Social Determinants of Health and Other Predictors in Initiation of Treatment with CDK4/6 Inhibitors for HR+/HER2- Metastatic Breast Cancer.

In hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC), cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) have replaced endocrine therapy alone as the standard of care; however, several barriers to treatment initiation still exist. We assessed social determinants of health (SDOH) and other factors associated with the initiation of CDK4/6i for HR+/HER2- MBC in the Medicare population. Using a retrospective cohort design, patients aged ≥65 years and diagnosed during 2015-2017 were selected from the SEER-Medicare database. Time from MBC diagnosis to first CDK4/6i initiation was the study outcome. The effect of SDOH measures and other predictors on the outcome was assessed using the multivariable Fine and Gray hazard modeling. Of 752 eligible women, 352 (46.8%) initiated CDK4/6i after MBC diagnosis (median time to initiation: 27.9 months). In adjusted analysis, SDOH factors significantly associated with CDK4/6i initiation included high versus low median household income (HHI) (hazard ratio [HR] = 1.70; 95% CI = 1.03-2.81) and the percentage of population with high versus low Medicare-only coverage (HR = 1.54; 95% CI = 1.04-2.27). In summary, older Medicare patients with HR+/HER2- MBC residing in areas with high median HHI and a high proportion of Medicare-only coverage had higher rates of initiating CDK4/6i, suggesting inequitable access to these novel, effective treatments and a need for policy intervention.

Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review.

INTRODUCTION: Urothelial carcinoma (UC) is a malignancy of the urothelium that encompasses the renal pelvis, bladder, and urethra. Current treatment guidelines for advanced (ie, locally advanced or metastatic) UC recommend using avelumab maintenance therapy in patients with nonprogressive disease following first-line platinum-based chemotherapy. This study aimed to assess the representativeness of the patient population in the JAVELIN Bladder 100 (JB-100) trial, which examined the efficacy and safety of avelumab first-line maintenance, vs. real-world patients with advanced UC that had not progressed with first-line platinum-based chemotherapy treated between 2015 and 2018 by reviewing demographic and clinical characteristics. PATIENTS AND METHODS: A medical chart review (MCR) study collected demographics and treatment characteristics for patients with advanced UC in the United States, the United Kingdom, and France. Data were analyzed descriptively for review with data collected from patients enrolled in JB-100. RESULTS: Clinical characteristics were consistent between JB-100 and the MCR. Most patients were male, received 4 to 6 cycles of platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients in the MCR had either stable disease or a response with platinum-based chemotherapy (∼75% achieved a complete or partial response). Fewer than half (42.5%) of all patients in the MCR received subsequent therapy. CONCLUSION: Patient demographics, clinical characteristics, and treatment patterns from a MCR of patients with advanced UC that had not progressed following first-line platinum-based chemotherapy appeared similar to data from patients enrolled in JB-100. Future studies should examine whether real-world outcomes are consistent with findings from JB-100. GOV IDENTIFIER: NCT02603432.

Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer in the United States: A SEER-Medicare population-based study.

BACKGROUND: Evidence on overall survival (OS) with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors is generally limited to data from clinical trials or a few observational studies with limited generalizability to Medicare population. The aim of this study was to determine OS benefits associated with CDK4/6 inhibitors in older Medicare patients with hormone receptor (HR)-positive and human epidermal growth factor receptor-2 overexpressing (HER2-) metastatic breast cancer (MBC). METHODS: In a retrospective cohort design, female patients aged ≥65 years with diagnosis of HR+/HER2- MBC from 2015 to 2017 who initiated first-line systemic therapy within 12 months of MBC diagnosis were selected from the Survey Epidemiology and End Results-Medicare database. The effect of treatment type (endocrine therapy [ET]+CDK4/6 inhibitor vs. ET alone) on OS was analyzed using Kaplan-Meier methods and multivariable Cox regression models. Adjusted hazard ratio (aHR) and 95% CIs were estimated. RESULTS: A total of 630 eligible patients were identified (169 patients treated with ET+CDK4/6 inhibitor and 461 patients treated with ET alone). In the Kaplan-Meier analysis, OS rate at 3 years after first-line treatment initiation was 73.0% for ET+CDK4/6 inhibitor versus 49.1% for ET alone (log-rank p < .0001). In Cox regression analysis, first-line ET+CDK4/6 inhibitor therapy was associated with 41% lower rate of mortality versus ET alone (aHR, 0.590; 95% CI, 0.423-0.823). CONCLUSIONS: The findings of this real-world study demonstrate significant OS benefit associated with ET+CDK4/6 inhibitor therapy over ET alone in an older Medicare population of patients with HR+/HER2- MBC, largely consistent with the evidence from clinical trials.

Impact of CDK4/6 inhibitors on chemotherapy utilization in earlier therapy lines for HR+/HER2- metastatic breast cancer in the United States.

PURPOSE: Delaying chemotherapy remains a vital goal in therapeutic management of HR+/HER2- metastatic breast cancer (MBC). However, recent reports continue to highlight substantially high chemotherapy utilization in earlier therapy lines. In this study, we explored the impact of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy class, introduced in 2015, on early chemotherapy utilization in an older population of patients with HR+/HER2- MBC in the United States (US). METHODS: Using an interrupted time series design, patients with a confirmed diagnosis of MBC aged ≥ 65 years initiating systemic therapy during 2010-2019 were selected from the SEER-Medicare database. The proportion of chemotherapy use was summarized quarterly based on the date of treatment initiation separately in the first, second, and third lines. Segmented regression models adjusted for autocorrelation over time were fitted to estimate trends before and after the availability of CDK4/6 inhibitors in the first quarter of 2015. RESULTS: Of the 3244 eligible women (median age at diagnosis: 74 years), all initiated first-line therapy; 47.9% (n = 1581) initiated second-line therapy, and 50.1% (n = 792) initiated third-line therapy. Overall utilization of chemotherapy (alone or in combination) during the study period was 15.7% for the first line, 19.6% for the second line, and 24.8% for the third line. Chemotherapy utilization in the period immediately after introduction of CDK4/6 inhibitor therapy decline by estimated 2.5% in the first line (P = 0.408), 15.5% in the second line (P = 0.005), and 16.3% in the third line (P = 0.003). CONCLUSIONS: This population-based study illustrates that chemotherapy utilization in earlier therapy lines for HR+/HER2- MBC declined steadily between 2010 and 2019. These declines were significantly accelerated by the introduction of CDK4/6 therapy class in 2015, notably in the second- and third-line settings.

Corrigendum to: Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection.

[This corrects the article DOI: 10.1093/ofid/ofz446.].

Clinical management patterns of advanced and metastatic gastro-oesophageal carcinoma after fluoropyrimidine/platinum treatment in France, Germany, Spain and the United Kingdom.

OBJECTIVE: To describe treatment patterns and resource utilisation in France, Germany, Spain and the United Kingdom (UK) in patients with unresectable locally advanced and/or metastatic gastro-oesophageal adenocarcinoma (GEA), who failed first-line fluoropyrimidine/platinum treatment. METHODS: Treating physicians completed a web-based chart review (2013-2015). Eligible patients were ≥ 18 years old; had unresectable locally advanced and/or metastatic gastric adenocarcinoma including the gastro-oesophageal junction; received first-line fluoropyrimidine/platinum-based therapy; and had ≥ 3 months of follow-up after first-line discontinuation. Data were summarised descriptively for each country. RESULTS: There were n = 201 patients in France, n = 202 in Germany, n = 208 in Spain and n = 200 in the UK whose charts were reviewed. Percentages of patients receiving second-line therapy were 55% (France), 48% (Germany), 54% (Spain) and 29% (UK). At the start of second-line therapy, most patients had an ECOG performance status of 1 (range 0-3). Second-line therapy was primarily monotherapy, but agents used varied within and across countries. Supportive care use and resource utilisation were frequent whether receiving additional therapy or not; >60% patients had clinic visits unrelated to chemotherapy administration, and > 30% has ≥ 1 hospital admission. CONCLUSIONS: For the time of study, established GEA treatment guidelines were generally followed. However, therapies varied widely in the second-line setting.

Costs of herpes zoster complications in older adults: A cohort study of US claims database.

BACKGROUND/OBJECTIVES: Herpes zoster (HZ) incidence increases with age, and the burden of HZ is expected to grow with aging of populations worldwide. We aim to determine the incremental healthcare resource utilization and associated costs of patients with common HZ-related complications other than postherpetic neuralgia (cutaneous, neurologic and ophthalmic) compared to uncomplicated HZ. METHODS: We conducted a retrospective cohort study of commercial health insurance claims covering about 40 million immunocompetent individuals aged ≥50 years at study entry from all over the US, from 2008 to 2013, with follow-up for one year after HZ onset. All-cause healthcare resource utilization and direct healthcare costs were recorded and calculated from six months before until 12 months after HZ onset. The mean costs for HZ patients with complications were compared to the mean costs for patients with uncomplicated HZ. Multivariable regression analyses estimated mean incremental costs adjusted for demographics, comorbidities, type of complication and time period. RESULTS: Over the five-year study period, 22,948 HZ patients (60% women, median age 62 years) who experienced at least one of the selected complications were compared to 213,232 patients (63% women, median age 61 years) with uncomplicated HZ. Overall, the mean annual incremental unadjusted costs for the patients with HZ-related complications were US$4716, ranging from US$2173 for ophthalmic to US$18,323 for neurologic complications. Most of the incremental costs associated with HZ complications were accrued during the first quarter after HZ onset. For each complication type the incremental costs increased with age up to, but not including the oldest group, aged ≥80 years. CONCLUSIONS: Approximately 10% of immunocompetent older patients with HZ develop complications which considerably increase the economic burden of HZ. Vaccination of older adults will offset some of the burden of HZ, including costs associated with HZ-related complications.

Healthcare costs and utilization associated with muscle weakness diagnosis codes in patients with chronic obstructive pulmonary disease: a United States claims analysis.

AIMS: Muscle weakness (MW)-attributable healthcare resource utilization (HCRU) and costs in patients with chronic obstructive pulmonary disease (COPD) have not been well-characterized in US insurance claims databases. The primary objective of this study was to estimate HCRU in patients with evidence of COPD with and without MW diagnosis codes. MATERIALS AND METHODS: This retrospective analysis used the MarketScan® Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. Between January 2007 and March 2016, we identified patients aged ≥40 years with diagnosis codes for COPD (≥1 emergency department or inpatient claim or ≥2 outpatient claims within 1 year). The cohort was divided into patients with and without ≥1 MW diagnosis code. Propensity score matching was used to generate pairs of patients with and without MW (1:1). Multivariable regression analyses were used to estimate adjusted incremental costs and utilization attributable to the presence of MW diagnosis codes among patients with COPD. RESULTS: Of 427,131 patients who met the study inclusion criteria, 14% had evidence of MW. After matching, 107,420 unique patients remained equally distributed across MW status. Patients with MW diagnosis codes had greater predicted annual HCRU, $2,465 greater total predicted annual COPD-related costs, and $15,179 greater total all-cause costs than those without MW diagnosis codes. Overall, <1% of patients received COPD-related pulmonary rehabilitation services. LIMITATIONS: Study limitations include the potential for undercoding of MW and lack of information on severity of MW in claims data. CONCLUSION: The presence of MW diagnosis codes yielded higher HCRU in this COPD population and suggests that the burden of MW affects both all-cause and COPD-related care. However, utilization of pulmonary rehabilitation, a known effective treatment for MW, remains low. Future research should expand on our results by assessing data sources that allow for clinical confirmation of MW among patients with COPD.

Impact of antiepileptic-drug treatment burden on health-care-resource utilization and costs.

BACKGROUND: Complex titration requirements and dosing of antiepileptic drugs (AEDs) may pose a significant treatment burden for patients with epilepsy. This study evaluated health-care-resource utilization (HCRU) rates and costs by treatment burden, defined as number of daily pills and dosing frequency, among managed-care enrollees with epilepsy who initiated AED monotherapy. METHODS: This retrospective longitudinal study examined administrative HC-claim data in patients aged ≥18 years with two or more pharmacy claims for an AED and two or more medical claims for epilepsy or afebrile convulsion. The number of daily AED pills was estimated at index as the total number of pills dispensed divided by the days supplied, and categorized as more than zero/one, one/two, two/three, and more than three per day. AED-dosing frequency was measured at index and categorized as one, two, three, or four times daily. Postindex 12-month all-cause and epilepsy-related HCRU and costs were estimated using multivariable Poisson regression models and generalized linear models, respectively. RESULTS: Unadjusted total all-cause and epilepsy-related costs at 12 months postindex averaged US$26,015 per person and US$5,557 per person (2017 values), respectively. Adjusted all-cause and epilepsy-related costs were US$25,918 per person and US$5,602 per person, respectively. A pill burden of more than three a day was associated with a 6.7% increase in total annual HC costs compared with one pill/day. Patients receiving one/two, two/three, and more than three pills per day had 13.3%, 23.9%, and 38.3% higher epilepsy-related costs, respectively, than those receiving one pill per day (P<0.0001). Increase in dosing frequency was associated with greater total HCRU and higher costs, but only patients with twice-daily dosing had significantly higher epilepsy-related costs. CONCLUSION: Findings from this study suggest that increased treatment burden is associated with greater HCRU and higher overall and epilepsy-related costs. Reducing treatment burden via selection of AED therapy with reduced pill numbers and dosing frequency should be considered to improve health and economic outcomes.

Health Care Resource Utilization and Costs among Adult Patients with Advanced Soft Tissue Sarcoma: A Retrospective Medical Record Review in the United Kingdom, Spain, Germany, and France.

OBJECTIVE: To describe health care resource utilization and costs for patients with advanced soft tissue sarcoma (STS) in the United Kingdom (UK), Spain, Germany, and France. METHODS: Physicians abstracted data for adult patients with a diagnosis of advanced STS (other than Kaposi's sarcoma or gastrointestinal stromal tumor) who received ≥1 lines of systemic therapy. Health care resource utilization related to advanced STS treatment was recorded; associated costs were estimated by applying unit costs. RESULTS: A total of 130 physicians provided data for 807 patients (UK: 199; Spain: 203; Germany: 204; and France: 201). The site of care during active treatment varied based on differences in the health care systems of these four countries. Total mean per-patient health care cost in the UK was £19,457; in Spain, €26,814; in Germany, €20,468; and in France, €24,368. Advanced STS-related systemic treatment costs were driven primarily by drug acquisition and administration costs. Treatment-related costs increased during later lines of therapy for all countries except France, where they decreased after first-line therapy. Pain control and antiemetics were the most common supportive care medications. CONCLUSIONS: This study provides real-world data on resource utilization and estimated costs in advanced STS and could inform policymakers about treatment burden.

Cost of herpes zoster and herpes zoster-related complications among immunocompromised individuals.

Herpes zoster (HZ) is a painful dermatomal rash caused by reactivation of latent varicella-zoster virus. The incidence of HZ is increased for immunocompromised (IC) individuals. The objective of this study is to assess the healthcare costs incurred by IC individuals who develop HZ with or without associated complications. We conducted a retrospective case-control study across the US over a 5-year period, based on health insurance claims data for individuals aged ≥50 years identified as IC by disease or immunosuppressive treatment. A cohort of 30,107 IC individuals who experienced HZ was matched to a cohort of 113,875 IC individuals without HZ. Average all-cause healthcare costs over 18 months were calculated and compared between IC individuals with and without HZ. In addition, the costs of HZ in IC individuals with HZ-related complications were compared to the costs of those with uncomplicated HZ. During the year following HZ onset, IC individuals with HZ had on average total unadjusted costs that were US$3879 higher than the controls. After adjusting costs, controlling for comorbidities and healthcare costs before the onset of HZ, the average annual costs for HZ cases and controls without HZ were similar. HZ-related complications led to increases in average adjusted annual costs compared to uncomplicated HZ ranging from US$612 for eye complications to US$4535 for neurologic complications. In conclusion, in IC individuals, episodes of HZ lead to substantially increased unadjusted annual healthcare costs. HZ-related complications add considerably to adjusted annual healthcare costs compared to uncomplicated HZ.

Treatment Patterns and Survival among Adult Patients with Advanced Soft Tissue Sarcoma: A Retrospective Medical Record Review in the United Kingdom, Spain, Germany, and France.

OBJECTIVE: To describe real-world treatment patterns and outcomes for patients with advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy in the United Kingdom, Spain, Germany, and France. METHODS: Physicians completed a web-based medical record abstraction for adult patients with advanced STS (other than Kaposi's sarcoma or gastrointestinal stromal tumor) who received ≥1 line of systemic therapy. Clinical characteristics, treatments, tumor responses, and mortality data were recorded. RESULTS: A total of 130 physicians provided data for 807 patients. Patients' mean age at advanced STS diagnosis was 57.1 (±12.3) years; 59% were male. The most commonly identified histologic categories were leiomyosarcoma (28%), liposarcoma (13%), and rhabdomyosarcoma (11%). Overall, 57% of patients received only 1 line of therapy, 32% received 2 lines of therapy, and 11% received ≥3 lines of therapy. The most common first-line regimens were doxorubicin alone (41%), doxorubicin plus ifosfamide (19%), docetaxel plus gemcitabine (9%), paclitaxel alone (4%), and ifosfamide (4%). Median overall survival from start of treatment was estimated to be 17.6 months (95% confidence interval, 15.6-19.0 months). CONCLUSIONS: In real-world clinical practice, advanced STS is most commonly treated with older therapies in the United Kingdom, Spain, Germany, and France. New therapies that improve overall survival in advanced STS are needed.

Treatment patterns and survival among older adults in the United States with advanced soft-tissue sarcomas.

BACKGROUND: To describe patient and tumor characteristics, treatments, and survival among older adults in the United States with advanced soft-tissue sarcoma (STS), across and by categories of specifically defined histologic subtypes. METHODS: We conducted a retrospective cohort analysis using the SEER. The study population comprised patients ≥ 65 years old with advanced STS (excluding osteosarcoma, Kaposi sarcoma, and gastrointestinal stromal tumors) diagnosed from January 1, 2001 to December 31, 2011. RESULTS: Of 4274 study patients, 2103 (49.2%) were male. Mean age was 77.8 years, and 1539 (36.0%) had distant disease at initial diagnosis. The most common histologic categories were leiomyosarcoma (922[21.6%]), undifferentiated pleomorphic sarcoma (652[15.3%]), and liposarcoma (554[13.0%]). Overall, 1227 (28.7%) patients received first-line systemic therapy. Among these patients, 325 (26.5%) received docetaxel plus gemcitabine and 231 (18.8%) received doxorubicin alone. Only 476 patients received second-line therapy (11.1%), most commonly doxorubicin alone (n = 101). Median overall survival (95% confidence interval) from advanced STS diagnosis was 8.9 (8.3, 9.7) months. CONCLUSIONS: Although previous studies of younger populations reported anthracycline-based therapy predominated in first line, our study of older advanced STS patients found that docetaxel plus gemcitabine was most commonly used. Despite variation by histologic category, prognosis remains poor for older adult patients with advanced STS.

Evaluation of comorbidities and health care resource use among patients with highly active neuromyelitis optica.

BACKGROUND: Neuromyelitis optica (NMO) is characterized by unpredictable attacks on the optic nerves and spinal cord, causing accumulations of neurological disability that may lead to blindness and paralysis. We examined comorbidities and health care use among patients with highly active NMO, defined as at least two relapses within 12months of the patient's first NMO encounter in the database. METHODS: This retrospective study of a US administrative claims database compared patients with highly active NMO to matched individuals without NMO. All outcomes, including Charlson Comorbidity Index (CCI) score, hospitalizations, and emergency department visits, were measured over the 12-month period following the patient's first NMO encounter in the database. RESULTS: A total of 1349 patients with NMO were identified. Of these, 134 had highly active NMO (80% female, mean age 45.6years) and were matched to 670 non-NMO controls. Patients with highly active NMO had significantly greater comorbidity burden than non-NMO controls (mean CCI score: 4.1 versus 0.6; P<0.0001) and greater proportions of hospitalization (53.7% versus 4.0%; P<0.0001) and emergency department visits (60.5% versus 9.7%; P<0.0001). CONCLUSIONS: High occurrence of several acute and chronic conditions and extensive health care use highlight the significant medical burden among patients with highly active NMO.

Time trends in utilization of G-CSF prophylaxis and risk of febrile neutropenia in a Medicare population receiving adjuvant chemotherapy for early-stage breast cancer.

PURPOSE: The purpose of this study is to assess temporal trends in the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis and risk of febrile neutropenia (FN) among older women receiving adjuvant chemotherapy for early-stage breast cancer. METHODS: Women aged ≥ 66 years with diagnosis of early-stage breast cancer who initiated selected adjuvant chemotherapy regimens were identified using the SEER-Medicare data from 2002 to 2012. Adjusted, calendar-year-specific proportions were estimated for use of G-CSF primary prophylaxis (PP) and secondary prophylaxis and FN risk in the first and the second/subsequent cycles during the first course of chemotherapy, using logistic regression models. calendar-year-specific mean probabilities were estimated with covariates set to modal values. RESULTS: Among 11,107 eligible patients (mean age 71.7 years), 74% received G-CSF in the first course of chemotherapy. Of all patients, 5819 (52%) received G-CSF PP, and among those not receiving G-CSF PP, only 5% received G-CSF secondary prophylaxis. The adjusted proportion using G-CSF PP increased from 6% in 2002 to 71% in 2012. During the same period, the adjusted risk of FN in the first cycle increased from 2% to 3%; the adjusted risk increased from 1.5% to 2.9% among those receiving G-CSF PP and from 2.3% to 3.5% among those not receiving G-CSF PP. CONCLUSION: The use of G-CSF PP increased substantially during the study period. Although channeling of higher-risk patients to treatment with G-CSF PP is expected, the adjusted risk of FN among patients treated with G-CSF PP tended to be lower than among those not receiving G-CSF PP.

Chronologic Age at Hospitalization for Respiratory Syncytial Virus Among Preterm and Term Infants in the United States.

INTRODUCTION: Respiratory syncytial virus (RSV) is the leading cause of hospitalization among infants in the United States, and the risk for RSV hospitalizations is greater for infants born preterm. Recent studies in preterm and term infants have shown that RSV hospitalization rates vary considerably depending on infant chronologic age. This study sought to aggregate the data available from published literature and from nationally representative databases of US infant hospitalizations to generate a composite description of the effect of young chronologic age on RSV hospitalizations among US preterm and term infants by individual month of age. METHODS: Data describing the relative incidence of RSV hospitalizations by individual month of chronologic age during the first year of life were obtained from recently published studies, the 2006-2011 National Inpatient Sample databases, and the 2006 and 2009 Kids Inpatient Databases. RESULTS: All data sources showed that ≥20% of infant RSV hospitalizations occurred in the second month of life and >50% and >75% of RSV hospitalizations were observed during the first 3 and 6 months of life, respectively. These findings were consistent for both preterm and term infants. CONCLUSION: Data from multiple sources demonstrate that the greatest risk of RSV hospitalization occurs during the first 6 months of life among US preterm and term infants. Strategies to prevent infant RSV hospitalizations should be targeted to infants during the first months of life. FUNDING: AstraZeneca.

Analysis of real-world health care costs among immunocompetent patients aged 50 years or older with herpes zoster in the United States.

Few peer-reviewed publications present real-world United States (US) data describing resource utilization and costs associated with herpes zoster (HZ) and postherpetic neuralgia (PHN). The primary objective of this analysis (GSK study identifier: HO-14-14270) was to assess direct costs associated with HZ and PHN in the US using a retrospective managed care insurance claims database. Patients ≥ 50 y at HZ diagnosis were selected. Patients were excluded if they were immunocompromised before diagnosis or received an HZ vaccine at any time. A subsample of patients with PHN was identified. Each patient with HZ was matched to ≤ 4 controls without HZ based on age, sex, and health plan enrollment. Incremental differences in mean HZ-related costs ("incremental costs") were assessed overall and stratified by age. Multivariable regression models controlled for the effect of demographic characteristics, prediagnosis costs, and comorbidity burden on costs using a recycled predictions approach. Overall, 142,519 patients with HZ (9,470 patients [6.6%] had PHN) and 357,907 matched controls without HZ were identified. Resource utilization was greater among patients with HZ than controls. After adjusting for demographic and clinical characteristics, annual incremental health care costs for HZ patients vs. controls were $1,210 for patients aged 50-59 years, $1,629 for those 60-64 years, $1,876 for those 65-69 years, $2,643 for those 70-79 years, and $3,804 for those 80+ years; adjusted annual incremental costs among PHN patients vs. controls were $4,670 for patients 50-59 years, $6,133 for those 60-64 years, $6,451 for those 65-69 years, $8,548 for those 70-79 years, and $11,147 for those 80+ years. HZ is associated with a significant cost burden, which increases with advancing patient age. Vaccination may reduce costs associated with HZ through case avoidance.

The impact of adjunctive guanfacine extended release on stimulant adherence in children/adolescents with attention-deficit/hyperactivity disorder.

AIM: To assess stimulant adherence among children/adolescents with attention-deficit/hyperactivity disorder (ADHD) augmenting stimulants with guanfacine extended-release (GXR). PATIENTS & METHODS: Inclusion criteria: 6-17 years, ≥1 ADHD diagnosis, ≥1 long-acting and/or short-acting stimulant with GXR augmentation. Modified medication possession ratio (mMPR; days medication available/days in period, excluding medication holidays) was assessed; mMPR <0.80 nonadherent. Regression models assessed change in mMPR adjusting for demographic and clinical characteristics. RESULTS: Among patients nonadherent to stimulants pre-augmentation (n = 165), unadjusted mean (SD) pre- and post-stimulant mMPRs were 0.68 (0.11) and 0.87 (0.16). Adjusted mean change in mMPR was 0.20 for long-acting versus 0.18 for short-acting stimulants (p = 0.34). CONCLUSION: Among patients nonadherent to stimulants, GXR augmentation was associated with increased stimulant adherence.

Antiretroviral Treatment Switching and Its Association With Economic Outcomes and Adverse Treatment Effects Among Commercially Insured and Medicaid-Enrolled Patients With HIV in the United States.

BACKGROUND: Antiretroviral therapy (ART) of HIV typically involves the use of 2 nucleoside reverse transcriptase inhibitors plus a third agent (eg, protease inhibitor). It has been shown that over the course of treatment, a proportion of patients switch their ART for various reasons (eg, tolerability, long-term toxicities). We hypothesize that there is a relationship between ART treatment switching and economic and clinical outcomes among HIV patients. OBJECTIVE: To determine whether switching ART regimens is associated with greater health care costs, resource use, and adverse treatment effects. METHODS: Administrative health care claims were used to identify commercially insured and Medicaid-enrolled patients in the United States who had ≥2 claims containing an HIV/AIDS diagnosis from 2006 to 2011 and received an ART prescription from 2007 to 2010. The final population included patients who were ≥18 years old on their index date (ie, date of first ART prescription) and had continuous health plan enrollment for ≥12 months before and after their index date. Treatment characteristics (eg, switching), adverse treatment effects, and health care resource utilization and costs, were evaluated during a 12-month follow-up period. Multivariable models assessed the relationship between ART switching and economic outcomes (ie, costs, number of health care encounters) and adverse treatment effects. RESULTS: A total of 14 590 commercially insured patients met all inclusion criteria and 12% had an ART switch; further, 5744 Medicaid-enrolled patients met all inclusion criteria, and 14% switched treatment. After adjusting for confounders, ART switching was associated with 64% and 36% (P < 0.0001) increases in hospitalizations, 36% and 25% (P < 0.0001) increases in nonpharmacy costs, and 15% and 18% (P < 0.0001) increases in pharmacy costs, among commercially insured and Medicaid-enrolled patients, respectively. ART switching increased the risk of adverse treatment effects, overall and for specific conditions of interest (eg, gastrointestinal intolerance). CONCLUSIONS: This study suggests that ART switching is associated with economic outcomes and certain adverse treatment effects. Efforts to put patients on an optimal ART regimen initially, therefore reducing the need for subsequent switching, may have a positive effect on patients specifically and the health care system in general.

Factors associated with inpatient readmission among managed care enrollees with COPD.

OBJECTIVE: To assess factors associated with inpatient readmission among a US managed care population with chronic obstructive pulmonary disease (COPD). BACKGROUND: COPD is often accompanied by intermittent acute exacerbations, which may result in hospitalizations. These exacerbations are often associated with an increased frequency of subsequent exacerbations, which may lead to inpatient readmissions. METHODS: We assessed US managed care claims data for enrollees≥40 years old with an inpatient admission with a primary diagnosis of COPD (ICD-9-CM codes 491.xx, 492.xx or 496.xx) between 1 January 2010 and 31 December 2013 (discharge date of first observed inpatient admission defined the "index date"). Patients were required to be continuously enrolled for ≥12 months before the index date. Two non-mutually exclusive cohorts were analyzed: (1) patients with ≥30 days of post-index date continuous enrollment (to evaluate 30-day readmission) and (2) patients with ≥90 days of post-index date continuous enrollment (to evaluate 90-day readmission). Logistic regression evaluated the association between patient characteristics and risk of 30- and 90-day COPD-related and all-cause readmission. RESULTS: After applying selection criteria, 140,981 patients had ≥30 days of enrollment post-index date, and 123,545 patients had ≥90 days of enrollment post-index date. Within 30 days, nearly 20% of patients had an all-cause readmission and 7% had a COPD-related readmission. Within 90 days, 28% had an all-cause readmission and 12% had a COPD-related readmission. Logistic regression indicated that longer length of stay, older age, greater comorbidity burden, specific comorbidities and COPD complexity were associated with significantly greater odds of COPD-related 30- and 90-day readmission. Results for all-cause readmission were generally similar. CONCLUSIONS: Many of the factors associated with inpatient readmission documented here can be ascertained at discharge and may be used to inform discharge plans, with the end goal of improving patient outcomes, including reducing the risk of readmission.