Increased relapse activity for multiple sclerosis natalizumab users who become nonpersistent: a retrospective study.

BACKGROUND: Natalizumab disease-modifying therapy for relapsing-remitting multiple sclerosis (MS) is efficacious in randomized controlled trials. Few studies have estimated the association between real-world natalizumab persistence behavior and relapse-related outcomes. OBJECTIVES: To (a) examine the impact of using natalizumab consistently (i.e., persistent) on relapse-related outcomes as compared with transitioning to inconsistent natalizumab use (i.e., nonpersistent) and (b) examine the impact of other treatment patterns on relapse-related outcomes for those who initiated natalizumab. METHODS: Using the IMS PharMetrics Plus claims database (years 2006-2012), we identified MS subjects who initiated natalizumab (no natalizumab claims in year prior) and had at least 2 years of follow-up. Persistence in annual follow-up periods was defined as no 90-day or greater gap in natalizumab therapy. Relapse was an MS-related hospitalization or outpatient visit with intravenous or oral steroid burst claim within 7 days. Analyses compared observations based on changes in natalizumab persistence and natalizumab nonpersistence status from 1 year to the next (e.g., transitioning from persistent to nonpersistent), estimating differences in mean annual relapses and mean annual relapse-related costs. RESULTS: A total of 2,407 natalizumab initiators had at least 2 years of follow-up, yielding 4,770 year-to-year natalizumab treatment patterns where each subject contributed 1, 2, or 3 year-to-year treatment patterns. In the year prior, 3,187 treatment patterns were persistent; 731 (22.9%) of these transitioned to nonpersistence. The remaining 1,583 treatment patterns were nonpersistent in the year prior; 132 (8.3%) of these transitioned to persistence. Persistent to nonpersistent treatment patterns were associated with a mean relapse-rate increase of 0.23 (95% CI = 0.12, 0.35), and a mean increase in relapse-related costs of $1,346 (95% CI = $97, $2,595). Nonpersistent to persistent treatment patterns were associated with a mean relapse-rate decrease of -0.15 (95% CI = -0.32, 0.017) and a mean decrease in relapse-related costs of -$1,369 (95% CI = -$2,761, $23). CONCLUSIONS: Findings suggest that real-world persistent natalizumab users who become nonpersistent have statistically significant increases in annual relapses and relapse-related costs. Those who transition from nonpersistent to persistent have nonsignificant reductions in relapses and their associated costs.

Comparison of patient characteristics and gout-related health-care resource utilization and costs in patients with frequent versus infrequent gouty arthritis attacks.

OBJECTIVE: To examine the association between frequent gouty arthritis and the presence of absolute/relative contraindications to gout therapies, and health-care expenditure associated with frequent gouty arthritis. METHODS: This retrospective study used administrative claims to identify patients with gouty arthritis between 1 July 2005 and 30 June 2010. Patients with ≥3 yearly gouty arthritis attacks (frequent gout) were matched 1:2 to patients with <3 yearly attacks (infrequent gout). Absolute and relative contraindications to gout medications were evaluated based on product labelling. Negative binomial regression and generalized linear models with logarithmic transformation were used for multivariate analysis of overall and gout-related health-care use and cost. RESULTS: Mean patient age was 58 years (n = 15 669) and 77% were men. Compared with patients with infrequent gout, those with frequent gout had higher rates of absolute/relative contraindications to NSAIDs (91.5% vs 78.7%, P < 0.0001), corticosteroids (96.4% vs 87.3%, P < 0.0001), allopurinol (51.0% vs 41.2%, P < 0.0001) and probenecid (13.4% vs 9.4%, P < 0.0001). Mean gout-related costs were $889 for frequent gout vs $210 for infrequent gout (P < 0.0001) and all-cause direct costs were $10 913 for frequent vs $10 685 for infrequent gout (P = ns). Mean all-cause outpatient visits among patients with comorbidities compared with those without were 25.8 vs 11.8 among frequent and 19.7 vs 9.0 among infrequent (both P < 0.001) groups. Gout-related costs were higher among frequent gout patients with comorbidities than those without comorbidities ($886 vs $513, P = 0.03). CONCLUSION: Patients with frequent gouty arthritis are likely to have absolute and/or relative contraindications to gout medications and higher gout-related treatment costs.

Use of diagnostic tests and procedures for disease-modifying therapy users and non-disease-modifying therapy users with multiple sclerosis.

We examined the use of 23 diagnostic procedures and monitoring tests for users of disease-modifying therapy (DMT) and non-DMT users with multiple sclerosis (MS). The Medstat MarketScan(®) Commercial Claims and Encounters database (2003-2007), which is composed of medical and pharmacy claims for approximately 8 million beneficiaries from 45 US commercial health plans, was used to identify DMT users with an index claim for an MS drug and a 6-month baseline period without MS drugs. Patients were followed for 12 months. Logistic regression models were used to estimate differences in rates and proportion of patients receiving procedures and tests between cohorts. Baseline rates for DMT users (n = 12,455) included MRIs (76.8%), spinal taps (15.7%), neuropsychological testing (4.7%), chemistry panels (61.4%), complete blood cell counts (76.7%) and liver function tests (60.5%). Relative to non-DMT users (n = 25,534), DMT users were more likely to receive an MRI, neuropsychological testing, chemistry panels, complete blood cell counts and liver function tests.

Comparing pre-gap and gap behaviors for Medicare beneficiaries in a Medicare managed care plan.

OBJECTIVE: To examine the impact of the coverage gap on pharmacy use, expenditures, and out-of-pocket costs for Medicare managed care beneficiaries before and after reaching the gap. STUDY DESIGN: A longitudinal comparison of behaviors for beneficiaries with non-gap coverage before and after reaching the gap. METHODS: Prescription drug use and expenditures were assessed for Medicare beneficiaries who reached the gap, including subsets with one of four chronic disorders (congestive heart failure (CHF), diabetes, dyslipidemia, or hypertension). Differences in pre- and post-prescription use were calculated using generalized estimating equations. Time until the end and start of the gap was estimated using a Cox proportional hazards model. Expenditure data were estimated using bootstrap methods. RESULTS: Roughly a quarter (27.1 percent) of patients reached the gap in 2006, of whom 3.6 percent passed through the gap. The most prevalent disease state was hypertension (58.5 percent). Beneficiaries took an average of 8.1 months to reach the gap. Patients <65 years (HR = 1.42, 95% CI = 1.29 - 1.56) and those with diabetes (HR = 1.19, 95% CI = 1.12 - 1.27) were more likely to reach the gap sooner as compared to older beneficiaries (aged 65 to 74) and those without diabetes. These individuals were more likely to pass through the gap as well. Beneficiaries faced a 60.7 percent increase in out-of-pocket expenditures in the gap phase. Brand-name medication use decreased by 9.3 percent, while generic medication use increased by 7.4 percent. For chronic conditions, however, over 90 percent of individuals continued brand-name medication use in the gap. CONCLUSIONS: Our findings suggest that, in general, beneficiaries take lower-cost generics while in the gap. However, taking brand-name medications is the predominant behavior for beneficiaries with chronic diseases. Health care reform provisions that close the gap over the next ten years may facilitate continuity of medication use while in the gap.

Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes.

BACKGROUND: The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research. OBJECTIVE: Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter. RESEARCH DESIGN: Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation. SUBJECTS: Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices. MEASURES: Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use. RESULTS: DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes. CONCLUSIONS: Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.

Consumer-driven health plans: impact on utilization and expenditures for chronic disease sufferers.

OBJECTIVES: The impact of consumer-driven health plans (CDHPs) on utilization and expenditures for members with chronic diseases. METHODS: Analyzed claims data from a national employer who switched from a preferred provider organization (PPO) plan to offering only CDHPs in 2005. A matched comparison group of PPO members was used. Analysis was conducted using generalized estimating equations for repeated measures. RESULTS: Compared with the PPO group, the CDHP group had lower: outpatient visits (-36% vs -22%), laboratory services (-34.3% vs -19%), emergency room (odds ratio [OR]: 0.1 vs 0.6), and inpatient visits (OR: 0.35 vs 0.68), and medication adherence (OR: 0.7 vs 1.0). Reductions in health care expenditures were not statistically different between the groups (-28% vs -15%, P = 0.5). CONCLUSIONS: Switching to a CDHP resulted in lower utilization and adherence. Potential underutilization of necessary services should be addressed in future research.

Prescription copay reduction program for diabetic employees: impact on medication compliance and healthcare costs and utilization.

OBJECTIVE: To examine the impact of a value-based benefit design on utilization and expenditures. METHODS: This benefit design involved all diabetes-related drugs and testing supplies placed on the lowest copay tier for 1 employer group. The sample of diabetic members were enrolled from a 9-month preperiod and for 2 years after the benefit design was implemented. Measured outcomes included prescription drug utilization for diabetes and medical utilization. Generalized measures were used to estimate differences between years 1 and 2 and the preperiod adjusting for age, gender, and comorbidity risk. RESULTS: Diabetes prescription drug use increased by 9.5% in year 1 and by 5.5% in year 2, and mean adherence increased by 7% to 8% in year 1 and fell slightly in year 2 compared with the preperiod. Pharmacy expenditures increased by 47% and 53% and expenditures for diabetes services increased by 16% and 32% in years 1 and 2, respectively. CONCLUSION: Increases in adherence and use of diabetes medications were observed. There were no compensatory cost-savings for the employer through lower utilization of medical expenditures in the first 2 years. Adherent patients had fewer emergency department visits than nonadherent patients after the implementation of this benefit design.