Observational study on the impact of initiating tiotropium alone versus tiotropium with fluticasone propionate/salmeterol combination therapy on outcomes and costs in chronic obstructive pulmonary disease.

BACKGROUND: This retrospective cohort study compared the risks of exacerbations and COPD-related healthcare costs between patients with chronic obstructive pulmonary disease (COPD) initiating tiotropium (TIO) alone and patients initiating triple therapy with fluticasone-salmeterol combination (FSC) added to TIO. METHODS: Managed-care enrollees who had an index event of ≥ 1 pharmacy claim for TIO during the study period (January 1, 2003-April 30, 2008) and met other eligibility criteria were categorized into one of two cohorts depending on their medication use. Patients in the TIO+FSC cohort had combination therapy with TIO and FSC, defined as having an FSC claim on the same date as the TIO claim. Patients in the TIO cohort had no such FSC use. The risks of COPD exacerbations and healthcare costs were compared between cohorts during 1 year of follow-up. RESULTS: The sample comprised 3333 patients (n = 852 TIO+FSC cohort, n = 2481 TIO cohort). Triple therapy with FSC added to TIO compared with TIO monotherapy was associated with significant reductions in the adjusted risks of moderate exacerbation (hazard ratio 0.772; 95% confidence interval [CI] 0.641, 0.930) and any exacerbation (hazard ratio 0.763; 95% CI 0.646, 0.949) and a nonsignificant reduction in COPD-related adjusted monthly medical costs. CONCLUSIONS: Triple therapy with FSC added to TIO compared with TIO monotherapy was associated with significant reductions in the adjusted risks of moderate exacerbation and any exacerbation over a follow-up period of up to 1 year. These improvements were gained with triple therapy at roughly equal cost of that of TIO alone.

Assessing asthma severity based on claims data: a systematic review.

INTRODUCTION: Asthma is one of the most common chronic diseases in Germany. Substantial economic evaluation of asthma cost requires knowledge of asthma severity, which is in general not part of claims data. Algorithms need to be defined to use this data source. AIMS AND OBJECTIVES: The aim of this study was to systematically review the international literature to identify algorithms for the stratification of asthma patients according to disease severity based on available information in claims data. METHODS: A systematic literature review was conducted in September 2015 using the DIMDI SmartSearch, a meta search engine including several databases with a national and international scope, e.g. BIOSIS, MEDLINE, and EMBASE. Claims data based studies that categorize asthma patients according to their disease severity were identified. RESULTS: The systematic research yielded 54 publications assessing asthma severity based on claims data. Thirty-nine studies used a standardized algorithm such as HEDIS, Leidy, the GINA based approach or CACQ. Sixteen publications applied a variety of different criteria for the severity categorisation such as asthma diagnoses, asthma-related drug prescriptions, emergency department visits, and hospitalisations. CONCLUSION: There is no best practice method for the categorisation of asthma severity with claims data. Rather, a combination of algorithms seems to be a pragmatic approach. A transfer to the German context is not entirely possible without considering particular conditions associated with German claims data.

Non-persistence and non-adherence to long-acting COPD medication therapy: A retrospective cohort study based on a large German claims dataset.

OBJECTIVES: The main objectives of this study, based on a large cohort of German COPD patients, were to assess the level of non-persistence (NP) and non-adherence (NA) with long-acting COPD inhaler treatment and to describe factors that may be associated with NP and NA. METHODS: This was a retrospective cohort analysis based on claims data provided by a German statutory health insurance fund (years 2010-2012). NP was analyzed for treatment-naïve patients only; it was defined as a gap of >90 days in medication availability. With regard to NA, first the overall yearly medication possession ratio (MPR) was analyzed, NA was defined as MPR<80%. Secondly, adherence was explored only for the period in which a patient continued therapy with a long-acting COPD agent (no gap>90 days). RESULTS: 45,937 COPD patients who received at least one prescription of any long-acting COPD agent were identified (mean age 71.4 years; 45.2% female). Among these, 22,276 (42.4%) were classified as newly treated. The percentage of NP patients after 12 months was 65.3% on an overall patient level. Agent-specific NP rates were: 58.5% for LABA, 47.9% for LAMA, 78.0% for ICS, and 69.4% for single-device LABA/ICS combination treatment. The overall 12-month MPR across all agent classes on a patient level was 57.9% (70.0% of patients classified as non-adherent). During periods of general treatment continuation, the mean MPR/NA rates were 85.0%/30.1% (patient level across all agents), 89.3%/28.2% (LABA), 92.1%/16.2% (LAMA), 84.2%/43.8% (ICS) and 84.1%/42.8% (LABA/ICS combination). In the Cox regression analyses, several factors like female gender, higher CCI or lower number of specialist' visits were associated with earlier discontinuation of therapy. In comparison to LABA therapy, LAMA therapy was less likely to be associated with early NP, whereas patients who initiated ICS therapy or a single-device LABA/ICS combination therapy faced a higher NP risk. CONCLUSIONS: In German COPD patients, persistence and adherence with respect to long-acting bronchodilator therapy is poor. Approximately two thirds of patients fail to continue treatment after 12 months. In addition, about one third implement their treatment poorly during periods of general therapy continuation.

Healthcare costs and resource utilization of asthma in Germany: a claims data analysis.

INTRODUCTION: Asthma is associated with a substantial economic burden on the German Statutory Health Insurance. AIMS AND OBJECTIVES: To determine costs and resource utilization associated with asthma and to analyze the impact of disease severity on subgroups based on age and gender. METHODS: A claims database analysis from the statutory health insurance perspective was conducted. Patients with an ICD-10-GM code of asthma were extracted from a 10% sample of a large German sickness fund. Five controls for each asthma patient matched by age and gender were randomly selected from the same database. Costs and resource utilization were calculated for each individual in the asthma and control group. Incremental asthma-related costs were calculated as the mean cost difference. Based on prescribed asthma medication, patients were classified as intermittent or persistent. In addition, age groups of ≤ 5, 6-18, and >18 years were analyzed separately and gender differences were investigated. RESULTS: Overall, 49,668 individuals were included in the asthma group. On average, total annual costs per patient were €753 higher (p = 0.000) compared to the control group (€2,168 vs. €1,415). Asthma patients had significantly higher (p = 0.000) outpatient (€217), inpatient (€176), and pharmacy costs (€259). Incremental asthma-related total costs were higher for patients with persistent asthma compared to patients with intermittent asthma (€1,091 vs. €408). Women aged >18 years with persistent asthma had the highest difference in costs compared to their controls (€1,207; p < 0.0001). Corresponding healthcare resource utilization was significantly higher in the asthma group (p = 0.000). CONCLUSIONS: The treatment of asthma is associated with an increased level of healthcare resource utilization and significantly higher healthcare costs. Asthma imposes a substantial economic burden on sickness funds.

Healthcare utilization and costs of systemic lupus erythematosus in Medicaid.

Objective. Healthcare utilization and costs associated with systemic lupus erythematosus (SLE) in a US Medicaid population were examined. Methods. Patients ≥ 18 years old with SLE diagnosis (ICD-9-CM 710.0x) were extracted from a large Medicaid database 2002-2009. Index date was date of the first SLE diagnosis. Patients with and without SLE were matched. All patients had a variable length of followup with a minimum of 12 months. Annualized healthcare utilization and costs associated with SLE and costs of SLE flares were assessed during the followup period. Multivariate regressions were conducted to estimate incremental healthcare utilization and costs associated with SLE. Results. A total of 14,777 SLE patients met the study criteria, and 14,262 were matched to non-SLE patients. SLE patients had significantly higher healthcare utilization per year than their matched controls. The estimated incremental annual cost associated with SLE was $10,984, with the highest increase in inpatient costs (P < 0.001). Cost per flare was $11,716 for severe flares, $562 for moderate flares, and $129 for mild flares. Annual total costs for patients with severe flares were $49,754. Conclusions. SLE patients had significantly higher healthcare resource utilization and costs than non-SLE patients. Patients with severe flares had the highest costs.

Cumulative burden of oral corticosteroid adverse effects and the economic implications of corticosteroid use in patients with systemic lupus erythematosus.

BACKGROUND: Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population. OBJECTIVE: To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE. METHODS: In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged ≥18 years having ≥2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or ≥1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts. RESULTS: Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers. CONCLUSIONS: Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.