Clinical characteristics,pharmacotherapy, and healthcare resource use among patients with fibromyalgia newly prescribed pregabalin or tricyclic antidepressants

Abstract

Objective:

To examine treatment patterns and costs among patients with fibromyalgia prescribed pregabalin or tricyclic antidepressants (TCAs).

Methods:

Using the LifeLink? Health Plan Claims Database, patients with fibromyalgia (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) newly prescribed (index date) TCAs (n?=?898) were identified and propensity score-matched (PSM) with patients newly prescribed pregabalin (n?=?898). Pain-related pharmacotherapy, comorbidities, and healthcare resource use/costs were examined during the 12 months, pre-index, and follow-up periods.

Results:

Both patient groups reported multiple comorbidities and received pain medications in the pre-index and follow-up periods. Among patients prescribed pregabalin, use of non-selective non-steroidal anti-inflammatory drugs (43.3% vs 39.8%), other anticonvulsants (28.6% vs 23.3%), and tetracyclic/miscellaneous antidepressants (28.5% vs 25.8%) significantly decreased, and cyclooxygenase 2 (COX-2) inhibitors (7.7% vs 10.4%), TCAs (4.8% vs 7.9%), and topical agents (10.8% vs 15.1%) increased in the follow-up period (p?<?0.05). Among patients prescribed TCAs, there were significant decreases in muscle relaxants (42.0% vs 38.4%) and sedative hypnotics (27.4% vs 23.9%), and increases in COX-2 inhibitors (5.8% vs 7.9%) and anticonvulsants (25.1% vs 33.7%; p?<?0.05). There were increases (p?<?0.0001) in pharmacy costs in both cohorts and total healthcare costs in the pregabalin cohort from pre-index to follow-up. Median total costs were higher (p?<?0.05) in the pregabalin group vs TCAs in the pre-index ($9935 vs $8771) and follow-up ($10,689 vs $8379) periods.

Limitations:

Despite attempts to address bias through PSM, the higher pre-index costs in the pregabalin cohort suggest a channeling of patients with more severe fibromyalgia to pregabalin.

Conclusions:

Patients with fibromyalgia prescribed pregabalin or TCAs had multiple comorbidities and a sizeable pain medication burden, which increased in the follow-up period for both cohorts. Only 5% of pregabalin initiators had been treated with concomitant TCAs at baseline, suggesting that TCAs were inappropriate for these patients owing to their contraindications.     

Utilization and cost comparison of erythropoiesis-stimulating agents in inpatient and outpatient hospital settings

Abstract

Objective:

To compare utilization and associated costs of epoetin alfa (EPO) and darbepoetin alfa (DARB), two erythropoiesis-stimulating agents (ESAs), in patients with cancer undergoing chemotherapy and patients with chronic kidney disease (CKD) not on dialysis in inpatient and outpatient hospital settings.

Methods:

An analysis of medical claims recorded between January 2006 and December 2009 was conducted using the Premier Perspective Comparative Hospital database. Patients included were ≥18 years old with cancer and chemotherapy or with pre-dialysis CKD and with ≥1 claim for EPO or DARB during a hospital inpatient or outpatient treatment episode. Patients treated with both ESAs or who were receiving dialysis were excluded. Mean cumulative drug costs and dose ratios (units EPO: mcg DARB) were calculated using cumulative dose and April 2010 wholesale acquisition costs.

Results:

Cancer chemotherapy: 13,832 inpatient stays (EPO: 10,454; DARB: 3378) and 5590 outpatient treatment episodes (EPO: 2856; DARB: 2734) were identified. The inpatient and outpatient populations reported ESA dose ratios of 230:1 and 238:1 with DARB cost premiums of 42% (EPO: $948; DARB: $1348) and 38% (EPO: $3358; DARB: $4627), respectively. CKD: 148,746 hospital stays (EPO: 116,017; DARB: 32,729) and 11,012 outpatient treatment episodes (EPO: 6921; DARB 4091) were identified. The inpatient and outpatient populations reported ESA dose ratios of 251:1 and 257:1 with DARB cost premiums of 30% (EPO: $566; DARB: $738) and 27% (EPO: $2077; DARB: $2642), respectively.

Limitations:

The lack of randomization may have led to confounding by indication. In addition, statistical significance must be interpreted with caution in studies involving large samples.

Conclusions:

This study of 19,422 patients with cancer receiving chemotherapy and 159,758 patients with pre-dialysis CKD reported ESA dose ratios ranging from 230:1–257:1 (units EPO: mcg DARB) and associated cost premiums of 27–42% for DARB.     

Burden of breast cancer with brain metastasis: a French national hospital database analysis

Abstract

Objective:

Incidence of breast cancer with brain metastases (BCBM) is increasing, especially among patients over-expressing HER2. Epidemiology on this sub-type of cancer is scarce, since cancer registries carry no information on the HER2 status. A retrospective database analysis was conducted to estimate the burden of BCBM, especially among HER2-positive patients in a secondary objective.

Methods:

Patients with a new diagnosis of BCBM carried out between January and December 2008 were identified from the national hospital database using the International Disease Classification. Patients receiving a targeted anti-HER2 therapy were identified from the national pharmacy database. Hospital and pharmacy claims were linked to estimate the burden of HER2-positive patients. Data on hospitalizations were extracted to describe treatment patterns and healthcare costs during a 1-year follow-up. Predictors of treatment cost were analyzed through multi-linear regression analysis.

Results:

Two thousand and ninety-nine BCBM patients were identified (mean age (SD)?=?57.8 (13.6)), of whom 12.2% received a targeted anti-HER2 therapy; 79% of patients had brain metastases associated with extracranial metastases, and the attrition rate reached 82%. Patients received mostly palliative care (47.4%), general medical care (40.6%), and chemotherapy (35.0%). The total annual hospital cost of treatment was 8,426,392€, representing a mean cost of 22,591€ (±14,726) per patient, mainly influenced by extracranial metastases, surgical acts, and HER2-overexpression (p?<?0.0001).

Conclusions:

The database linkage of hospital and pharmacy claims is a relevant approach to identify sub-type of cancer. Chemotherapy was widely used as a systemic treatment for breast cancer rather than for local treatment of brain metastases whose morbi-mortality remains high. The variability of treatment costs suggests clinical heterogeneity and, thus, extensive individualization of protocols.     

Derivation of severity index for rheumatoid arthritis and its association with healthcare outcomes

Abstract

Objectives:

To develop a claims-based severity index for rheumatoid arthritis (RA) using the Veterans Health Administration (VHA) database.

Methods:

Adult patients with at least two RA diagnoses 2 months apart were identified between 10/1/2008–09/30/2009. Patients were required to have at least 12 months continuous health plan enrollment before and after the index date (first RA diagnosis date) for an overall study period of 10/1/2007–09/30/2010. A severity index for rheumatoid arthritis (SIFRA, a proprietary algorithm of SIMR, Inc. [STATinMED Research]) was developed by calculating a weighted sum of 34 RA-related indicators assessed by an expert Delphi panel of six rheumatologists, including laboratory, clinical, and functional status, extra-articular manifestations, surgical history, and medications, during a 1-year pre-index period. Separate SIFRA versions were derived for patients with and without laboratory information. Correlations between SIFRA and previously validated claims-based indexes for RA severity (CIRAS), and other traditional comorbidity indexes were calculated during the pre-index period. The relationship between SIFRA and follow-up healthcare outcomes was also examined using histograms.

Results:

The Spearman’s rank correlations between SIFRA and CIRAS were 0.525 for SIFRA without and 0.539 with laboratory data. The correlations between SIFRA and the Charlson Comorbidity Index (CCI) (0.1503 without, 0.1135 with laboratory data), Elixhauser Index (ELIX) (0.105 without, 0.079 with laboratory data), and Chronic Disease Score (CDS) (0.255 without, 0.239 with laboratory data) were low. Histograms showed that patients in the upper tercile of SIFRA incurred $9123 more all-cause and $1326 more RA-related healthcare costs during the 1-year post-index period than patients in the lower tercile. Using SIFRA in combination with CCI, CDS, or ELIX significantly increased the percentage of variation explained in outcomes measures.

Limitations:

Patients in the VHA database may not represent typical RA patients since the database generally contains older, economically disadvantaged men with a high disease burden. Validity of the score is indirectly based on disease activity score 28 (DAS28), which measures disease activity rather than severity.

Conclusions:

SIFRA was found to have moderate correlations with the previously validated CIRAS score, and demonstrated evidence of being a significant determinant of total and RA-related healthcare costs for RA patients. This study suggests that SIFRA could be an important methodological tool to control for severity in RA-related outcomes research. The algorithm can be applied to any claims dataset.     

Initial treatment failure in non-ICU community-acquired pneumonia: risk factors and association with length of stay,total hospital charges,and mortality

Abstract

Objectives:

To identify risk factors for initial treatment failure in patients with community-acquired pneumonia (CAP) in non-intensive care unit (non-ICU) settings, and to characterize the association between initial treatment failure and length of stay, total hospital charges, and mortality.

Methods:

Retrospective cohort study. Using data from >100 US hospitals, this study identified all adults (age ≥18 years) hospitalized for pneumonia between January 1, 2000 and June 30, 2009 who began antibiotic therapy within 24?h of admission and were treated for at least 48?h if alive; patients admitted to intensive care within the first 24?h in hospital were excluded. Initial therapy was defined as all parenteral antibiotics administered within the first 24?h in hospital. Treatment failure was assessed based on subsequent receipt of new antibiotic(s), excluding agents of similar/narrower spectrum and those begun at discharge. Multivariate logistic regression was used to identify risk factors for treatment failure, and multivariate linear and logistic regression to compare length of stay, total hospital charges, and in-hospital mortality between patients experiencing initial treatment failure and those who did not.

Results:

Among 32,324 patients with non-ICU CAP, 4695 (14.6%) experienced initial treatment failure, most often within 72?h of hospital admission. Significant predictors of initial treatment failure included malnourishment (OR?=?1.87; 95% CI?=?1.60–2.18), receipt of vasoactive medications within 24?h of admission (1.51 [1.17–1.94]), and renal failure (1.45 [1.32–1.59]). Treatment failure was associated with higher case fatality (8.5% vs 3.3%), longer hospital stays (mean [SD]?=?10.1 [8.1] days vs 4.9 [3.3] days), and higher total hospital charges ($37,602 [$71,876] vs $14,371 [$21,633]) (all comparisons, p?<?0.01). Study limitations include possible inclusion of patients with healthcare-associated pneumonia (HCAP) in the study sample, our focus on the 40 most commonly used antibiotic regimens, and indirect measurement of treatment failure.

Conclusions:

Approximately one in seven non-ICU CAP patients experience failure of initial antibiotic therapy. Risk of failure is higher for patients with significant comorbidities and/or severe infections. Non-ICU patients who experience initial treatment failure have significantly longer hospital stays, higher total hospital charges, and higher rates of mortality.     

Treatment and Control Groups in a Dynamic Setting

The paper considers a version of the question of how to define treatment and control groups in a dynamic setting where treatments can occur at any time (but only once). The version considered pre‐supposes that treatments as well as outcomes can be conceptualised as events occurring in temporal locations of a discrete time axis. It is proposed to think of effects as being dependent on both the time when and the time since the treatment occurred. The paper develops corresponding definitions of treatment and control groups, and proposes a notion of ‘comprehensive treatment effect’ that takes into account how treatment and control groups are generated. Based on this notion, the paper discusses causal interpretations that do not pre‐suppose a potential outcomes framework.     

医药分开改革的政策效果——基于医疗保险报销数据的经验分析

2015年开始,按照国务院对公立医院改革的政策要求,公立医院改革试点城市全部取消药品加成,实施医药分开改革。本文基于某省会城市医疗保险报销数据,采用双重差分模型,估计了医药分开改革对医疗费用支出水平和支出结构的影响,为评估医药分开改革的政策效果提供了及时的和严谨的经验证据。实证分析显示,从支出水平看,医药分开改革使患者住院费用总支出显著增加了4.9%,但是由于病人自付比例同时出现了显著下降,自付金额没有显著地上涨;从支出结构看,医药分开改革使患者药费支出显著下降了9.5%,但是护理费和治疗费支出显著增加了69.7%和53.4%。医药分开改革还导致患者在短时期内的就诊次数出现了显著增加。总结而言,公立医院医药分开改革改善了公立医院收入结构,但是没有起到降低医疗费用支出的效果,也没有显著降低病人医疗成本负担。     

A note on variance estimation for the Oaxaca estimator of average treatment effects

We derive the limiting distribution of the Oaxaca estimator of average treatment effects studied by Kline (2011). A consistent estimator of the asymptotic variance is proposed that makes use of standard regression routines. It is shown that ignoring uncertainty in group means will tend to lead to an overstatement of the asymptotic standard errors. Monte Carlo experiments examine the finite sample performance of competing approaches to inference.     

乙肝肝硬化失代偿期治疗方案的成本效果分析

目的对乙肝肝硬化失代偿期治疗方案的成本效果进行探讨与分析。方法抽取我院于2010年4月～2013年4月诊治的88例乙肝肝硬化失代偿期患者,依照随机抽签的方式将患者分成甲、乙、丙、丁四组,每组22例,利用拉米夫定治疗甲组,利用阿德福韦酯治疗乙组,利用拉米夫定+阿德福韦酯联合治疗丙组,利用恩替卡韦治疗丁组,对各组的治疗成本效果进行观察和分析。结果在ALT复常率上,甲、乙、丙、丁四组分别为50.0%、45.5%、72.7%和63.6%;在HBV-DNA转阴率上,甲、乙、丙、丁四组分别为45.5%、40.9%、77.3%和72.7%;在ALT复常率成本效果上,甲组为34463、乙组为41028、丙组为44972、丁组为42020;在HBV-DNA转阴率成本效果上,甲组为36667、乙组为43854、丙组为37540、丁组为38988。结论在治疗乙肝肝硬化失代偿期中,拉米夫定+阿德福韦酯联合治疗方案可作为首选方案。     

Does a cassava research-for-development program have impact at the farm level? Evidence from the Democratic Republic of Congo

This paper evaluates the impact of a cassava research-for-development program on farm level outcomes. The program was implemented in the Democratic Republic of Congo from 2001 to 2009. We apply propensity score matching, Rosenbaum bounds on treatment effects, Altonji et al. method of selection on observables and unobservables and endogenous switching regression to farm survey data collected during the 2009 cropping season. We use these methods to test whether the R4D program has a statistically significant effect on outcomes of interest and if these are not driven by selection on unobservables. Using propensity score matching, we find statistically significant positive effects on household participation in cassava markets, adoption of improved varieties and crop management practices and household food adequacy; and no statistically significant effects on yields and profits. The results show that bias due to selection on unobservables is not severe enough to invalidate the impact estimates. Bias may still be a problem that is present in the analysis. But there is evidence that it is not substantial. Although the program does not have a statistically significant positive effect on yields and profits, the significant program effects on market participation, variety adoption, and food adequacy merit further promotion of the program since these positive outcomes tend to be pre-conditions for realizing long-term yield and profit benefits.