Prevalence, treatment patterns, and stay characteristics associated with hospitalizations for major depressive disorder.

BACKGROUND: Hospitalizations for major depressive disorder (MDD) are a significant burden on patients, their families, and to healthcare systems. This study characterized the prevalence of MDD hospitalizations in the US and described clinical characteristics, treatment patterns, length of stay, costs, and MDD-related hospitalization readmissions. METHODS: A retrospective analysis of the Premier Perspective® Hospital Database was conducted using records of hospital admissions for MDD from January 1, 2014 to December 31, 2015. To supplement this analysis, healthcare claims data from Truven MarketScan® Research Database were also evaluated between January 1, 2013 and December 31, 2014. RESULTS: Among adult hospital stays in the Premier network, 1.3% included a primary diagnosis of MDD. The mean length of MDD-related stays was 6 days, with a mean total hospital charge per stay of $6713. Of those with hospital stays, 5.2% of patients had at least 1 readmission for MDD within 30 days of discharge. In the MarketScan database, 4% of adults with MDD had a MDD-related hospital stay, with a mean length of stay of 6 days and total reimbursed amount per stay of $8441. Of those with hospital stays, 5.4% had at least 1 readmission for MDD within 30 days. LIMITATIONS: Results may not be generalizable to hospitals outside of those represented by these databases. CONCLUSIONS: Adult MDD hospitalizations are costly and associated with high rates of readmission. There is a need for new treatments that may help reduce hospitalizations and costs related to hospitalizations in patients with MDD.

Long-term opioid users with chronic noncancer pain: Assessment of opioid abuse risk and relationship with healthcare resource use.

OBJECTIVE: Identify opioid abuse risk factors among chronic noncancer pain (CNCP) patients receiving long-term opioid therapy and assess healthcare resource use (HRU) among patients at elevated abuse risk. DESIGN: Data were obtained from an integrated administrative claims database. Classification and Regression Tree (CART) analysis identified risk factors potentially predictive of opioid abuse, which were used to classify the overall population into cohorts defined by levels of abuse risk. Multivariable logistic regression compared HRU across risk cohorts. SETTING: Retrospective cohort study. PATIENTS, PARTICIPANTS: 21,072 patients aged ≥18 years diagnosed with ≥1 of 5 types of CNCP and a prescription for Schedule II or III/IV opioid medication used long-term (≥90 days). MAIN OUTCOME MEASURES: (1) Opioid abuse risk factors; (2) HRU differences between risk cohorts. RESULTS: CART analysis identified four groups at elevated opioid abuse risk defined by three factors (age, daily opioid dose, and total days' supply of opioids); sensitivity: 70.3 percent, specificity: 74.1 percent, and positive predictive value: 5.6 percent. The analysis results were used to classify patients into low-risk (72.5 percent), at-risk (25.4 percent), and opioid-abuser (2.2 percent) cohorts. In multivariable analysis, emergency department (ED) use was higher among at-risk vs low-risk patients (odds ratio [OR]: 1.14; p<0.05); hospitalization and ED visits were higher for opioid-abusers vs low-risk patients (OR: 2.33 and 2.14, respectively; p<0.05). CONCLUSIONS: This study identifies a subpopulation of CNCP patients at risk of opioid abuse. However, limited sensitivity and specificity of criteria defining this subpopulation reinforce the importance of physician discretion in patient-level treatment decisions.

Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care.

AIMS: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US. METHODS: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs. RESULTS: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p < .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts. LIMITATIONS: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present. CONCLUSIONS: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

Health care resource use and cost differences by opioid therapy type among chronic noncancer pain patients.

The study assessed 12-month chronic pain (CP)-related health care utilization and costs among chronic noncancer pain (CNCP) patients who initiated various long-term opioid treatments. Treatments included monotherapy with long-acting opioids (mono-LAOs), mono-therapy with short-acting opioids (mono-SAOs), both LAOs and SAOs (combination), and opioid therapy initiated with SAO or LAO and switched to the other class (switch). Using MarketScan® claims databases (2006-2012), we identified CNCP patients with ≥90 days opioid supply after pain diagnosis and continuous enrollment 12 months before pain diagnosis (baseline period) and 12 months after opioid start (post-index period). Outcomes included CP-related health care utilization and costs. Among CNCP patients (n=21,203), the cohort distribution was 74% mono-SAOs, 22% combination, 2% mono-LAOs, and 2% switch. During follow-up, the average daily morphine equivalent dose was highest in mono-LAO patients (96.4 mg) compared with combination patients (89.8 mg), switch patients (64.3 mg), and mono-SAO patients (36.2 mg). After adjusting for baseline differences, the mono-LAO cohort had lower total CP-related costs ($4,933) compared with the mono-SAO ($8,604), switch ($10,470), and combination ($15,190) cohorts (all: P<0.05). Mono-LAO patients had greater CP-related prescription costs but lower medical costs than the other cohorts during the follow-up period, including lower CP-related hospitalizations (1% vs 11%-20%), emergency department visits (4% vs 11%-18%), and diagnostic radiology use (21% vs 54%-61%) (all: P<0.001). Use of pain-related medications and other treatment modalities was also significantly lower in the mono-LAO cohort relative to the other cohorts. CNCP patients using long-term monotherapy with LAOs had the lowest CP-related total health care costs in the 12 months after opioid initiation compared with mono-SAO, switch, or combination patients despite higher opioid daily doses and higher prescription costs. Future research accounting for severity and duration of pain would aid in determining the optimal long-term opioid regimen for CNCP patients.

Elevated Cardiovascular Disease Risk in Patients With Chronic Myelogenous Leukemia Seen in Community-based Oncology Practices in the United States.

INTRODUCTION: Current National Comprehensive Cancer Network guidelines recommend that comorbidities, including cardiovascular disease (CVD), be considered when selecting tyrosine kinase inhibitors for the treatment of chronic myelogenous leukemia (CML). We report here the prevalence of CVD and its risk factors in patients with CML treated by community-based United States (US) oncologists. PATIENTS AND METHODS: Adult patients with a confirmed diagnosis of CML and ≥ 1 encounter after the first date of CML diagnosis in an electronic medical record database between January 1, 2005 and October 31, 2014 were enrolled. CVD conditions/risk factors were assessed at baseline and during the 5-year follow-up period using International Classification of Diseases, 9th Revision, Clinical Modification diagnoses codes and information from physician progress notes. One-year prevalence estimates were age- and gender-standardized for comparison to annual rates in the US population. RESULTS: A total of 1639 patients were included. At 5-year follow-up, the prevalence of CVD conditions and CVD risk factors was 33.0% and 77.7%, respectively. Compared with the general US adult population, the standardized prevalence rates at 1 year in patients with CML were significantly higher by factors of 1.3 to 3.5 times for CVD conditions, and 20% to 40% significantly higher for hypertension, diabetes, and obesity (P < .001). The prevalence of cardiovascular risk factors was not significantly higher in patients residing in the US Stroke Belt. CONCLUSION: The increased risk of CVD observed in this real-world analysis of patients with CML underscores the importance of current National Comprehensive Cancer Network recommendations to consider cardiovascular risk when selecting tyrosine kinase inhibitors.

Use and cost comparison of clobazam to other antiepileptic drugs for treatment of Lennox-Gastaut syndrome.

Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited. Objectives: To compare the baseline characteristics and treatment patterns of new initiators of clobazam and other AEDs among LGS patients and compare healthcare utilization and costs before and after clobazam initiation among LGS patients. Methods: A retrospective study of probable LGS patients was conducted using the MarketScan® Commercial, Medicare Supplemental, and Medicaid databases (10/1/2010-3/31/2014). Results: In the Commercial/Medicare Supplemental population, clobazam users were younger, had fewer comorbidities, and more prior AED use than non-clobazam users. In the 12 months pre-treatment initiation, clobazam users had significantly more seizure-related inpatient stays and outpatient visits and higher total seizure-related (P < 0.001) and all-cause (P < 0.001) costs than non-clobazam users. Among clobazam users, when compared to the 12 months pre-clobazam initiation, seizure-related medical utilization and costs were lower in the 12 months post-clobazam initiation (P = 0.004). Total all-cause (P < 0.001) and seizure-related (P = 0.029) costs increased post-clobazam initiation mainly due to the increase in outpatient pharmacy costs. Similar results were observed in the Medicaid population. Conclusions: Baseline results suggest a prescribing preference for clobazam in severe LGS patients. Clobazam users had a reduction in seizure-related medical utilization and costs after clobazam initiation. The improvement in medical costs mostly offset the higher prescription costs following clobazam initiation.

Burden of Alcohol Abuse or Dependence Among Long-Term Opioid Users with Chronic Noncancer Pain.

BACKGROUND: Substance abuse disorders among chronic noncancer pain (CNCP) patients add to the clinical challenges and economic burden of caring for such patients. Despite potential risks, some CNCP patients with a history of alcohol abuse or dependence (AAD) and pain that is refractory to nonopioid treatment options may still need opioids for pain management. However, there is a lack of data on adverse outcomes in long-term opioid users with CNCP and a history of substance abuse or AAD disorders. OBJECTIVE: To compare adverse outcomes and all-cause health care costs among CNCP patients on long-term opioid treatment with and without a previous diagnosis of AAD. METHODS: Using MarketScan claims databases (2006-2012), CNCP patients with ≥ 90 days of opioid supply after CNCP diagnosis and continuous enrollment 12 months before CNCP diagnosis (baseline period) and 12 months after opioid start (post-index period) were identified. AAD was defined by diagnosis codes at any time before opioid initiation. Outcomes included opioid overdose, accident, and injury episodes identified by ICD-9-CM diagnoses codes. T-tests and Mann-Whitney tests compared continuous measures, and chi-square and Fisher's exact tests compared categorical measures between those with and without AAD. Multivariable analyses for outcomes were conducted, adjusting for baseline differences between cohorts. RESULTS: Of 21,203 CNCP patients with long-term opioid treatment, 750 (3.5%) had an AAD diagnosis before opioid initiation. AAD patients were significantly younger (48.4 [SD ± 11.4] years vs. 52.8 [SD ± 14.8] years), less likely to be enrolled in Medicare (17% commercial vs. 4% Medicare), and more likely to be male (67% vs. 48%; all P < 0.001). There were no differences in type or number of CNCP diagnoses or Charlson Comorbidity Index (CCI) scores. Patients with AAD had significantly higher rates of depression and anxiety diagnoses, antidepressant and benzodiazepine use, and drug abuse/dependence diagnoses in the baseline period. Twelvemonth post-index rates of opioid overdose (1.2% vs. 0.2%), accident (7.3% vs. 2.8%), and injury (46.1% vs. 36.8%) were greater in the AAD cohort (all P < 0.001). The differences were nonsignificant for accidents in multivariable analyses. While mean prescription costs were similar ($3,562 vs. $3,312; P = 0.212), AAD patients had significantly higher mean all-cause medical costs ($28,429 vs. $22,082; P < 0.001) and significantly higher all-cause total health care costs ($31,991 vs. $25,395; P < 0.001). The cost differences remained significant in multivariable analyses. CONCLUSIONS: In the first year after long-term opioid initiation, CNCP patients with a previous AAD diagnosis had 5 times the rate of opioid overdose, 2.3 times the rate of accidents, 1.2 times the rate of injury, and higher all-cause health care costs compared with those not diagnosed with AAD. DISCLOSURES: Funding for this research study and resultant publication was provided by Teva Global Health Economics and Outcomes Research, which fully reviewed the manuscript. Gajria and Yeung are employees of Teva Pharmaceuticals. White was an employee of Teva Pharmaceuticals at the time this research was conducted. Blumberg and Coutinho are employees of Xcenda, which received research funding from Teva Pharmaceuticals for the conduct of this study and for the preparation of this manuscript. Katz has received research funding and consulting fees from Teva Pharmaceuticals unrelated to this study. Study concept and design were contributed by Katz, White, and Blumberg, along with Coutinho and Yeung. Coutinho took the lead in data collection, assisted by the other authors. Data interpretation was performed by Blumberg, Katz, and Gajria, along with the other authors. The manuscript was written by Gajria, Yeung, Coutinho, and Blumberg, along with Katz and White, and revised by Gajria, Blumberg, Katz, and Coutinho, along with Yeung and White.

Healthcare resource use and costs of multiple sclerosis patients in Germany before and during fampridine treatment.

BACKGROUND: Multiple sclerosis (MS) patients often suffer from gait impairment and fampridine is indicated to medically improve walking ability in this population. Patient characteristics, healthcare resource use, and costs of MS patients on fampridine treatment for 12 months in Germany were analyzed. METHODS: A retrospective claims database analysis was conducted including MS patients who initiated fampridine treatment (index date) between July 2011 and December 2013. Continuous insurance enrollment during 12 months pre- and post-index date was required, as was at least 1 additional fampridine prescription in the fourth quarter after the index date. Patient characteristics were evaluated and pre- vs post-index MS-related healthcare utilization and costs were compared. RESULTS: A total of 562 patients were included in this study. The mean (standard deviation [SD]) age was 50.5 (9.8) years and 63% were female. In the treatment period, almost every patient had at least 1 MS-related outpatient visit, 24% were hospitalized due to MS, and 79% utilized MS-specific physical therapy in addition to the fampridine treatment. Total MS-related healthcare costs were significantly higher in the fampridine treatment period than in the period prior to fampridine initiation (€17,392 vs €10,960, P < 0.001). While this difference was driven primarily by prescription costs, MS-related inpatient costs were lower during fampridine treatment (€1,333 vs €1,565, P < 0.001). CONCLUSIONS: Physical therapy is mainly used concomitant to fampridine treatment. While healthcare costs were higher during fampridine treatment compared to the pre-treatment period, inpatient costs were lower. Further research is necessary to better understand the fampridine influence.

Health care resource utilization before and after natalizumab initiation among patients with multiple sclerosis in Germany.

BACKGROUND: Multiple sclerosis (MS), a progressive neurodegenerative disease, greatly impacts the quality of life and economic status of people affected by this disease. In Germany, the total annual cost of MS is estimated at €40,000 per person with MS. Natalizumab has shown to slow MS disease progression, reduce relapses, and improve the quality of life of people with MS. OBJECTIVE: To evaluate MS-related and all-cause health care resource utilization and costs among German MS patients during the 12 months before and after initiation of natalizumab in a real-world setting. METHODS: The current analysis was conducted using the Health Risk Institute research database. Identified patients were aged ≥18 years with ≥1 diagnosis of MS and had initiated natalizumab therapy (index), with 12-month pre- and post-index-period data. Patients were stratified by prior disease-modifying therapy (DMT) usage or no DMT usage in the pre-index period. Outcome measures included corticosteroid use and number of sick/disability days, inpatient stays, and outpatient visits. Health care costs were calculated separately for pre- and post-index periods on a per-patient basis and adjusted for inflation. RESULTS: In a final sample of 193 natalizumab-treated patients, per-patient MS-related corticosteroid use was reduced by 62.3%, MS-related sick days by 27.6%, and inpatient costs by 78.3% from the pre- to post-index period. Furthermore, the proportion of patients with MS-related hospitalizations decreased from 49.7% to 14.0% (P<0.001); this reduction was seen for patients with and without prior DMT use. CONCLUSIONS: In a real-world setting in Germany, initiation of natalizumab treatment in people with MS significantly reduced MS-related hospitalizations, corticosteroid use, sick days, and associated costs.

Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population.

BACKGROUND: The aim of this study was to extend previous findings and determine the value of prompt initiation of maintenance treatment (MT) following COPD exacerbations requiring hospitalization or an emergency department (ED) visit. PATIENTS AND METHODS: Administrative claims data (collected between January 1, 2009 and June 30, 2012) from an employer-sponsored commercially insured population were retrospectively used to identify patients with a COPD exacerbation resulting in hospitalization or an ED visit. Patients initiating approved MT for COPD within 30 days of discharge/diagnosis (prompt) were compared with those initiating MT within 31-180 days (delayed). COPD-related total, medical, and prescription drug costs during a 1-year follow-up period were evaluated using semilog ordinary least square regressions, controlling for baseline characteristics plus COPD-related costs from the previous year. The odds and number of subsequent COPD-related exacerbations during the follow-up were compared between the prompt and delayed cohorts using logistic regression and zero-inflated negative binomial models, respectively. RESULTS: A total of 6,521 patients with a COPD-related hospitalization or an ED visit were included, of whom 4,555 received prompt MT and 1,966 received delayed MT. Adjusted COPD-related total and medical costs were significantly lower for the prompt MT than the delayed MT cohorts (US$3,931 vs US$4,857 and US$2,327 vs US$3,087, respectively; both P<0.010), as were COPD-related prescription costs (US$1,526 vs US$1,683, P<0.010) during the 1-year follow-up period. Patients receiving delayed MT were 68% more likely to have a subsequent exacerbation requiring hospitalization and 80% more likely to have an exacerbation requiring an ED visit. CONCLUSION: Prompt initiation of MT following a COPD-related hospitalization or an ED visit was associated with a significant reduction in COPD-related costs and odds of exacerbation in the following year compared with delayed initiation.

The Additional Cost Burden of Preexisting Medical Conditions During Pregnancy and Childbirth.

OBJECTIVES: To identify the prevalence of comorbidities in pregnant women and examine the incremental costs of these conditions on the care for mothers and their newborns. METHODS: This was a retrospective comparative cohort study of women ages 15-49 years with a documented live-birth delivery using de-identified claims from the MarketScan Research Commercial Claims and Encounters database incurred between January 1, 2007, and December 31, 2011. Total health care costs from date of first pregnancy-related claim through 3 months postdelivery were reported; pregnancy-related comorbidities prior to the pregnancy diagnosis were identified and categorized in the 12 months prior to the pregnancy diagnosis, and costs associated with each condition were compiled. A subset of newborns was matched to their mothers using a unique family identifier and their costs were captured for the three months following birth. Comparisons of costs for both mothers and newborns were made using both unadjusted and multivariate analyses between mothers with and without each condition. RESULTS: A total of 322,141 women with live births were identified; 135,572 of these mothers were linked to their newborn(s). Prevalent conditions included back disorders (8.9%), mental disorders (6.5%), headache (5.5%), allergic rhinitis (5.5%), and osteoarthritis (4.8%). Diabetes (0.97%) and hypertension (1.9%) were associated with the highest adjusted incremental costs of care in both mothers ($6,211 [95% confidence interval 5,720-6,702] and $3,367 [95% CI 2,935-3,799] respectively) and newborns ($2,067 [95% CI 1,515-2618]; and $1,210 [95% CI 725-1,695] respectively). The two most common conditions, back disorders and mental disorders, were associated with unadjusted costs of $1,895/$978 (mothers/infants) and $2,097/$1,902 (mothers/infants) respectively. CONCLUSION: Preexisting conditions common in pregnant women may result in additional resource utilization and costs for both mothers and newborns.

KRAS testing of patients with metastatic colorectal cancer in a community-based oncology setting: a retrospective database analysis.

BACKGROUND: In 2009, treatment guidelines were updated to recommend KRAS testing at diagnosis for patients with metastatic colorectal cancer (mCRC). We investigated KRAS testing rates over time and compared characteristics of KRAS-tested and not-tested patients in a community-based oncology setting. METHODS: Adult patients with a diagnosis of mCRC from 2008-2011 were selected from the ACORN Data Warehouse (ACORN Research LLC, Memphis, TN). Text mining of physician progress notes and full chart reviews identified KRAS-tested patients, test dates, and test results (KRAS status). The overall proportion of eligible patients KRAS-tested in each calendar year was calculated. Among KRAS-tested patients, the proportion tested at diagnosis (within 60 days) was calculated by year. Univariate and multivariate analyses were used to compare patient characteristics at diagnosis between tested and not-tested cohorts, and to identify factors associated with KRAS testing. RESULTS: Among 1,363 mCRC patients seen from 2008-2011, 648 (47.5%) were KRAS-tested. Among newly diagnosed mCRC patients, the rate of KRAS testing increased from 5.9% prior to 2008, to 13.9% in 2008, and then jumped dramatically to 32.3% in 2009, after which a modest yearly increase continued. The proportions of KRAS-tested patients who had been diagnosed in previous years but not tested previously increased from 17.7% in 2008 to 27.0% in 2009, then decreased to 19.0% in 2010 and 17.6% in 2011. Among patients who were KRAS-tested, the proportions tested at the time of diagnosis increased annually (to 78.4% in 2011). Patients more likely to have been tested included those with lung metastases, poor performance status, more comorbidities, and mCRC diagnosis in 2009 or later. CONCLUSIONS: The frequency of KRAS testing increased over time, corresponding to changes in treatment guidelines and epidermal growth factor receptor inhibitor product labels; however, approximately 50% of eligible patients were untested during the study period.

The prevalence of complications and healthcare costs during pregnancy.

OBJECTIVE: To study the economic burden of pregnancy in the US, common complications during pregnancy, and the incremental costs attributable to these complications. METHODS: A retrospective comparative cohort study was conducted of pregnant women aged 15-49 years using de-identified medical and pharmacy claims from the Truven Health MarketScan Commercial Claims and Encounters database incurred between January 1, 2007 and December 31, 2011. The total healthcare costs are reported (adjusted to 2011 dollars) from the date of the first pregnancy-related claim through to 3 months post-delivery and these costs were compared to matched controls of non-pregnant women. Pregnancy-related complications were categorized, and the incremental costs associated with each complication were estimated using multivariate analyses. RESULTS: A total of 322,141 eligible women with live births were studied. Compared to matched controls, the average costs of care for pregnant women were nearly $13,000 higher through 3 months post-delivery. A total of 46.9% of women had at least one pre-specified pregnancy complication; the most commonly observed were fetal abnormality (24.7%) and early or threatened labor (16.3%). Multiple gestation (1.9%) resulted in the highest adjusted incremental cost ($12,212; 95% CI = 11,298, 13,216); hypertension ($6152; 95% CI = 5312, 6992) and diabetes ($5081; 95% CI = 4244, 5918) were also among those complications that led to high incremental costs of care. CONCLUSION: Pregnancy and delivery are frequently compounded by complications that lead to increased costs and resource utilization.

Costs of Newborn Care Following Complications During Pregnancy and Delivery.

The aim of this study is examine the impact of pregnancy and delivery complications on the healthcare costs of newborns during the first 3 months of life. We conducted a retrospective cohort study of newborns born to women ages 15-49 using de-identified medical and pharmacy claims from the Truven Health MarketScan Commercial Claims and Encounters database incurred between January 1, 2007 and December 31, 2011. Total healthcare costs and resource utilization were examined and compared for the first 3 months of life between cohorts of newborns either with or without evidence of categorized maternal complications. Incremental costs were also determined using multivariable analysis for the conditions found to be the most prevalent in the study population. A total of 137,040 infants were studied, 75.4% of which were born to mothers who had experienced at least one complication during pregnancy or delivery. Fetal abnormalities (26.2%), early or threatened labor (16.6%), and hemorrhage (10.8%) were the most frequently observed complications. Diabetes (8.0%) and hypertension (7.7%) were also common, with the majority of other conditions present in 1% or less of the study population. Adjusted analyses found significant differences for seven conditions where incremental costs ranged from $987 to $10,287. Complications are common during pregnancy and delivery and some complications may lead to increased healthcare costs for newborns immediately following birth.

Rotavirus vaccination compliance and completion in a Medicaid infant population.

We examined completion and compliance rates of rotavirus (RV) vaccination according to the recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Food and Drug Administration approved Prescribing Information (PI) for Rotarix® (RV1, GlaxoSmithKline Vaccines) and RotaTeq® (RV5, Merck and Co.) among infants under one year of age covered by Medicaid programs. Healthcare claims data from state Medicaid programs that constituted the Truven Health MarketScan® Multi-State Medicaid Database were retrieved from May 2008-June 2012. Infants were grouped under PI and ACIP cohorts based on the dosing regimens followed. The overall compliance per PI (n=673,956) and ACIP (n=695,612) recommendations were 24.5% and 28.2%, respectively; completion rates were 30.3% and 32.6%, respectively. In the PI cohort, infants who received RV1 had significantly higher compliance as compared with infants who received RV5 (65.2% vs. 31.3%; p<0.0001); completion rates among infants receiving RV1 and RV5 were 65.3% and 46.4%, respectively (p<0.0001). In the ACIP cohort, compliance with RV1 was significantly higher than RV5 (68.8% vs. 45.9%; p<0.0001) as was the overall completion rate (73.5% vs. 48.8%; p<0.0001). While compliance is increasing year over year, overall compliance of RV vaccines is suboptimal, with over 40% of eligible infants unvaccinated in both populations. The 2-dose RV vaccine showed better completion rates and higher compliance than the 3-dose RV vaccine in the United States. Public health initiatives focusing on suboptimal compliance and completion rates of RV vaccination in the Medicaid population could improve these metrics, thereby offering protection against RV infection.

Adherence and persistence among chronic myeloid leukemia patients during second-line tyrosine kinase inhibitor treatment.

BACKGROUND: Chronic myeloid leukemia (CML) treatment is lifelong, and while it is important for patients to remain adherent to treatment, there are conflicting findings with respect to differences in adherence and persistence with dasatinib or nilotinib during second-line treatment.  OBJECTIVE: To compare the rates of adherence, persistence, and discontinuation of 2 oral second-generation tyrosine kinase inhibitors (TKI), dasatinib and nilotinib, in CML patients during their first 12 months of second-line treatment.  METHODS: Adult CML patients (ICD-9-CM: 205.1x) with 2 consecutive dasatinib or nilotinib prescription claims within 12 months were identified from the Truven Health MarketScan Databases (January 1, 2006-September 30, 2011). Patients were excluded if they had FDA-approved non-CML indications for imatinib, had less than 6 months continuous enrollment, or had a stem cell/bone marrow transplant in the 6 months pre-index. Patients were followed until the first occurrence of index TKI discontinuation/switch; enrollment end; December 31, 2011; or 12 months follow-up post-index. Index treatment (dasatinib ≤ 100 mg or nilotinib) was categorized as second-line if there was evidence of only 1 alternative TKI exposure (e.g., imatinib, dasatinib, or nilotinib) anytime during the patient's available claims history. When comparing adherence, persistence, and discontinuation, inverse probability treatment weighting (IPTW) was used. Adherence and persistence measures were calculated as specified by the International Society for Pharmacoeconomics and Outcomes Research Medication Compliance and Persistence Special Interest Group. Treatment adherence was calculated using medication possession ratio (MPR) and was reported as both continuous and binary measures (i.e., high adherence = MPR ≥ 85%). Persistence was reported as the proportion of days covered (PDC) and estimated level of persistence (ELPT). Finally, discontinuation was defined as a treatment gap of greater than 90 days and absence of index TKI during the remainder of the follow-up period. Time to discontinuation and high adherence of index TKI were compared using weighted Cox proportional hazards and logistic regression models, respectively.  RESULTS: After propensity weighting, the 219 second-line dasatinib patients and the 158 second-line nilotinib patients were similar in mean age, gender, cancer complexity, and comorbidity burden at baseline. Age as a categorical measure, population density, and index year remained imbalanced and were, therefore, included as covariates in the multivariate analysis of adherence. In the bivariate analyses, mean MPR (88.2% vs. 84.4%, P = 0.036); proportion of patients with high adherence (72.7% vs. 63.3%, P = 0.006); and ELPT (70.4% vs. 62.7%, P = 0.026) were significantly higher among dasatinib patients than nilotinib patients. Mean PDC was not significantly different between dasatinib and nilotinib patients (0.79 vs. 0.77, P = 0.328) after propensity weighting. In addition, a significantly lower proportion of second-line dasatinib patients discontinued their index therapy compared with second-line nilotinib patients (4.4% vs. 8.6%, P = 0.020). With a hazard ratio (HR) of 0.50 (95% CI = 0.27-0.93, P = 0.029), dasatinib patients had half the possibility of discontinuing treatment compared with nilotinib patients at any point in time. After accounting for the baseline factors remaining imbalanced and controlling for cancer complexity and number of concomitant medications at baseline, second-line dasatinib patients were 1.7 times (95% CI = 1.2-2.4) more likely to be highly adherent than second-line nilotinib patients (P = 0.0016).  CONCLUSIONS: Among second-line TKI-treated CML patients, dasatinib patients had significantly higher adherence and lower discontinuation rates compared with patients receiving second-line nilotinib.

Metastatic colorectal cancer treatment patterns according to kirsten rat sarcoma viral oncogene homolog genotype in U.S. Community-based oncology practices.

INTRODUCTION: In 2008, the National Comprehensive Cancer Network guidelines were revised in light of the identification of the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) gene as a biomarker of nonresponse to epidermal growth factor receptor inhibitors. This study sought to describe and compare real-world treatment patterns of metastatic colorectal cancer (mCRC) according to KRAS genotype in community-based oncology practices in the United States. MATERIALS AND METHODS: Data from the ACORN (ACORN LLC, Memphis, TN) electronic medical record data warehouse, containing data of approximately 180,000 patients from 12 oncology practices across the United States were used. Records of adult patients with mCRC who had undergone KRAS testing between January 2008 and December 2011 were evaluated. Patient demographic characteristics, KRAS genotype, and treatment patterns were identified and compared. RESULTS: Six hundred forty-eight mCRC patients who were tested for KRAS were identified. Of these, 48.1% had wild type (WT), 42.3% mutant, and 9.6% unknown genotypes. Most patients (72.1%) were tested in 2009 or later, after the guideline revision. Bevacizumab-containing combinations were the most common first-line regimens in KRAS mutant and WT patients. Approximately 90% of patients received at least 1 line of therapy, however, WT patients received significantly more lines of therapy than KRAS mutant patients (2.6 ± 1.5 vs. 2.1 ± 1.2; P < .001). CONCLUSIONS: KRAS WT and mutant genotypes had similar first-line regimens; however, WT patients received more lines of therapy. Although there does not appear to be a lag between changes in guidelines and treatment practice, professional and government organizations must keep up with the changing science and disseminate this information to oncologists in a timely manner.

Concordance with recommended postdischarge care guidelines among children with food-induced anaphylaxis.

OBJECTIVE: To describe patient characteristics, concordance with recommended postdischarge care, and risk of repeat events within a cohort of children discharged from an emergency department (ED) or hospital for food-induced anaphylaxis in the US. STUDY DESIGN: Children (aged <18 years) with an ED visit/hospitalization for food-induced anaphylaxis were identified from the 2002-2008 Truven Health MarketScan databases using an expanded International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code algorithm. The initial identified ED visit/hospitalization was the index event. Claims data for the children with continuous medical and prescription coverage for ≥1 year before and after the index event were evaluated. Analyses included the rates of 1-year postdischarge epinephrine autoinjector (EAI) prescription fills, allergist/immunologist visits, and repeat events. RESULTS: The study cohort comprised 1009 patients with an average age of 7 years, including 58% males, 27% with a history of asthma, and 90% discharged from an ED. Within 1 year postdischarge, 83% had an EAI prescription fill (69% within 1 week postdischarge), 43% had a specialist visit (51% within 4 weeks postdischarge), and 6.4% had evidence of another anaphylaxis-related ED visit/hospitalization. CONCLUSION: Among children with food-induced anaphylaxis, within 1 year postdischarge from the ED or hospital, concordance was higher for EAI prescription fills than for allergist/immunologist visits. Subsequent ED visits/hospital stays for anaphylactic events were low. More research is needed to identify barriers between recommendations and physician/patient behaviors, as well as the impact of not following the recommendations on patient outcomes and healthcare costs.

Patterns of treatment, healthcare utilization and costs by lines of therapy in metastatic breast cancer in a large insured US population.

AIM: Metastatic breast cancer guidelines contain multiple lines of treatment and regimens; however, little data on therapeutic patterns and costs is available from real-world clinical practice. This descriptive study reports chemotherapy and biologic use, healthcare utilization and costs by line of therapy in a large insured US population. MATERIALS & METHODS: Adult women with newly diagnosed metastatic breast cancer (between 2005 and 2009) were identified from MarketScan® databases containing medical and pharmacy claims of >40 million enrollees insured with >100 US health plans. Descriptive statistics were reported for use, duration and mean per patient per month costs across four lines of therapy. RESULTS: Out of 7767 patients identified (mean [standard deviation] age = 58.2 [12] years), ≥50% received a subsequent line of therapy across the four lines (line 2: n = 4077; line 3: n = 2033; line four: n = 1059). The top two chemotherapies were paclitaxel and capecitabine in lines one and two, and paclitaxel and gemcitabine in lines three and four. The top two biologics were trastuzumab and bevacizumab across the multiple lines of treatments. Duration (mean, standard deviation and median days) varied across multiple lines of treatments: 162.7, 176.9 and 108.0 in line one; 147.5, 146.7 and 99.0 in line two; 139.9, 131.1 and 99.0 in line three; and 130.9, 123.4 and 94.0 in line four, respectively. Mean per patient per month costs decreased with increasing follow-up from US$13,147 (<6 months) to US$11,610 (7-12 months) to US$10,219 (12-24 months) to US$9,192 (24-36 months) to US$7,384 (>36 months). Cumulative costs increased with follow-up, from US$78,882 (<6 months) to US$443,062 (>36 months). CONCLUSION: Longer follow-up, regardless of number of lines of therapy, was associated with higher cumulative, but lower monthly, costs. Delaying progression and improving survival with more individualized treatment regimens may help slow the rate of increasing long-term costs of metastatic breast cancer treatment and care.