Clinical burden of asynchrony in patients with asthma when using metered-dose inhalers for control.

Background: Asynchrony, or lack of coordination between inhalation and actuation when using a pressurized metered-dose inhaler (MDI), could theoretically impact the delivery of inhaled medications and treatment efficacy. Objective: To assess the real-world association between asynchrony and clinical outcomes among patients with asthma who receive controller therapy delivered by MDIs. Methods: A cohort of patients was assembled via electronic health records. The patients were aged ≥12 years, with one or more documentations of an asthma diagnosis, no diagnosis of chronic obstructive pulmonary disease, and two or more prescriptions for an inhalation aerosol corticosteroid alone or with long-acting beta-2-agonist delivered via MDI. Their inhaler technique, demonstrated by using a placebo MDI, was evaluated at a clinic visit by study nurses who used a standardized 10-step checklist. Asynchrony was defined as any gap in timing between inhalation and actuation. Clinical outcomes were assessed via electronic health records during the 6 months before the clinic visit and were compared between patients with and patients without asynchrony by using multivariable regression analyses adjusted for age, gender, asthma severity proxy, and baseline comorbidities. Results: Of the total 254 eligible patients, mean age of 49.3 years, 90 males (35.4%), 32 (12.6%) had asynchrony. Patients with asynchrony had higher odds of an asthma exacerbation (adjusted odds ratio, 2.99; p = 0.009), and lower odds of risk domain asthma control (adjusted odds ratio, 0.41; p = 0.04) compared with patients without asynchrony. Conclusion: This study provided real-world evidence that asynchrony in MDI use among patients with asthma who were treated with controller MDIs was associated with clinical burden in terms of asthma exacerbations and control.

A review of the use and effectiveness of digital health technologies in patients with asthma.

OBJECTIVE: A new generation of digital health technologies (DHT) offers the opportunity to improve adherence and asthma control. Recent literature was reviewed to summarize the use of technological aids and evaluate their impact on health outcomes in patients with asthma. DATA SOURCES: PubMed and Embase were searched to identify articles published over the past 5 years (2013 to 2017). STUDY SELECTIONS: All records were judged for eligibility by 2 independent reviewers; 28 articles met the inclusion criteria. RESULTS: Interactive websites were the most frequently evaluated type of DHT (50% of all studies), followed by mobile apps in adult patient cohorts. Relatively few studies assessed electronic monitoring devices, phone calls, or text messaging. Among the 16 studies that focused on children, most interventions that used interactive websites (n = 8) showed at least some benefit, although results varied based on the specific outcome. Twelve studies focused on adults, with interventions using interactive websites (n = 6) reporting results that were generally less consistent compared with the pediatric studies. The 6 studies that assessed mobile apps with adult patients reported consistent benefits across a range of outcomes, including medication adherence and asthma control. CONCLUSION: Most interventions reported at least some benefit, although results varied based on the specific outcome. Overall, technology that included more interactive features, such as website-based daily diary entries and apps that provided real-time feedback, was associated with increased asthma control, as was the case for multidimensional interventions that combined the use of several complementary types of DHT.

Assessment of rituximab-abbs, a biosimilar, and rituximab outcomes in patients with CLL or NHL: A real-world UK study.

BACKGROUND: Rituximab (chimeric anti-CD20 monoclonal antibody) treatment is approved for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Rituximab-abbs (first biosimilar approved in 2017) is expected to significantly reduce healthcare economic burden due to lower acquisition costs. This non-interventional, non-comparative study assessed real-world effectiveness and tolerability of rituximab-abbs and rituximab in treatment-naive patients with CLL or NHL. MATERIALS AND METHODS: Via an online physician survey, 46 UK-registered hematologists and oncologists retrospectively reported on randomly selected patients aged ≥18 years with CLL or NHL with rituximab-abbs or rituximab as first-line immunotherapy. Overall, 201 patient charts were examined across 4 cohorts: rituximab-abbs in CLL, rituximab-abbs in NHL, rituximab in CLL, rituximab in NHL. RESULTS: Demographic profiles across cohorts were similar. Most patients (94 %-100 %) received combination therapy (rituximab-abbs or rituximab mainly with chemotherapy). For both treatments, overall response rate (94 %-98 %) and 1-year overall survival (98 %-100 %) were very high for patients with CLL or NHL. Most common serious adverse events were neutropenia, fatigue, anemia and infusion reactions. The majority of patients (54 %-66 %) did not experience a grade ≥3 adverse event. Healthcare resource utilization was similarly high across cohorts, driven by diagnostic testing, oncologist office visits, and day-case hospital admissions; many patients required supportive medical therapies. Mean annual savings of ∼£1000/patient driven by acquisition costs occurred with rituximab-abbs versus rituximab, administration costs were similar. CONCLUSION: Rituximab-abbs and rituximab demonstrated similar effectiveness and tolerability in treating CLL and NHL in routine UK clinical practice and demonstrate the utility of the biosimilar as a cost-saving alternative treatment.

Treatment patterns following initiation of generic glatiramer acetate among patients with multiple sclerosis from two large real-world databases in the United States.

INTRODUCTION: To better understand treatment patterns in US patients with multiple sclerosis (MS) initiating generic glatiramer acetate (GA), this study examined adherence, discontinuation and switching patterns from generic follow-on glatiramer acetate (FOGA) therapy in real-world patient cohorts. METHODS: Retrospective analyses utilized data from two large US databases (administrative claims and linked electronic medical records). Eligible adult MS patients had ≥1 pharmacy claim for FOGA during the identification period; the first FOGA claim was the index date. All analyses were descriptive; proportion of days covered (PDC) was calculated as a measure of adherence to FOGA during the follow-up period. RESULTS: The first cohort consisted of 95 patients, with 93.6% having a branded GA claim for Copaxone during the baseline period. Half these patients (48.4%) had high adherence to FOGA therapy (PDC: 0.8-1.0). Fifty-five patients (57.9%) initially discontinued FOGA with a mean persistence of 112 days. Of those who discontinued, 7.3% had no subsequent disease-modifying therapy (DMT), 30.9% restarted FOGA and 61.8% did not restart FOGA. The second cohort consisted of 1957 patients, with 63.8% having a branded GA claim for Copaxone during the baseline period and 33.5% were treatment naïve. The majority of patients (61.9%) had high adherence to FOGA therapy. A total of 1597 patients (81.6%) initially discontinued FOGA with a mean persistence of 93 days. Of those who discontinued, 55.8% switched to another DMT, 16.7% restarted FOGA and 37.5% had no subsequent DMT. CONCLUSION: Adherence to FOGA therapy was reasonably high across cohorts; however, most patients discontinued their initial FOGA within four months of the index date and most switches from FOGA were to branded GA products.

Clinical Outcomes and Health-Care Resource Use Associated With Reslizumab Treatment in Adults With Severe Eosinophilic Asthma in Real-World Practice.

BACKGROUND: Reslizumab, an anti-IL-5 monoclonal antibody, is indicated as add-on maintenance treatment for adults with severe eosinophilic asthma. RESEARCH QUESTION: What are the real-world outcomes associated with reslizumab use in patients with severe eosinophilic asthma in a US clinical practice? STUDY DESIGN AND METHODS: In this retrospective study, patient-level data from adults treated with reslizumab were obtained from center- and panel-based medical chart reviews. Eligible patients had available medical records and treatment history for ≥ 6 months before initiation of reslizumab treatment (index date) to ≥ 7 months after reslizumab initiation. The primary outcome was response to reslizumab treatment, based on clinical expert predefined definitions of response. Other outcomes included clinical asthma exacerbations (CAEs), use of maintenance oral corticosteroids (OCS), FEV1 percent predicted, Asthma Control Test (ACT) score, and health-care resource use (HRU). RESULTS: Medical charts were obtained for 215 patients. Most patients (58.6%) showed an excellent response, 16.3% showed a clinically meaningful response, 21.9% showed a partial response, and 3.3% were nonresponders or treatment failures. A significant reduction was observed in the proportion of patients experiencing a CAE in a 6-month period (from 86.0% to 40.5%; P < .001) and in the mean number of CAEs per patient (2.84 [SD, 2.41] vs 0.94 [SD, 1.86]) after reslizumab initiation. Improvements were observed in FEV1 percent predicted (65.1% [SD, 20.5%] vs 73.1% [SD, 23.1%]; P < .001) and in ACT scores (13.8 [SD, 4.2] vs 18.6 [SD, 4.0]; P < .001) before to after reslizumab initiation. Among patients using maintenance OCS at baseline, more than half discontinued use of these by approximately 10 months after reslizumab initiation. Significant reductions in asthma-related HRU were observed after reslizumab initiation. INTERPRETATION: In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Asthma control is associated with economic outcomes, work productivity and health-related quality of life in patients with asthma.

BACKGROUND: The objective of this analysis was to examine the association between asthma control (based on Asthma Control Test (ACT) responses) and healthcare resource utilisation (HRU), work productivity and health-related quality of life (HRQoL) among a nationwide sample of US adults with a self-reported diagnosis of asthma and without comorbid chronic obstructive pulmonary disease. METHODS: Data were obtained from the 2015 and 2016 self-administered, internet-based National Health and Wellness Surveys. Patients were grouped by ACT score (≤15: poorly controlled; 16-19: partly controlled; 20-25: well-controlled asthma). Study outcomes included HRU (patient-reported healthcare provider visits, emergency department visits and hospitalisations during the previous 6 months); work productivity, measured using the Work Productivity and Activity Impairment-General Health Scale; HRU-associated costs and work productivity loss and HRQoL, measured using EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) and the Short Form Health Survey-36V.2 (SF-36V.2). Incremental differences in outcomes between groups were assessed using generalised linear models adjusted for covariates. RESULTS: Of 7820 eligible adults, 17.4% had poorly controlled, 20.1% partly controlled and 62.5% well-controlled asthma. Well-controlled asthma was associated with significantly lower HRU (p<0.001) and lower mean direct costs ($6012 vs $8554 and $15 262, respectively; p<0.001); well-controlled asthma was also associated with significantly lower mean scores for work absenteeism, work presenteeism, overall work impairment and activity impairment (all p<0.001), and lower mean indirect costs ($6353 vs $10 448 and $14 764, respectively; p<0.001). Clinically meaningful differences favouring well-controlled asthma were seen for all HRQoL measures, with statistically significantly higher adjusted mean EQ-5D-5L index and SF-6D Health Utilities Index scores (derived from SF-36V.2) for patients with well-controlled asthma compared with partly controlled or poorly controlled asthma (p<0.001). CONCLUSIONS: The study demonstrates a clear relationship between asthma control and its impact on HRU, costs, work productivity and HRQoL. This will allow for better identification and management of patients with poorly controlled asthma.

Clinical and Economic Outcomes in Patients with Persistent Asthma Who Attain Healthcare Effectiveness and Data Information Set Measures.

BACKGROUND: Attainment of asthma-specific US Healthcare Effectiveness Data and Information Set (HEDIS) quality measures may be associated with improved clinical outcomes and reduced economic burden. OBJECTIVE: We examined the relationship between the attainment of HEDIS measures asthma medication ratio (AMR) and medication management for people with asthma (MMA) on clinical and economic outcomes. METHODS: This retrospective claims database analysis linked to ambulatory electronic medical records enrolled US patients aged ≥5 years with persistent asthma between May 2015 and April 2017. The attainment of AMR ≥0.5 and MMA ≥75% was determined over a 1-year premeasurement period. Asthma exacerbations and asthma-related health care costs were evaluated during the subsequent 12-month measurement period, comparing patients attaining 1 or both measures with those not attaining either. RESULTS: In total, 32,748 patients were included, 75.2% of whom attained AMR (n = 24,388) and/or MMA (n = 12,042) during the premeasurement period. Fewer attainers of 1 or more HEDIS measures had ≥1 asthma-related hospitalizations, emergency department visit, corticosteroid burst, or exacerbation (4.9% vs 7.3%; 9.6% vs 18.2%; 43.8% vs 51.6%; 14.3% vs 23.3%, respectively; all P < .001) compared with nonattainers. In adjusted analyses, HEDIS attainment was associated with a lower likelihood of exacerbations (odds ratio: 0.63, [95% confidence interval: 0.60-0.67]; P < .001). The attainment of ≥1 HEDIS measures lowered total and asthma-related costs, and asthma exacerbation-related health care costs per patient relative to nonattainers (cost ratio: 0.87, P < .001; 0.96, P = .02; and 0.59, P < .001, respectively). Overall and asthma-specific costs were lower for patients attaining AMR, but not MMA. CONCLUSIONS: HEDIS attainment was associated with significantly improved asthma outcomes and lower asthma-specific costs.

Psychometric validation of the overactive bladder satisfaction with treatment questionnaire (OAB-SAT-q).

AIMS: Valid and reliable questionnaires must be used to accurately assess patients' satisfaction with overactive bladder (OAB) treatment. This study evaluated the reliability and validity of the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q). METHODS: This was a secondary analysis of clinical study data of patients randomized to darifenacin or darifenacin plus Behavioral Modification Program. Patients completed the Overactive Bladder Questionnaire (OAB-q) and a 3-day bladder diary at Baseline and Week 12 and the OAB-SAT-q at Week 12. Internal consistency reliability was assessed by Cronbach's alpha. Concurrent validity was assessed through correlations with OAB-q change scores and adverse events (AEs). Discriminant validity was assessed among subgroups using general linear models. RESULTS: Analyses utilized a per-protocol population (completion of OAB-q at Baseline and OAB-q and OAB-SAT-q at Week 12) (n = 375). Exploratory factor analysis of the OAB-SAT-q revealed three 3-item subscales (Satisfaction, Side Effects, Endorsement) and two single items (Convenience, Preference). Cronbach's alphas = 0.84-0.95. Subscale-to-subscale correlations = 0.10-0.67 (all P < 0.01 except Side Effects and Convenience). The Side Effects subscale significantly correlated with number of treatment-related AEs (r = 0.27; P < 0.01) and discriminated between patients with/without dry mouth and patients with/without constipation. The Satisfaction and Endorsement subscales discriminated between patients who worsened or had no change in micturition frequency and urinary urgency and patients who had a reduction of >3 episodes (all P < 0.001). The OAB-SAT-q does not appear to discriminate by incontinence episodes. CONCLUSION: The OAB-SAT-q demonstrated good psychometric properties in this initial evaluation-including internal consistency reliability and concurrent and discriminant validity-and appears to be a useful assessment of OAB treatment satisfaction. Neurourol. Urodynam. 28:416-422, 2009. (c) 2008 Wiley-Liss, Inc.

Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study.

BACKGROUND AND AIMS: Overactive bladder (OAB), a chronic condition requiring long-term management, is associated with substantial impact on health-related quality of life (HRQoL). The short-term benefits of antimuscarinic drug treatment are well known. Here we investigate the impact on HRQoL of long-term treatment with the M(3)-selective muscarinic receptor antagonist darifenacin over 2 years. METHODS: HRQoL was assessed using the King's Health Questionnaire (KHQ) for patients with 'wet' OAB treated with darifenacin (7.5/15 mg once daily [o.d.]) in an open-label 2-year extension of two double-blind feeder studies. Data were also analyzed for the subset of patients who continued darifenacin 7.5/15 mg o.d. directly into the extension study from the feeder studies (the 'darifenacin continuation' group), and also older patients (>or=65 years) and men within this group. RESULTS: The total study population comprised 716 patients, of whom 303 patients formed the 'darifenacin continuation' group (including 85 patients >or=65 years and 41 men). Substantial impairment of HRQoL was noted in baseline KHQ assessments. KHQ scores improved significantly from feeder-study baseline to extension study end/last visit in eight of the nine domains, with more than 50% of patients reporting improvements in seven of the nine domains. Despite fewer patients, significant improvements in KHQ scores were also observed in the subsets of older patients (>or=65 years) and men. Almost two-thirds of the 'darifenacin continuation' group were either satisfied or extremely satisfied with treatment. CONCLUSIONS: Long-term darifenacin treatment was associated with significant and clinically meaningful improvements in HRQoL for patients with 'wet' OAB over 2 years.

Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan.

BACKGROUND: Pharmacotherapy constitutes an important adjunct to behavioral therapy for the treatment of overactive bladder (OAB). Tolterodine and oxybutynin are commonly prescribed drugs for OAB treatment that exert their beneficial effect by suppressing bladder muscle contractions. However, high discontinuation rates have been observed for these drugs in clinical trials, as well as in real-world settings, in part due to adverse effects. Extended-release (ER) formulations were introduced with an improved tolerability profile over immediate-release (IR) versions of the 2 drugs. No study has compared persistence and adherence to therapy for both the ER and IR versions of tolterodine and oxybutynin. OBJECTIVE: To compare persistence, adherence, and switch rates for the IR and ER formulations of oxybutynin and tolterodine for patients enrolled in a regional managed care plan. METHODS: Study patients were adults (aged e 18 years), with at least 1 pharmacy claim for either tolterodine extended-release (tol-ER), oxybutynin extended-release (oxy-ER), tolterodine immediate-release (tol-IR), or oxybutynin immediate-release (oxy-IR) during the period from July 1, 1999, to December 31, 2003, and were continuously eligible for benefits from 6 months before through 12 months after the initial OAB pharmacy claim (index) date. A retrospective cohort study design was used following patients from the index date to the occurrence of non-persistence with the index medication (i.e., a gap of > 45 days between successive prescription fills or a switch to any other OAB medication), or the end of a 1-year follow-up period, through December 31, 2004. Switching was defined as any change from the index medication, including a change in dose form (e.g., tol-IR to tol-ER), to one of the other 3 study drugs, or to a different OAB treatment (e.g., trospium chloride, oxybutynin patch, flavoxate, hyoscyamine sulfate, or propantheline bromide) during the follow-up period. Adherence was measured as the proportion of patients with a medication possession ratio (MPR) of at least 80%. MPR was calculated as (1) the sum of days supply for all pharmacy claims except the last pharmacy claim, divided by (2) the total number of days from the first fill date to the fill date of the last pharmacy claim. The association of drug therapy with study outcomes was assessed with bivariate and adjusted (multivariate) analyses. Multivariate analyses controlled for demographic and clinical characteristics, plan type, patient out-of-pocket cost for the index medication, and year of therapy initiation. RESULTS: 1,117 patients had at least 1 pharmacy claim for an OAB study drug (n = 454 for tol-ER [40.6%], n = 249 for oxy-ER [22.3%], n = 306 for tol-IR [27.4%], n = 108 for oxy-IR [9.7%]), of whom 81.6% were women. The mean (standard deviation [SD]) age of the study population was 55.7 (14.5) years. Only 53.7% had at least 1 OAB diagnosis recorded during the 18-month eligibility period. 44.5% of patients did not have a refill after the initial (index) pharmacy claim (39.4% for oxy-ER, 42.7% for tol-ER, 46.1% for tol-IR, and 59.3% for oxy-IR; P = 0.004). Only 13.2% persisted with treatment for at least 1 year (tol-ER = 15.0%, oxy-ER = 15.3%, tol-IR = 11.4%, oxy-IR = 6.5%; P = 0.050). The median days to discontinuation (non-persistency) were 31.0 overall, 33.0 for tol-ER, 34.0 for oxy-ER, 32.0 for tol-IR, and 0 for oxy-IR; P = 0.010. The overall switch rate as a percentage of all study patients was 13.3%, ranging from 9.9% for tol-ER, 13.7% for tol-IR, 16.5% for oxy-ER, and 19.4% for oxy-IR; P = 0.020. Of patients who refilled their initial prescription at least once, 24.0% made a medication switch. Adherence rates as measured by percentage of patients with MPR >or= 80% were 30.3% overall and higher for the ER formulations: 35.2% for tol-ER, 36.1% for oxy-ER, 23.5% for tol-IR, and 14.8% for oxy-IR; P < 0.001. CONCLUSIONS: Adherence was significantly better for ER than IR agents. The high rate of non-persistence (44.5%) following the first (index) prescription highlights the need for medication counseling by health care professionals.

Real-world health care utilization in asthma patients using albuterol sulfate inhalation aerosol (ProAir ® HFA) with and without integrated dose counters.

BACKGROUND: Accurate tracking of the administered dose of asthma rescue inhalers is critical for optimal disease management and is related to reductions in rates of unscheduled health care utilization in asthma patients. There are few published data on the real-world impact of rescue inhalers with integrated dose counters (IDCs) on health care resource utilization (HRU) for asthma patients. This study evaluates HRU among users of ProAir® hydrofluoroalkane (HFA) (albuterol sulfate inhalation aerosol), with IDC versus without IDC, in asthma patients. METHODS: This was a retrospective administrative claims study of asthma patients receiving a new prescription for albuterol inhalation aerosol without IDC during 2 years (January 2011-December 2012) or with IDC during the first full year after IDC implementation in the USA (July 2013-July 2014). Six months of continuous enrollment with medical and prescription drug benefits were required before and after the first prescription during the study period. Data on respiratory-related hospitalizations and emergency department (ED) visits were collected during the follow-up period. RESULTS: A total of 135,305 (32%) patients used albuterol inhalation aerosol with IDC, and 287,243 (68%) patients received albuterol inhalation aerosol without IDC. After adjusting for baseline confounding factors, the odds ratio (OR) for experiencing a respiratory-related hospitalization (OR=0.92; 95% confidence interval [CI] 0.88-0.96) or ED visit (OR=0.92; 95% CI 0.90-0.94) was significantly lower among patients using albuterol inhalation aerosol with IDC versus without IDC. CONCLUSION: In a real-world setting, asthma patients using ProAir HFA with IDC experienced significantly fewer hospitalizations and ED visits compared with patients using ProAir HFA without IDC. Dosage information provided by IDCs may allow providers to better understand patients' disease severity and aid in titrating controller medications and also decrease the likelihood that the canister will be empty when needed, thereby enhancing disease management and reducing HRU.

Health care resource utilization and costs associated with nonfatal major adverse cardiovascular events.

BACKGROUND: Risk of recurrent cardiovascular events following an initial cardiovascular-related hospitalization remains high despite available interventions. Rates of cardiovascular events as well as associated health care resource utilization and costs are needed to assess the value of treatments. OBJECTIVE: To quantify, in patients with previous hospitalization for acute coronary syndrome (ACS), rates of nonfatal major adverse cardiovascular events (MACE) and secondary coronary events (SCE), as well as health care utilization and costs associated with a first MACE. METHODS: Administrative data from a large population of commercial managed care and managed Medicare enrollees in the United States were retrospectively analyzed. Patients with an ACS-related hospitalization from 2006 to 2011 were followed for 12 months to assess subsequent MACE and SCE rates. Patients were aged ≥ 18 years at initial ACS hospitalization (the index episode) and had ≥ 12 months of continuous health plan enrollment before and after the end of the index episode. Resource utilization and costs during a first MACE were assessed. Multivariable analyses were used to assess the associations between cardiovascular risk factors and the occurrence of a MACE, as well as the costs incurred during a first MACE. RESULTS: Of 75,231 study patients identified, 3.3% had a MACE and 8.3% had an SCE during the 12-month follow-up. Median time to first MACE and SCE from end of the index episode was 4.6 and 3.7 months, respectively. Mean MACE-related cost incurred during the first MACE was $19,642. Logistic analyses showed that age and diabetes were associated with increased odds of a MACE, while index ACS episodes involving ST-elevation myocardial infarction were associated with reduced odds. Findings from generalized linear models indicated that statin use and age were associated with lower episode-related costs and that MACE occurrence within 3 months of ACS hospitalization was associated with increased episode-related costs. CONCLUSIONS: MACEs and SCEs represent a common and costly burden in the year following ACS hospitalization. Our findings may inform future economic assessments of new therapies aimed at prevention of MACEs and SCEs.

The burden of preserved ejection fraction heart failure in a real-world Swedish patient population.

OBJECTIVES: To evaluate resource use and associated costs in patients with a diagnosis of heart failure with preserved ejection fraction (HF-PEF) in Sweden. METHODS: This retrospective study identified real-world patients with an ICD-10 diagnosis code for heart failure (I50) for the period between July 1, 2005 and December 31, 2006 from electronic medical records of primary care centers in Uppsala County Council, and in the Swedish patient registry data. Patients were categorized as having HF-PEF (left ventricle ejection fraction [LVEF] > 50%) during the index period. The study assessed medication utilization, outpatient visits, hospitalizations, and associated healthcare costs, as well as the incidence rates and time to all-cause and heart failure mortality following the index period. RESULTS: The study included 137 HF-PEF patients with a mean age of 77.1 (SD = 9.1) years. Over 50% of HF-PEF patients were female and hypertensive. Nearly all patients received ≥ 1 medication post-index. Patients had an average of 1.5 heart failure related hospitalizations per follow-up year. The average annual per patient cost for the management of a HF-PEF patient was found in Sweden to be Swedish Krona (SEK) 108,246 (EURO [EUR] 11,344). Hospitalizations contributed to more than 80% of the total cost. All-cause mortality over the 18-month study period was 25.5%, and more than 50% of these deaths occurred within 1 year of index. LIMITATIONS: Due to the limitations of registry data, it is not possible to confirm the HF diagnosis, and therefore the accuracy of registry records must be assumed. Other factors such as short follow-up time, the study-mandated LVEF assessment, and a lack of drug duration data may also have an impact on the study results. CONCLUSIONS: All-cause mortality was high in the HF-PEF population, with more than half of patients dying within 1 year of study follow-up. Study results also indicate that 60% of HF-PEF patients have ≥ 1 hospitalization during follow-up. Hospitalizations, especially heart failure related admissions, represent a substantial proportion of the total healthcare burden of patients with HF-PEF in Sweden.

Heart failure in China: a review of the literature.

Heart failure (HF) is a serious disease associated with high morbidity and mortality. In China, as in other countries, it is a common cause for hospital admission; however, as yet there are few data documenting the epidemiology and management of HF in China, or quality of life-related considerations in this population. This review aims to identify relevant Chinese and English language publications that discuss the causes, risks, treatment, and health outcomes (costs, health-related quality of life) of HF in China (excluding Taiwan and Hong Kong). The prevalence of HF in China appears to be lower than that reported in many Western countries, including the US. Hypertension and coronary heart disease are the leading causes of HF in China, as they are in many Western nations, potentially highlighting the improvement in socioeconomic conditions in China. Evidence suggests that use of newer pharmacological agents for the treatment of HF is increasing; however, it is still believed that there is a lack of physician knowledge regarding newer, more effective treatment options, with rural (poor) areas appearing to be the most reliant on older, less expensive, medications. Interest in Chinese quality of life measures for HF has risen recently, with the development of valid and reliable rating scales in the Chinese population. Although the amount of available literature on HF in China is improving, there remain significant gaps in our understanding of the issue, and further research is needed to provide a reliable Chinese evidence base for the improvement of clinical practice.

Resource utilization and cost of heart failure associated with reduced ejection fraction in Swedish patients.

AIM: The purpose of this study was to assess healthcare utilization and costs for heart failure patients with reduced ejection fraction (HF-REF) in Sweden. METHODS AND RESULTS: This was a retrospective, population-based cohort study of patients diagnosed with HF-REF during a period of 18 months at 31 primary care centers in Uppsala County, Sweden. Data was obtained from computerized records from these centers, the Swedish Patient Registry, the Swedish Prescription Registry, the Cause of Death Registry, and a local echocardiography registry maintained by the Department of Physiology, Uppsala University Hospital. Main outcome measures were cardiovascular and heart-failure-related hospitalizations, outpatient visits, medication utilization, mortality (all-cause, cardiovascular, and heart-failure), and healthcare costs for HF-REF patients. During the index period, 252 heart failure patients had a left ventricular ejection fraction measurement ≤ 40% and were categorized as having HF-REF. More than half of the patients had ≥ 1 cardiovascular or heart failure-related hospitalization. On average, patients had >2 such hospitalizations annually. They also averaged ∼1 cardiovascular or heart-failure-related outpatient visit per year. All-cause mortality was high: 15.9% patients died within 1 year after the index date. The mean annual cost per patient for heart-failure-related hospitalizations was SEK 72,613 (EUR 7610). In contrast, annual prescription costs were low, on average 3% of total cost (SEK 3503, EUR 367 per patient) LIMITATIONS: The main limitations of this study include a short follow-up time and small sample size. Also, certain data were missing, such as echocardiograms (available for only 28% of patients), and information on patients' New York Heart Association (NYHA) functional class, validity period for prescriptions or the units of medication prescribed, and medication dosing. Furthermore, the overall mortality could have been under-estimated, as only the primary cause of death was included in the analysis. CONCLUSIONS: The main burden associated with HF-REF is related to hospitalizations for heart-failure events. Effective treatment options that decrease hospitalization rates could reduce patients' suffering and potentially offer considerable cost savings.

Health insurance, access to prescription medicines and health outcomes in children.

Ensuring optimal access to medications has received increasing attention as healthcare systems struggle with increasing costs. Although this has been studied extensively in adults, there has been little investigation in pediatric populations, which have different healthcare needs. A literature review was conducted to examine the evidence regarding the relationship between insurance-mediated access to prescription medicines and outcomes in children. In total, 12 studies were classified according to uninsured versus insured, type of insurance provider and impact of family income. The studies demonstrated that insurance coverage and low-cost sharing are both essential to facilitate access to medications. Increased access was consistently observed for insured compared with uninsured children. Access to prescription drugs frequently differed by type of health provider organization. Adequate family income was an important determinant of access to and receipt of prescriptions. Moreover, income-indexed insurance coverage may increase unmet need. Compared with the literature on access to prescription medicines and health outcomes in adults, there have been few studies in children. Further research relating pharmaceutical policies to pediatric health outcomes is needed to strengthen the quality of policy decision making regarding access to prescription medicines for children.