine. METHODS: Using an administrative claims database of 36 million members from 61 health plans, this retrospective cohort analysis examined patients who had (1) a diagnosis of major depressive disorder (MDD, International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 296.2x for MDD single episode, 296.3x for MDD recurrent episode, 300.4 for dysthymic disorder, and 311 for depressive disorder not elsewhere classified) and (2) a newly prescribed antidepressant during the year 2002. Costs were defined as amounts paid by health plans for all inpatient, outpatient, physician and pharmacy services (i.e., allowed charges after subtraction of member cost-share). Depression-related costs were defined using (1) medical claims with primary diagnosis of depression and (2) pharmacy claims for antidepressants. Using an index date of the first antidepressant claim, 12 months of pre-index and postindex data were available for all eligible patients. Switching was defined as occurring between the SSRIs and venlafaxine (i.e., patients who switched within the SSRI drug class across different SSRIs were treated as non-switchers until they switched to venlafaxine), and there was no minimum or maximum gap in therapy. The SSRIs included fluoxetine, citalopram, sertraline, and paroxetine; the only SNRI on the market at the time was venlafaxine. Multivariate regression analyses determined predictors of switching and factors influencing overall and depression-related costs, while controlling for confounding factors. For the 12-month period following the index date (fixed length of follow-up), the study compared per-patient per-year (PPPY) costs for (1) patients who switched versus those who did not switch and (2) patients with single versus multiple trials of SSRI for the subgroup of patients who switched from an SSRI to venlafaxine. For the time periods before versus after the switch (variable lengths of follow-up), per-patient means and medians of monthly cost averages (with follow-up periods <1 month set to 1 month for 16.5% [n=272] of SSRI-to-venlafaxine switchers and 14.1% [n=103] of venlafaxine-to-SSRI switchers) were calculated for the subgroup of patients who made a switch. RESULTS: A total of 48,950 patients were included in the study, with 43,653 (89.2%) treated first with SSRIs and 5,297 (10.8%) treated first with venlafaxine. Of the initial SSRI users, 1,645 (3.8%) switched to venlafaxine, and of the initial venlafaxine users, 733 (13.8%) switched to an SSRI. Mean (standard deviation [SD]) 12-month total (medical plus pharmacy) depression-related costs in 2002-2003 dollars were 118.0% higher for SSRI switchers ($1,225 [$3,438] vs. $562 [$2,153], P<0.001) and 18.4% higher for venlafaxine switchers ($863 [$1,503] vs. $729 [$1,185], P=0.021) as compared with non-switchers. From the pre-switch to post-switch periods, depression-related mean monthly medical costs declined by 66.4% among switchers from SSRIs ($113 [$912] vs. $38 [$347], P=0.001) and by 61.1% among switchers from venlafaxine ($54 [$299] vs. $21 [$138], P=0.005). Monthly mean depression-related pharmacy costs increased by 62.2% following a switch from an SSRI to venlafaxine (from $45 [$38] to $73 [$62], P<0.001) and declined by 17.3% following a switch from venlafaxine to an SSRI (from $52 [$45] to $43 [$38], P<0.001). After adjustment for multiple covariates including demographic characteristics, 10 selected comorbidities, and physician specialty, general linear models with log-transformed costs as the dependent variables demonstrated significant associations between switching and total costs (both all-cause and depression-related) in both the SSRI and the venlafaxine cohorts. CONCLUSIONS: Although relatively few patients switched antidepressant drug classes, patients who made a switch had higher all-cause health care costs and higher depression-related costs than patients who did not switch. Switching drug classes was associated with lower mean monthly depression-related health care costs following the switch. For those patients switching from an SSRI to venlafaxine, mean medical cost reductions offset higher pharmacy costs; for patients switching from venlafaxine to an SSRI, mean medical and pharmacy costs declined.

Overlap of anxiety and depression in a managed care population: Prevalence and association with resource utilization.

OBJECTIVE: To characterize the diagnosis of anxiety and depression within a large managed care population and to measure the impact of having both of these conditions on treatment patterns, health care utilization, and cost. Further, to compare the impact of having both conditions with having neither or either condition alone. METHOD: A retrospective, cross-sectional analysis of population-level anxiety-related and depression-related utilization over a 12-month study period was conducted. Data were from the PharMetrics Patient-Centric database, which is composed of medical and pharmaceutical claims for approximately 36 million patients from 61 health plans across the United States. Patients 18 years and older were included as cases in the analysis if they had a diagnosis of depression or anxiety during 2002. Four groups were identified based on the presence of anxiety and/or depression diagnosis: anxiety only, depression only, anxiety and depression, and controls. Controls were matched to the anxiety and depression cohort using a 4:1 ratio, based on patient age, gender, and similarity of health coverage. Cohorts were compared with respect to patient demographics, comorbid diagnoses, medication use, specialist care, utilization of health care services, and treatment costs, using both univariate and multivariate statistics. RESULTS: Significant differences in comorbid diagnoses, medication use, health care utilization, and treatment costs existed between the study groups. Specifically, patients with both anxiety and depression tended to have more somatic complaints such as abdominal pain, malaise, or chest pain than patients with either condition alone or the control group. Antidepressant use was highest among the anxiety and depression cohort, while anxiolytic use was as prevalent in the anxiety and depression cohort as in the anxiety only cohort. Patients in the anxiety only, depression only, or anxiety plus depression groups had a higher number of anxiety- and/or depression-related visits as well as visits not related to depression or anxiety than the control group, with the anxiety and depression cohort incurring the highest utilization of medical services. Similarly, in terms of cost, the disease cohorts incurred significantly higher cost than their control counterparts, with the anxiety and depression cohort incurring higher cost than those with either condition alone, even after accounting for differences in patient characteristics. CONCLUSIONS: Combination of anxiety and depression is fairly common in a managed care population as evidenced by diagnosis and treatment. The combination of both diagnoses appears to increase the complexity of these patients with respect to comorbid conditions as well as increases the economic cost to payers.

Recovery from depression predicts lower health services costs.

OBJECTIVE: To examine the association between outcome of acute-phase depression treatment and subsequent health services costs. METHOD: Data from 9 longitudinal studies of patients starting depression treatment were used to examine the relationship between outcome of acute-phase treatment and health services costs over the subsequent 6 months. All studies were 2- to 4-year studies conducted between the years 1991 and 2004. Assessment of diagnosis was done using the Inventory of Depressive Symptoms or the Structured Clinical Interview for DSM-IV. Clinical outcomes were assessed by structured telephone interviews using the Hamilton Rating Scale for Depression or a 20-item depression scale extracted from the Hopkins Symptom Checklist. Costs were assessed using health plan accounting records. RESULTS: Of 1814 patients entering treatment and meeting criteria for major depressive episode, 29% had persistent major depression 3 to 4 months later, 37% were improved but did not meet criteria for remission, and 34% achieved remission of depression. Those with persistent depression had higher baseline depression scores and higher health services costs before beginning treatment. After adjustment for baseline differences, mean health services costs over the 6 months following acute-phase treatment were 2012 dollars (95% CI = 1832 dollars to 2210 dollars) for those achieving remission, 2571 dollars (95% CI = 2350 dollars to 2812 dollars) for those improved but not remitted, and 3094 dollars(95% CI = 2802 dollars to 3416 dollars) for those with persistent major depression. Average costs for depression treatment (antidepressant prescriptions, outpatient visits, and mental health inpatient care) ranged from 429 dollars in the full remission group to 585 dollars in the persistent depression group. CONCLUSIONS: Among patients treated for depression in community practice, only one third reached full remission after acute-phase treatment. Compared with persistent depression, remission is associated with significantly lower subsequent utilization and costs across the full range of mental health and general medical services.

A one-year comparison of cost and outcomes of angioplasty in stent and nonstent patients.

Most studies on costs and outcomes of stent use in percutaneous transluminal coronary angioplasty (PTCA) have been limited to less than 1 year of follow-up, in-hospital costs, or regional samples. The objective of this study was to compare restenosis rates and all direct medical care costs during the 1-year period following stent PTCA and nonstent PTCA. A nationwide claims database covering 1.7 million lives was used to identify patients with PTCA during 1995 and no PTCA during the previous year. All costs and rate of restenotic events during the 1-year period following PTCA were examined. Symptomatic restenosis was defined as the occurrence of any of the following: repeat angioplasty, coronary artery bypass surgery (CABG), and myocardial infarction (MI). Stents were placed in 304 of 1367 identified patients. Both the rate of restenotic events (stent, 16.1%; no stent, 20.1%) and ischemic disease-related costs (stent, $9207; no stent, $10,498) were lower for patients with a stent during the follow-up period; however, the difference was not significant. Because of the higher cost of placing a stent during the initial procedure, patients with a stent had a significantly higher cost at the end of the 1-year period (stent, $49,245; stent, $40,683). Multivariate analyses further confirmed this finding. Thus, although restenotic events were lower for patients with stents by a nonsignificant margin, follow-up costs did not offset the higher cost of the initial stent placement.

Long-term resource use and cost of percutaneous transluminal coronary angioplasty versus stenting in the elderly: a retrospective claims data analysis.

OBJECTIVE: Although the benefits of coronary stenting have been demonstrated in several large clinical trials, controversy remains as to whether stenting results in long-term cost savings compared to percutaneous transluminal coronary angioplasty (PTCA). The objective of this study was to evaluate the resource use and cost (Medicare payment) of PTCA versus bare stent in actual practice over a 2-year period. METHODS: The data for this study came from the 1996 through 1998 Standard Analytic Files that contain 5% of Medicare claims. The rates of repeat revascularization procedures and hospitalizations were reported at 1 and 2 years. Costs associated with inpatient admission, outpatient procedures, physician services, skilled nursing facility admissions, and home health-care services were included to perform a comprehensive assessment. Regression analysis was performed to test for cost differences controlling for case-mix variation between the patient groups. RESULTS: The selection process yielded 3782 PTCA patients and 2690 stent patients for analysis. The rate of revascularization was 26.7% for the PTCA group and 22.2% for the stent group at 2 years. The mean total cost for the initial procedure was 13,724 dollars for PTCA and 15,021 dollars for stenting. At 2 years, the total cumulative cost was 32,654 dollars for the PTCA group and 32,102 dollars for the stent group, a difference that was not statistically significant. CONCLUSION: Although the difference in the rate of repeat revascularization procedures between PTCA and stenting is not as large as those reported in clinical trials, bare stents are cost-neutral when compared to PTCA for the Medicare population.