Economic Burden of Treatment-Resistant Depression in Privately Insured U.S. Patients with Physical Conditions.

BACKGROUND: Little is known about the economic burden of treatment-resistant depression (TRD) in patients with physical conditions. OBJECTIVE: To assess health care resource utilization (HRU) and costs, work loss days, and related costs in patients with TRD and physical conditions versus patients with the same conditions and non-TRD major depressive disorder (MDD) or without MDD. METHODS: Adults aged < 65 years with MDD treated with antidepressants were identified in the OptumHealth Care Solutions database (July 2009-March 2017). Patients who received a diagnosis of MDD and initiated a third antidepressant regimen (index date) after 2 regimens of adequate dose and duration were defined as having TRD. Patients with non-TRD MDD and without MDD were assigned a random index date. Patients with < 6 months of continuous health plan eligibility pre- or post-index; a diagnosis of psychosis, schizophrenia, bipolar disorder/mania, dementia, and developmental disorders; and/or no baseline physical conditions (cardiovascular, metabolic, and respiratory disease or cancer) were excluded. Patients with TRD were matched 1:1 to each of the non-TRD MDD and non-MDD cohorts based on propensity scores. Per patient per year HRU, costs, and work loss outcomes were compared up to 24 months post-index date using negative binominal and ordinary least square regressions. RESULTS: A total of 2,317 patients with TRD (mean age, 47.6 years; 63.1%, female; mean follow-up, 19.7 months) had ≥ 1 co-occurring key physical condition (cardiovascular, 52.5%; metabolic, 48.2%; respiratory, 16.4%; and cancer, 9.5%). Relative to non-TRD MDD and non-MDD cohorts, respectively, patients with TRD had 46% and 235% more inpatient admissions, 28% and 128% more emergency department visits, and 53% and 155% more outpatient visits (all P < 0.05). Health care costs were $22,541 in the TRD cohort, $17,450 in the non-TRD MDD cohort, and $10,047 in the non-MDD cohort, yielding cost differences of $5,091 (vs. non-TRD MDD) and $12,494 (vs. non-MDD; all P < 0.01). In patients with work loss data available (n = 278/cohort), those with TRD had 2.0 and 2.9 times more work loss as well as $8,676 and $10,323 higher work loss costs relative to those with non-TRD MDD and without MDD, respectively (all P < 0.001). CONCLUSIONS: In patients with physical conditions, those with TRD had higher HRU and health care costs, work loss days, and associated costs compared with non-TRD MDD and non-MDD cohorts. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs (JSA), which was involved in all aspects of the research, including the design of the study; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Joshi and Daly are employed by JSA. Zhdanava, Pilon, Rossi, Morrison, and Lefebvre are employees of Analysis Group, which received funding from JSA for conducting this study and has received consulting fees from Novartis Pharmaceuticals and GSK, unrelated to this study. Kuvadia is employed by Integrated Resources, which has provided research services to JSA unrelated to this study; Joshi reports past employment by and stock ownership in Johnson & Johnson; Nelson reports advisory board, data and safety monitoring board, and consulting fees from Assurex, Eisai, FSV-7, JSA, Lundbeck, Otsuka, and Sunovion and royalties from UpToDate, unrelated to this study. This work was presented at AMCP Nexus 2019, held in National Harbor, MD, from October 29 to November 1, 2019.

Real-world data on new users of atypical antipsychotics: characterisation, prescription patterns, healthcare costs and early cardio-metabolic occurrences from a large Italian database.

PURPOSE: To describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardio-metabolic risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation. METHODS: Atypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardio-metabolic diseases (group A), patients without these clinical conditions but with predisposing conditions (group B) and patients without cardio-metabolic diseases and predisposing conditions (group C). Annual prescription patterns and healthcare costs were analysed. Subjects of groups B and C were matched with controls to compare the occurrences of cardio-metabolic events over 24 months. RESULTS: Thirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardio-metabolic diseases, 14.8% had predisposing conditions and 62.9% had none of these. The 99.3% received monotherapy. The mean annual cost per patient was €2785, and the median cost was €1108. After 24 months, a cardio-metabolic event occurred in 11.5% of group B vs. 8.7% of the controls (p < .01), and in 5.0% of group C vs. 2.1% of the controls (p < .01). CONCLUSION: Patients treated with atypical AP were on average old and, in a non-negligible amount, with cardio-metabolic disease or predisposing conditions. New users of atypical APs showed a significantly higher likelihood to develop a cardio-metabolic event early after treatment initiation.

Use and Costs of Medical Foods and Convenience-Packaged Drugs in the California Workers' Compensation System.

BACKGROUND: Sales of medical foods (MFs) and convenience packages (CPs) are projected to exceed $2 billion in the United States, with an annual growth rate of 10%. Several studies have highlighted the rapid growth of MF use within the California Workers' Compensation System (CAWCS). To curb this growth, California implemented Assembly Bill 378 (AB 378) in 2012 to regulate physicians' incentives to dispense MFs and CPs. AB 378's regulation on only physician-dispensed MFs and CPs and not pharmacy-dispensed MFs and CPs generated a setting for evaluating the differential effect of the bill on MF and CP use and cost. OBJECTIVES: To (a) examine the use and cost of MFs and CPs in the CAWCS that are not for inborn errors of metabolism and (b) evaluate the regulatory effect of AB 378. METHODS: This study adopted a quantitative approach and employed descriptive statistics and t-tests. The analyses used the most recent complete annual claims data from the Workers' Compensation Information System dataset to evaluate MF and CP claims frequencies and dollar amounts reimbursed from 2011 to 2013 and to compare the difference between physician-dispensed and pharmacy-dispensed products. RESULTS: Of 151,107 MFs and CPs billed, 95,528 (63.2%) prescriptions were reimbursed. The reimbursed MFs and CPs accounted for approximately $19 million paid to pharmacies and physicians over 3 years. Physician-dispensed MFs, which were regulated by AB 378 in January 2012, experienced a reduction in mean amount reimbursed by $9.95 (P < 0.001)-from $195.64 to $185.68-compared with the mean amount reimbursed in 2011. Conversely, physician-dispensed CPs, as well as pharmacy-dispensed MFs and CPs, did not experience a decrease in mean amount reimbursed. CONCLUSIONS: The results indicated that AB 378 was associated with a statistically significant reduction in physician-dispensed MFs. Concomitantly, the results from t-tests showed no statistically significant difference in mean amount reimbursed for MFs and CPs to pharmacies before and after AB 378. The finding was expected and as hypothesized because AB 378 did not regulate pharmacy-dispensed MFs and CPs. Legislative measures, such as AB 378 in California, may influence rising costs and use of MFs and CPs in general. Other workers' compensation systems could adopt similar legislation to affect the behavior of physician prescribing of non-inborn errors of metabolism MFs and further test these findings. DISCLOSURES: Funding for this study was contributed by the California Workers' Compensation System. The authors have nothing to disclose.

Physical multimorbidity and psychosis: comprehensive cross sectional analysis including 242,952 people across 48 low- and middle-income countries.

BACKGROUND: In people with psychosis, physical comorbidities, including cardiovascular and metabolic diseases, are highly prevalent and leading contributors to the premature mortality encountered. However, little is known about physical health multimorbidity in this population or in people with subclinical psychosis and in low- and middle-income countries (LMICs). This study explores physical health multimorbidity patterns among people with psychosis or subclinical psychosis. METHODS: Overall, data from 242,952 individuals from 48 LMICs, recruited via the World Health Survey, were included in this cross-sectional study. Participants were subdivided into those (1) with a lifetime diagnosis of psychosis ("psychosis"); (2) with more than one psychotic symptom in the past 12 months, but no lifetime diagnosis of psychosis ("subclinical psychosis"); and (3) without psychotic symptoms in the past 12 months or a lifetime diagnosis of psychosis ("controls"). Nine operationalized somatic disorders were examined: arthritis, angina pectoris, asthma, diabetes, chronic back pain, visual impairment, hearing problems, edentulism, and tuberculosis. The association between psychosis and multimorbidity was assessed by multivariable logistic regression analysis. RESULTS: The prevalence of multimorbidity (i.e., two or more physical health conditions) was: controls = 11.4% (95% CI, 11.0-11.8%); subclinical psychosis = 21.8% (95% CI, 20.6-23.0%), and psychosis = 36.0% (95% CI, 32.1-40.2%) (P < 0.0001). After adjustment for age, sex, education, country-wise wealth, and country, subclinical psychosis and psychosis were associated with 2.20 (95% CI, 2.02-2.39) and 4.05 (95% CI, 3.25-5.04) times higher odds for multimorbidity. Moreover, multimorbidity was increased in subclinical and established psychosis in all age ranges (18-44, 45-64, ≥ 65 years). However, multimorbidity was most evident in younger age groups, with people aged 18-44 years with psychosis at greatest odds of physical health multimorbidity (OR = 4.68; 95% CI, 3.46-6.32). CONCLUSIONS: This large multinational study demonstrates that physical health multimorbidity is increased across the psychosis-spectrum. Most notably, the association between multimorbidity and psychosis was stronger among younger adults, thus adding further impetus to the calls for the early intervention efforts to prevent the burden of physical health comorbidity at later stages. Urgent public health interventions are necessary not only for those with a psychosis diagnosis, but also for subclinical psychosis to address this considerable public health problem.

Healthcare Costs Associated with an Adequate Intake of Sugars, Salt and Saturated Fat in Germany: A Health Econometrical Analysis.

Non-communicable diseases (NCDs) represent not only the major driver for quality-restricted and lost life years; NCDs and their related medical treatment costs also pose a substantial economic burden on healthcare and intra-generational tax distribution systems. The main objective of this study was therefore to quantify the economic burden of unbalanced nutrition in Germany--in particular the effects of an excessive consumption of fat, salt and sugar--and to examine different reduction scenarios on this basis. In this study, the avoidable direct cost savings in the German healthcare system attributable to an adequate intake of saturated fatty acids (SFA), salt and sugar (mono- & disaccharides, MDS) were calculated. To this end, disease-specific healthcare cost data from the official Federal Health Monitoring for the years 2002-2008 and disease-related risk factors, obtained by thoroughly searching the literature, were used. A total of 22 clinical endpoints with 48 risk-outcome pairs were considered. Direct healthcare costs attributable to an unbalanced intake of fat, salt and sugar are calculated to be 16.8 billion EUR (CI95%: 6.3-24.1 billion EUR) in the year 2008, which represents 7% (CI95% 2%-10%) of the total treatment costs in Germany (254 billion EUR). This is equal to 205 EUR per person annually. The excessive consumption of sugar poses the highest burden, at 8.6 billion EUR (CI95%: 3.0-12.1); salt ranks 2nd at 5.3 billion EUR (CI95%: 3.2-7.3) and saturated fat ranks 3rd at 2.9 billion EUR (CI95%: 32 million-4.7 billion). Predicted direct healthcare cost savings by means of a balanced intake of sugars, salt and saturated fat are substantial. However, as this study solely considered direct medical treatment costs regarding an adequate consumption of fat, salt and sugars, the actual societal and economic gains, resulting both from direct and indirect cost savings, may easily exceed 16.8 billion EUR.

Managing comorbidities in COPD.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Age and smoking are common risk factors for COPD and other illnesses, often leading COPD patients to demonstrate multiple coexisting comorbidities. COPD exacerbations and comorbidities contribute to the overall severity in individual patients. Clinical trials investigating the treatment of COPD routinely exclude patients with multiple comorbidities or advanced age. Clinical practice guidelines for a specific disease do not usually address comorbidities in their recommendations. However, the management and the medical intervention in COPD patients with comorbidities need a holistic approach that is not clearly established worldwide. This holistic approach should include the specific burden of each comorbidity in the COPD severity classification scale. Further, the pharmacological and nonpharmacological management should also include optimal interventions and risk factor modifications simultaneously for all diseases. All health care specialists in COPD management need to work together with professionals specialized in the management of the other major chronic diseases in order to provide a multidisciplinary approach to COPD patients with multiple diseases. In this review, we focus on the major comorbidities that affect COPD patients. We present an overview of the problems faced, the reasons and risk factors for the most commonly encountered comorbidities, and the burden on health care costs. We also provide a rationale for approaching the therapeutic options of the COPD patient afflicted by comorbidity.

National Survey of Providers Treating Patients With Metabolic Disorders Identified by Newborn Screening Demonstrates Challenges Faced by Clinical Care Systems.

OBJECTIVES: To evaluate care processes for infants who are identified by newborn screening (NBS) and diagnosed with metabolic disorders during their first year of life. METHODS: A survey instrument was used to assess the scope and intensity of services needed to provide quality health care for patients from birth to 1 year of age who have a metabolic disorder identified by NBS. Significance testing was not performed; descriptive analyses are reported. RESULTS: Providers spend significant amounts of time on activities that are not direct patient care. The most challenging aspect of their work was the lack of reimbursement for care. CONCLUSION: Provision of genetics services for patients with a metabolic disorder is time and labor intensive, and insurance coverage and reimbursement for these services remain inadequate. Health care payment and/or system reform is necessary to provide optimal care to patients with metabolic disorders identified by NBS.

Family-directed umbilical cord blood banking.

Umbilical cord blood transplantation from HLA-identical siblings provides good results in children. These results support targeted efforts to bank family cord blood units that can be used for a sibling diagnosed with a disease which can be cured by allogeneic hematopoietic stem cell transplantation or for research that investigates the use of allogeneic or autologous cord blood cells. Over 500 patients transplanted with related cord blood units have been reported to the Eurocord registry with a 4-year overall survival of 91% for patients with non-malignant diseases and 56% for patients with malignant diseases. Main hematologic indications in children are leukemia, hemoglobinopathies or inherited hematologic, immunological or metabolic disorders. However, family-directed cord blood banking is not widely promoted; many cord blood units used in sibling transplantation have been obtained from private banks that do not meet the necessary criteria required to store these units. Marketing by private banks who predominantly store autologous cord blood units has created public confusion. There are very few current validated indications for autologous storage but some new indications might appear in the future. Little effort is devoted to provide unbiased information and to educate the public as to the distinction between the different types of banking, economic models and standards involved in such programs. In order to provide a better service for families in need, directed-family cord blood banking activities should be encouraged and closely monitored with common standards, and better information on current and future indications should be made available.

Incidence and costs of cardiometabolic conditions in patients with schizophrenia treated with antipsychotic medications.

To examine the incidence of cardiometabolic conditions and change in care costs for patients with schizophrenia treated with antipsychotic medications, medical and pharmacy claims from the South Carolina Medicaid program were used to compare the incidence rates for five cardiometabolic conditions in 2,231 patients with schizophrenia who were newly prescribed one of seven antipsychotic medications, using a retrospective cohort design spanning three years. Incidence and cumulative prevalence (pre-existing + incident) rates for the five cardiometabolic conditions were: 10%/23.3% for Type II diabetes mellitus, 7%/13.3% for obesity/excessive weight gain, 17%/20.9% for dyslipidemia, 4.5%/7.3% for high blood pressure, and 15.6%/41.8% for hypertension. After being treated with the antipsychotic medications examined, the odds of developing obesity/excessive weight gain, Type II diabetes mellitus, or dyslipidemia were not significantly related to any specific atypical agent compared to haloperidol. Incidence rates for elevated blood pressure and clinically diagnosed hypertension were higher for patients prescribed ziprasidone (Odds Ratio [OR]=2.41, Confidence Intervals [CI]=1.20-4.85; OR=1.83, CI=1.16-2.90, respectively) relative to those prescribed haloperidol. Cost results indicate significant differences over time in medical service and pharmacy costs in the group which developed incident cardiometabolic conditions. Individuals diagnosed with schizophrenia with moderate prevalence and incidence rates for these cardiometabolic conditions demonstrated substantially decreasing medical care costs over the three years examined, perhaps indicating a widening gap in access to needed services for conditions that are known mortality risk factors.

[Rehabilitation for digestive and metabolic diseases. Quo vadis?]. / Rehabilitation bei Verdauungs- und Stoffwechselkrankheiten. Quo vadis?

The position of rehabilitation in gastroenterology, hepatology and metabolic diseases has changed little in the last 25 years. Initial improvements in quality are oriented more to the content of rehabilitative measures and less to organizational basic conditions. Nevertheless, there is an urgent need for action if rehabilitation medicine is to achieve an equivalent and recognized position in the interaction between primary care and other medical specialties. In this article suggestions for expedient prerequisites and utilization options of rehabilitation in the fields of hepatogastroenterology and metabolism will be presented, which are also oriented to the exemplary implemented concepts from Sweden and The Netherlands.

Health and economic burden of metabolic comorbidity among individuals with bipolar disorder.

OBJECTIVES: To compare the prevalence and health care costs of metabolic conditions in patients with bipolar disorder to age- and sex-matched control patients using a large insurance claims database. METHODS: A retrospective analysis of medical service and prescription claims from the Thomson Reuters (Healthcare) MarketScan Commercial Database (which includes claims information on >12 million employees with employer-based insurance and their dependents in the United States) was conducted. Claims data for 28,531 patients with bipolar disorder were compared for 1 year with data for 85,593 age- and sex-matched control patients with no mental health disorders and no psychotropic medication use. RESULTS: Patients with bipolar disorder had a significantly higher prevalence of metabolic comorbidities than the general population (37% vs 30%, P < 0.0001), and annual medical service treatment costs for metabolic conditions were twice that of the control cohort (531 dollars vs 233 dollars, P < 0.0001). The bipolar cohort had significantly higher overall medical service and prescription drug costs than those of the control cohort (12,764 dollars vs 3,140 dollars, P < 0.0001). Prescription medication costs for metabolic conditions were higher as well, with bipolar cohort per-patient costs of 571 dollars versus 301 dollars for the control cohort (P < 0.0001). CONCLUSIONS: Patients with bipolar disorder have significantly more metabolic comorbidities and higher medical costs than age- and sex-matched controls. Studies that link claims data with medical records or primary data collection pertaining to metabolic conditions may overcome limitations in the diagnostic information and outcome predictors. To reduce the medical and economic burden of bipolar disorder, strategies should be identified to prevent the development of metabolic comorbidities and improve medication adherence.

Monetary cost of dietary energy is negatively associated with BMI and waist circumference, but not with other metabolic risk factors, in young Japanese women.

OBJECTIVE: Little is known about the relationship of dietary cost to health status. The present cross-sectional study examined the association between the monetary cost of dietary energy (Japanese yen/4184 kJ) and several metabolic risk factors. DESIGN: Monetary cost of dietary energy was estimated based on dietary intake assessed by a self-administered diet history questionnaire and retail food prices. Body height and weight, from which BMI was derived, waist circumference and blood pressure were measured and fasting blood samples were collected for biochemical measurements. SETTING: A total of fifteen universities and colleges in Japan. SUBJECTS: A total of 1136 female Japanese dietetic students aged 18-22 years. RESULTS: After adjustment for potential confounding factors, monetary cost of dietary energy was significantly and negatively associated with BMI (P for trend = 0.0024). Monetary cost of dietary energy also showed a significant and negative association with waist circumference independently of potential confounding factors, including BMI (P for trend = 0.0003). No significant associations were observed for other metabolic risk factors examined (P for trend = 0.10-0.88). CONCLUSIONS: The monetary cost of dietary energy was independently and negatively associated with both BMI and waist circumference, but not other metabolic risk factors, in a group of young Japanese women.

Bipolar disorder and the metabolic syndrome: causal factors, psychiatric outcomes and economic burden.

Overweight and obesity are highly prevalent in patients with bipolar disorder, and metabolic disorders also affect a significant portion of this population. Obesity and metabolic disorders cause significant economic burden and impair quality of life in both the general population and patients with bipolar disorder. This review examines the relationship between bipolar disorder and the metabolic syndrome, and the associated economic impact. The metabolic syndrome and bipolar disorder appear to share common risk factors, including endocrine disturbances, dysregulation of the sympathetic nervous system, and behaviour patterns, such as physical inactivity and overeating. In addition, many of the commonly used pharmacological treatments for bipolar disorder may intensify the medical burden in bipolar patients by causing weight gain and metabolic disturbances, including alterations in lipid and glucose metabolism, which can result in an increased risk for diabetes mellitus, hypertension, dyslipidaemia, cardiovascular disease and the metabolic syndrome. These medical co-morbidities and obesity have been associated with a worse disease course and likely contribute to the premature mortality observed in bipolar patients. Weight gain is also a major cause of treatment noncompliance, increased use of outpatient and inpatient services and, consequently, higher healthcare costs. Prevention of weight gain and metabolic disturbances or early intervention when these are present in bipolar disorder could result in significant health and economic benefits.

Moderately overweight and obese patients in general practice: a population based survey.

BACKGROUND: Obesity is a main threat to public health in the Western world and is associated with diseases such as diabetes mellitus and coronary heart diseases. Up to now a minority of research studied the relation between obesity and the use of primary health care. In the Netherlands the general practitioner (GP) is the main primary health care provider. The objective of this article is to evaluate GP consultation and prescription of drugs in moderate and severely overweight (obese) persons in the Netherlands. METHODS: Data were used from a representative survey of morbidity in Dutch general practice in 2001. Our study sample consisted of 8,944 adult respondents (18+ years) who participated in an extensive health interview. Interview data were linked to morbidity and prescription registration data from 95 general practices where respondents were listed. Body mass index (BMI) was calculated using self-reported height and weight. Analyses were controlled for clustering within practices as well as for socio-demographic and life style characteristics. RESULTS: Obesity (BMI > or = 30 kg/m2) was observed in 8.9% of men and 12.4% of women; for moderate overweight (BMI 25-< 30 kg/m2) these percentages were 42.2% and 30.4% respectively. Obese men and women were more likely to consult their GP than persons without overweight. This especially holds for diseases of the endocrine system, the cardiovascular system, the musculoskeletal system, the gastro-intestinal system, and skin problems. Related to this, obese men and women were more likely to receive drugs for the cardiovascular system, the musculoskeletal system, alimentary tract and metabolism (including, for example, antidiabetics), and dermatologicals, but also antibiotics and drugs for the respiratory system. For moderately overweight men and women (BMI 25- < 30 kg/m2) smaller but significant differences were found for diseases of the endocrine system, the cardiovascular system, and the musculoskeletal system. CONCLUSION: Obesity increases the workload of Dutch general practitioners and the use of prescribed medication. The current increase in the prevalence of obesity will further increase the use of health care and related costs. Since a large majority of Dutch persons visit their GP over the course of one year, GPs' potential role in effective prevention strategies cannot be denied.