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Introduction: French Guiana is a multicultural overseas territory in the Amazon, where precariousness and difficulties in access to care are widespread. The prevalence of diabetes is double that of other French departments, and cardiovascular morbidity and mortality is high. The objective of the study was to analyze the biological, clinical and therapeutic follow-up of patients with diabetes mellitus using exhaustive data and to correlate it with national and European recommendations., Material and Methods: Using the national health insurance data, 9079 and 10075 patients with diabetes mellitus were analyzed in 2018 and 2019, respectively. We analyzed antidiabetic treatments, medical, dental, and podiatric consultations, examinations prescribed as part of the annual follow-up, and home nursing care., Results: There was a significant increase over one year in the number of patients (+10%) with diabetes, mainly women (60%), and 31% were under 54 years of age, with a disparity depending on the area of the territory, the most isolated having less access to screening. Less than 56% of patients had HbA1c measurements twice a year, less than 43% had an annual renal check-up, only 19% had an ophthalmic check-up at least every two years, less than 25% had an annual dental check-up, and less than 4% had an annual follow-up with the podiatrist., Conclusions: Substandard diabetes monitoring is a major problem likely to increase morbidity and mortality. Adapting health care to the specificities of the territory is crucial, notably by formalizing the delegation of care to advanced practice nurse and non-healthcare professionals in precarious or geographically isolated areas., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Sudre, Duplan, Bukasakakamba, Nacher, Peyre-Costa and Sabbah.)

Background and Purpose: Mechanical thrombectomy helps prevent disability in patients with acute ischemic stroke involving occlusion of a large cerebral vessel. Thrombectomy requires procedural expertise and not all hospitals have the staff to perform this intervention. Few population-wide data exist regarding access to mechanical thrombectomy., Methods: We examined access to thrombectomy for ischemic stroke using discharge data from calendar years 2016 to 2018 from all nonfederal emergency departments and acute care hospitals across 11 US states encompassing 80 million residents. Facilities were classified as hubs if they performed mechanical thrombectomy, gateways if they transferred patients who ultimately underwent mechanical thrombectomy, and gaps otherwise. We used standard descriptive statistics and unadjusted logistic regression models in our primary analyses., Results: Among 205 681 patients with ischemic stroke, 100 139 (48.7% [95% CI, 48.5%–48.9%]) initially received care at a thrombectomy hub, 72 534 (35.3% [95% CI, 35.1%–35.5%]) at a thrombectomy gateway, and 33 008 (16.0% [95% CI, 15.9%–16.2%]) at a thrombectomy gap. Patients who initially received care at thrombectomy gateways were substantially less likely to ultimately undergo thrombectomy than patients who initially received care at thrombectomy hubs (odds ratio, 0.27 [95% CI, 0.25–0.28]). Rural patients had particularly limited access: 27.7% (95% CI, 26.9%–28.6%) of such patients initially received care at hubs versus 69.5% (95% CI, 69.1%–69.9%) of urban patients. For 93.8% (95% CI, 93.6%–94.0%) of patients with stroke at gateways, their initial facility was capable of delivering intravenous thrombolysis, compared with 76.3% (95% CI, 75.8%–76.7%) of patients at gaps. Our findings were unchanged in models adjusted for demographics and comorbidities and persisted across multiple sensitivity analyses, including analyses adjusting for estimated stroke severity., Conclusions: We found that a substantial proportion of patients with ischemic stroke across the United States lacked access to thrombectomy even after accounting for interhospital transfers. US systems of stroke care require further development to optimize thrombectomy access.

Background: Although mechanical thrombectomy for acute ischemic stroke from a large vessel occlusion is now the standard of care, little is known about cost variations in stroke patients following thrombectomy and factors that influence these variations., Methods: We evaluated claims data for 2016 to 2018 for thrombectomy-performing hospitals within Michigan through a registry that includes detailed episode payment information for both Medicare and privately insured patients. We aimed to analyze price-standardized and risk-adjusted 90-day episode payments in patients who underwent thrombectomy. Hospitals were grouped into three payment terciles for comparison. Statistical analysis was carried out using unpaired t -test, Chi-square, and ANOVA tests., Results: 1076 thrombectomy cases treated at 16 centers were analyzed. The average 90-day episode payment by hospital ranged from $53 046 to $81,767, with a mean of $65 357. A $20 467 difference (35.1%) existed between the high and low payment hospital terciles (P<0.0001), highlighting a significant payment variation across hospital terciles. The primary drivers of payment variation were related to post-discharge care which accounted for 38% of the payment variation (P=0.0058, inter-tercile range $11,977-$19,703) and readmissions accounting for 26% (P=0.016, inter-tercile range $3,315-$7,992). This was followed by professional payments representing 20% of the variation (P<0.0001, inter-tercile range $7525-$9,922), while index hospitalization payment was responsible for only 16% of the 90-day episode payment variation (P=0.10, inter-tercile range $35,432-$41,099)., Conclusions: There is a wide variation in 90-day episode payments for patients undergoing mechanical thrombectomy across centers. The main drivers of payment variation are related to differences in post-discharge care and readmissions., Competing Interests: Competing interests: MLY and JDS receive salary support from Blue Cross Blue Shield of Michigan for their work with the Michigan Value Collaborative., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Neurosurgery is a specialty associated with high risk of malpractice claims, which can be influenced by quality and safety of care. Diagnostic errors have gained increasing attention as a potentially preventable problem. Despite the burden of diagnostic errors, few studies have analyzed diagnostic errors in neurosurgery. We aimed to delineate the effect of diagnostic errors on malpractice claims involving a neurosurgeon., Methods: This retrospective study used the national Japanese malpractice claims database and included cases closed between 1961 and 2017. To examine the effect of diagnostic errors in neurosurgery, we compared diagnostic error-related claims (DERCs) with non-DERCs in indemnity, clinical outcomes, and factors relating to neurosurgeons., Results: There were 95 closed malpractice claims involving neurosurgeons during the study period. Of these claims, 36 (37.9%, 95% confidence interval [CI] 28.7%-47.9%) were DERCs. Patient death was the most common outcome associated with DERCs. Wrong, delayed, and missed diagnosis occurred in 25 (69.4%, 95% CI 53.1%-82.0%), 4 (11.1%, 95% CI 4.4%-25.3%), and 7 (19.4%, 95% CI 9.8%-35.0%) cases, respectively. The most common presenting medical condition in DERCs was stroke. Subarachnoid hemorrhage, accounting for 85.7% of stroke cases, led to 27.8% of the total indemnity paid in DERCs., Conclusions: DERCs are associated with higher numbers of accepted claims and worse outcomes. Identifying diagnostic errors is important in neurosurgery, and countermeasures are required to reduce the burden on neurosurgeons and improve quality. This is the first study to focus on diagnostic errors in malpractice claims arising from neurosurgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: In 2003, the Government of Ghana launched the National Health Insurance Scheme (NHIS) to enable all Ghanaian residents to have access to health services at the point of care without financial difficulty. However, the system has faced a number of challenges relating to delays in submission and reimbursement of claims. This study assessed views of stakeholders on claims submission, processing and re-imbursement under the NHIS and how that affected health service delivery in Ghana., Methods: The study employed qualitative methods where in-depth interviews were conducted with stakeholders in three administrative regions in Ghana. Purposive sampling method was used to select health facilities and study participants for the interviews. QSR Nvivo 12 software was used to code the data into themes for thematic analysis., Results: The results point to key barriers such as lack of qualified staff to process claims, unclear vetting procedure and the failure of National Health Insurance Scheme officers to draw the attention of health facility staff to resolve discrepancies on time. Participants perceived that lack of clarity, inaccurate data and the use of non-professional staff for NHIS claims vetting prolonged reimbursement of claims. This affected operations of credentialed health facilities including the provision of health services. It is perceived that unavailability of funds led to re-use of disposable medical supplies in health service delivery in credentialed health facilities. Stakeholders suggested that submission of genuine claims by health providers and regular monitoring of health facilities reduces errors on claims reports and delays in reimbursement of claims., Conclusion: Long delays in claims reimbursement, perceived vetting discrepancies affect health service delivery. Thus, effective collaboration of all stakeholders is necessary in order to develop a long-term strategy to address the issue under the NHIS to improve health service delivery., Competing Interests: The authors have declared that no competing interests exist.

Objective: Anticipating postdischarge complications after neurosurgery remains difficult. The LACE index, based on 4 hospitalization descriptors, stratifies patients by risk of 30-day postdischarge adverse events but has not been validated in a procedure-specific manner in neurosurgery. Our study sought to explore the usefulness of the LACE index in a population undergoing cranial neurosurgery and to develop an enhanced model, LACE-Cranial., Methods: The OptumClinformatics Database was used to identify cranial neurosurgery admissions (2004-2017). Procedures were grouped as trauma/hematoma/intracranial pressure, open vascular, functional/pain, skull base, tumor, or endovascular. Adverse events were defined as postdischarge death/readmission. LACE-Cranial was developed using a logistic regression framework incorporating an expanded feature set in addition to the original LACE components., Results: A total of 40,431 admissions were included. Predictions of 30-day readmissions was best for skull base (area under the curve [AUC], 0.636) and tumor (AUC, 0.63) admissions but was generally poor. Predictive ability of 30-day mortality was best for functional/pain admissions (AUC, 0.957) and poorest for trauma/hematoma/intracranial pressure admissions (AUC, 0.613). Across procedure types except for functional/pain, a high-risk LACE score was associated with higher postdischarge bundled payment costs. Incorporating features identified to contribute independent predictive value, the LACE-Cranial model achieved procedure-specific 30-day mortality AUCs ranging from 0.904 to 0.98. Prediction of 30-day and 90-day readmissions was also improved, with tumor and skull base cases achieving 90-day readmission AUCs of 0.718 and 0.717, respectively., Conclusions: Although the unmodified LACE index shows inconsistent classification performance, the enhanced LACE-Cranial model offers excellent prediction of short-term postdischarge mortality across procedure groups and significantly improved anticipation of short-term postdischarge readmissions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Understanding the dynamics of epidemiologic trends in Alzheimer's disease (AD) and related dementias (ADRD) and their epidemiologic causes is vital to providing important insights into reducing the burden associated with these conditions., Objective: To model the time trends in age-adjusted AD/ADRD prevalence and incidence-based mortality (IBM), and identify the main causes of the changes in these measures over time in terms of interpretable epidemiologic quantities., Methods: Trend decomposition was applied to a 5%sample of Medicare beneficiaries between 1991 and 2017., Results: Prevalence of AD was increasing between 1992 and 2011 and declining thereafter, while IBM increased over the study period with a significant slowdown in its rate of growth from 2011 onwards. For ADRD, prevalence and IBM increased through 2014 prior to taking a downwards turn. The primary determinant responsible for declines in prevalence and IBM was the deceleration in the increase and eventual decrease in incidence rates though changes in relative survival began to affect the overall trends in prevalence/IBM in a noticeable manner after 2008. Other components showed only minor effects., Conclusion: The prevalence and IBM of ADRD is expected to continue to decrease. The directions of these trends for AD are not clear because AD incidence, the main contributing component, is decreasing but at a decreasing rate suggesting a possible reversal. Furthermore, emerging treatments may contribute through their effects on survival. Improving ascertainment of AD played an important role in trends of AD/ADRD over the 1991-2009/10 period but this effect has exhausted itself by 2017.

Background: Antipsychotics are commonly prescribed in high doses in combination with multiple psychotropic drugs. This study focused on the high-dose antipsychotic prescriptions in patients with schizophrenia, while aiming to identify their associations with patients' characteristics and concurrent psychotropic prescriptions., Methods: This cross-sectional study used claims data from a prefecture in Japan, between October 2014 and March 2015, to investigate antipsychotic prescriptions in adult outpatients with schizophrenia. The objective variable was the presence/absence of a high-dose prescription. The explanatory variables included sex, age (category), presence of comorbid conditions, and the use of psychiatrist's therapy., Results: After exclusion, a total of 13 471 patients with schizophrenia were analyzed. The frequency of high-dose prescriptions was higher in men, with chlorpromazine-equivalent values highest in the age ranges of 45-54 and 35-44 years for men and women, respectively. Patients aged below 65 years with cerebrovascular diseases showed a decrease in high-dose prescriptions. There was a high frequency of polypharmacy psychotropic drug use in combination with a high-dose antipsychotic prescription in patients aged below 65 years., Conclusion: High-dose antipsychotics are often used in combination with several psychotropic agents in patients with schizophrenia. Our findings emphasize the need to evaluate the prescribing behavior of physicians to avoid high-dose antipsychotic prescriptions for improved patient care., (© 2020 The Authors. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Society of NeuropsychoPharmacology.)

Background: Venous thromboembolism (VTE), constituting deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common cause of vascular-related morbidity and mortality, resulting in a significant clinical and economic burden in the United States each year. Clinical guidelines recommend that patients with DVT and PE without cancer should be initiated on anticoagulation therapy with a direct oral anticoagulant over a vitamin K antagonist. Yet there is limited real-world evidence comparing the economic burden of warfarin and apixaban in treating VTE patients in a large commercially insured population., Objective: To compare safety and effectiveness of warfarin and apixaban and evaluate associated economic burden in treating VTE patients in a large U.S. commercial health care claims database., Methods: The PharMetrics Plus database was used to identify oral anticoagulant (OAC)-naive patients aged ≥ 18 years who initiated apixaban or warfarin within 30 days of a qualifying VTE encounter and had continuous health plan enrollment with medical and pharmacy benefits for 6 months before treatment initiation. Apixaban initiators and warfarin initiators were matched using the propensity score matching (PSM) technique. Cox proportional hazard models were used to assess and compare the risk of major bleeding (MB), clinically relevant nonmajor (CRNM) bleeding, and recurrent VTE. Generalized linear models were used to assess and compare the all-cause health care costs. A 2-part model with bootstrapping was used to evaluate MB- and recurrent VTE-related medical costs., Results: Among 25,193 prematched patients, 13,421 (53.3%) were prescribed warfarin and 11,772 (46.7%) were prescribed apixaban. After 1:1 PSM, 8,858 matched warfarin-apixaban pairs were selected with a mean follow-up of 109 days and 103 days, respectively. Warfarin was associated with a significantly higher risk of MB (HR = 1.52, 95% CI = 1.14-2.04), CRNM bleeding (HR = 1.27, 95% CI = 1017.15-1.40), and recurrent VTE (HR = 1.50, 95% CI = 1.24-1.82) compared with apixaban. Warfarin patients had significantly higher all-cause medical costs per patient per month (PPPM; $2,333 vs. $1,992; P = 0.001), MB-related costs PPPM ($112 vs. $65; P = 0.020), and recurrent VTE-related costs PPPM ($287 vs. $206; P = 0.014) compared with apixaban patients. Warfarin patients had similar all-cause total health care costs PPPM ($2,630 vs. $2,420; P = 0.051) compared with apixaban patients., Conclusions: Warfarin use was associated with a higher risk of MB, CRNM bleeding, and recurrent VTE compared with apixaban. Warfarin use was also associated with higher all-cause medical costs, MB-related medical costs, and recurrent VTE-related costs PPPM compared with apixaban. DISCLOSURES: This study was funded by Bristol Myers Squibb and Pfizer, which were also involved in the study design, as well as writing and revising of the manuscript. Guo, Rajpura, Okano, and Rosenblatt are employees of Bristol Myers Squibb. Hlavacek, Mardekian, and Russ are employees of Pfizer. Keshishian, Sah, Delinger, and Mu are employees of SIMR, LLC, which received funding from the study sponsors to conduct this study.

Background: Major depressive disorder (MDD) is a prevalent and debilitating condition. While numerous treatment options are available, low treatment response and high remission rates remain common, leading to the concept of treatment-resistant depression (TRD): a classification applied to patients who fail multiple courses of therapy. A patient with TRD can only be identified after repeated, and often prolonged, therapeutic efforts., Objective: To use data readily available to integrated delivery networks to identify characteristics predictive of TRD among patients initiating pharmacotherapy for MDD., Methods: Decision Resources Group Real-World Data, an integrated medical/pharmacy claims and electronic health record dataset, was used to conduct a retrospective, longitudinal cohort study of patients with MDD who initiated antidepressant treatment between July 1, 2014, and December 31, 2015. Individuals were followed for 24 months to determine treatment resistance. Eligible individuals had integrated claims and electronic health record data available, completed at least 1 course of therapy of adequate dose and duration to achieve response, and had 30 months of continuous benefits eligibility (6 months before and 24 months after treatment initiation). Stepwise logistic regression and demographic, health history, health care utilization, medication, provider, and related characteristics were used to predict onset of TRD., Results: 35,246 people met eligibility and 7,098 (20.1%) met TRD criteria after an average of 402 days. Significant predictors of TRD included patient age, diagnosis of insomnia and hypertension, psychiatric office visits, nurse telephonic encounters, anticonvulsant medication use, suicidality, physician specialty associated with index prescription, total prescription drug claims, unique antidepressants attempted, and duration of untreated illness (the lag between diagnosis and index prescription). The final model achieved an area under the curve (AUC) = 0.83. Structured patient-generated health data, specifically, the Patient Health Questionnaire-2 and the Patient Health Questionnaire-9 were only reported for 542 patients (1.5%)., Conclusions: TRD transition occurs after a prolonged treatment period, suggesting clinical inertia. Using data routinely available to integrated delivery networks and accountable care organizations, it is feasible to identify patients likely to qualify as treatment resistant. Monitoring risk factors may allow health systems to identify patients at risk for TRD earlier, potentially improving outcomes. Early identification of this at-risk population can allow for targeted resources for earlier intervention, more aggressive follow-up, and alternative treatment options. Furthermore, this model can be used to estimate future demand for specialized care resources, such as those delivered by mood disorder clinics., Disclosures: This project was sponsored by Janssen Scientific Affairs. Pesa, Chow, and Verbanac are employed by Janssen Scientific Affairs and report stock ownership in Johnson & Johnson. Liberman, Davis, Heverly-Fitt, and Ruetsch are employed by Health Analytics, which received funding from Janssen Scientific Affairs for work on this project. This study was presented as a poster at the U.S. Psych Congress; October 3-6, 2019; San Diego, CA.

Background: Targeted immunomodulators (TIMs) are used for the treatment of moderate to severe rheumatoid arthritis (RA) and include biologic and nonbiologic medications with different mechanisms of action. Data describing disease activity levels in RA are not directly available in claims databases but can be determined using a claims-based effectiveness algorithm. Rheumatology has benefited from the recent introduction of new drugs, many with new mechanisms of action. We provide an analysis of this broader range of medications., Objectives: To (a) describe and summarize the effectiveness of available TIMs for the treatment of moderate to severe RA and (b) determine the RA-related health care costs per effectively treated patient, using recent data., Methods: This was a retrospective analysis using data from the IBM MarketScan Commercial Claims and Encounters Database from July 1, 2012, through December 31, 2016. Index date was the new prescription claim for a TIM (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, tocilizumab, or tofacitinib). A 6-month pre-index baseline period was used to determine demographic and clinical characteristics. Patients without a TIM claim during the baseline period were considered naive; patients with a TIM claim in the baseline period that was different than the index TIM were assessed as receiving second-line therapy. A claims-based algorithm was used to assess 12-month treatment effectiveness and total RA-related costs. Costs included RA-related pharmacy costs and medical costs., Results: Data from 14,775 patients were analyzed, including patients prescribed abatacept (n = 1,250), adalimumab (n = 4,986), certolizumab pegol (n = 387), etanercept (n = 5,266), golimumab (n = 577), infliximab (n = 969), tocilizumab (n = 451), and tofacitinib (n = 889). Of these, 705 were receiving second-line therapy. TIM effectiveness by first-line and second-line therapy, respectively, were abatacept 27.1%, 18.1%; adalimumab 30.9%, 22.1%; certolizumab pegol 20.9%, 14.3%; etanercept 31.4%, 31.5%; golimumab 32.7%, 22.2%; infliximab 21.9%, 21.3%; tocilizumab 30.9%, 30.6%; and tofacitinib 26.0%, 21.6%. The main reason for failing effectiveness was not achieving an 80% medication possession ratio or being nonadherent. The 1-year total RA-related cost per effectively treated patient for first-line and second-line therapies, respectively, were abatacept $121,835, $174,090; adalimumab $112,708, $154,540; certolizumab pegol $149,946, $236,743; etanercept $102,058, $94,821; golimumab $108,802, $140,651; infliximab $155,123, $185,369; tocilizumab $93,333, $109,351; and tofacitinib $100,306, $130,501., Conclusions: The effectiveness of TIMs from this real-world experience showed that the range of patients who were effectively treated with first-line therapy was higher for certain tumor necrosis factor inhibitors and tocilizumab. The percentages of effectively treated patients were generally lower in second-line treatment compared with first-line except for etanercept, which had the same percentage between lines of therapy. Etanercept had the lowest RA-related cost per effectively treated patient among tumor necrosis factor inhibitors in first-line use and the lowest RA-related cost per effectively treated patient compared with all second-line treatments., Disclosures: This study was sponsored by Amgen. Amgen employees contributed to study design, analysis of the data, and the decision to publish the results. Maksabedian Hernandez and Stolshek are employees and shareholders of Amgen; Gharaibeh was employed by Amgen at the time of this study. Bonafede was employed by IBM Watson Health, at the time of this study, and McMorrow is employed by IBM Watson Health, which received funding from Amgen to conduct this study. Data from this study were presented at AMCP Nexus, October 22-25, 2018, in Orlando, FL.

Objective: Approximately 550,000 Americans experience vertebral fracture annually, and most receive opioids to treat the resulting pain. Kyphoplasty of the fractured vertebra is a procedural alternative that may mitigate risks of even short-term opioid use. While reports of kyphoplasty's impact on pain scores are mixed, no large-scale data exist regarding opioid prescribing before and after the procedure. This study was conducted to determine whether timing of kyphoplasty following vertebral fracture is associated with duration or intensity of opioid prescribing., Methods: This retrospective cohort study used 2001-2014 insurance claims data from a single, large private insurer in the US across multiple care settings. Patients were adults with vertebral fractures who were prescribed opioids and underwent balloon-assisted kyphoplasty within 4 months of fracture. Opioid overdose risk was stratified by prescribed average daily morphine milligram equivalents using CDC guidelines. Filled prescriptions and risk categories were evaluated at baseline and 90 days following kyphoplasty., Results: Inclusion criteria were met by 7119 patients (median age 77 years, 71.7% female). Among included patients, 3505 (49.2%) were opioid naïve before fracture. Of these patients, 31.1% had new persistent opioid prescribing beyond 90 days after kyphoplasty, and multivariable logistic regression identified kyphoplasty after 8 weeks as a predictor (OR 1.34, 95% CI 1.02-1.76). For patients previously receiving opioids, kyphoplasty > 4 weeks after fracture was associated with persistently elevated prescribing risk (OR 1.84, 95% CI 1.23-2.74)., Conclusions: New persistent opioid prescribing occurred in nearly one-third of patients undergoing kyphoplasty after vertebral fracture, although early treatment was associated with a reduction in this risk. For patients not naïve to opioids before fracture diagnosis, early kyphoplasty was associated with less persistent elevation of opioid overdose risk. Subsequent trials must compare opioid use by vertebral fracture patients treated via operative (kyphoplasty) and nonoperative (ongoing opioid) strategies before concluding that kyphoplasty lacks value, and early referral for kyphoplasty may be appropriate to avoid missing a window of efficacy.

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.

Background: Since 2010, heroin-related overdoses have risen sharply, coinciding with policies to restrict access to prescription opioids. It is unknown if patients tapered or discontinued off prescription opioids transitioned to riskier heroin use. This study examined opioid prescribing, including long-term opioid therapy (LTOT) and discontinuation, prior to heroin overdose., Methods: We used retrospective longitudinal data from a national claims database to identify adults with an emergency or inpatient claim for heroin overdose between January 2010 and June 2017. Receipt of opioid prescription, LTOT episodes, and discontinuation of LTOT were measured for the period of one year prior to heroin overdose., Results: We identified 3183 individuals (53.2% age 18-25; 70.0% male) with a heroin overdose (incidence rate 4.20 per 100k person years). Nearly half (42.3%) received an opioid prescription in the prior 12 months, and 10.9% had an active opioid prescription in the week prior to overdose. LTOT at any time in the 12 months prior to overdose was uncommon (12.8%) among those with heroin overdoses, especially among individuals 18-25 years old (3.5%, P < 0.001). LTOT discontinuation prior to overdose was also relatively uncommon, experienced by 6.7% of individuals aged 46 and over and 2.5% of individuals aged 18-25 years (P < 0.001)., Conclusions: Prior to heroin overdose, prescription opioid use was common, but LTOT discontinuation was uncommon and observed primarily in older individuals with the lowest heroin overdose rates. Further study is needed to determine if these prescribing patterns are associated with increased heroin overdose., Competing Interests: Declaration of competing interest An author who is a CDC employee (KZ) was involved in the design and analysis. Experts on CDC subject matter provided feedback for accuracy and clarity but were not otherwise involved in the study., (Published by Elsevier B.V.)

Introduction: Idiopathic pulmonary fibrosis (IPF) is the classic progressive fibrosing interstitial lung disease (ILD), but some patients with ILDs other than IPF also develop a progressive fibrosing phenotype (PF-ILD). Information on use and cost of healthcare resources in patients with PF-ILD is limited., Methods: We used USA-based medical insurance claims (2014-2016) to assess use and cost of healthcare resources in PF-ILD. Patients with at least two ILD claims and at least one pulmonologist visit were considered to have ILD. Pulmonologist visit frequency was used as a proxy to identify PF-ILD (at least four visits in 2016, or at least three more visits in 2016 vs. 2014)., Results: Of 2517 patients with non-IPF ILD, 15% (n = 373) had PF-ILD. Mean annual medical costs associated with ILD claims were $35,364 in patients with non-IPF PF-ILD versus $20,211 in the non-IPF ILD population. In 2016, patients with non-IPF PF-ILD made more hospital ILD claims than patients with non-IPF ILD (10.5 vs. 4.7)., Conclusions: These findings suggest higher disease severity and overall healthcare use for patients with a non-IPF ILD manifesting a progressive fibrosing phenotype (non-IPF PF-ILD).

Background: Few studies have examined patient characteristics and treatment patterns of high-dose insulin therapy (> 200 units/day) among patients with type 2 diabetes mellitus (T2DM)., Objective: To understand patient characteristics, dosing, adherence, and persistence related to high-dose insulin therapy., Methods: This was a retrospective observational study that used administrative claims from a large national health plan. Patients were identified who had been diagnosed with T2DM and who were aged 18-89 years, enrolled in a commercial or Medicare Advantage Prescription Drug plan, newly initiated on a total daily dose (TDD) > 200 units of insulin between January 2011 and August 2015. Patients were required to be enrolled 6 months before and 12 months after the index date. Patients were categorized to Regimen-100 if treated with U-100 insulin only or Regimen-500 if treated with U-500R with or without U-100. Baseline demographic and clinical characteristics were evaluated. An adjustment factor for the days supply was calculated as the ratio of median time between insulin claims, and median pharmacy reported days supply for each insulin prescription. Adjusted days supply, quantity, and concentration were used to calculate TDD for each quarter after the index date. Adherence was measured as the proportion of days covered (PDC) for each regimen. Persistence was measured in 2 ways: the percentage of patients remaining on index medications in each quarter and the proportion of patients who maintained TDD > 200 units during all 4 quarters of the 12-month post-index period., Results: We identified 2,339 patients newly titrated up to TDD > 200 units on either Regimen-100 (2,062, 88.2%) or Regimen-500 (277, 11.8%). Patients on Regimen-500 were slightly younger with higher prevalence of comorbidities. The mean TDD (SD) for Regimen-100 decreased from 228.6 (36.0) units during the first quarter to 194.2 (181.4) units during the last quarter. The mean TDD (SD) for Regimen-500 increased from 294.2 (102.2) units in the first quarter to 304.8 (281.6) units in last quarter. The average adherence to the high-dose insulin regimen was 68.2% (30.7; median 72.6%) for the Regimen-100 cohort and 75.5% (27.0; median 85.2%) for the Regimen-500 cohort. In the Regimen-100 and Regimen-500 cohorts, 45.3% and 55.2% had a PDC ≥ 80%, respectively. Only 23.0% and 51.6% of patients maintained TDD > 200 units for the Regimen-100 and Regimen-500 cohorts, respectively, throughout the 4 quarters after the index date., Conclusions: We observed that many patients did not maintain high-dose insulin use over time, especially those on standard U-100 insulin only. This dosing pattern appears to reflect the differences in patient characteristics, insulin needs, and adherence/persistence behavior between those on Regimen-100 and those on Regimen-500., Disclosures: This study was supported by funding from Eli Lilly and Company to Humana as a collaborative research project involving employees of both companies. Chen, Brown, Fan, Taylor, and He are employees of Eli Lilly and Company. Nair and Meah are employees of Humana, which received funding to complete this research. Siadaty was an employee of Humana at the time of this study.

Background: Nonadherence to medication regimens can lead to adverse health care outcomes and increasing costs., Objectives: To (a) assess the level of medication complexity at an outpatient setting using population-level electronic health record (EHR) data and (b) evaluate its association with medication adherence measures derived from medication-dispensing claims., Methods: We linked EHR data with insurance claims of 70,054 patients who had an encounter with a U.S. midwestern health system between 2012 and 2013. We constructed 3 medication-derived indices: medication regimen complexity index (MRCI) using EHR data; medication possession ratio (MPR) using insurance pharmacy claims; and prescription fill rates (PFR; 7 and 30 days) using both data sources. We estimated the partial correlation between indices using Spearman's coefficient (SC) after adjusting for age and sex., Results: The mean age (SD) of 70,054 patients was 37.9 (18.0) years, with an average Charlson Comorbidity Index of 0.308 (0.778). The 2012 data showed mean (SD) MRCI, MPR, and 30-day PFR of 14.6 (17.8), 0.624 (0.310), and 81.0 (27.0), respectively. Patients with previous inpatient stays were likely to have high MRCI scores (36.3 [37.9], P < 0.001) and were less adherent to outpatient prescriptions (MPR = 50.3 [27.6%], P < 0.001; 30-day PFR = 75.7 [23.6%], P < 0.001). However, MRCI did not show a negative correlation with MPR (SC = -0.31, P < 0.001) or with 30-day PFR (SC = -0.17, P < 0.001) at significant levels., Conclusions: Medication complexity and adherence indices can be calculated on a population level using linked EHR and claims data. Regimen complexity affects patient adherence to outpatient medication, and strength of correlations vary modestly across populations. Future studies should assess the added values of MRCI, MPR, and PFR to population health management efforts., Disclosures: No outside funding supported this study. The authors have nothing to disclose. The abstract of this work was presented at INFORMS Healthcare Conference, held on July 27-29, 2019, in Cambridge, MA.

Background: In the United States, the incidence of acute myeloid leukemia (AML) has steadily increased over the last decade; in 2019, it was estimated that AML would affect 21,450 new patients and lead to 10,920 deaths. Detailed real-world cost estimates and comparisons of key AML treatment episodes, such as in high-intensity chemotherapy (HIC), low-intensity chemotherapy (LIC), hematopoietic stem cell transplantation (HSCT), and relapsed/refractory (R/R), are scarce in the commercially insured U.S., Objective: To examine health resource utilization (HRU), clinical burden, and direct health care costs across various AML treatment episodes in a large sample of commercially insured U.S., Methods: A retrospective cohort analysis was conducted. Patients with newly diagnosed AML were followed to identify the key active treatment episodes across the course of their disease. Data were obtained from 2 sources: IQVIA's Real-World Data (RWD) Adjudicated Claims Database - U.S. (formerly known as PharMetrics Plus), which comprises adjudicated claims for more than 150 million unique enrollees across the United States, and IQVIA Charge Detail Master Hospital Database, which has detailed data regarding services received in an inpatient setting. Calculation of all-cause HRU was based on physician office visits, nonphysician office visits, emergency department visits, inpatient visits, and outpatient pharmacy utilization. Calculation of all-cause health care costs was based on total allowed costs and reported by the following cost components: physician office visits, nonphysician office visits, emergency department visits, inpatient visits, and outpatient pharmacy utilization. Symptom and toxicity events were estimated via proxies such as diagnosis codes, procedures, and treatments administered., Results: The final study sample consisted of 1,542 HIC-induction (HIC-I), 591 HIC-consolidation (HIC-C), 628 LIC, 1,000 patients with HSCT, and 707 patients with R/R AML. Total mean episode costs were highest in R/R episodes ($439,104), followed by HSCT ($329,621), HIC-I ($198,657), HIC-C ($73,428), and LIC ($53,081) episodes. Across all treatment episodes, hospitalization was the largest contributor to cost with mean hospitalization costs ranging from $308,978 in the R/R setting to $49,580 for patients receiving LIC; of these, costs related to intensive care unit admission were a noteworthy contributor. In patients with R/R AML and HSCT, expenditures related to pharmacy utilization averaged $24,640 and $12,203, respectively, and expenditures related to physician office visits averaged $10,926 and $6,090, respectively; these expenditures were much lower across other episodes. Across all categories of symptom and toxicity events, cardiovascular events was the only category of event that was a significant predictor of higher cost across all episodes. Symptom and toxicity events commonly associated with AML were associated with significantly increased costs, especially in R/R episodes., Conclusions: This resource utilization and direct health care cost analysis highlights the substantial economic burden associated with key AML treatment episodes in the United States, specifically during HIC-I, HSCT, and R/R episodes., Disclosures: This study was funded by Astellas Pharma. Astellas employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit the manuscript for publication. Pandya and Wilson are employees of Astellas Pharma U.S. Walsh was an employee of Astellas Pharma U.S. while the study was conducted. Chen, McGuiness, and Wade are employees of IQVIA, which received funding from Astellas Pharma U.S. Madeiros was employed at Stanford University while this study was conducted and received a consulting fee from Astellas for work on this study. Data discussed in this study were previously presented at the 59th Annual American Society for Hematology Meeting & Exposition, 2017; December 9-12, 2017; Atlanta, GA.

Background: In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients., Methods: The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively., Results: The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days., Conclusions: Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

Introduction: The Affordable Care Act mandated that health plans cover preventive health services without patient cost sharing. A process, based on the analyses of medical claims data, is presented that allows companies to assess whether their healthcare plans are providing employees and dependents with age- and sex-appropriate high-priority preventive healthcare services., Methods: High-priority preventive healthcare services are defined as, a physical examination; type 2 diabetes screening; blood lipid screening; cervical, breast, and colon cancer screening; and osteoporosis screening. Current Procedural Terminology codes reflecting billing for these screening services were identified. Receipt of these age- and sex-appropriate services in rolling 3-year windows from 2010 to 2016 was assessed in 86,895,424 person-years of medical claims data from the IBM Watson Health MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefit Database. Data were analyzed in 2018 and 2019., Results: In the 2014-2016 period, 29% of men and 36% of women received the complete set of age- and sex-appropriate preventive health services, whereas 33% of men and 13% of women received none of these services., Conclusions: Only a minority of individuals received a complete set of the defined high-priority preventive healthcare services. The process presented here allows employers to routinely analyze their medical claims data to assess the performance of their health and wellness plans in delivering these preventive services. The strengths and weaknesses of this approach are also described., (Copyright © 2020 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Temporal changes in the dispensing of glucose-lowering drugs (GLD) and their associated costs among elderly populations is unclear. This information is especially relevant to countries in which medications are partly or fully government subsidized., Objective: Our objective was to estimate the trends in prevalence, incidence and costs associated with GLD dispensed to older Australians., Methods: We analysed Pharmaceutical Benefits Scheme data for 76,906 people aged ≥ 65 years dispensed diabetes medications over the period 2013-2016., Results: Older males were dispensed more GLD than were older females, with the marginal difference increasing from 3.2% in 2013 (age-sex adjusted incidence rate ratio [aIRR] 1.032; 95% confidence interval [CI] 1.024-1.041; p < 0.001) to 3.9% in 2016 (aIRR 1.039; 95% CI 1.030-1.047; p < 0.001). The number of GLD dispensed per person was consistently lower in those aged ≥ 75 years than in those aged 65-74 years, with the gap widening over the years. More patients were initiated with sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors over the study period, at the expense of older GLD. The proportion of users and attributed costs associated with the use of metformin, sulfonylureas, α-glucosidase inhibitors and thiazolidinediones decreased over time. The total subsidized costs of GLD is forecast to increase to $A395 million by 2020., Conclusions: The treatment landscape for diabetes in Australia is undergoing dynamic change. More patients were initiated with the newer but costlier GLD over the study period.

Background: In 2015, there were approximately 40,000 new HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) is an effective strategy that reduces the risk of HIV acquisition; however, uptake among those who can benefit from it has lagged. In this study, we 1) compared the characteristics of patients who were prescribed PrEP with individuals newly diagnosed with HIV infection, 2) identified the specialties of practitioners prescribing PrEP, 3) identified metropolitan statistical areas (MSAs) within the US where there is relatively low uptake of PrEP, and 4) reported median amounts paid by patients and third-party payors for PrEP., Methods and Findings: We analyzed prescription drug claims for individuals prescribed PrEP in the Integrated Dataverse (IDV) from Symphony Health for the period of September 2015 to August 2016 to describe PrEP patients, prescribers, relative uptake, and payment methods in the US. Data were available for 75,839 individuals prescribed PrEP, and findings were extrapolated to approximately 101,000 individuals, which is less than 10% of the 1.1 million adults for whom PrEP was indicated. Compared to individuals with newly diagnosed HIV infection, PrEP patients were more likely to be non-Hispanic white (45% versus 26.2%), older (25% versus 19% at ages 35-44), male (94% versus 81%), and not reside in the South (30% versus 52% reside in the South).Using a ratio of the number of PrEP patients within an MSA to the number of newly diagnosed individuals with HIV infection, we found MSAs with relatively low uptake of PrEP were concentrated in the South. Of the approximately 24,000 providers who prescribed PrEP, two-thirds reported primary care as their specialty. Compared to the types of payment methods that people living with diagnosed HIV (PLWH) used to pay for their antiretroviral treatment in 2015 to 2016 reported in the Centers for Disease Control and Prevention (CDC) HIV Surveillance Special Report, PrEP patients were more likely to have used commercial health insurance (80% versus 35%) and less likely to have used public healthcare coverage or a publicly sponsored assistance program to pay for PrEP (12% versus 45% for Medicaid). Third-party payors covered 95% of the costs of PrEP. Overall, we estimated the median annual per patient out-of-pocket spending on PrEP was approximately US$72. Limitations of this study include missing information on prescription claims of patients not included in the database, and for those included, some patients were missing information on patient diagnosis, race/ethnicity, educational attainment, and income (34%-36%)., Conclusions: Our findings indicate that in 2015-2016, many individuals in the US who could benefit from being on PrEP were not receiving this HIV prevention medication, and those prescribed PrEP had a significantly different distribution of characteristics from the broader population that is at risk for acquiring HIV. PrEP patients were more likely to pay for PrEP using commercial or private insurance, whereas PLWH were more likely to pay for their antiretroviral treatment using publicly sponsored programs. Addressing the affordability of PrEP and otherwise promoting its use among those with indications for PrEP represents an important opportunity to help end the HIV epidemic., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: One co-author, KJM, has declared a competing interest in relation to this manuscript. KJM receives research support from the National Heart, Lung, and Blood Institute (R01HL143421), National Institute on Aging (R01AG060935), and Commonwealth Fund and previously did contract work for the US Department of Health and Human Services.

Purpose: The CHA 2 DS 2 -VaSc and HAS-BLED risk scores are commonly used in the studies of oral anticoagulants (OACs). The best ways to map these scores to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes is unclear, as is how they perform in various types of OAC users. We aimed to assess the distributions of CHA 2 DS 2 -VaSc and HAS-BLED scores and C-statistics for outcome prediction in the ICD-10-CM era using different mapping strategies., Methods: We compared the distributions of CHA 2 DS 2 -VaSc and HAS-BLED scores from various mapping strategies in atrial fibrillation patients before, during, and after ICD-10-CM transition. We estimated the C-statistics predicting the 90-day risk of hospitalized stroke (for CHA 2 DS 2 -VaSc) or hospitalized bleeding (for HAS-BLED) in patients identified at least 6 months after the ICD-10-CM transition, overall and by anticoagulant type., Results: Forward-backward mapping produced higher CHA 2 DS 2 -VaSc and HAS-BLED scores in the ICD-10-CM era compared to the ICD-9-CM era: the mean difference was 0.074 (95% confidence interval 0.064-0.085) for CHA 2 DS 2 -VaSc and 0.055 (0.048-0.062) for HAS-BLED. Both scores had higher C-statistics in patients taking no OACs (0.697 [0.677-0.717] for CHA 2 DS 2 -VaSc; 0.719 [0.702-0.737] for HAS-BLED) or direct OACs (0.695 [0.654-0.735] for CHA 2 DS 2 -VaSc; 0.700 [0.673-0.728] for HAS-BLED) than those taking warfarin (0.655 [0.613-0.697] for CHA 2 DS 2 -VaSc; 0.663 [0.6320.695] for HAS-BLED)., Conclusions: Existing mapping strategies generally preserved the distributions of CHA 2 DS 2 -VaSc and HAS-BLED scores after ICD-10-CM transition. Both scores performed better in patients on no OACs or direct OACs than patients on warfarin., (© 2020 John Wiley & Sons Ltd.)

Purpose: An increasing number of new medications are being developed and approved for psoriatic arthritis (PsA). To generate real-world evidence on comparative safety and effectiveness of these drugs, a claims-based algorithm that can accurately identify PsA is greatly needed., Methods: To identify patients with PsA, we developed seven claims-based algorithms based on a combination of diagnosis codes and medication dispensing using the claims data from Medicare parts A/B/D linked to electronic medical records (2012-2014). Two physicians independently conducted a chart review using the treating physician's diagnosis of PsA as the gold standard. We calculated the positive predictive value (PPV) and 95% confidence intervals of each algorithm., Results: Of the total 2157 records identified by the seven algorithms, 45% of the records had relevant clinical data to determine the presence of PsA. The PPV of the algorithms ranged from 75.2% (algorithm 1: ≥2 diagnosis codes for PsA and ≥1 diagnosis code for psoriasis) to 88.6% (algorithm 7: ≥2 diagnosis codes for PsA with ≥1 code by rheumatologist and ≥1 dispensing for PsA medication). Having ≥2 diagnosis codes and ≥1 dispensing for PsA medications (algorithm 6) also had PPV of 82.4%., Conclusions: All seven claims-based algorithms demonstrated a moderately high PPV of 75% to 89% in identifying PsA. The use of ≥2 diagnosis codes plus ≥1 prescription claim for PsA appears to be a valid and efficient tool in identifying PsA patients in the claims data, while broader algorithms based on diagnoses without a prescription claim also have reasonably good PPVs., (© 2019 John Wiley & Sons Ltd.)

Purpose: In course of the new migraine drug development on the global market it is important to quantify the current burden of migraine medication. This study aimed to estimate the comorbidity burden and its relation to healthcare costs in patients using triptans in Switzerland by analyzing a large population-based database., Methods: This retrospective cohort study was based on Swiss health insurance claims data (2015/2016). The study sample comprised adult patients with ≥1 triptan prescription in 2015. We evaluated pharmaceutically treated comorbid conditions (CCs) and costs (12 months after index prescription) of patients using triptan. Multivariable linear regression models with log-transformed outcomes were performed to identify the factors related to healthcare costs., Results: From a total of 749 092, we identified 10,090 patients using triptans (1-year prevalence of 1.35%), whereas 58.9% had ≥2 CCs. The most frequent CCs were pain- and rheumatologic-related diseases and psychological disorders. Among triptan users, the mean total healthcare costs were highest in older patients with ≥2 CCs (>64 years: migraine with ≥2 CC "12 331 SFr"). Multivariate regression analyses showed that psychological disorders had the strongest impact on healthcare costs (Coefficient: 1.29; 95%-CI: 1.27-1.31)., Conclusions: The present study provides an overview of comorbidities and its related costs in migraine patients, which helps to quantify the current burden of migraine. This is relevant as the recently licensed CGRP antagonists are likely to change current treatment schemes for migraine, which strongly depends also on the comorbidities. The present study might therefore be helpful for the future development of treatment guidelines., (© 2019 John Wiley & Sons, Ltd.)

Background: After myocardial infarction, guidelines recommend pharmaceutical treatment with a combination of five different types of drugs for prevention in patients. However, studies from different countries have shown that this goal is not achieved in many patients. The aim of this study was to assess both healthcare and prescribed pharmaceutical treatment in the fourth quarter after index myocardial infarction., Methods: We conducted a claims data analysis with the data of patients who had had a myocardial infarction in the years 2013 or 2014, using information from the largest German health insurance fund ('AOK'). We analysed contact with physicians, hospital care and actual prescriptions for medication recommended in international guidelines, referring to beta-blockers, ACE inhibitors or angiotensin II receptor blockers, P2Y12-antiplatelet agents, acetylsalicylic acid and statins, one year after myocardial infarction. Analysis was stratified by age and sex, compared between patient groups and over time., Results: We identified 2352 patients who had survived myocardial infarction. Some 96.9% of these participants had at least one contact with their general practitioner (GP) one year after myocardial infarction, 22.8% contacted a cardiologist and 19.7% were hospitalised. Prescription rates range from 37.8% for acetylsalicylic acid to 70.4% for ACE inhibitors. However, only 24.1% received statins, beta-blockers, ACE inhibitors and an antiplatelet drug simultaneously. Prescription of recommended drugs after myocardial infarction decreased steadily over time., Discussion: Long-term medical prevention after myocardial infarction is improvable. GPs should take care of the pharmaceutical prevention after myocardial infarction as they are the physicians seen most intensively in this period., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: Osteoarthritis (OA) is a major reason for chronic pain, stiffness, and functional limitation. This study was undertaken to analyze factors associated with the burden of OA, taking the pattern of joint involvement into account., Methods: From a random sample of 8,995 patients with OA (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, German Modification codes M15 [polyarticular], M16 [hip], or M17 [knee]) from a German statutory health insurance database, 3,564 patients completed a survey including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Patients with knee, hip, concomitant hip and knee, or polyarticular manifestation were compared concerning pain, stiffness, function, and impact on work and personal life. Data were linked to dispensation records. The association of age, sex, body mass index (BMI), symptom duration, and the World Health Organization-5 Well-Being Index (WHO-5) with WOMAC results was assessed in multiple linear regression models., Results: Patients with knee (n = 1,448), hip (n = 959), hip and knee (n = 399), or polyarthritic (n = 758) OA were included. Concomitant hip and knee OA was accompanied by the highest WOMAC values (mean 44), frequent impairment of personal life (75%), and the highest use of analgesics (52% nonsteroidal antiinflammatory drugs, 22% opioids, and 37% others). In the regression analyses, BMI per 5 units and WHO-5 per 10% worsening were associated with an increase in WOMAC values of 4-5 points, irrespective of the joint manifestations., Conclusion: Disease burden is high in patients with concomitant hip and knee OA and is connected with frequent prescription of analgesics. Involvement of several joints, BMI, and depressive symptoms need to be considered when using the WOMAC as an outcome instrument., (© 2019 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.)

Vaccination coverage among older adults is low in the United States. A recommendation from a provider is a strong predictor of vaccine receipt. Using Medicare Fee-For-Service data (2015-2017) this study characterized providers by the number of influenza and pneumococcal vaccines administered in physician offices, age, gender, and professional specialty to determine the volume of vaccines provided by individual providers and characteristics of these providers. Half of all vaccinations were provided by 10% of providers. The mean age of 224,483 and 165,710 unique influenza and pneumococcal providers respectively was 49 years (SD: 12 years) with males and females equally distributed. The highest vaccinating quartile of providers tended to be older, more likely male and more likely general physicians. Those who administered a high volume of one vaccine were likely to administer a high volume of the other. Providers administering vaccines in office-based settings can do more to increase vaccination coverage rates., (Published by Elsevier Ltd.)

Background: The brand name Suboxone and its generic formulation buprenorphine/naloxone is a medication for treating opioid use disorder. While this medication has been shown to be effective, little research has examined the extent to which it is being prescribed and under what circumstances. Objective: This study examined patterns of prescription claims for buprenorphine/naloxone in terms of volume and associated clinical conditions. Methods: The study was conducted using a statewide database comprising pharmacy and medical claims that were covered by commercial health insurance plans in Massachusetts between 2011 and 2015. Trends in prescription volume for buprenorphine/naloxone were assessed based on the annual number of patients with a prescription for buprenorphine/naloxone. To examine clinical conditions associated with buprenorphine/naloxone prescriptions, patients' pharmacy claims were linked to their medical claims within the prior three months. For patients with common pain-related conditions, the odds they were prescribed buprenorphine/naloxone rather than oxycodone, a widely used opioid for pain management, were also examined. Results: The number of patients with a buprenorphine/naloxone prescription increased substantially during the study period, from approximately 25,000 in 2011 to over 39,000 in 2015. The most common clinical condition associated with buprenorphine/naloxone prescribing was opioid use disorder, but a substantial percentage of prescriptions were preceded by diagnoses that included pain or were for pain alone. Conclusion: A substantial increase in the number of patients with a prescription for buprenorphine/naloxone was observed. While buprenorphine/naloxone is most frequently prescribed for opioid use disorder, clinicians also appear to prescribe it for pain, particularly for patients who may be at elevated risk for opioid use disorder.

Hemorrhoids are a common anorectal disease. Epidemiological studies on medication trends and risk factors using information from real-world databases are rare. Our objective was to analyze the relationship between hemorrhoid treatment prescription trends and several risk factors using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan and related medical information datasets. We calculated the standardized prescription ratio (SPR) based on the 2nd NDB Open Data Japan from 2015. The correlation coefficients between the SPR of antihemorrhoidals and those of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations" were 0.7474, 0.7366, 0.7184, 0.6501, 0.6320, 0.4571, and 0.4542, respectively. The correlation coefficient between the SPR of antihemorrhoidals and those of "average annual temperature," "percentage of people who were smokers," and "percentage of people who drank regularly" were -0.7204, 0.6002, and 0.3537, respectively. The results of cluster analysis revealed that Hokkaido and Tohoku regions tended to have low average annual temperature values and high percentage of people who were smokers and had comparatively high SPRs of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations." Antihemorrhoidals are frequently used in Hokkaido and Tohoku, Japan; thus, it is important for these prefectural governments to focus on these factors when taking measures regarding health promotion.

The anti-inflammatory agent colchicine may cause toxic effects such as rhabdomyolysis, pancytopenia, and acute respiratory distress syndrome in cases of overdose and when patients have renal or liver impairment. As colchicine is a substrate for CYP3A4 and P-glycoprotein (P-gp), drug-drug interactions are important factors that cause fatal colchicine-related side effects. Thus, we conducted a nation-wide survey to determine the status of inappropriate colchicine prescriptions in Japan. Patients prescribed the regular use of colchicine from April 2014 to March 2017 were identified using the Japanese large health insurance claims database. As the primary endpoint, we evaluated the concomitant prescription proportions of strong CYP3A4 and/or P-gp inhibitors classified as "contraindications for co-administration" with colchicine in patients with renal or liver impairment. We defined these cases as "inappropriate colchicine prescriptions." Additionally, factors affecting inappropriate colchicine prescriptions were analyzed. Among the 3302 enrolled patients, 43 (1.30%) were inappropriately prescribed colchicine. Of these 43 patients, 11 had baseline renal and/or liver impairment. By multiple regression analysis, the primary diseases "gout" and "Behçet's disease" were extracted as independent factors for inappropriate colchicine prescriptions with odds ratios of 0.40 (95% confidence interval: 0.19-0.84) and 4.93 (95% confidence interval: 2.12-11.5), respectively. We found that approximately 1% of patients had important colchicine interactions. Particularly, Behçet's disease was a risk factor for inappropriate prescriptions, with approximately 25% of patients showing renal and/or liver impairment (classified as "contraindications for co-administration"). These findings may be useful for medical professionals who prescribe colchicine therapy.

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: Challenges of future dementia care include increasing shortage of qualified healthcare providers and decreasing potential of informal care by relatives. In order to meet those challenges, changes in dementia care are needed. These changes should be based on data of both care utilisation and care supply. The aim of this study was to provide insight into individual and regional characteristics that influence the utilisation of long-term care by people with dementia., Methods: The study was a retrospective cross-sectional analysis of claims-based data and other available data referring to one index year. All data were aggregated for small geographic districts. The study population comprised people with a dementia diagnosis, 65 years and older in Baden-Wuerttemberg and insured by the largest health insurer. Utilisation of nursing home care, informal care, and respite care was analysed using binary coded logistic multilevel analyses., Results: Seventy nine thousand three hundred forty-nine people with dementia were included in the analyses. Nursing home care was used by 20.4%, informal care by 30.6%, and respite care by 3.5% of people with dementia. Individual characteristics that influence care utilisation included age, sex and the level of care dependency. The utilisation of informal care (OR = 1.713) and respite care (OR = 2.036) was higher in rural districts than in city districts. Respite care supply had an effect on the utilisation of respite care (OR = 1.173)., Conclusions: The study found differences between districts in the utilisation of long-term care for dementia. These differences were largely explained by the composition of the population within the districts. An exception was the utilisation of respite care, which was higher in districts which have higher supply. Individual characteristics that influenced care utilisation are age, sex, level of care dependency and, with regard to informal care, comorbidity. Further research should be conducted on a small-area level, include further individual characteristics as well as other care and living forms.

Background and Objectives: In Japan, polypharmacy reduction policy, which reduces the reimbursement of medical cost, was introduced to address unnecessary psychotropic polypharmacy. The rule was applied to the prescriptions of three or more anxiolytics or three or more hypnotics in the policy introduced in 2012. The prescriptions of four or more antidepressants or four or more antipsychotics were added to the rule in the policy revised in 2014. Furthermore, the prescriptions of three or more drugs of anxiolytics, hypnotics, antidepressants, or antipsychotics were subject to the reduction criteria of the policy revision in 2016. Benzodiazepine receptor agonists (BZs) are classified both into anxiolytics and hypnotics, and the reduction rule was not applied to the category of BZs before April 2018. This study aimed to examine the effect of the policy on the prescriptions of four drug categories as well as BZs from the point of view of the number of drugs and doses., Methods: This was a retrospective observational study using a large-scale Japanese health insurance claims database. Patients who were prescribed at least one psychotropic drug (anxiolytic, hypnotic, antidepressant, or antipsychotic) during the study period (from April 2011 to March 2017) were selected. Segmented regression analysis was used to analyze the proportions of patients with three or more or four or more drugs as well as patients above clinically recommended doses, and the means of the average daily doses by drug category., Results: A total of 312,167 patients were identified as a study population. The proportions of patients with three or more drugs in anxiolytics, hypnotics, antidepressants, and antipsychotics significantly decreased after the introduction or revisions of the policy, but not BZs. The proportions of patients with three or more drugs in March 2017 were 0.9%, 2.0%, 1.2%, 2.4%, and 8.9% in anxiolytics, hypnotics, antidepressants, antipsychotics, and BZs, respectively. The effect of the policy in reducing the proportions of patients above clinically recommended doses was identified in antipsychotics after the revision in 2016, but not identified in the sum of anxiolytics and hypnotics as well as BZs after the revision in 2014, and antidepressants after the revision in 2016. The proportions of monotherapy were increased from April 2011 to March 2017 only for antidepressants (76.9% → 80.8%) and antipsychotics (79.8% → 82.1%), and not changed or decreased for anxiolytics (85.2% → 85.7%), hypnotics (78.6% → 77.6%), sum of anxiolytics and hypnotics (68.1% → 65.7%), BZs (68.0% → 67.3%), and sum of psychotropic drugs (52.1% → 49.9%)., Conclusions: The polypharmacy reduction policy reduced the proportions of patients with three or more drugs in four drug categories, but not BZs. Only limited effects were seen for reducing the proportions of patients above clinically recommended doses. The policy was revised in April 2018 again. Further investigation is needed to examine the effect of the revision in 2018.

Objectives: Patient treatment within the Swedish medical service system can claim negligence injuries to the malpractice insurance review board and request financial compensation. The aim of this paper was to analyse the consequences of a negligence claim after arterial surgery between two periods with increasing use of endovascular treatment., Methods: This was a retrospective cohort study of the arterial surgery negligence claims from two three year periods 2005-2007 (Period A) and 2012-2014 (Period B) from the County Council's Mutual Insurance Company. The analysis was restricted to aortic, carotid, and lower limb arterial diseases. The magnitude of surgery for vascular diseases was obtained from the Swedish vascular register (Swedvasc)., Results: The number of patients undergoing arterial procedures increased from 16 628 to 20 709 (p = .01). There was an increase of 54% in the number of negligence claims between the periods. In Period A, the number of compensated claims was 22 out of 83 (29%) and in Period B 60 out of 151 (41%) (p = .06). Patients treated for aortic disorders and peripheral arterial surgery received compensation with increasing frequency whereas carotid diseases decreased. Claimants treated for aortic disorders were compensated in four out of 23 (17%) and 21 out of 54 (39%) in the two periods (p = .07), and after lower limb arterial surgery in six out of 34 (18%) and in 24 out of 71 (34%) (p = .09). After carotid surgery the corresponding figures were 12 out of 26 (46%) and 14 out of 25 (46%) (p = .48). The increasing use of endovascular procedures (but not in carotid artery surgery) did not seem to influence the pattern of negligence claims., Conclusions: Between the two three year periods there has been an increase in negligence claims but not in compensated ones. The increased use of endovascular procedures has not influenced the pattern of compensated negligence claims., (Copyright © 2019. Published by Elsevier B.V.)

Background: For older adults, a good transition from hospital to the primary or long-term care setting can decrease readmissions. This paper presents the 6-month post-discharge healthcare utilization of older adults and describes the numbers of readmissions and deaths for the most frequently occurring aftercare arrangements as a starting point in optimizing the post-discharge healthcare organization., Methods: This cross-sectional study included older adults insured with the largest Dutch insurance company. We described the utilization of healthcare within 180 days after discharge from their first hospital admission of 2015 and the most frequently occurring combinations of aftercare in the form of geriatric rehabilitation, community nursing, long-term care, and short stay during the first 90 days after discharge. We calculated the proportion of older adults that was readmitted or had died in the 90-180 days after discharge for the six most frequent combinations. We performed all analyses in the total group of older adults and in a sub-group of older adults who had been hospitalized due to a hip fracture., Results: A total of 31.7% of all older adults and 11.4% of the older adults with a hip fracture did not receive aftercare. Almost half of all older adults received care of a community nurse, whereas less than 5% received long-term home care. Up to 18% received care in a nursing home during the 6 months after discharge. Readmissions were lowest for older adults with a short stay and highest in the group geriatric rehabilitation + community nursing. Mortality was lowest in the total group of older aldults and subgroup with hip fracture without aftercare., Conclusions: The organization of post-discharge healthcare for older adults may not be organized sufficiently to guarantee appropriate care to restore functional activity. Although receiving aftercare is not a clear predictor of readmissions in our study, the results do seem to indicate that older adults receiving community nursing in the first 90 days less often die compared to older adults with other types of aftercare or no aftercare. Future research is necessary to examine predictors of readmissions and mortality in both older adult patients discharged from hospital.

Background: Over the past two decades, several quality improvement projects have been implemented in emergency departments (EDs) in the Netherlands, one of these being the training and deployment of emergency physicians. In this study we aim to perform a trend analysis of ED quality of care in Dutch hospitals, as measured by the incidence of medical malpractice claims., Patients and Methods: We performed a multicentre retrospective cohort study of malpractice claims in five Dutch EDs over the period 1998-2014. Incidence risk ratios were calculated to demonstrate any relation of specific quality improvement initiatives with the primary outcome, defined as the number of claims per 10 000 ED visits per year., Results: During the study period, the cumulative number of ED visits increased significantly from 99 145 in 1998 to 162 490 in 2014 (P < 0.01). In total, 228 of 2 348 417 ED visits (0.97 per 10 000) resulted in a malpractice claim. At the same time, the yearly number of ED claims filed decreased with 0.07 (0.03-0.10) per 10 000 each year. The claim rate was higher in the period before emergency physicians were employed in the ED [1.18 (0.98-1.41) claims per 10 000 visits] compared with the period after they were employed [0.81 (0.67-0.97), incidence risk ratio 0.69 (0.53-0.89), P < 0.01]., Conclusion: Even though the number of ED visits increased significantly over the past two decades, the number of malpractice claims filed after an ED visit decreased. Various quality improvement initiatives, including the training and employment of emergency physicians, may have contributed to the observed decrease in claims.

Objective: To determine whether levothyroxine (L-T4) preparation (generic vs brand) affected hospitalization for cardiovascular events., Patients and Methods: We performed a retrospective analysis using a large administrative claims database, OptumLabs Data Warehouse, creating two 1-to-1 propensity score-matched cohorts initiating generic or brand L-T4. Patients were followed for a mean of 1.0±1.2 years (range, 0-9.3 years). We included 87,902 propensity score-matched patients (43,951 patients per cohort) initiating generic or brand L-T4. Variables included in matching were age, sex, race/ethnicity, residence region, selected comorbidities, and Charlson-Deyo comorbidity score. Patients with previous use of any thyroid preparation, amiodarone, or lithium were excluded. Primary outcomes were the event rates for hospitalizations for incident atrial fibrillation, myocardial infarction, congestive heart failure, or stroke., Results: In the generic L-T4 cohort, 35,242 (80.2%) were women and 7327 (16.7%) were 65 years of age or older; in the brand L-T4 cohort, 34,633 (78.8%) were women and 8092 (18.4%) were 65 years of age or older. We found no differences in event rates (events per 1000 person-years) for 4 outcomes comparing generic and brand L-T4 therapy: (1) atrial fibrillation (1.82 vs 2.19; hazard ratio [HR], 1.22; 95% CI, 0.90-1.65; P=.19); (2) myocardial infarction (2.12 vs 1.83; HR, 0.86; 95% CI, 0.64-1.17; P=.35); (3) congestive heart failure (2.27 vs 2.00; HR, 0.88; 95% CI, 0.66-1.18; P=.41); and (4) stroke (3.10 vs 2.38; HR, 0.77; 95% CI, 0.59-1.00; P=.05). Stratification by age group revealed no differences., Conclusion: In patients with newly treated hypothyroidism, cardiovascular event rates were similar for generic and brand L-T4., (Copyright © 2019. Published by Elsevier Inc.)

Retrospective administrative claims database studies provide real-world evidence about treatment patterns, healthcare resource use, and costs for patients and are increasingly used to inform policy-making, drug formulary, and regulatory decisions. However, there is no standard methodology to identify patients with pulmonary arterial hypertension (PAH) from administrative claims data. Given the number of approved drugs now available for patients with PAH, the cost of PAH treatments, and the significant healthcare resource use associated with the care of patients with PAH, there is a considerable need to develop an evidence-based and systematic approach to accurately identify these patients in claims databases. A panel of pulmonary hypertension clinical experts and researchers experienced in retrospective claims database studies convened to review relevant literature and recommend best practices for developing algorithms to identify patients with PAH in administrative claims databases specific to a particular research hypothesis.

Background: The aim of the study was to examine the prevalence of and factors associated with antidepressant (AD) prescriptions in order to draw a comprehensive picture of prescribing practices in Switzerland., Method: We conducted a population-based, cross-sectional descriptive study using a large Swiss healthcare claims database, covering approximately 13% of the Swiss population. AD prescription was determined by identifying patients (N = 105,663) with health claims data of at least 1 AD prescription in the year 2016. AD medication was identified using ATC-codes classified by the World Health Organisation. Univariate, bivariate and multivariate analyses using logistic regression were performed., Results: The extrapolated 1-year prevalence of AD prescription was 8.7% (95% CI, 8.7-8.8) with two thirds of AD recipients being female and the average age being 59 years (SD = 19.1). The regional distribution of prescription rates varied between cantons and ranged from 6.5 to 11.7%. Logistic regression revealed higher prescription rates among females compared to males (OR: 1.52) and an increased probability of AD prescription by age up until 54 years (OR: 2.25) and ≥ 85 years (OR: 2.32). Comorbidity is associated with higher odds (OR: 3.26 with 1-2 comorbidities) and enrollment in a managed care plan (compared to standard care) with lower odds for an AD prescription (OR: 0.85)., Conclusion: This study is the first in Switzerland to describe the prevalence of and factors associated with AD prescription based on a large health claims database reflecting routine care. The results provide important information about regional variation, prescription source, and potential over-prescription in the treatment of depressive disorders.

Background: Although bronchodilator inhaler therapy can improve lung function in patients with tuberculous destroyed lung (TDL), its effect on mortality has not been studied. We evaluated the effect of tiotropium inhaler therapy on mortality in patients with TDL., Methods: A retrospective cohort of 963 patients with TDL was followed for up to ten years by linking hospital and nationwide health insurance claims data. We compared patients receiving tiotropium inhaler with patients without tiotropium after matching with propensity scores. In addition, we elucidated the risk factors of mortality using Cox proportional hazards model., Results: After the propensity score matching, the baseline characteristics were balanced in both the tiotropium group (n = 105) and the non-tiotropium group (n = 105); including mean age (63.9 vs. 64.4 years, P = 0.715), mean forced expiratory volume in 1 s (FEV 1 ) (45.0 vs. 45.3%, P = 0.903), and others. After the propensity score matching, the tiotropium group showed better survival than the non-tiotropium group (median survival period: not reached for the tiotropium group vs. 7.24 years for the non-tiotropium group, Prentice-Wilcoxon test, P = 0.008). Multivariate Cox proportional hazard analysis revealed that tiotropium inhaler usage was associated with lower risk of mortality in the multivariate analysis (HR, 0.560; 95% CI, 0.380-0.824; P = 0.003) after adjusting age, sex, BMI, smoking history, mMRC dyspnea score, Charlson Comorbidity Index, concomitant COPD diagnosis, FEV 1 , X-ray severity score, and home oxygen usage., Conclusions: Our results suggest that tiotropium inhaler is associated with decreased all-cause mortality in TDL. Further prospective study is required for validation.

Purpose: The study purpose was to describe trends in the size and demographics of the population of transgender Medicare beneficiaries identified using International Classification of Diseases (ICD) Clinical Modification codes over time. We also assessed how the change from ICD, Ninth Revision (ICD-9) diagnosis codes to ICD, 10th Revision (ICD-10) diagnosis codes in October 2015 has affected the ability to identify transgender beneficiaries within claims data. Methods: We used Medicare Fee-for-Service claims within the Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse from 2010 through 2016 to identify transgender beneficiaries. We linked these data to Medicare enrollment records to study demographic trends. Results: Within the Medicare program, the number of beneficiaries identified as transgender through claims data in each year has increased from 2088 beneficiaries in 2010 to 10,242 beneficiaries in 2016 (a 390% increase). The highest numbers of transgender beneficiaries were identified in 2015 and 2016, which coincide with the change to ICD-10. Similarly, more beneficiaries were identified as transgender in the 12 months after the change to ICD-10 ( N  = 8733) than in the 12 months before ( N  = 4857). Conclusion: Given that a first and critical step to better understand and eliminate health disparities and deliver culturally competent care is to identify and characterize the population of interest, this study provides an innovative view into how the change to the ICD-10 coding system affects the ability to study a transgender cohort within Medicare claims data.

Objective: The objective of the study was to assess the direct cost of medically treated seizure events in severe childhood-onset epilepsies. Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC) are representative conditions associated with frequent intractable seizures., Methods: Commercial and Medicaid insurance claims from 2010 to 2015 were queried to identify patients with possible LGS, possible DS, or TSC, having ≥2 years of continuous insurance from the date of first epilepsy/seizure diagnosis or antiepileptic drug (AED) fill (index date). Utilization and cost data in patients with and without seizure events requiring acute treatment were evaluated for two years postindex. Medically treated seizure events resulting in minor, moderate, severe, and no injury were included. Average costs were normalized to 2017 dollars at 3% per annum and reported for each cohort, by insurance type and degree of injury., Results: Among 9754 patients, 55.4-58.8% of LGS, 47.7-55.8% of DS, and 13.7-28.0% of TSC cohorts had ≥1 medically treated seizure event, depending on insurance type. Events during two-year postindex averaged 2.8-3.3 in LGS, 3.1-3.3 in DS, and 1.9-2.2 in TSC; cost per event averaged $8147-$14,759 in LGS, $4637-$8751 in DS, and $5335-$9672 in TSC. In patients with events, average all-cause costs per-patient-per-year (PPPY) were $71,512-$84,939 in LGS; $31,278-$43,758 in DS; and $42,997-$48,330 in TSC., Conclusions: Patients with intractable seizures having at least one medically treated seizure event incur substantial all-cause costs. Our results can be used to inform cost effectiveness and budget impact models to estimate the value of existing and future treatments for these and similar conditions., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Phenylketonuria is a well-known rare disease included in the neonatal screening of many countries. Therefore, there are few published data on the admissions and costs of phenylketonuria in Spain., Objective: The objective of this study was to assess the number of admissions and the economic burden of phenylketonuria in Spain., Methods: Patients with phenylketonuria were identified from a Spanish database containing data from public and private healthcare centres from 1997 to 2015. The parameters obtained were characteristics of the patients, type of admissions, readmissions, discharges, length of stay, medical service, annual number of visits, annual number of patients, visit-associated costs and patient-associated costs., Results: Five hundred and ninety-four patients with phenylketonuria were identified: 48.32% were male with a mean (standard deviation) age of 4.50 (10.23) years. The hospital admissions were divided into emergency visits (55.94%) and scheduled visits (43.92%). The majority of patients were discharged home (98.86%). The mean (standard deviation) duration of stay was 4.04 (4.98) days. The number of admissions per year ranged between 13 and 88, with an average of 1.18 admissions per patient per year. Finally, the mean cost per visit increased from €1064.91 to €3709.40, and the mean cost per patient increased from €1818.90 to €4239.32 from 1999 to 2015., Conclusions: The access to economic and social data on phenylketonuria in Spain has been updated. The number of admissions in Spain between 1997 and 2015 and healthcare costs between 1999 and 2015 were calculated. There were 24 admissions as a result of a phenylketonuria diagnosis in 2015 and the mean healthcare cost per patient was €4239.32. This information can help to adapt and improve each healthcare system to take into consideration rare diseases.

Objective: To assess real-world durability of reduction in relapse rates among patients with multiple sclerosis (MS) receiving fingolimod therapy over a longer-term period of follow-up., Methods: Patients with MS who initiated fingolimod were identified from a US claims database (January 1, 2009 to September 30, 2016) and followed for 3 years post-initiation. Annualized relapse rates (ARRs) were calculated during the 1-year pre-initiation period, and during each year over the 3-year follow-up period. Time from fingolimod initiation to discontinuation (≥60-day treatment gap) was also summarized., Results: Among 1599 fingolimod initiators, 1158 (72%) had continuous fingolimod use up to the start of year 2 and 937 (59%) had continuous fingolimod use up to the start of year 3. The mean baseline ARR during the 1-year pre-initiation period for all initiators was 0.51. After fingolimod initiation, mean ARRs were consistently lower in each year of follow-up: 0.25 (95% CI: 0.22, 0.28) in year 1 for all fingolimod initiators, 0.22 (0.18, 0.25) in year 2 for patients with continuous fingolimod use up to the start of year 2, and 0.23 (0.19, 0.27) in year 3 for patients with continuous fingolimod use up to the start of year 3. Median time on treatment was 33 months for all patients initiating fingolimod., Conclusions: Patients with MS who received continuous fingolimod therapy experienced a sustained reduction in relapse rates (>50% vs. baseline) during each year of a 3-year follow-up period., (Copyright © 2019. Published by Elsevier B.V.)

Background: To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications., Methods and Findings: For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics., Conclusions: In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: JJG is or was Principal Investigator of research grants from Eli Lilly and Company and Novartis Pharmaceuticals Corporation to the Brigham and Women’s Hospital and is a consultant to Aetion, Inc. and Optum, Inc., all for unrelated work. RJD is Principal Investigator of a research grant from Merck to the Brigham and Women’s Hospital for unrelated work. JR is a consultant to Aetion Inc. for unrelated work. ASK and AS’s work is supported by the Laura and John Arnold Foundation, as well as the Engelberg Foundation and Harvard Program in Therapeutic Science. ASK is an Academic Editor on PLOS Medicine’s editorial board. SKD is an employee of the Food and Drug Administration, which funded the research grant on which this manuscript is based.

Background: The health care costs associated with treating autism spectrum disorder (ASD) in children can be substantial. State-level mandates that require insurers to cover ASD-specific services may lessen the financial burden families face by shifting health care spending to insurers., Methods: We estimated the effects of ASD mandates on out-of-pocket spending, insurer spending, and the share of total spending paid out of pocket for ASD-specific services. We used administrative claims data from 2008 to 2012 from 3 commercial insurers, and took a difference-in-differences approach in which children who were subject to mandates were compared with children who were not. Because mandates have heterogeneous effects based on the extent of children's service use, we performed subsample analyses by calculating quintiles based on average monthly total spending on ASD-specific services. The sample included 106 977 children with ASD across 50 states., Results: Mandates increased out-of-pocket spending but decreased the share of spending paid out of pocket for ASD-specific services on average. The effects were driven largely by children in the highest-spending quintile, who experienced an average increase of $35 per month in out-of-pocket spending ( P < .001) and a 4 percentage point decline in the share of spending paid out of pocket ( P < .001)., Conclusions: ASD mandates shifted health care spending for ASD-specific services from families to insurers. However, families in the highest-spending quintile still spent an average of >$200 per month out of pocket on these services. To help ease their financial burden, policies in which children with higher service use are targeted may be warranted., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)

Objectives: Neonatal abstinence syndrome (NAS) is a postnatal withdrawal syndrome experienced by some infants with opioid exposure. Hospital administrative data are commonly used for research and surveillance but have not been validated for NAS. Our objectives for this study were to validate the diagnostic codes for NAS and to develop an algorithm to optimize identification., Methods: Tennessee Medicaid claims from 2009 to 2011 (primary sample) and 2016 (secondary sample; post- International Classification of Diseases, 10th Revision, Clinical Modification [ ICD-10-CM ]) were obtained. Cases of NAS were identified by using International Classification of Diseases, Ninth Revision, Clinical Modification code (2009-2011) 779.5 and ICD-10-CM code (2016) P96.1. Medical record review cases were then conducted by 2 physicians using a standardized algorithm, and positive predictive value (PPV) was calculated. Algorithms were developed for optimizing the identification of NAS in administrative data., Results: In our primary sample of 112 029 mother-infant dyads, 950 potential NAS cases were identified from Medicaid claims data and reviewed. Among reviewed records, 863 were confirmed as having NAS (including 628 [66.1%] cases identified as NAS requiring pharmacotherapy, 224 [23.5%] as NAS not requiring pharmacotherapy, and 11 [1.2%] as iatrogenic NAS), and 87 (9.2%) did not meet clinical criteria for NAS. The PPV of the International Classification of Diseases, Ninth Revision, Clinical Modification code for NAS in clinically confirmed NAS was 91% (95% confidence interval: 88.8%-92.5%). Similarly, the PPV for the ICD-10-CM code in the secondary sample was 98.2% (95% confidence interval: 95.4%-99.2%). Algorithms using elements from the Medicaid claims and from length of stay improved PPV., Conclusions: In a large population-based cohort of Medicaid participants, hospital administrative data had a high PPV in identifying cases of clinically diagnosed NAS., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)