Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study.

OBJECTIVE: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy. METHODS: Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2-3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO). RESULTS: Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01). CONCLUSION: Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.

The cost-utility of maintenance treatment with venlafaxine in patients with recurrent major depressive disorder.

AIMS: The Prevention of Recurrent Episodes of Depression with venlafaxine XR for Two Years trial has reported advantages with maintenance treatment for patients with recurrent depressive disorder. The aim of this study was to assess the cost-utility of maintenance treatment with venlafaxine in patients with recurrent major depressive disorder, based on a recent clinical trial. METHODS: A Markov simulation model was constructed to assess the cost-utility of maintenance treatment for 2 years in recurrently depressed patients in Sweden. Risk of relapse and recurrence was based on a recent randomised clinical trial assessing the efficacy and tolerability of maintenance treatment with venlafaxine over 2 years. Costs and quality of life estimations were retrieved from a naturalistic longitudinal observational study conducted in Sweden. Health effects were quantified as quality-adjusted life-years (QALYs). Sensitivity analyses were conducted on key parameters employed in the model. RESULTS: In the base-case analysis, the cost per QALY gained of venlafaxine compared with no treatment was estimated at $18,500 over 2 years. In a probabilistic sensitivity analysis, we found that maintenance treatment with venlafaxine is cost-effective with 90% probability at a willingness to pay per QALY of $67,000 or less. Our long-term analyses also indicate that even under conservative assumptions about future risks of recurrences, maintenance treatment is cost-effective. CONCLUSION: The present study indicates that maintenance treatment for 2 years with venlafaxine is cost-effective in patients with recurrent major depressive disorder.

A decision model and cost-effectiveness analysis of colorectal cancer screening and surveillance guidelines for average-risk adults.

OBJECTIVES: Guidelines for colorectal cancer screening and surveillance in people at average risk and at increased risk have recently been published by the American Gastroenterological Association. The guidelines for the population at average risk were evaluated using cost-effectiveness analyses. METHODS: Since colorectal cancers primarily arise from precancerous adenomas, a state transition model of disease progression from adenomatous polyps was developed. Rather than assuming that polyps turn to cancer after a fixed interval (dwell time), such transitions were modeled to occur as an exponential function of the age of the polyps. Screening strategies included periodic fecal occult blood test, flexible sigmoidoscopy, double-contrast barium enema, and colonoscopy. Screening costs in 1994 dollars were estimated using Medicare and private claims data, and clinical parameters were based upon published studies. RESULTS: Cost per life-year saved was $12,636 for flexible sigmoidoscopy every 5 years and $14,394 for annual fecal occult blood testing. The assumption made for polyp dwell time critically affected the attractiveness of alternative screening strategies. CONCLUSIONS: Sigmoidoscopy every 5 years and annual fecal blood testing were the two most cost-effective strategies, but with low compliance, occult blood testing was less cost-effective. Lowering colonoscopy costs greatly improved the cost-effectiveness of colonoscopy every 10 years.

Medicare spending by beneficiaries with various types of supplemental insurance.

The authors analyzed Medicare spending by elderly noninstitutionalized Medicare beneficiaries with and without supplemental insurance such as Medigap, employer-sponsored plans, and Medicaid. Use of a detailed survey of Medicare beneficiaries and their Medicare health insurance claims enabled the authors to control for health status, chronic conditions, functional limitations, and other factors that explain spending variations across supplemental insurance categories. The authors found that supplemental insurance was associated with a higher probability and level of Medicare spending, particularly for Part B services. Beneficiaries with both Medigap and employer plans had the highest levels of spending ceteris paribus, suggesting a possible moral hazard effect of insurance. Findings from this study are discussed in the context of the overall financing of health care for the elderly.

Differences in prescription drug utilization and expenditures between Blacks and Whites in the Georgia Medicaid population.

To address policy concerns regarding prescription drug access by vulnerable minority groups, we analyzed prescription drug use and spending among black and white enrollees in the Georgia Medicaid program. Using a two-part model estimating use and level of use of any prescription drugs, the study examined black/white differences controlling for age, sex, and Medicaid eligibility characteristics. Results showed black enrollees were significantly less likely to use any prescription drugs and received significantly fewer prescriptions than white enrollees. After adjustment, the black/white difference for children was 43%, with black children using 2.7 fewer prescriptions relative to white children. Patterns of use were similar for adults and the elderly, with black adults using 4.9 fewer prescriptions, and black elders using 6.3 fewer prescriptions, than their white peers. Spending rates per full-year enrollee were similar to utilization patterns and maintained the black/white differential. White Medicaid enrollees had higher use and spending than black enrollees across most high-volume therapeutic drug categories. The study explores several possible explanations for these differences.

Impact of Medicare SELECT on cost and utilization in 11 states.

In this article, the authors evaluate the cost and utilization effects of the SELECT implementations in 11 States. In particular they compare the before-and-after enrollment experiences of Medicare beneficiaries newly enrolled in SELECT plans with the experiences of those newly enrolled in traditional medigap plans. Using Medicare claims data for 1991 through 1994, the authors find that Medicare SELECT increased costs in five States, decreased costs in three States, and had no effect in three States. Cost increases were generally related to Part B utilization.

Variations in Medicare access and satisfaction by health status: 1991-93.

This article examines Medicare access, use, and satisfaction before and after implementation of the Medicare Fee Schedule (MFS), based on 3 years of data from the Medicare Current Beneficiary Survey (MCBS). Descriptive and multivariate analysis revealed that access has not deteriorated from 1991 to 1993; Medicare beneficiaries are reporting increased satisfaction--especially with the costs of care as well as reporting fewer barriers to care. Moreover, the gaps in levels of satisfaction and frequency of perceived barriers have narrowed among those in better and poorer health, suggesting that the program has become more equitable over time.

Black-white treatment differences in acute myocardial infarction.

Previous research has documented that black patients with acute myocardial infarction (AMI) are significantly less likely than white patients to receive cardiac procedures. This article seeks to expand this research by: controlling for the limited ability of low income elderly to pay for care; and adjusting for the impact of differential mortality. We selected a sample of 18,202 Medicare beneficiaries admitted during 1992 with AMI, and followed them for 90 days. Even after adjusting for other factors, black patients with AMI were less likely to undergo cardiac catheterization, and if catheterized, less likely to receive a revascularization procedure.

Utilization review savings at the micro level.

Utilization review (UR) programs have become an integral part of efforts to contain health care costs for private health insurers, employers, and health care organizations. While some studies have measured the overall performance of these programs, important information in the prior level of the health care utilization has not been used in estimating the effectiveness of the program for micro units (e.g., employer groups). In this article, the authors present a model to determine how the impact of the hospital UR program on health care utilization for specific groups varies with historical use patterns. The estimation approach used in this article can be used to determine the effect of UR for specific employer groups without having to rely on the average effectiveness measures for all. Claims obtained from Aetna Health Plans provided data for more than 5,300 employer accounts covering approximately 580,000 employees, 44% of whom had the UR program sometime during the period 1987 to 1990. Because of regression to the mean, UR savings were greater for units with higher prior use and smaller for units with lower use. In addition to prior use, the size of the group also determined the extent of regression to the mean. Groups with smaller number of enrollees had greater potential to save from the UR because of UR's ability to reduce the outliers.

The impact of utilization review on costs and utilization.

This paper examines the performance of a utilization review program using data from Aetna's utilization review (UR) customers compared to a representative sample of its customers which had no utilization review during the study period. Statistical adjustments were made for the utilization management status, employee demographics, plan benefits, group size, year effects and seasonality. The study period covered from the first quarter of 1987 through the last quarter of 1988. The data suggest that UR reduces overall medical expenses by 4.4 percent, and inpatient expenses by 8.1 percent after a year of experience, largely by reducing length of stay.