Treatment Patterns by Race and Ethnicity in Newly Diagnosed Persons with Multiple Sclerosis.

BACKGROUND: Non-Hispanic Black and Hispanic persons with MS (pwMS) are more likely to experience rapid disease progression and severe disability than non-Hispanic White pwMS; however, it is unknown how the initiation of high-efficacy disease-modifying therapies (DMTs) differs by race/ethnicity. This real-world study describes DMT treatment patterns in newly diagnosed pwMS in the United States (US) overall and by race/ethnicity. METHODS: This retrospective analysis used the US Optum Market Clarity claims/electronic health records database (January 2015-September 2020). pwMS who were first diagnosed in 2016 or later and initiated any DMT in the two years following diagnosis were included. Continuous enrollment in the claims data for ≥ 12 months before and ≥ 24 months after diagnosis was required. Treatment patterns 2 years after diagnosis were analyzed descriptively overall and by race/ethnicity. RESULTS: The sample included 682 newly diagnosed and treated pwMS (non-Hispanic Black, n = 99; non-Hispanic White, n = 479; Hispanic, n = 35; other/unknown race/ethnicity, n = 69). The mean time from diagnosis to DMT initiation was 4.9 months in all pwMS. Glatiramer acetate and dimethyl fumarate were the most common first-line DMTs in non-Hispanic Black (28% and 20% respectively) and Hispanic pwMS (31%, 29%); however, glatiramer acetate and ocrelizumab were the most common in non-Hispanic White pwMS (33%, 18%). Use of first-line high-efficacy DMTs was limited across all race/ethnicity subgroups (11-29%), but uptake increased in non-Hispanic Black and White pwMS over the study period. CONCLUSION: Use of high-efficacy DMTs was low across all race/ethnicity subgroups of newly diagnosed pwMS in the US, including populations at a greater risk of experiencing rapid disease progression and severe disability.

Real-World Clinical and Economic Outcomes Among Persons With Multiple Sclerosis Initiating First- Versus Second- or Later-Line Treatment With Ocrelizumab.

INTRODUCTION: Prior research has demonstrated that early treatment with high-efficacy disease-modifying therapies (DMTs), including ocrelizumab (OCR), can reduce relapses and delay disease progression among persons with multiple sclerosis (pwMS) compared with escalation from low-/moderate-efficacy DMTs. However, there is a lack of research examining the impact of early use of OCR on real-world clinical and economic outcomes. This study aimed to evaluate differences in events often associated with a relapse (EOAR) as well as non-DMT healthcare resource use (HCRU) and costs among pwMS who received OCR as a first-line treatment compared with later-line treatment after diagnosis. METHODS: Newly diagnosed adult pwMS were selected from deidentified Optum Market Clarity claims data (study period: January 1, 2015-June 30, 2021). All pwMS were required to have initiated OCR after diagnosis and have 12 months of continuous eligibility prior to diagnosis. The index date was the date of initiation of the first-line DMT after diagnosis. pwMS who initiated OCR as first-line (1L OCR cohort) or a second- or later-line treatment (2L + OCR cohort) were matched 1:1 based on length of continuous eligibility after the first-line DMT and weighted using stabilized inverse probability of treatment. In the follow-up period, differences in outcomes, including annualized EOAR, non-DMT HCRU and costs, were evaluated for pwMS in the 1L vs. 2L + OCR cohorts. RESULTS: The sample included 748 pwMS. During the follow-up period, pwMS in the 1L OCR cohort had a significantly lower annual rate of EOAR compared with pwMS in the 2L + OCR cohort (0.37 vs. 0.56; difference: 0.20 [95% CI 0.08, 0.32]). pwMS in the 1L OCR cohort had a significantly lower probability of any hospitalization within 1 year, fewer non-DMT outpatient visits and lower all-cause and MS-related, non-DMT costs compared with pwMS in the 2L + OCR cohort. CONCLUSIONS: First-line initiation OCR was associated with improvements in clinical and non-DMT economic outcomes compared with later-line initiation of OCR, suggesting that early initiation may benefit both patients and the healthcare system.

The Association Between Persistence and Adherence to Disease-Modifying Therapies and Healthcare Resource Utilization and Costs in Patients With Multiple Sclerosis.

Background: Persistence and adherence to disease-modifying therapies (DMTs) affects treatment efficacy and economic outcomes, both of which contribute to overall patient disease burden. Current literature suggests that patients with multiple sclerosis (MS) who adhere to DMT for 12 months have fewer relapses and reduced MS-related healthcare resource utilization (HCRU) and medical costs than nonadherent patients. Objective: To expand on previous research by estimating the association of persistence and adherence with all-cause and MS-related HCRU and non-DMT costs of patients with MS across 12 and 24 months of therapy use. Methods: This study was a retrospective analysis of adult patients with MS in the IBM MarketScan Commercial and Medicare Supplemental databases using claims data between April 2016 and December 2019. The index date was defined as the initiation of the DMT. Patients were required to have ≥12 months' continuous enrollment pre-index and ≥12 or ≥24 months' continuous enrollment post-index. Persistence was defined as no gap in DMT supply for ≥60 days within the post-index period or switch to another DMT. Adherence was calculated using the proportion of days covered (for this study, number of days covered by the DMT was 365 or 730 days), with ≥80% proportion of days covered considered adherent. Multivariable analyses were conducted to estimate total and individual components of non-DMT costs by persistence and adherence while controlling for baseline differences. Results: Patients who were persistent with medication for 12 months showed a reduction in mean total non-DMT medical costs of $10 022 compared with nonpersistent patients; these savings nearly doubled ($19 230) after 24 months of persistence. A similar pattern was observed for adherent vs nonadherent patients (reduction in costs at 12 months, $8543; at 24 months, $16 091). The largest reduction in all-cause HCRU costs was observed in the inpatient setting, while the largest reduction in MS-related costs was observed in the outpatient setting. Discussion: Patients with MS who were persistent and adherent to medication had substantially lower all-cause and MS-related non-DMT medical costs compared with those who were nonpersistent or nonadherent. Conclusions: These findings further support the importance of persistence and adherence to DMTs in patients with MS.

Adherence to and Persistence with Disease-Modifying Therapies for Multiple Sclerosis Over 24 Months: A Retrospective Claims Analysis.

INTRODUCTION: We sought to assess adherence to and persistence with ocrelizumab (OCR) compared with other disease-modifying treatments (DMTs), by route of administration (RoA), for multiple sclerosis (MS) after 24 months in the United States. METHODS: This retrospective claims analysis of MS patients initiating a new DMT was conducted using the IBM MarketScan Commercial and Medicare Supplemental databases between April 2016 and December 2019. Continuous enrollment of ≥ 12 months before and up to 24 months after initiating the index DMT was required. Adherence was assessed based on proportion of days covered (PDC) in the follow-up period with values ≥ 80% considered adherent. Persistence was defined as no evidence of switching to another DMT or no gap ≥ 60 days in DMT coverage. RESULTS: A total of 1710 patients with ≥ 24 months of follow-up (OCR, n = 524; oral, n = 701; injectable, n = 365; other intravenous [IV], n = 120) were included. Patients initiating OCR had higher adherence (80% vs. 55%, 35%, and 54% for oral, injectable, and other IV, respectively) and persistence (75% vs. 54%, 33%, and 55%, respectively) at 24 months. Relative risks (RRs) of 24-month non-adherence for those initiating orals, injectables, and other IVs were 2.2 (95% CI, 1.7-2.9), 3.0 (95% CI, 2.2-4.0), and 2.2 (95% CI, 1.5-3.3), respectively, compared to those initiating OCR. Similarly, patients receiving orals, injectables, and other IVs had RR of 1.9 (95% CI, 1.4-2.4), 2.5 (95% CI, 1.9-3.4), and 1.8 (95% CI, 1.2-2.6) for 24-month discontinuation, respectively. Similar patterns were observed at 12 and 18 months. CONCLUSIONS: Patients initiating OCR in a real-world setting achieved higher rates of adherence and persistence at 24 months compared with those initiating other DMTs, consistent with published literature showing similar results at 12 and 18 months. Optimizing medication adherence and persistence is fundamental to MS care, so clinicians should consider all elements of DMTs that may improve compliance.

Contemporary treatment utilization among women diagnosed with symptomatic uterine fibroids in the United States.

BACKGROUND: This study evaluated treatment patterns among women diagnosed with symptomatic uterine fibroids (UF) in the United States. Data were retrospectively extracted from the IBM Watson Health MarketScan® Commercial Claims and Encounters and Medicaid Multi-State databases. METHODS: Women aged 18-64 years with ≥1 medical claim with a UF diagnosis (primary position, or secondary position plus ≥1 associated symptom) from January 2010 to June 2015 (Commercial) and January 2009 to December 2014 (Medicaid) were eligible; the first UF claim during these time periods was designated the index date. Data collected 12 months pre- and 12 and 60 months post-diagnosis included clinical/demographic characteristics, pharmacologic/surgical treatments, and surgical complications. Prevalence (2015) and cumulative incidence (Commercial, 2010-2015; Medicaid, 2009-2015) of symptomatic UF were estimated. RESULTS: 225,737 (Commercial) and 19,062 (Medicaid) women had a minimum of 12 months post-index continuous enrollment and were eligible for study. Symptomatic UF prevalence and cumulative incidence were: 0.57, 1.23% (Commercial) and 0.46, 0.64% (Medicaid). Initial treatments within 12 months post-diagnosis were surgical (Commercial, 36.7%; Medicaid, 28.7%), pharmacologic (31.7%; 53.0%), or none (31.6%; 18.3%). Pharmacologic treatments were most commonly non-steroidal anti-inflammatory drugs and oral contraceptives; hysterectomy was the most common surgical treatment. Of procedures of abdominal hysterectomy, abdominal myomectomy, uterine artery embolization, and ablation in the first 12 months post-index, 14.9% (Commercial) and 24.9% (Medicaid) resulted in a treatment-associated complication. Abdominal hysterectomy had the highest complication rates (Commercial, 18.5%; Medicaid, 31.0%). CONCLUSIONS: Off-label use of pharmacologic therapies and hysterectomy for treatment of symptomatic UF suggests a need for indicated non-invasive treatments for symptomatic UF.

Direct Costs Incurred Among Women Undergoing Surgical Procedures to Treat Uterine Fibroids.

BACKGROUND: Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE: To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS: Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS: Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS: This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES: This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

Development of a bedside tool to predict the probability of drug-resistant pathogens among hospitalized adult patients with gram-negative infections.

BACKGROUND: We developed a clinical bedside tool to simultaneously estimate the probabilities of third-generation cephalosporin-resistant Enterobacteriaceae (3GC-R), carbapenem-resistant Enterobacteriaceae (CRE), and multidrug-resistant Pseudomonas aeruginosa (MDRP) among hospitalized adult patients with Gram-negative infections. METHODS: Data were obtained from a retrospective observational study of the Premier Hospital that included hospitalized adult patients with a complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), hospital-acquired/ventilator-associated pneumonia (HAP/VAP), or bloodstream infection (BSI) due to Gram-negative bacteria between 2011 and 2015. Risk factors for 3GC-R, CRE, and MDRP were ascertained by multivariate logistic regression, and separate models were developed for patients with community-acquired versus hospital-acquired infections for each resistance phenotype (N = 6). Models were converted to a singular user-friendly interface to estimate the probabilities of a patient having an infection due to 3GC-R, CRE, or MDRP when ≥ 1 risk factor was present. RESULTS: Overall, 124,068 patients contributed to the dataset. Percentages of patients admitted for cUTI, cIAI, HAP/VAP, and BSI were 61.6, 4.6, 16.5, and 26.4%, respectively (some patients contributed > 1 infection type). Resistant infection rates were 1.90% for CRE, 12.09% for 3GC-R, and 3.91% for MDRP. A greater percentage of the resistant infections were community-acquired relative to hospital-acquired (CRE, 1.30% vs 0.62% of 1.90%; 3GC-R, 9.27% vs 3.42% of 12.09%; MDRP, 2.39% vs 1.59% of 3.91%). The most important predictors of having an 3GC-R, CRE or MDRP infection were prior number of antibiotics; infection site; infection during the previous 3 months; and hospital prevalence of 3GC-R, CRE, or MDRP. To enable application of the six predictive multivariate logistic regression models to real-world clinical practice, we developed a user-friendly interface that estimates the risk of 3GC-R, CRE, and MDRP simultaneously in a given patient with a Gram-negative infection based on their risk (Additional file 1). CONCLUSIONS: We developed a clinical prediction tool to estimate the probabilities of 3GC-R, CRE, and MDRP among hospitalized adult patients with confirmed community- and hospital-acquired Gram-negative infections. Our predictive model has been implemented as a user-friendly bedside tool for use by clinicians/healthcare professionals to predict the probability of resistant infections in individual patients, to guide early appropriate therapy.

Healthcare resource utilization and costs among women diagnosed with uterine fibroids compared to women without uterine fibroids.

Objective: To perform a retrospective, matched-cohort, longitudinal evaluation of annual pre- and post-diagnosis costs incurred among women with uterine fibroids (UF) (cases) compared to controls without UF. Methods: Data were derived from the IBM Watson Health MarketScan Commercial Claims and Encounters and Medicaid Multi-State databases. Women aged 18-64 years with ≥1 inpatient or outpatient medical claim with an initial UF diagnosis (index date) from 1 January 2010 to 31 December 2014 were included. Healthcare resource utilization (HCRU) data including pharmacy, outpatient and inpatient hospital claims were collected for 1 year pre-index and ≤5 years post-index. All-cause costs (adjusted to 2017 $US) were compared between cases and controls using multivariable regression models. Results: Analysis included 205,098 (Commercial) and 24,755 (Medicaid) case-control pairs. HCRU and total all-cause healthcare costs were higher for cases versus controls during the pre-index year and all years post-index. Total unadjusted mean all-cause costs were $1197 higher (p < .0001; Commercial) and $2813 higher (standardized difference 0.08; Medicaid) for cases during the pre-index year. Total adjusted mean all-cause costs in the first year post-index were $14,917 for cases versus $5717 for controls in the Commercial population, and $20,244 versus $10,544, respectively, in the Medicaid population. In Years 2-5 post-index, incremental mean adjusted total costs decreased, but remained significantly higher for cases versus controls at all time points in both populations (all p < .05). Conclusions: Costs were higher for women with UF compared to women without UF during the pre-index year and over 5 years post-index; differences were greatest in the first year post-index.

Antimicrobial Resistance or Delayed Appropriate Therapy-Does One Influence Outcomes More Than the Other Among Patients With Serious Infections Due to Carbapenem-Resistant Versus Carbapenem-Susceptible Enterobacteriaceae?

BACKGROUND: The relative contribution of antimicrobial resistance versus delayed appropriate treatment to the clinical and economic burden of Enterobacteriaceae infections is not well understood. METHODS: Using a large US hospital database, we identified all admissions between July 2011 and September 2014 with evidence of serious Enterobacteriaceae infection. The "index date" was the earliest date on which a culture positive for Enterobacteriaceae was drawn. Infections were classified as carbapenem-resistant (CRE) or carbapenem-susceptible (CSE). Receipt of antimicrobials with activity against all index pathogens on the index date or ≤2 days thereafter was deemed as "timely"; all other instances were "delayed." Associations between CRE status and delayed appropriate therapy on outcomes were estimated using inverse probability weighting and multivariate regression models (ie, logistic model for discharge destination and composite mortality [in-hospital death or discharge to hospice] or generalized linear model for duration of antibiotic therapy, hospital length of stay [LOS], and costs). RESULTS: A total of 50 069 patients met selection criteria; 514 patients (1.0%) had CRE. Overall, 67.5% of CSE patients (vs 44.6%, CRE) received timely appropriate therapy (P < .01). Irrespective of CRE status, patients who received delayed appropriate therapy had longer durations of antibiotic therapy and LOS, higher costs, lower likelihood of discharge to home, and greater likelihood of the composite mortality outcome (P for trend < .01). CONCLUSIONS: Delayed appropriate therapy is a more important driver of outcomes than CRE, although the 2 factors are somewhat synergistic. Better methods of early CRE identification may improve outcomes in this patient population.

Impact of Delayed Appropriate Antibiotic Therapy on Patient Outcomes by Antibiotic Resistance Status From Serious Gram-negative Bacterial Infections.

BACKGROUND: To examine the clinical and economic burdens associated with delayed receipt of appropriate therapy among patients with Gram-negative bacteria (GNB) infections, stratified by antibiotic resistance status. MATERIALS AND METHODS: Retrospective analysis using the Premier Hospital Database. Adult admissions (July 2011-September 2014) with evidence of complicated urinary tract infection, complicated intra-abdominal infection, hospital-associated pneumonia, or bloodstream infection, length of stay (LOS) ≥1 days and a positive GNB culture from a site consistent with infection type (culture draw date = index date) were identified and stratified by antibiotic susceptibility to index pathogens. Delayed appropriate therapy was defined as no receipt of antibiotic(s) with relevant microbiological activity on or within 2 days of index date. Inverse probability weighting and multivariate regression analyses were used to estimate the association between delayed appropriate therapy and outcomes. Generalized linear models were used to evaluate postindex duration of antibiotic therapy, LOS and total in-hospital costs. Logistic models were used to evaluate discharge destination and in-hospital mortality/discharge to hospice. RESULTS: A total of 56,357 patients with GNB infections were identified (resistant, n = 6,055; susceptible, n = 50,302). Delayed appropriate therapy was received by 2,800 (46.2%) patients with resistant and 16,585 (33.0%) patients with susceptible infections. Using multivariate analysis, delayed appropriate therapy was associated with worse outcomes including ∼70% increase in LOS, ∼65% increase in total in-hospital costs and ∼20% increase in the risk of in-hospital mortality/discharge to hospice, regardless of susceptibility status. CONCLUSIONS: Our results suggest that outcomes in patients with GNB infections, regardless of resistance status, significantly improve if timely appropriate therapy can be provided.

Clinical characteristics, patterns of lipid-lowering medication use, and health care resource utilization and costs among patients with atherosclerotic cardiovascular disease.

PURPOSE: The aim of this study was to investigate real-world patient characteristics, medication use, and health care resource utilization (HCRU) and costs among patients with clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, to examine burden of disease and unmet needs, such as potential undertreatment. PATIENTS AND METHODS: This retrospective cohort study utilized a nationally representative managed care database to identify newly diagnosed ASCVD patients between January 1, 2007, and November 30, 2012 (index = first ASCVD diagnosis date) in the USA. Patients had ≥12-month pre-index (baseline) and ≥12-month post-index (follow-up) health plan enrollment and no baseline lipid-lowering medication (LLM). Patient characteristics, LLM utilization patterns, HCRU, and costs were examined for all patients and by subgroups based on LLM use pattern and/or follow-up low-density lipoprotein cholesterol (LDL-C) levels. RESULTS: A total of 128,017 ASCVD patients were identified with a mean (SD) age of 59 (13) years, 43.1% female, and 48.8% with ≥36-month follow-up. Within 12-month follow-up, 10.6% had high-intensity statins and 56.9% had no LLM fills. Baseline mean (SD) all-cause costs were $8,852 ($25,608). At 12-month follow-up, mean (SD) all-cause and ASCVD-related costs were $31,443 ($54,040) and $20,289 ($45,159), respectively. The 36-month analyses showed similar distributions. Multivariable analyses showed that age, gender, region, health insurance type, baseline comorbidities, baseline use of specific medications, baseline lipid profiles, and index ASCVD type were significantly associated with all-cause and ASCVD-related health care costs. CONCLUSION: Patients have nonoptimal treatment for ASCVD and substantial HCRU and costs associated with residual risk. Unmet needs and cost burdens of ASCVD patients merit additional investigation.

Clinical Characteristics, Health Care Utilization and Costs Among Men with Primary or Secondary Hypogonadism in a US Commercially Insured Population.

INTRODUCTION: Hypogonadism is broadly associated with increases in chronic comorbid conditions and health care costs. Little is known about the specific impact of primary and secondary hypogonadism on health care costs. AIM: To characterize the health care cost and utilization burden of primary and secondary hypogonadism in a population of US men with commercial insurance. METHODS: Newly diagnosed patients with International Classification of Diseases, Ninth Revision, Clinical Modification codes associated with specific medical conditions known to have a high prevalence of testosterone deficiency (ie, relating to primary or secondary hypogonadism) or who had fills for testosterone replacement therapy from January 1, 2007 through April 30, 2013 were identified in administrative claims data from the HealthCore Integrated Research Database. A cohort of patients without hypogonadism was matched on demographics and comorbidities. The matched hypogonadism and non-hypogonadism cohorts (n = 5,777 in each cohort) were compared during a 12-month follow-up period. MAIN OUTCOME MEASURES: Direct health care expenditures and utilization were assessed for all causes and for hypogonadism-related claims. Costs included out-of-pocket patient expenditures and those paid by the insurer. RESULTS: Hypogonadism and matched non-hypogonadism cohorts were similar in demographics (mean age = 50 years) and diagnosed comorbid conditions in the 12 months preceding the index date. In the year after the index date, mean all-cause expenditures for patients with hypogonadism increased by 62% (from $5,425 to $8,813) compared with 25% for the matched controls (from $4,786 to $5,992; P < .01 for follow-up difference between groups). Approximately 16% of total mean costs ($1,377), primarily outpatient and pharmacy costs, were identifiable as related to hypogonadism. CONCLUSION: These data from a population of US men with commercial insurance coverage showed a greater resource use burden for patients with primary and secondary hypogonadism compared with similar patients without hypogonadism. Additional management might be required to address unmet need and decrease the cost burden for patients with hypogonadism.

The SWEET SPOTS study: a real-world interpretation of the 2012 American Diabetes Association Position Statement regarding individualized A1C targets.

OBJECTIVE: To evaluate awareness of the 2012 American Diabetes Association (ADA) Position Statement among physicians and assess its effects on patient-centered glycated hemoglobin (A1C) goals in the management of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: The Summarizing Real-World Individualized TrEatmEnT GoalS and Potential SuppOrT Systems in Type 2 Diabetes (SWEET SPOTS) study used the HealthCore claims database to identify T2D patients, stratified by risk, and their treating physicians to assess primary care physician and endocrinologist awareness of the 2012 ADA Position Statement. Physicians completed online surveys on A1C targets before and after receiving an educational intervention to review the position statement. RESULTS: Of 125 responding physicians (mean age 50.3 years, 12.8% endocrinologists) who were linked to 125 patient profiles (mean age 56.9 years, 42% female, mean A1C 7.2%), 92% were at least somewhat aware of the position statement prior to the intervention and 59% believed that the statement would impact how they set A1C targets. The educational intervention resulted in mostly less stringent goal setting for both lower and higher risk patients, but changes were not significant. The proportion of physician-assigned A1C targets within ADA-recommended ranges increased from 56% to 66% post-intervention (P<0.0001). CONCLUSION: Physicians treating T2D are aware of the 2012 ADA Position Statement and believe that it may influence treatment goals. While patient-specific A1C targets were not significantly impacted, physicians indicated that they would make targets more or less stringent for lower and higher risk patients, respectively, across their practice. Further research into optimizing physician education regarding individualized A1C targets is warranted.

Are patients on basal insulin attaining glycemic targets? Characteristics and goal achievement of patients with type 2 diabetes mellitus treated with basal insulin and physician-perceived barriers to achieving glycemic targets.

AIMS: To investigate treatment patterns and achievement of glycemic targets in patients with type 2 diabetes mellitus treated with basal insulin in a real-world setting, and to determine physicians' beliefs and practices regarding these patients. METHODS: This study had two components; a retrospective analysis using a US claims database of patient and treatment data, and a survey of physicians' beliefs and practices. RESULTS: A total of 39,074 patients treated with basal insulin were included in this analysis. The proportion of patients achieving HbA1c<7.0% (53mmol/mol) was similar in ongoing basal insulin users at baseline (26%) and at 3months follow-up (27%). The number of new initiators achieving HbA1c<7.0% (53mmol/mol) increased from baseline (11%) to 3months (27%). In the physician survey component, the majority of physicians indicated they would continue to increase basal insulin dose as long as was needed to reach HbA1c/fasting blood glucose goals (85% of physicians treating 'not on-goal' patients, 78% of physicians treating 'on-goal' patients). Physician-perceived barriers to insulin intensification included patient's lifestyle, non-adherence, and concerns about out-of-pocket costs. CONCLUSIONS: A large proportion of patients on insulin-based therapy fail to reach glycemic goals. More education of clinicians may improve insulin intensification rates and increase the proportion of patients reaching glycemic targets.