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Background Sacubitril/valsartan has been highly efficacious in randomized clinical trials of patients with HFrEF. However, the effectiveness of sacubitril/valsartan in routine US clinical practice is unclear. Methods This study included patients age ≥65 years who were hospitalized for HFrEF (ejection fraction ≤40%), were eligible for sacubitril/valsartan at discharge, and were enrolled in the Get With The Guidelines-Heart Failure registry linked to Medicare claims between October 2015 and September 2017. Patients prescribed sacubitril/valsartan at discharge were compared with (1) patients not prescribed sacubitril/valsartan, and (2) patients prescribed ACEI/ARB at discharge. Study endpoints were post-discharge mortality and hospitalization outcomes at 12 months. Negative control (falsification) endpoints included hospitalization for urinary tract infection and hospitalization for nutritional disorder. To adjust for selection bias, inverse probability of treatment weighting and adjustment for other HFrEF medications prescribed at discharge were performed. Results Overall, 746 (8.1%) patients were discharged on sacubitril/valsartan and 8,466 (91.9%) were not. Of those not prescribed sacubitril/valsartan, 5,286 (62.4%) were prescribed an ACEI/ARB. As compared with no sacubitril/valsartan, discharge prescription of sacubitril/valsartan was independently associated with lower risk of all-cause mortality, all-cause hospitalization, and the composite of mortality or HF hospitalization at 12-month follow-up (Table). These findings were consistent in comparisons between sacubitril/valsartan and ACEI/ARB. Discharge sacubitril/valsartan prescription was not significantly associated with the negative control endpoints, suggesting the findings were unlikely due to residual confounding. Conclusions In this contemporary real-world population of US patients hospitalized for HFrEF and eligible for sacubitril/valsartan, prescription of sacubitril/valsartan at discharge was independently associated with substantial reductions in post-discharge mortality and hospitalization. These findings suggest that the significant benefits of sacubitril/valsartan observed in clinical trials extend to patients seen in routine US clinical practice.

Aim: We examined characteristics of early sacubitril/valsartan users in a large US electronic health records database. Patients & methods: We identified three cohorts of patients with heart failure (HF): sacubitril/valsartan patients with a prior HF diagnosis; patients with HF with reduced ejection fraction; and patients with HF treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a β-blocker. Results: Sacubitril/valsartan patients were younger than patients in the other cohorts; the mean age of sacubitril/valsartan patients increased by 2 years in the first 15 months of marketing. Most sacubitril/valsartan patients had prior use of HF treatment. Conclusion: Overall, sacubitril/valsartan patients resembled those in the HF with reduced ejection fraction cohort, and commonly used other drugs for HF.

Background On May 20, 2016, US professional organizations in cardiology published joint treatment guidelines recommending the use of angiotensin-receptor neprilysin inhibitor (ARNI) for eligible patients with heart failure with reduced ejection fraction (HFrEF). Using data from the Get With The Guidelines–Heart Failure registry, we evaluated the early impact of this update on temporal trends in ARNI prescription. Methods We analyzed patients with HFrEF who were eligible for ARNI prescription (EF ≤40%, no contraindications) and hospitalized from February 20, 2016, through August 19, 2016—allowing for 13 weeks before and after guideline publication. We quantified trends in ARNI use associated with guidelines publication with an interrupted time-series design using logistic regression and accounting for correlations within hospitals using general estimating equation methods. Results Of 7,200 eligible patient hospitalizations, 51.9% were discharged in the period directly preceding publication of the guidelines, and 48.1% were discharged after. Odds ratios of ARNI prescription at discharge were significantly higher in the postguideline period compared with the preguideline period in adjusted models (adjusted odds ratio 1.29, 95% CI 1.06-1.57, P = .01). However, there was no significant interaction between observed and expected ARNI use after guideline publication (Pinteraction = .14). Results were consistent using a 6-month before and after time frame. Conclusions The model suggested a small increase in ARNI use in HF patients being discharged from the hospital immediately after guideline release. However, the publication of national guidelines recommending ARNI use seemed to have little influence on the adoption of this evidence-based medication in the first 3 to 6 months.

Factors associated with mortality for patients with heart failure and reduced ejection fraction (HFrEF) are known; however, the association between initial pharmacotherapy (IPT) and mortality is unclear in real-world settings. Using a retrospective design and claims database, 14,359 Medicare patients with HFrEF from August 2010 to July 2015 were identified. Index date was first HF claim. IPT was mono- or combo-angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), beta-blocker (BB), hydralazine–nitrate (HN), and aldosterone antagonist (AA) within 1 year post-index. A multivariable time-dependent Cox model estimated associations between IPT and 2-year all-cause mortality. Patients’ median age was 76 (70–82) years; 45.1% were female. Within 1 month post-index, 61.4% had IPT, 6.1% started after the first month, and 32.4% had no IPT in the first year. Of IPTs, 47.5% were mono-vasodilators (ACEI, ARB or HN), 23.3% mono-vasodilator + BB, 16.9% mono-BB, and 3.5% triple therapy [(ACEI or ARB) + BB + (HN or AA)]. Two-year mortality rate was 27.9%. Compared to mono-vasodilator therapy, patients initiating triple therapy had 29.3% lower risk of 2-year mortality; those on mono-BB or no IPT had higher mortality risk. IPT was associated with decreased 2-year mortality risk. Timely consideration of triple IPT therapies may be warranted once HFrEF diagnosis is confirmed. Novartis Pharmaceuticals Corp. located in East Hanover, NJ, USA.

To evaluate heart failure (HF) patients' disease knowledge and preferences for avoiding different disease outcomes.An online survey was administered to 400 individuals with a self-reported diagnosis of HF to elicit relative importance weights (RIWs) for avoiding 11 potential HF symptoms and outcomes using best-worst scaling. The survey also included questions about individuals' HF knowledge, and demographic and disease-experience characteristics. Differences in RIWs among sub-groups, defined by HF knowledge, caregiver support, age, recent hospitalization or emergency room visit for HF, health-related quality-of-life, and cardiac device experience were examined.Relative to limitations in usual activities (RIW 1.00), respondents preferred avoiding severe, infrequent cardiovascular events (e.g. stroke [RIW 8.51], heart transplant [RIW 7.84], or heart attack [RIW 5.3]) most, followed by difficulty breathing (RIW 2.55), inability to enjoy life (RIW 1.84), cardiac device implantation (RIW 1.74), and atrial fibrillation (RIW 1.57). Patients preferred avoiding swelling (RIW 0.47) and fatigue (RIW 0.58) least. RIWs for avoiding severe, infrequent events were higher among those with high disease knowledge, those without caregivers, and those without a recent hospitalization or emergency room visit.Patients' preferences for avoiding HF outcomes vary across outcomes and by individuals' knowledge, caregiver status, and age. Healthcare providers should solicit and incorporate insights about patients' knowledge of HF and their preferences for avoiding HF outcomes into HF education and management planning efforts.

Background Outcomes data among patients with heart failure (HF) with reduced ejection fraction treated with sacubitril/valsartan ( SAC / VAL ) are largely limited to clinical trial results. We compared hospitalization and healthcare costs among real‐world patients with HF with reduced ejection fraction treated with SAC / VAL versus angiotensin‐converting enzyme inhibitor or angiotensin‐receptor blocker ( ACEI / ARB ). Methods and Results Using retrospective administrative claims data, stable patients with HF with reduced ejection fraction treated with SAC / VAL or ACEI / ARB from October 2015 to June 2016 were identified. Postindex hospitalization and healthcare costs were assessed in propensity‐matched cohorts using robust variance estimation. Time to first hospitalization was modeled using unadjusted Kaplan–Meier estimates and multivariable models. Postindex all‐cause healthcare costs were modeled using an adjusted multivariable model. Among 279 patients per matched cohort, postindex hospitalization risk was lower for SAC / VAL compared with ACEI / ARB using Kaplan–Meier estimation and unadjusted Cox models. For HF hospitalization, the hazard ratio (95% CI) was 0.56 (0.33–0.94; P =0.030). Adjusted results were similar to unadjusted. Mean ( SD ) monthly healthcare costs were lower for SAC / VAL versus ACEI / ARB for all categories except pharmacy, with hospital costs being particularly disparate between cohorts: for HF hospitalization, $248 ($1588) for SAC / VAL versus $1122 ($7290) for ACEI / ARB . The adjusted risk of incurring increased all‐cause postindex costs was lower for SAC / VAL versus ACEI / ARB (cost ratio [95% CI] 0.74 [0.59–0.94]; P =0.013). Conclusions In clinical practice, patients with HF with reduced ejection fraction treated with SAC / VAL were less likely to be hospitalized than matched patients treated with ACEI / ARB . Despite higher pharmacy costs, SAC / VAL –treated patients incurred lower monthly medical and total healthcare costs.

Background The angiotensin‐receptor/neprilysin inhibitor (ARNI) sacubitril/valsartan reduces hospitalization and mortality for patients with heart failure with reduced ejection fraction. However, adoption of ARNI into clinical practice has been slow. Factors influencing use of ARNI have not been fully elucidated. Using data from the Get With The Guidelines‐Heart Failure registry, Hospital Compare, Dartmouth Atlas, and the American Hospital Association Survey, we sought to identify hospital characteristics associated with patient‐level receipt of an ARNI prescription. Methods and Results We analyzed patients with heart failure with reduced ejection fraction who were eligible for ARNI prescription (ejection fraction≤40%, no contraindications) and hospitalized from October 1, 2015 through December 31, 2016. We used logistic regression to estimate the associations between hospital characteristics and patient ARNI prescription at hospital discharge, accounting for clustering of patients within hospitals using generalized estimating equation methods and adjusting for patient‐level covariates. Of 16 674 eligible hospitalizations from 210 hospitals, 1020 patients (6.1%) were prescribed ARNI at discharge. The median hospital‐level proportion of patients prescribed ARNI was 3.3% (Q1, Q3: 0%, 12.6%). After adjustment for patient‐level covariates, for‐profit hospitals had significantly higher odds of ARNI prescription compared with not‐for‐profit hospitals (odds ratio, 2.53; 95% CI, 1.05–6.10; P=0.04), and hospitals located in the Western United States had lower odds of ARNI prescription compared with those in the Northeast (odds ratio, 0.33; 95% CI, 0.13–0.84; P=0.02). Conclusions Relatively few hospital characteristics were associated with ARNI prescription at hospital discharge, in contrast to what has been observed in early adoption in other disease areas. Additional evaluation of barriers to implementing new evidence into heart failure practice is needed., See Editorial by Bergethon and Wasfy

Background In the PARADIGM-HF trial, sacubitril/valsartan (SAC/VAL) was superior to enalapril in reducing risks of cardiovascular death and heart failure (HF) hospitalization in patients with HF and reduced ejection fraction (HFrEF); however, there is limited knowledge of the impact of SAC/VAL on real-world clinical outcomes and costs compared to angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB). Objective To compare hospitalization and healthcar e costs among patients with HFrEF treated with SAC/VAL vs. ACEI/ARB. Methods De-identified claims data of adults in a large US managed care health plan (commercial and Medicare Advantage [MA]) were used from Oct 2014 to Sep 2016. Stable patients were identified with claims-based proxy for HFrEF and >=1 claim for SAC/VAL (identified first), ACEI or ARB during Oct 2015 to Jun 2016. Index therapy with >=80% proportion of days covered for first 3 months was required. SAC/VAL and ACEI/ARB cohorts were matched for demographics, baseline characteristics and length of follow-up using propensity scores. Per-patient-per-month (PPPM) hospitalization and healthcare costs (health plan + patient paid amounts) were calculated during a variable follow-up period (3-12 months). Robust variance estimation was used to compare hospitalization and healthcare costs between matched cohorts. Results Post-match, 279 patients/cohort were identified (mean [SD] age, 67.9 [12.6] years; 73.5% MA enrollee; 68.1% male; 90.9% hypertension; 56.1% diabetes; 46.1% atrial fibrillation; mean (SD) follow-up, 185.0 [70.1] days). Patients in the SAC/VAL cohort, compared with the ACEI/ARB cohort, experienced lower mean (SD) PPPM HF hospitalizations (0.01 [0.06] vs. 0.03 [0.10], p=.003) and all-cause hospitalizations (0.05 [0.11] vs. 0.11 [0.20], p Conclusions Compared to ACEI/ARB-treated patients, patients initiated with SAC/VAL within the first year of US market approval experienced fewer monthly hospitalizations, which may have been associated with lower medical costs. Reduced monthly medical costs among patients initiated with SAC/VAL offset increased outpatient pharmacy costs, resulting in lower total healthcare costs. This study was supported by Novartis Pharmaceuticals Corporation.

BackgroundSurveys of patients with cardiovascular disease have suggested that "home-time"-being alive and out of any health care institution-is a prioritized outcome. This novel measure has not been studied among patients with heart failure (HF).ObjectivesThis study sought to characterize home-time following hospitalization for HF and assess its relationship with patient characteristics and traditionally reported clinical outcomes.MethodsUsing GWTG-HF (Get With The Guidelines-Heart Failure) registry data, patients discharged alive from an HF hospitalization between 2011 and 2014 and≥65 years of age were identified. Using Medicare claims, post-discharge home-time over 30-day and 1-year follow-up was calculated for each patient as the number of days alive and spent outside of a hospital, skilled nursing facility (SNF), or rehabilitation facility.ResultsAmong 59,736 patients, 57,992 (97.1%) and 42,153 (70.6%) had complete follow-up for home-time calculation through 30days and 1 year, respectively. The mean home-time was 21.6 ± 11.7days at 30days and 243.9 ± 137.6days at 1 year. Contributions to reduced home-time varied by follow-up period, with days spent in SNF being the largest contributor though 30days and death being the largest contributor through 1 year. Over 1 year, 2,044 (4.8%) patients had no home-time following index hospitalization discharge, whereas 8,194 (19.4%) had 365days of home-time. In regression models, several conditions were associated with substantially reduced home-time, including chronic obstructive pulmonary disease, renal insufficiency, and dementia. Through 1 year, home-time was highly correlated with time-to-event endpoints of death (tau=0.72) and the composite of death or HF readmission (tau=0.59).ConclusionsHome-time, which can be readily calculated from administrative claims data, is substantially reduced for many patients following hospitalization for HF and is highly correlated with traditional time-to-event mortality and hospitalization outcomes. Home-time represents a novel, easily measured, patient-centered endpoint that may reflect effectiveness of interventions in future HF studies.

Introduction: Among patients with HFrEF, treatment with sacubitril/valsartan (SAC/VAL) was shown in PARADIGM-HF to reduce risks of CV death and HF hospitalization compared with enalapril; however, scarce data exist regarding the impact of SAC/VAL on real-world healthcare resource utilization (HCRU) compared to ACEI or ARB. Objective: To compare HCRU among patients with HFrEF treated with SAC/VAL vs. ACEI or ARB. Methods: Using managed care claims data, we identified stable adults with claims-based proxy for HFrEF and ≥1 claim for SAC/VAL (identified first), ACEI or ARB during Oct 2015 to Jun 2016. We required ≥80% proportion of days covered with SAC/VAL or ACE/ARB for first 3 months post index claim. SAC/VAL and ACEI/ARB cohorts were propensity score matched on demographics, baseline characteristics and length of follow-up. Per patient per month (PPPM) HCRU (ambulatory visit, ER visit and hospitalization) and timing of first hospitalization (including estimated failure probabilities) were calculated during a variable follow-up period (3-12 months). HF hospitalization was identified based on first-listed diagnosis code of HF on a hospital facility claim. Robust variance estimation was used to compare PPPM HCRU between matched cohorts and proportional hazards models (no covariate adjustment) were used to evaluate risk of first hospitalization. Results: With mean (SD) follow-up of 185.0 (70.1) days, 279 patients were identified in each of the SAC/VAL cohort and matched ACEI/ARB cohort (mean [SD] age, 67.9 [12.6] years; 73.5% Medicare Advantage enrollee; 26.5% commercial enrollee; 68.1% male; 56.1% diabetes; 46.1% AF; 46.6% hospitalization in 1 year pre index claim). Patients in the SAC/VAL cohort, compared with the ACEI/ARB cohort, experienced lower mean (SD) PPPM all-cause ER visits (0.10 vs. 0.19, p Conclusions: Based on a real-world sample of patients with HFrEF, those initiated with SAC/VAL ≤12 months following US market approval experienced fewer monthly hospitalizations and ER visits compared to ACEI/ARB, and no difference in ambulatory visits. Lower risk of hospitalization after initiating SAC/VAL, rather than using ACEI/ARB, is important since HF hospitalization was previously associated with higher 30-60 day mortality and readmission rate.

Recent advances have increased treatment options for, and improved clinical outcomes in, metastatic melanoma (mM). Using a large claims database, this retrospective study compared healthcare and adverse event (AE) costs in a US managed care population of mM patients initiating vemurafenib (VEM), ipilimumab (IPI), dacarbazine (DTIC), paclitaxel (PAC), or temozolomide (TMZ) from July 2009 to September 2012. Treatment episodes were identified from the start of study drugs (index date) to a switch to a different study drug, or a gap greater than 45 days (>112 days for IPI). Grade 3/4 adverse events occurring ≥5% from study drug package inserts were selected for this analysis. All-cause costs for treatment episodes and AEs were normalized as monthly costs. Generalized estimating equation models with log link and gamma distribution provided adjusted monthly treatment episode and AE costs. A total of 809 treatment episodes were identified in 541 mM patients, with a mean (SD) age of 57.5 (11.5) years. The total mean (SD) all-cause cost per treatment episode for VEM was $77 687 ($60 329), for IPI was $153 062 ($134 048), for DTIC was $35 243 ($33 641), for TMZ was $42 870 ($41 384), and for PAC was $58 991 ($81 306). The adjusted mean monthly treatment episode cost for VEM was significantly lower than that for IPI and comparable to that for other drugs. VEM had a significantly lower monthly AE cost than IPI, DTIC, and PAC. In combination with safety and efficacy findings, these results may assist clinicians, patients, policy makers, and payers in the treatment of mM.

Introduction: Heart failure (HF) and reduced ejection fraction (HF r EF) requires timely ACC/AHA guideline recommended treatment (Tx) with multiple pharmacotherapies, including renin-angiotensin system and sympathetic nervous system blockers. The relationship between initial pharmacotherapies (IPT) and treatment modifications ([TM]: add-on or switch to a new class, or discontinuation of IPT) in real world practice is not well understood. Methods: This retrospective cohort study identified Humana Medicare managed care patients (pts) with ≥2 claims for HF from 8/2010-7/2015. The 1st HF claim was the index date. Patients had 1-year (yr) continuous enrollment, no HF diagnosis prior to index, and continuous enrollment 2-yrs post-index or until death. A claims-based algorithm was used to derive HF r EF status. IPT were mono- or combo-use of ACE-inhibitor (ACEI), angiotensin II receptor blocker (ARB), beta blocker (BB), hydralazine-nitrate (HN), and aldosterone antagonist (AA) in 1 yr post-index. No IPT was no drug use, only 1 fill, or st TM in 2 yrs post-index and subsequent therapies were identified. Results: Of 14,359 HF r EF pts, mean (SD) age was 75 (±8) yrs; 45% were female. Post-index, 32% had no IPT after 1 yr, 61% had IPT within 1 month, and 7% initiated IPT after the 1 st month. Of pts with IPT (n=9705), 48% received mono vasodilators (ACEI/ARB or HN), 17% mono BB, 23% vasodilator+BB, and 4% triple therapy [(ACEI/ARB)+BB+(HN or AA)]. Among pts on IPT, 52% had 1 st TM within 2 yrs post-index, with 26% adding a new class, 7% switching to a new class, 9% discontinuing a class of IPT, and 9% discontinuing all IPT. Mean (SD) time from IPT to 1 st TM was 9 (±7) months. For pts with subsequent therapies after 1 st TM, vasodilator+BB was most common (41%), followed by mono vasodilator (15%); then triple therapy (12%). (Table 1) Conclusion: Despite national HF r EF Tx guidelines recommending combo use of vasodilator+BB, nearly 1/3 of pts had no IPT within 1 yr post-index and over ½ received mono Tx as IPT. Of pts on IPT, mean time to 1 st TM was 9 months and few initiated triple therapy. In clinical trials, dual (vasodilator+BB) or triple therapies improved health outcomes. Consequences of HF pharmacotherapy gaps warrant further study.

Guidelines for preventing and treating patients with coronary artery disease have traditionally focused on reducing low-density lipoprotein cholesterol (LDL-C). Current treatments are effective; however, previous studies have identified a significant proportion of patients that are not achieving the recommended lipid levels. New guidelines were introduced November 2013. The objective of this study was to examine recent practice patterns and factors related to initiating treatment for hypercholesterolemia, which provides a comparative baseline to the introduction of new guidelines.We conducted a retrospective cohort analysis utilizing laboratory results of lipid profiles and medical claims from January 2007 to September 2011 to identify patients with elevated LDL-C and diagnoses of hypercholesterolemia without prior pharmacotherapy. Pharmacotherapy dispensed, treatment modifications, LDL-C-goal attainment, and potential drug intolerance were evaluated.Overall, among newly treated patients, 70.9% achieved the recommended LDL-C level within the first year of treatment; however, only 19.4% of those with coronary heart disease (CHD) or CHD risk equivalents achieved the more aggressive LDL-C goal of70 mg/dL (1.8 mmol/L). LDL-C goals were generally achieved with the use of statins; however, a majority of patients underwent treatment modification(s) (e.g., discontinuation or restart). More than half of the patients diagnosed with elevated LDL-C did not initiate pharmacotherapy.Data was unavailable for inpatient hospitalizations, family history of cardiovascular diseases, body weight, and height, and likely under-reporting of smoking within claims data.Newly treated patients with elevated LDL-C results generally achieved the recommended and risk-specific LDL-C goal with the use of lipid-altering drugs; however, there still exists a notable population of patients with CHD or CHD risk equivalents who were not treated to goal and a significant number of patients who do not receive lipid-lowering pharmacotherapy. New therapies and prescribing practices are warranted to adequately address these two patient populations.

Medication prescribing information provides guidance to healthcare providers on how to prescribe a drug properly. Oftentimes patient factors in addition to the prescribing information are considered when selecting medications. Utilizing real-world pharmacy and medical claims data, this study assessed US practitioner prescribing practices of US approved transdermal buprenorphine system (BTDS) in relation to BTDS's full prescribing information (FPI) as well as the relationship between patient factors and initial BTDS dose.Patients aged ≥18 years initiating BTDS between 1 January 2011 and 30 November 2011 were identified in the IMS Pharmacy and Private Practitioner Medical Claims databases. The index date was defined as the first filled BTDS prescription. Demographics, chronic pain-related medical conditions in the 12 months pre-index and prior medication use in the 6 months pre-index were assessed. Initial BTDS dosing strength, receipt of approved initial BTDS dose per the FPI, and concomitant medications were assessed in the post-index 6 month period.The study included 10,457 patients newly treated with BTDS. The majority of patients were female (69.9%) with a mean (±SD) age of 54.5 (±15.2) years. Within the 6 months prior to the index BTDS prescription, 91.7% of the patients used opioids. Overall, 48.9% of patients were prescribed the FPI approved BTDS dose. When stratified, 73.5% of opioid-naïve patients received the FPI approved initial dose compared to 46.0% of those with prior opioid experience of ≤80 mg morphine-equivalent daily dose. Patients on BTDS alone (i.e. monotherapy) had a higher rate of receiving the FPI approved initial BTDS dose compared to patients on BTDS concomitant regimens (p 0.05).Practitioners demonstrated that they prescribe in accordance with BTDS's prescribing information in the majority of opioid-naïve patients and in approximately half of opioid-experienced patients. The initial opioid dose is a critical step in treatment, setting the stage for preventing side-effects and improving treatment effectiveness. Understanding practitioner prescribing practices with regard to the initial dose selection of BTDS may provide insight on how to improve outcomes of care and reduce healthcare resource utilization and costs associated with pain management.Data obtained from prescription claims reflect only the activities of prescriptions filled, not medication use or other clinical characteristics observed by physicians when treating patients.

Few data have been reported on anemia management practices in hospital-based dialysis centers (HBDCs), which are uniquely different from other freestanding dialysis centers. Examining data from HBDCs would help determine if HBDCs and the general US dialysis population have similar trends related to how anemia is managed in dialysis patients.Given recent changes in the prescribing information of erythropoiesis-stimulating agents (ESAs) and in end-stage renal disease-related health policy and reimbursement, this study describes trends in anemia management practices in HBDCs from January 2010 through March 2013.Electronic medical records of 5404 adult hemodialysis patients in 50 US-based HBDCs were analyzed retrospectively. Patients included in the study cohort were aged ≥18 years and had at least 1 hemoglobin (Hb) measurement and 1 dose of an ESA between January 2010 and March 2013. End points included Hb concentration, darbepoetin alfa dosing, epoetin alfa dosing, and iron biomarkers (transferrin saturation and ferritin) and dosing.From 2010 to 2013, mean monthly Hb levels declined from 11.4 to 10.7 g/dL; the percentage of patients with mean monthly Hb levels10 g/dL increased from 11.3% to 24.4%; and the percentage of patients with mean monthly Hb levels12 g/dL declined from 30.1% to 11.2%. The median darbepoetin alfa cumulative 4-week dose also declined 38.8%, and the weekly epoetin alfa dose declined 24%. From January 2010 to March 2013, the percentage of patients with transferrin saturation30% increased from 35.8% to 43.6%, the percentage of patients with ferritin levels500 ng/mL increased from 62.0% to 77.9%, the percentage of patients with ferritin levels ≥800 ng/mL increased from 28.9% to 47.3%, and the median cumulative 4-week intravenous iron dose increased 50%.These study results support growing evidence that meaningful changes have occurred over the last 3 years in how anemia is clinically managed in US hemodialysis patients. Study limitations include that changes in patient clinical/demographic characteristics over time were not controlled for and that study findings may not be applicable to HBDCs that have different patient populations and/or do not use an electronic medical record system. Continuing to evaluate anemia management practices in HBDCs would provide additional information on the risks and benefits of anemia care. Consistent with national data, the findings from this study indicate that from 2010 to 2013, HBDCs modified anemia management practices for dialysis patients, as evidenced by reductions in mean monthly Hb levels and ESA dosing and by increases in iron biomarkers and dosing.

Persistence, the duration a patient remains on therapy, in chronic, symptomatic conditions plays an important role in therapy effectiveness. Understanding the duration and patient factors associated with prescribed medication persistence is, therefore, an important step toward better treatment and health outcomes for patients. In the following study, an analysis of such factors associated with buprenorphine transdermal system (BTDS) persistence was conducted utilizing a large US private practitioner and pharmacy claims database and is herein reported.Patients aged ≥ 18 years initiating BTDS during January 1, 2011-November 30, 2011 were identified in the IMS Private Practitioner Medical Claims and Pharmacy Claims databases. An index date was defined as the first prescription of BTDS during the studied interval. During the preindex period, Charlson Comorbidity Index (CCI), chronic pain-related conditions, and prior medication use were assessed. Concomitant medications and various treatment patterns (eg, last dose strength and dose adjustments) were assessed in the postindex 6-month period. Persistence was measured as the duration of BTDS from initiation to the 1st28-day refill gap in the postindex 6-month period. Descriptive statistical and survival analysis was used to assess the predictors of BTDS persistence.During the study period, 10,457 patients newly treated with BTDS were identified. Patients' mean (± SD) age was 54.5 (± 15.2) years; 69.9% were women, and the mean (± SD) CCI was 1 (± 1.4). Utilizing a hierarchical approach, patients were separated into different cohorts based on the initial analgesic prescription identified during postindex period with 91.7%, 34.7%, and 59.0% of the patients using opioids, NSAIDs and adjuvant analgesics, respectively. Multivariate regression analyses showed that patients with prior opioid and adjuvant analgesic use were 21% and 5% less likely to discontinue BTDS (P0.05), respectively, as compared to patients not using these agents. Patients with concomitant use of adjuvant analgesics were 15% less likely to discontinue therapy (P0.05) as compared to patients without concomitant use of these agents. Long-term BTDS persistence was also observed in patients who had a dose change or a last dose strength5 mcg/hour. Sensitivity analyses for those with 30-day prior opioid use and patients with ≥ 2 claims of BTDS confirmed these findings.Prior and concomitant use of adjuvant analgesics, prior use of opioids, and dose adjustments were associated with significantly longer persistence among patients initiating BTDS. The results suggest that patients are less likely to discontinue BTDS early if practitioners account for prior treatment history and dose titration.

Clinical guidelines recommend concurrent treatment of anemia in end-stage renal disease with erythropoiesis-stimulating agents (ESAs) and iron. However, there are mixed data about optimal iron supplementation. To help address this gap, the relationship between iron markers and hemoglobin (Hb) response to ESA (Epoetin alfa) dose was examined. Electronic medical records of 1902 US chronic hemodialysis patients were analyzed over a 12-month period between June 2009 and June 2010. The analysis included patients who had at least one Hb value during each 4-week interval for four consecutive intervals (k − 2, k − 1, k, and k + 1; k is the index interval), received at least one ESA dose during intervals k − 1 or k, had at least one transferrin saturation (TSAT) value at interval k, and at least one ferritin value during intervals k − 2, k − 1, or k. Effect modification by TSAT and ferritin on Hb response was evaluated using the generalized estimating equations approach. Patients had a mean (standard deviation) age of 62 (15) years; 41% were Caucasian, 34% African American, 65% had hypertension, and 39% diabetes. Transferrin saturation, but not ferritin, had a statistically significant (P

Purpose Diagnosis codes have been valid tools to identify severe neutropenia leading to hospitalization in claims data, but no data exist on the accuracy of outpatient diagnosis of neutropenia. We examined the validity and accuracy of claims-based algorithms to identify neutropenia from outpatient visits.

To compare asthma-related resource utilization, adherence and costs among adults prescribed asthma controller regimens.Medical and pharmacy claims from a US managed-care claims database were used to identify adults (18-56 years) initiating asthma controller therapy. Patients had 2 years continuous enrollment and ≥ 1 medical claims for asthma (ICD9: 493.xx) (January 2004 - March 2009). Asthma exacerbations, short-acting β-agonist (SABA) fills, adherence (MPR ≥ 0.80) and asthma-related costs were assessed for 1 year after the initial asthma controller medication claim. Separate logistic and negative binomial regression models for monotherapy and combination therapy were developed to examine the impact of controller therapy on outcomes.A total of 28 074 patients [inhaled corticosteroids (ICS) (26.3%), leukotriene modifiers (LM) (23.2%), ICS + long acting β-agonist (LABA) (48.5%), ICS + LM (2%)] were included. LM patients had lower odds of ≥ 6 SABA fills (OR(adj) = 0.83, 95% CI: 0.73-0.96) and lower rates of asthma exacerbations (RR(adj) = 0.82, 0.75-0.89) vs. ICS patients. Odds of ≥ 6 SABA fills were similar for ICS + LM vs. ICS + LABA (OR(adj) = 1.3, 0.96-1.76); the rate of asthma exacerbations was greater for ICS + LM compared with ICS + LABA (OR(adj) = 1.4, 1.2-1.6). The proportion adherent was greatest for LM (14.9%) and ICS + LABA (4.1%). LM patients had higher unadjusted pharmacy costs, but lower medical costs compared to ICS patients. For combination therapy, ICS + LM had higher unadjusted mean medical and pharmacy costs vs. ICS + LABA. Higher adjusted mean total costs in the post-index period were observed for LM vs. ICS patients ($837 vs. 684) and for ICS + LM vs. ICS + LABA patients ($1223 vs. 873).LM monotherapy was associated with lower medical costs but higher total costs resulting from greater treatment adherence. Conversely, higher costs for ICS + LM resulted from greater exacerbations compared to ICS + LABA despite similar adherence. Higher total costs with LM were due to drug costs. Precise utilization of the medications filled by patients could not be determined.

Background— This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. Methods and Results— Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had P =0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. Conclusions— In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score–matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.

Background Total direct and indirect cost for HF is expected to more than double between 2012 and 2030; however, little is known how new therapies, such as sacubitril/valsartan (S/V), may impact patient (pt) paid costs. Objective To compare pt paid healthcare costs in the 3 months pre- and post-S/V initiation. Methods Using de-identified claims data from a large US managed care health plan, we identified adults with first S/V pharmacy claim during Oct 2015 to Jun 2016. Heart failure-related medication utilization and pt paid healthcare costs in 3-month pre- and post-index periods were calculated. Medication fills and costs were compared between periods using McNemar and paired t-tests. Results A total of 606 pts treated with S/V were identified: mean (SD) age, 68.6 (12.7) years; 77.7% Medicare Advantage enrollee; 67.8% male; 76.6% shortness of breath; 71.6% ischemic heart disease (other than MI); 33.0% renal disease; 25.9% sleep apnea; 22.9% edema and fluid overload. During the 3-month post-index period, pts experienced 2.6 (1.1) mean (SD) S/V fills, 54.8% of pts filled index S/V dose of ≤24/26 mg twice daily, 33.3% with index dose of 49/51 mg twice daily, and 11.9% with index dose at target dose of 97/103 twice daily; 20.0% of pts achieved target S/V dose of 97/103 mg twice daily. During the 3-month post-index, compared with the 3-month pre-index, there were no differences in percentages of pts with fill(s) for evidence-based BB: 78.1% vs. 80.7%, p=.070, MRA: 42.1% vs. 42.1%, p=1.000, loop diuretic: 63.0% vs. 66.0%, p=.086, or digoxin: 20.3% vs. 19.1%, p=.209; however, a lower percentage of pts filled thiazide diuretics (5.0 vs. 9.7%, p Conclusions Compared to 3 months pre-initiation, overall pt cost burden for medical care was lower in the first 3 months of S/V initiation, despite higher pt costs for outpatient pharmacy fills. Potential patient paid cost neutrality early after S/V initiation should be included in discussions, as needed, as part of shared decision making when introducing S/V therapy.

On May 20, 2016, the ACC/AHA/ HFSA published joint treatment guidelines recommending the use of angiotensin-receptor neprilysin inhibitor (ARNI) for eligible patients with heart failure with reduced ejection fraction (HFrEF). Using data from the Get With The Guidelines-Heart Failure registry, we

Background The emergence of community-associated methicillin-resistant S. aureus was associated with dramatically increased skin and soft tissue infection (SSTI) incidence in the first few years of the 21st century in the U.S. However, subsequent trends are poorly understood. Methods We examined ambulatory and inpatient data of over 48 million persons years aged 0–64 years from the HealthCore Integrated Research Database (HIRD) between 2005 and 2010. Data were extracted from medical, pharmacy, and eligibility databases. We quantified SSTI incidence, type, and complications and comparative incidence trends for urinary tract infections (UTIs) and pneumonia. Results A total of 2,301,803 SSTIs were identified. Most SSTIs (95 %) were treated in the ambulatory setting and most (60 %) were categorized as abscesses or cellulitis. During the study period, SSTI incidence remained relatively stable from 47.9 (95 % CI: 47.8–48.1) cases/1,000 PY in 2005 to 48.5 cases/1,000 PY (95 % CI: 48.3–48.6) in 2010). Persons aged 45–64 years had the highest incidence of both ambulatory-treated and inpatient-treated SSTIs (51.2 (95 % CI: 51.1–51.3) and 3.87 (95 % CI: 3.84–3.90) cases/1,000 PY, respectively). SSTI complications such as myositis, gangrene, and sepsis occurred in 0.93 % (95 % CI: 0.92–0.94 %) and 16.92 % (95 % CI: 16.87–16.97 %) of ambulatory-treated and inpatient-treated patients, respectively. SSTI incidence was approximately twice that of UTIs and tenfold of that of pneumonia. Conclusions Among our large, diverse population of persons less than 65 years, SSTI incidence 2005 through 2010 has remained relatively constant at approximately 4.8 SSTIs per 100 person years, suggesting that previously observed increases in SSTI incidence remain sustained.

New health care services are salient in the supply chain. The market success of new health care services depends on the knowledge-based view to integrate organizational knowledge and attain service innovation performance. This study suggests that the hospitals integrate total market orientation and entrepreneurial orientation as organizational knowledge to sustain marketing operations advantages and achieve market performance in the new health care service supply chain.

Prior research suggests increases in resource use and costs in the final months of life, yet limited data exist on such trends in patients with HF. This study evaluated healthcare costs in the last 2 years of life among patients with HF by race/ethnicity. Findings will provide better understanding

Guidelines recommend chronic use of tobramycin solution for inhalation (TSI) for cystic fibrosis (CF) patients with moderate-to-severe lung disease and persistent airway Pseudomonas aeruginosa. This study evaluated the economic impact of TSI in managed care CF patients.Patients (0-64 years) with ≥2 CF medical claims between 01/01/04-03/31/09 were identified. For TSI users, the index date was the first TSI claim in the period; for non-users, a pseudo-index date was determined and randomly assigned by simulating the distribution of index dates of TSI users. Maximum sample size was obtained for patients with ≥3 months pre- and ≥12 months post-index eligibility. Users were categorized by number of TSI prescriptions filled during 12-month post-index period as low (1 fill), medium (2-3 fills) and high adherence (≥4 fills). Differences in per member per month (PMPM) costs pre-index to post-index were analyzed using paired t-tests.A total of 388 TSI users (mean age 19 years, 48% female) and 444 non-users (mean age 30 years, 54% female) met study criteria. In users, total and CF-related PMPM costs decreased $959 (17%) and $113 (3%), respectively, after starting TSI. Among TSI users, CF-related inpatient PMPM costs decreased by $1171 (49%; p=0.01), while CF-related prescription PMPM costs increased by $992 (p0.01). CF-related inpatient PMPM costs decreased by $381 (38%; p=0.16) for low and $1425 (50%; p=0.21) for medium users and decreased by $1829 (51%; p=0.02) for high users.Limitations include use of administrative claims data, small sample size due to disease rarity, random assignment of pseudo-index date to non-users and differences in baseline characteristics between TSI users and non-users.All-cause and CF-related PMPM medical costs significantly decreased after TSI initiation. Among TSI users, total healthcare costs decreased, although not significantly, due to PMPM increases in prescription costs. A trend towards greater decrease in inpatient PMPM costs was observed with increasing TSI adherence.

Guidelines support clopidogrel therapy in medically-treated or percutaneous coronary intervention (PCI) patients after hospitalization for acute coronary syndrome (ACS). However, clopidogrel discontinuation has been associated with increased short-term risks. This study evaluated the risk of adverse outcomes (AOs), defined as death or recurrent ACS, after clopidogrel discontinuation in a managed-care population.ACS patients (n = 7625) with ≥1 clopidogrel pharmacy claim from 2001 to 2006 and no AO before discontinuing clopidogrel were identified from administrative claims data. AO occurrences were recorded at 90-day intervals following clopidogrel discontinuation.The mean (SD) duration of clopidogrel therapy for medically-treated, bare metal stent (BMS) and drug eluting stent (DES) patients was 349.2 (393.1) days, 235.6 (383.0) days, and 280.2 (227.1) days, respectively. Among medically-treated patients, Poisson regression analysis showed a 2.19 times higher AO risk (p 0.01), a 1.63 times greater risk among BMS patients (p 0.01), and a 1.56 times greater risk for DES patients (p ≥ 0.05) during days 0-90 versus days 91-180 after clopidogrel discontinuation. Sensitivity analysis showed that medically-treated, BMS and DES patients with ≤90 days of clopidogrel therapy had 2.13, 1.68 and 2.40 times higher AO risk, respectively, during days 0-90 versus 91-180 after discontinuation. No significant elevated AO risk was observed after discontinuation in patients on clopidogrel for 91-270 days. Limitations included those associated with the use of administration claims date, the absence of clinical data and lack of knowledge of aspirin use.Patients who discontinued clopidogrel therapy were at high risk of death or recurrent ACS during the first 90 days. AO risks following discontinuation appeared elevated in patients with ≤90 days of clopidogrel therapy versus those with90 days of treatment.

Suboptimal adherence to lipid-lowering therapies is associated with and potentially contributes to increased cardiovascular morbidity and mortality. Single-pill combination (SPC) lipid-modifying therapies may improve patient adherence due to decreased pill burden and increased convenience for the patient.To compare adherence to SPC versus multi-pill combination (MPC) lipid-modifying medications.This retrospective study used pharmacy and medical claims and laboratory result data from a national managed care dataset to evaluate patients who were newly prescribed simvastatin plus ezetimibe, simvastatin plus niacin, and lovastatin plus niacin either as SPC or MPC. Patients were considered adherent to therapy if they had a proportion of days covered (PDC) ≥ 0.80.The mean PDC was 0.76 and 0.70 in the first 3 months of therapy, 0.54 and 0.45 in the second 3 months, and 0.50 and 0.41 for the remaining 30 months of follow-up for the SPC and MPC groups, respectively. SPC patients were 32% (OR = 1.32; 95% CI: 1.27-1.36; P0.01) more likely to be adherent to treatment than MPC patients.Adherence was significantly higher among patients receiving SPC than MPC. Although only associations and not temporality were assessed due to the observational design of this study, the use of SPC may be a successful method for improving adherence in a real-world setting.

Allergic rhinitis (AR), also known as hay fever, is caused by an overreaction of the immune system to airborne allergens. AR is a substantial cause of widespread morbidity, medical treatment costs, and reduced productivity at work and school.The goal of this research was to describe patient characteristics and prescription fill patterns for patients with AR and to determine those factors associated with the use of montelukast in a large population of commercially insured patients who sought medical treatment for AR.This was a retrospective cohort study using administrative claims data from a commercially available database. Patients, aged 4 to 64 years, withor=3 years' continuous enrollment andor=1 medical claim for AR between January 1, 2004, and December 31, 2006, were included. Patients with a concomitant asthma diagnosis were excluded. Patients' demographic and clinical characteristics, comorbidities, health care resource utilization, AR-related medication use, and AR-related physician office visits were assessed for 12 months before the first AR medication fill (index) in 2006. Stepwise logistic regression was used to identify factors predicting the initiation of montelukast therapy for the treatment of AR in 2006.The study population consisted of 75,140 children (mean [SD] age, 10.6 [4.0] years) and 226,236 adults (mean age, 43.8 [11.8] years). Slightly more than half (52.4%) of the pediatric population was male compared with 44.7% of the adult population. Fifty percent of patients had no pharmacy fills for an AR medication in 2006. Among patients with AR pharmacy fills (n = 150,751), 78.1% had a single index medication fill (montelukast represented 4.5%) and 21.9% were prescribed multiple index medications. Children with AR were more likely to fill a prescription for montelukast (n = 7513) if they were 4 to 11 years of age; male; diagnosed with cough/wheeze; and had 1 or 2 oral corticosteroid fills,or=3 antibiotic fills, and AR-related physician office visits in the prior 12 months (all, P0.001). Prescription fills for montelukast among adult patients with AR were significantly (P0.001) associated with other respiratory/atopic conditions; prior fills for antihistamines, oral corticosteroids, or intranasal corticosteroids; and AR-related physician office visits in the prior 12 months. Children and adults with health plans based in the midwestern or southern region of the United States had greater odds of initiating montelukast than those with plans based in the western region (P0.001).Half of the patients identified with AR did not fill a prescription for an AR medication. Among those patients with AR-related prescription drug fills, most were prescribed a single index pharmacotherapy and did not receive additional AR medications within 30 days of the index date. The use of montelukast was limited and was more commonly prescribed to children and adults with AR whose condition was not controlled with other AR medications.

9007 Background: Advances in mM have increased treatment (tx) options, where previously, few therapies were available. This study compares HC and adverse event (AE) costs in a U.S. managed care pop...

Introduction Although osteoporosis has been reported to be more common in patients with rheumatoid arthritis (RA), little is known whether the risk of osteoporotic fractures in these patients differs by age, sex, and anatomic site. Methods A retrospective cohort study was conducted using a health care utilization database. Incidence rates (IRs) and rate ratios (RRs) of osteoporotic fractures with 95% confidence intervals (CIs) were calculated. Multivariable Cox proportional hazards models compared the risk of osteoporotic fracture at typical sites between RA and non-RA patients. Results During a median 1.63-year follow-up, 872 (1.9%) of 47,034 RA patients experienced a fracture. The IR for osteoporotic fracture at typical sites among RA patients was 9.6 per 1,000 person-years, 1.5 times higher than the rate of non-RA patients. The IR was highest for hip fracture (3.4 per 1,000 person-years) in RA. The IRs across all age groups were higher for women than men and increased with older age in both groups. The RRs were elevated in RA patients across all common sites of osteoporotic fracture: hip (1.62, 95% CI 1.43 to 1.84), wrist (1.15, 95% CI 1.00 to 1.32), pelvis (2.02, 95% CI 1.77 to 2.30), and humerus (1.51, 95% CI 1.27 to 1.84). After confounding adjustment, a modest increase in risk for fracture was noted with RA (hazard ratio 1.26, 95% CI 1.15 to 1.38). Conclusions Our study showed an increased risk of osteoporotic fractures for RA patients across all age groups, sex and various anatomic sites, compared with non-RA patients.

Background Parathyroidectomy (PTX) is often performed in dialysis patients when medical treatment fails to control secondary hyperparathyroidism (SHPT). PTX is viewed by many as a cost-containing measure for patients who have been treated with vitamin D analogs and calcimimetics. Yet, information about health resource utilization and costs before and after PTX is limited. Methods This retrospective cohort study used professional service and pharmacy claims to identify subjects on dialysis undergoing PTX from 1/1/2008-12/31/2010. Only subjects with at least six months of information before and after PTX were considered. Subjects with primary hyperparathyroidism or kidney transplant were excluded. Prescription use, physician encounters, and surgical complications were compared during the six months immediately before and after PTX. Results The mean (SD) age of the 181 study subjects was 51 (15) years; 59% female; and 80% insured by Medicare. Overall, the percentage of patients receiving medications to manage altered mineral metabolism increased from 67% before to 79% after PTX. Specifically, oral vitamin D use increased, while the utilization of cinacalcet decreased resulting in mean (SD) monthly medication charges decreasing from $486 (507) to $226 (288) (p