Pivoting to Childbirth at Home or in Freestanding Birth Centers in the US During COVID-19: Safety, Economics and Logistics.

Birth-related decisions principally center on safety; giving birth during a pandemic brings safety challenges to a new level, especially when choosing the birth setting. Amid the COVID-19 crisis, the concurrent work furloughs, business failures, and mounting public and private debt have made prudent expenditures an inescapable second concern. This article examines the intersections of safety, economic efficiency, insurance, liability and birthing persons' needs that have become critical as the pandemic has ravaged bodies and economies around the world. Those interests, and the challenges and solutions discussed in this article, remain important even in less troubled times. Our economic analysis suggests that having an additional 10% of deliveries take place in private homes or freestanding birth centers could save almost $11 billion per year in the United States without compromising safety.

Metropolitan Reclassification and the Urbanization of Rural America.

We highlight the paradoxical implications of decadal reclassification of U.S. counties (and America's population) from nonmetropolitan to metropolitan status between 1960 and 2017. Using data from the U.S. Census Bureau, we show that the reclassification of U.S. counties has been a significant engine of metropolitan growth and nonmetropolitan decline. Over the study period, 753-or nearly 25% of all nonmetropolitan counties-were redefined by the Office of Management and Budget (OMB) as metropolitan, shifting nearly 70 million residents from nonmetropolitan to metropolitan America by 2017. All the growth since 1970 in the metropolitan share of the U.S. population came from reclassification rather than endogenous growth in existing metropolitan areas. Reclassification of nonmetropolitan counties also had implications for drawing appropriate inferences about rural poverty, population aging, education, and economic growth. The paradox is that these many nonmetropolitan "winners"-those experiencing population and economic growth-have, over successive decades, left behind many nonmetropolitan counties with limited prospects for growth. Our study provides cautionary lessons regarding the commonplace narrative of widespread rural decline and economic malaise but also highlights the interdependent demographic fates of metropolitan and nonmetropolitan counties.

Education and gastric cancer risk-An individual participant data meta-analysis in the StoP project consortium.

Low socioeconomic position (SEP) is a strong risk factor for incidence and premature mortality from several cancers. Our study aimed at quantifying the association between SEP and gastric cancer (GC) risk through an individual participant data meta-analysis within the "Stomach cancer Pooling (StoP) Project". Educational level and household income were used as proxies for the SEP. We estimated pooled odds ratios (ORs) and the corresponding 95% confidence intervals (CIs) across levels of education and household income by pooling study-specific ORs through random-effects meta-analytic models. The relative index of inequality (RII) was also computed. A total of 9,773 GC cases and 24,373 controls from 25 studies from Europe, Asia and America were included. The pooled OR for the highest compared to the lowest level of education was 0.60 (95% CI, 0.44-0.84), while the pooled RII was 0.45 (95% CI, 0.29-0.69). A strong inverse association was observed both for noncardia (OR 0.39, 95% CI, 0.22-0.70) and cardia GC (OR 0.47, 95% CI, 0.22-0.99). The relation was stronger among H. pylori negative subjects (RII 0.14, 95% CI, 0.04-0.48) as compared to H. pylori positive ones (RII 0.29, 95% CI, 0.10-0.84), in the absence of a significant interaction (p = 0.28). The highest household income category showed a pooled OR of 0.65 (95% CI, 0.48-0.89), while the corresponding RII was 0.40 (95% CI, 0.22-0.72). Our collaborative pooled-analysis showed a strong inverse relationship between SEP indicators and GC risk. Our data call for public health interventions to reduce GC risk among the more vulnerable groups of the population.

A Summary of Preclinical Poster Presentations at the Sixth Biennial Pediatric Anesthesia Neurodevelopment Assessment (PANDA) Symposium.

The potential for long-term neurotoxic effects of anesthetics on the developing human brain has led to intensified research in this area. To date, the human evidence has been inconclusive, but a large body of animal evidence continues to demonstrate cause for concern. On April 14 and 15, 2018 the sixth biennial Pediatric Anesthesia and Neurodevelopmental Assessment (PANDA) study symposium was held at Morgan Stanley Children's Hospital of New York. This symposium brought together clinicians and researchers and served as a platform to review preclinical and clinical data related to anesthesia and neurotoxicity in developing brains. The program participants included many active investigators in the field of anesthesia neurotoxicity as well as stakeholders from different backgrounds with the common interest of potential anesthetic neurotoxicity in children. The moderated poster session included presentations of preclinical animal research studies. These studies focused on defining the anesthetic-induced neurotoxicity phenotype, understanding the mechanism of injury and discovering potential inhibitors of neurotoxic effects.

Microperimetry and swept-source optical coherence tomography in the assessment of the preferred retinal locus in a child with macular retinoblastoma in the remaining eye.

Assessing the visual capabilities that remain to children affected with bilateral retinoblastoma has relied on psychophysical tests based on recognition visual acuity. We report a case in which fundus-driven perimetry and swept-source optical coherence tomography was performed in a patient with a macular tumor in the remaining eye as a novel way of further assessing fixation after oncological disease and treatment.

Primary enucleation for group D retinoblastoma in the era of systemic and targeted chemotherapy: the price of retaining an eye.

BACKGROUND: Chemotherapy is increasingly used as primary treatment for group D retinoblastoma, whereas primary enucleation is considered to have a diminishing role. This study aimed to compare the management course, including number of examinations under anaesthesia (EUAs), of group D patients treated by enucleation versus chemotherapy. METHODS: A retrospective analysis of 92 group D patients, of which 40 (37 unilateral) underwent primary enucleation and 52 (17 unilateral) were treated with intravenous chemotherapy. Number of EUAs was compared between the treatment groups with respect to the whole cohort, using univariate and multivariate analysis, and to unilateral cases only. RESULTS: Patients were followed up for a median of 61 months (mean: 66, range: 14-156), in which time primary enucleated patients had on average seven EUAs and chemotherapy-treated patients 21 EUAs (p<0.001). Chemotherapy, young age, bilateral disease, multifocal tumours, familial and germline retinoblastoma were found on univariate analysis to correlate with increased number of EUAs (p≤0.019). On multivariate analysis, however, only treatment type and presentation age were found significant (p≤0.001). On subanalysis of the unilateral cases, patients undergoing primary enucleation had in average seven EUAs, as compared with 16 in the chemotherapy group (p<0.001). Of the 55 unilateral-presenting patients, a new tumour developed in the fellow eye only in a single familial case. CONCLUSION: Group D patients' families should be counselled regarding the significant difference in number of EUAs following primary enucleation versus chemotherapy when deciding on a treatment strategy. In this regard, primary enucleation would be most beneficial for older patients with unilateral disease.

Preventing alcohol-exposed pregnancies among Hispanic women.

Project Healthy CHOICES, a self-administered, mail-based prevention intervention, was developed for women at risk of an alcohol-exposed pregnancy (AEP). Participants were sent their assessment and study materials through the United States Postal Service. This article uses data from a larger study (N = 354) and focuses on the 89 women who identified as Hispanic. Potential participants who called in response to English and Spanish ads and who said they could read and write Spanish were given a choice of receiving the intervention materials in English or Spanish. The main objective of the present study was to evaluate differences in outcomes as a function of (a) the language in which the intervention materials were received, and (b) the participants' acculturation levels. Prior to the study, all women were at risk of an AEP. At the 6-month follow-up, two thirds (66%) of all Hispanic women had reduced their overall risk of an AEP, primarily by practicing effective birth control. These outcomes are similar to those reported for previous Project CHOICES studies. Significantly more women who requested the intervention materials in English (75%) compared to Spanish (41%) reduced their overall risk of an AEP. Women with high English cultural domain scores were at significantly less risk of an AEP due to effective contraception and a reduced overall risk of an AEP. Compared to other Project CHOICES studies, Project Healthy CHOICES is less intensive; it is self-administered, freely available, and can be completed without visiting a health care practitioner or clinic.

Rising United States Hospital Admissions for Acute Bacterial Skin and Skin Structure Infections: Recent Trends and Economic Impact.

BACKGROUND: The number of ambulatory patients seeking treatment for skin and skin structure infections (SSSI) are increasing. The objective of this study is to determine recent trends in hospital admissions and healthcare resource utilization and identify covariates associated with hospital costs and mortality for hospitalized adult patients with a primary SSSI diagnosis in the United States. METHODS: We performed a retrospective cross-sectional analysis (years 2005-2011) of data from the US Healthcare Cost and Utilization Project National Inpatient Sample. Recent trends, patient characteristics, and healthcare resource utilization for patients hospitalized with a primary SSSI diagnosis were evaluated. Descriptive and bivariate analyses were conducted to assess patient and hospital characteristics. RESULTS: A total of 1.8% of hospital admissions for the years 2005 through 2011 were for adult patients with a SSSI primary diagnosis. SSSI-related hospital admissions significantly changed during the study period (P < .001 for trend) ranging from 1.6% (in 2005) to 2.0% (in 2011). Mean hospital length of stay (LOS) decreased from 5.4 days in the year 2005 to 5.0 days in the year 2011 (overall change, P < .001) with no change in hospital costs. Patients with postoperative wound infections had the longest hospital stays (adjusted mean, 5.81 days; 95% confidence interval (CI), 5.80-5.83) and highest total costs (adjusted mean, $9388; 95% CI, $9366-$9410). Year of hospital admission was strongly associated with mortality; infection type, all patient refined diagnosis related group severity of illness level, and LOS were strongly associated with hospital costs. CONCLUSIONS: Hospital admissions for adult patients in the United States with a SSSI primary diagnosis continue to increase. Decreasing hospital inpatient LOS and mortality rate may be due to improved early treatment. Future research should focus on identifying alternative treatment processes for patients with SSSI that could shift management from inpatient to outpatient treatment settings.

Migration signatures across the decades: Net migration by age in U.S. counties, 1950-2010.

BACKGROUND: Migration is the primary population redistribution process in the United States. Selective migration by age, race/ethnic group, and spatial location governs population integration, affects community and economic development, contributes to land use change, and structures service needs. OBJECTIVE: Delineate historical net migration patterns by age, race/ethnic, and rural-urban dimensions for United States counties. METHODS: Net migration rates by age for all US counties are aggregated from 1950-2010, summarized by rural-urban location and compared to explore differential race/ethnic patterns of age-specific net migration over time. RESULTS: We identify distinct age-specific net migration 'signatures' that are consistent over time within county types, but different by rural-urban location and race/ethnic group. There is evidence of moderate population deconcentration and diminished racial segregation between 1990 and 2010. This includes a net outflow of Blacks from large urban core counties to suburban and smaller metropolitan counties, continued Hispanic deconcentration, and a slowdown in White counterurbanization. CONCLUSIONS: This paper contributes to a fuller understanding of the complex patterns of migration that have redistributed the U.S. population over the past six decades. It documents the variability in county age-specific net migration patterns both temporally and spatially, as well as the longitudinal consistency in migration signatures among county types and race/ethnic groups.

The surgeon general report on smoking and health 50 years later: breast cancer and the cost of increasing caution.

Despite the Surgeon General's strong track record and the rapidly expanding body of solid scientific work demonstrating that smoking caused a wide range of diseases, the decision making process for concluding "causality" in Surgeon General reports has become increasingly cautious and defensive. Whereas, the 1964 report did not conclude that smoking caused heart disease, it recommended that "from the public health viewpoint [one should] assume that the established association has causative meaning rather than to suspend judgment until no uncertainty remains," the de facto practice has become to do just the opposite. In particular, the 2004 report reached an affirmative negative conclusion that active smoking did not cause breast cancer and the 2006 report on passive smoking only found the link "suggestive." In contrast, in 2005 the California EPA found both active and passive smoking caused breast cancer in younger women. The evidence has continued to strengthen since 2005: there are now 12 large cohort studies that consistently demonstrate a dose-response relationship with smoking before first birth and increased breast cancer risk. The Surgeon General's increasing caution is preventing young women around the world from appreciating the risks that smoking and secondhand smoke pose for developing breast cancer.

Neighbourhood socioeconomic status and individual lung cancer risk: evaluating long-term exposure measures and mediating mechanisms.

Neighbourhood socioeconomic status (SES) has been associated with numerous chronic diseases, yet little information exists on its association with lung cancer incidence. This outcome presents two key empirical challenges: a long latency period that requires study participants' residential histories and long-term neighbourhood characteristics; and adequate data on many risk factors to test hypothesized mediating pathways between neighbourhood SES and lung cancer incidence. Analysing data on urban participants of a large Canadian population-based lung cancer case-control study, we investigate three issues pertaining to these challenges. First, we examine whether there is an association between long-term neighbourhood SES, derived from 20 years of residential histories and five national censuses, and lung cancer incidence. Second, we determine how this long-term neighbourhood SES association changes when using neighbourhood SES measures based on different latency periods or at time of study entry. Third, we estimate the extent to which long-term neighbourhood SES is mediated by a range of individual-level smoking behaviours, other health behaviours, and environmental and occupational exposures. Results of hierarchical logistic regression models indicate significantly higher odds of lung cancer cases residing in the most compared to the least deprived quintile of the long-term neighbourhood SES index (OR: 1.46; 95% CI: 1.13-1.89) after adjustment for individual SES. This association remained significant (OR: 1.38; 1.01-1.88) after adjusting for smoking behaviour and other known and suspected lung cancer risk factors. Important differences were observed between long-term and study entry neighbourhood SES measures, with the latter attenuating effect estimates by over 50 percent. Smoking behaviour was the strongest partial mediating pathway of the long-term neighbourhood SES effect. This research is the first to examine the effects of long-term neighbourhood SES on lung cancer risk and more research is needed to further identify specific, modifiable pathways by which neighbourhood context may influence lung cancer risk.

Budget impact modeling for a single-tablet formulation of ibuprofen and famotidine for prevention of upper gastrointestinal ulcers in patients with osteoarthritis and/or rheumatoid arthritis.

BACKGROUND: Single-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications. Currently, little is known about the cost impact of gastroprotective therapies, and an estimate of the financial consequences of adopting these therapies will be helpful to decision makers. OBJECTIVES: The goal of this study was to review a model that evaluates the expected financial impact to US health care plans from the introduction of single-tablet ibuprofen/famotidine into the chronic NSAID user population. METHODS: A budget impact model, considering a typical health plan of 1 million enrollees, was used to compare patients receiving: (1) single-tablet ibuprofen/famotidine; (2) chronic NSAID treatment plus any GI-protective agent; and (3) chronic NSAID treatment without a GI-protective agent. RESULTS: The expected medication cost for single-tablet ibuprofen/famotidine was $734,192 ($81,577 in year 1, $244,731 in year 2, and $407,884 in year 3), corresponding to a total per-member per-month cost of $0.020 ($0.007 in year 1, $0.020 in year 2, and $0.034 in year 3). Considering anticipated decreases in the use of other NSAIDs, the use of GI-protective agents, and GI complications, the total expected 3-year drug cost for single-tablet ibuprofen/famotidine was offset by 50%, representing an estimated total budget impact of $364,396 or $0.010 per member per month. Sensitivity analyses of cost and market share variables and clinical and drug characteristics identified the most influential variables to be the cost of the drug and persistence to the ibuprofen/famotidine formulation, respectively. CONCLUSIONS: The expected decrease in treatment costs for less serious GI-related complications illustrates the benefits of single-tablet ibuprofen/famotidine as a gastroprotective therapy in patients receiving chronic NSAID treatment, with a modest financial impact on total health care costs.

Spatiotemporal air pollution exposure assessment for a Canadian population-based lung cancer case-control study.

BACKGROUND: Few epidemiological studies of air pollution have used residential histories to develop long-term retrospective exposure estimates for multiple ambient air pollutants and vehicle and industrial emissions. We present such an exposure assessment for a Canadian population-based lung cancer case-control study of 8353 individuals using self-reported residential histories from 1975 to 1994. We also examine the implications of disregarding and/or improperly accounting for residential mobility in long-term exposure assessments. METHODS: National spatial surfaces of ambient air pollution were compiled from recent satellite-based estimates (for PM2.5 and NO2) and a chemical transport model (for O3). The surfaces were adjusted with historical annual air pollution monitoring data, using either spatiotemporal interpolation or linear regression. Model evaluation was conducted using an independent ten percent subset of monitoring data per year. Proximity to major roads, incorporating a temporal weighting factor based on Canadian mobile-source emission estimates, was used to estimate exposure to vehicle emissions. A comprehensive inventory of geocoded industries was used to estimate proximity to major and minor industrial emissions. RESULTS: Calibration of the national PM2.5 surface using annual spatiotemporal interpolation predicted historical PM2.5 measurement data best (R2 = 0.51), while linear regression incorporating the national surfaces, a time-trend and population density best predicted historical concentrations of NO2 (R2 = 0.38) and O3 (R2 = 0.56). Applying the models to study participants residential histories between 1975 and 1994 resulted in mean PM2.5, NO2 and O3 exposures of 11.3 µg/m3 (SD = 2.6), 17.7 ppb (4.1), and 26.4 ppb (3.4) respectively. On average, individuals lived within 300 m of a highway for 2.9 years (15% of exposure-years) and within 3 km of a major industrial emitter for 6.4 years (32% of exposure-years). Approximately 50% of individuals were classified into a different PM2.5, NO2 and O3 exposure quintile when using study entry postal codes and spatial pollution surfaces, in comparison to exposures derived from residential histories and spatiotemporal air pollution models. Recall bias was also present for self-reported residential histories prior to 1975, with cases recalling older residences more often than controls. CONCLUSIONS: We demonstrate a flexible exposure assessment approach for estimating historical air pollution concentrations over large geographical areas and time-periods. In addition, we highlight the importance of including residential histories in long-term exposure assessments. For submission to: Environmental Health.

Burden of a multiple sclerosis relapse: the patient's perspective.

BACKGROUND: Relapses are a common feature of relapsing-remitting multiple sclerosis (RRMS) and increasing severity has been shown to be associated with higher healthcare costs, and to result in transient increases in disability. Increasing disability likely impacts work and leisure productivity, and lowers quality of life. OBJECTIVE: The objective of this study was to characterize from the patient's perspective the impact of a multiple sclerosis (MS) relapse in terms of the economic cost, work and leisure productivity, functional ability, and health-related quality of life (HR-QOL), for a sample of patients with RRMS in the US treated with immunomodulatory agents. METHODS: A cross-sectional, web-based, self-report survey was conducted among members of MSWatch.com, a patient support website now known as Copaxone.com. Qualified respondents in the US had been diagnosed with RRMS and were using an immunomodulatory agent. The survey captured costs of RRMS with questions about healthcare resource utilization, use of community services, and purchased alterations and assistive items related to MS. The Work and Leisure Impairment instrument and the EQ-5D were used to measure productivity losses and HR-QOL (health utility), respectively. The Goodin MS neurological impairment questionnaire was used to measure functional disability; questions were added about relapses in the past year. RESULTS: Of 711 qualified respondents, 67% reported having at least one relapse during the last year, with a mean of 2.2 ± 2.3 relapses/year. Respondents who experienced at least one relapse had significantly higher mean annual direct and indirect costs compared with those who did not experience a relapse ($US38 458 vs $US28 669; p = 0.0004) [year 2009 values]. Direct health-related costs accounted for the majority of the increased cost ($US5201; 53%) and were mainly due to increases in hospitalizations, medications, and ambulatory care. Indirect costs, including informal care and productivity loss, accounted for the additional 47% of increased cost ($US4588). Accounting for the mean number of relapses associated with these increased costs, the total economic cost of one relapse episode could be estimated at about $US4449, exclusive of intangible costs. The mean self-reported Expanded Disability Status Scale (EDSS) score, derived from the Goodin MS questionnaire, was significantly higher with relapse than with a clinically stable state (EDSS 4.3 vs 3.7; p < 0.0001), while the mean health utility score was significantly lower with relapse compared with a clinically stable state (0.66 vs 0.75; p = 0.0001). The value of these intangible costs of relapse can be estimated at $US5400. The overall burden (direct, indirect, and intangible costs) of one relapse in patients treated with immunomodulatory agents is therefore estimated conservatively at $US9849. CONCLUSIONS: This study shows that from a patient's perspective an MS relapse is associated with a significant increase in the economic costs as well as a decline in HR-QOL and functional ability.

Glatiramer acetate and interferon beta-1a for intramuscular administration: a study of outcomes among multiple sclerosis intent-to-treat and persistent-use cohorts.

OBJECTIVE: To study outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (Copaxone) or interferon beta-1a for once-weekly, intramuscular administration (Avonex). METHODS: An 'intent-to-treat' (ITT) cohort (n=1282) was established, consisting of patients diagnosed with MS who began therapy on either glatiramer acetate (GA) or intramuscular interferon beta-1a (IFN beta-1a-IM) and had continuous insurance coverage from 6 months before to 24 months after the date when they began taking the medication. A 'persistent use' (PU) cohort (n=639) was also constructed, consisting of individuals who, in addition to the criteria listed above, had a claim for GA or IFN beta-1a-IM within 28 days of the end of the 2-year post-period. Data were obtained from the i3 InVision Data Mart Database from July 2001 to June 2006. Multivariate regressions were used to examine both the 2-year total direct medical costs and the likelihood of relapse associated with the use of each of these alternative MS medications. A relapse was defined as either being hospitalized with a principal diagnosis of MS or having an outpatient visit with a MS diagnosis followed within 7 days by a claim for a corticosteroid. All regressions controlled a wide range of factors that may potentially affect outcomes. RESULTS: In the ITT cohort, patients who started therapy on GA had a significantly lower 2-year risk of relapse (10.01 vs. 5.18%; p=0.0034) as well as significantly lower 2-year total medical costs ($44,201 vs. $41,121; p=0.0294). In the PU cohort, patients who used GA also had a significantly lower 2-year risk of relapse (7.25 vs. 2.16%; p=0.0048) as well as significantly lower total medical costs ($67,744 vs. 63,714; p=0.0445). LIMITATIONS: The analyses relies on an administrative claims database of an insured population and hence, may not be generalizeable to other populations. In addition, such a database precludes measurement of lost work time, unemployment, caregiver burden or other costs associated with MS. CONCLUSIONS: Results from this study indicate that the use of GA is associated with significantly lower probability of relapse as well as significantly lower 2-year total direct medical costs than IFN beta-1a-IM.

Cost effectiveness of glatiramer acetate and natalizumab in relapsing-remitting multiple sclerosis.

BACKGROUND: Disease-modifying drugs are a significant expenditure for treating multiple sclerosis. Natalizumab (NZ) has been shown to be effective in reducing relapses and disease progression. However, assessment of the cost effectiveness of NZ compared with other disease-modifying drugs in the presence of long-term data has been limited. OBJECTIVE: To assess the lifetime cost effectiveness from the US healthcare and societal perspectives of glatiramer acetate (GA) and NZ (both given with symptom management) relative to symptom management alone in patients with relapsing-remitting multiple sclerosis (RRMS) using evidence from long-term published studies. METHODS: A Markov model was developed with patients transitioning through health states based on Kurtzke's expanded disability status scale (EDSS). Patients were >/=18 years of age with RRMS, EDSS <6.0 and receiving treatment. Treatment effects were obtained from clinical trials for years 1 and 2 of therapy and long-term clinical assessments thereafter. Transitions were adjusted for discontinuation and persistent NZ antibodies. Patients incurred drug, other medical and lost worker productivity costs. Patient quality of life was considered in the form of utilities, which were taken from assessments of patients with MS. Costs were valued in 2007 $US, and costs and outcomes were discounted at 3% per annum. Various parameters and assumptions were tested in one-way sensitivity analyses, and scenario-based analyses were also performed. RESULTS: Remaining lifetime, direct medical costs for patients receiving GA or NZ versus symptom management were $US408 000, $US422 208 and $US341 436, respectively. Patients receiving GA or NZ benefited from increased years in EDSS 0.0-5.5 (1.18 and 1.09, respectively), years relapse-free (1.30 and 1.18) and QALYs (0.1341 and 0.1332). The incremental cost per QALY for GA or NZ compared with symptom management was $US496 222 and $US606 228, respectively, excluding lost worker productivity costs. GA was associated with a cost saving compared with NZ. The incremental cost per QALY results were sensitive to changes in time horizon, disease progression and drug costs. Improved QALYs for NZ were sensitive to changes in the clinical effect of NZ on disease progression and discontinuation over time. CONCLUSIONS: GA or NZ in RRMS patients is associated with increased benefits compared with symptom management, albeit at higher costs. Although year 1 and 2 disease progression and relapse rates were better for NZ than GA, long-term evidence may show GA to have similar, if not improved, clinical benefit.

Benefits of glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis.

Relapsing-remitting multiple sclerosis is a chronic, progressive disorder marked by repeated exacerbations that lead to increases in neurological disability. Glatiramer acetate and the IFN-betas are recommended as first-line agents for relapsing-remitting multiple sclerosis owing to their potential to reduce frequency and severity of relapses, decrease development of new brain lesions and delay permanent disability. After three decades of study, the preponderance of the evidence suggests that the efficacy of glatiramer acetate is similar to the IFN-betas and new data collected in more naturalistic settings suggest that it may provide improved quality of life, increased productivity and cost-effectiveness. This article will review this evidence including data from very recent head-to-head clinical trials and pharmacoeconomic analyses of cost-effectiveness.

Glatiramer acetate and interferon beta-1b: a study of outcomes among patients with multiple sclerosis.

INTRODUCTION: To study the medical cost and probability of relapse in patients with multiple sclerosis (MS) treated with either glatiramer acetate (GA) or interferon beta-1b (IFN beta.1b). METHODS: Data were obtained from the i3 InVision Data Mart Database from July 2001 to June 2006. We established an "intent-totreat" (ITT) cohort (n=842) of patients diagnosed with MS who began treatment with either GA or IFN beta-1b and had continuous insurance coverage from 6 months before to 2 years after the date when they began taking the medication. We also created a "continuous use" (CU) cohort (n=418) of individuals who, in addition to the criteria listed above, used either GA or IFN beta-1b within 28 days of the end of the 2-year postperiod. Using multivariate regressions, we examined both the 2-year total average direct medical costs and the likelihood of relapse within this period associated with the use of each of these MS medications. We defined relapse as being either hospitalization with a principal diagnosis of MS or having an outpatient visit with a diagnosis of MS and then prescribed steroids within a 7-day period. All regression analyses controlled for a wide range of factors that may potentially affect outcomes. RESULTS: In the ITT cohort, patients who started treatment with GA had a significantly lower 2-year estimated risk of relapse (13.54% vs. 5.31%; P=0.0006). In the CU cohort, patients who used GA also had a significantly lower 2-year estimated risk of relapse (10.91% vs. 2.09%; P=0.0018), as well as significantly lower average total medical costs ($53,157 vs. $48,130; P=0.0345). CONCLUSIONS: Results from this study indicate that users of GA have a significantly lower probability of 2-year relapse than users of IFN beta-1b. In addition, among continuous users, the 2-year total average direct medical costs are significantly lower for users of GA than for users of IFN beta-1b.

Glatiramer acetate versus interferon beta-1a for subcutaneous administration: comparison of outcomes among multiple sclerosis patients.

INTRODUCTION: We compared the outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (GA) (Copaxone, Teva Pharmaceutical Industries, Israel) or interferon beta-1a for subcutaneous administration (IFN beta-1a-SC) (Rebif, Merck Serono, Switzerland). METHODS: Data were obtained from i3's Lab Rx Database from July 2001 to June 2006. We established an 'intent-to-treat' (ITT) cohort (n=845) of patients diagnosed with MS who began therapy on either GA (n=542) or IFN beta-1a-SC (n=303) and had continuous insurance coverage from 6 months before to 24 months after the date they began taking the medication. We also created a 'continuous use' (CU) cohort (n=410) of individuals who, in addition to the criteria listed above, used either GA or IFN beta-1a-SC within 28 days of the end of the 2-year-post period. Using multivariate regressions, we examined both the 2-year total direct medical costs and the likelihood of relapse associated with the use of these two MS medications. We defined relapse as either being hospitalised with a diagnosis of MS, or being diagnosed with MS during an outpatient visit and then prescribed steroids within a 7-day period. All regressions controlled a wide range of factors that have potentially affected outcomes. RESULTS: In the ITT cohort, patients who started therapy on GA had a significantly lower 2-year risk of relapse (5.92% versus 10.89%; P=0.0305), as well as significantly lower 2-year total medical costs (US$41,786 versus US$49,030; P=0.0002). In the CU cohort, patients who used GA also had a significantly lower 2-year risk of relapse (1.94% versus 9.09%; P=0.0049) and significantly lower total medical costs (US$45,213 versus US$57,311; P<0.0001). CONCLUSIONS: Results indicate that, compared with the use of IFN beta-1a-SC, use of GA is associated with significantly lower probability of relapse as well as significantly lower 2-year total direct medical costs. In addition, these results are more pronounced among patients defined as continuous users.