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Rheumatology Practice Management September 2013 Vol 1 No 1 — September 11, 2013

This is a summary of the original article published in American Health & Drug Benefits. 2013;6(2): 126-136. Copyright © 2013 Engage Healthcare Communications. Used with permission. The full article is available at www.AHDBonline.com.

Rheumatoid arthritis (RA) is ranked among the highest of all chronic diseases for its adverse impact on health-related quality of life (QOL), limitations in physical function, increased pain and fatigue, and diminished work performance and attendance.1

Roughly 1.3 million adults in the United States have RA, representing approximately 1% of the population.2 Without optimal treatment, approximately 30% of patients with RA become permanently work disabled within 2 to 3 years of diagnosis.3

Predictors of poor outcomes in the initial stages of RA include a relatively low functional score early in the disease progression, lower socioeconomic status, lower education level, strong family history of the disease, and early involvement of multiple joints.3

The 2008 American College of Rheumatology (ACR) recommendation for first-line pharmacologic treatment of RA is the use of nonbiologic disease-modifying antirheumatic drugs (DMARDs), which have been found to slow the progression of joint destruction when used over the long-term.4 If patients fail to respond to nonbiologic DMARDs, the ACR’s current recommendation is to administer biologic DMARDs, or tumor necrosis factor (TNF)-alpha blockers, to patients with moderate disease activity and poor prognosis, as well as to patients with high disease activity and to patients with RA of intermediate or long duration.4

TNF-alpha blockers are frequently used along with other medications for the treatment of RA. Adalimumab, etanercept, and infliximab are the primary biologic drugs (and TNF-alpha blockers) recommended in the 2008 ACR guidelines.


Table 1


Table 2

The cost of untreated RA represents a significant financial burden on the US healthcare system and the economy, predominantly because of lost productivity.5,6 A US claims-based analysis of excess payer- and beneficiary-paid costs per patient with RA (compared with matched controls) reported annual excess healthcare costs of $8.4 billion, indirect costs of $10.9 billion, and total annual societal costs of $19.3 billion, including direct, indirect, and intangible costs, such as QOL deterioration.7 According to this analysis, patients incurred an estimated 28% of that burden, employers incurred 33%, the government incurred 20%, and caregivers incurred an estimated 19% of the total cost. Adding intangible costs of QOL deterioration ($10.3 billion) and premature mortality ($9.6 billion), the total annual societal costs of RA (direct, indirect, and intangible) increased to $39.2 billion.7

Benefits in terms of enhanced productivity and quality-adjusted life-years conferred by the use of TNF-alpha blockers have been demonstrated in several cost-effectiveness analyses.8-10 These evaluations have been based on the concept that, if treated, patients with RA will not progress to a greater disease severity—or will not progress as quickly—and thereby will avoid or defer the high costs and low utilization associated with more severe and progressed disease.11

Study Background

The Medical Expenditure Pan­el Survey (MEPS) database, co­spon­sored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics, is a nationally representative survey of the US civilian noninstitutionalized population. The uniqueness of the MEPS database lies in its abundance of information, which includes patient self-reported outcomes of functioning and mental health, along with information on sociodemographics, medical utilization, cost of healthcare services, employment, missed workdays, and Short Form (SF)-12 scores. The ability to link these many domains within the MEPS data source allowed the authors of this study to develop different severity categories for RA based on a unique algorithm created for the study. This RA severity–ranking algorithm was based on 5 health-related outcomes (ie, SF-12 physical and mental summary scores, patient’s perceived physical and mental health status, and the number of comorbid conditions), which were used to group TNF-alpha blocker nonusers into the 3 mutually exclusive RA severity cohorts—mild, moderate, and severe RA. Patients with RA using TNF-alpha blockers were not grouped using this algorithm and were not ranked. In addition, the MEPS data provide self-reports of work loss because of illness.

The objective of the study was to use data from the MEPS for the following outcomes—healthcare expenditures, utilization, and self-reported productivity—and to compare these outcomes between patients with RA who are TNF-alpha blocker users and TNF-alpha blocker nonusers with mild, moderate, or severe RA.

Outcome Measures

Total annual healthcare expenditures were defined as the sum of all-cause medical and pharmacy expenditures; in addition, medical and pharmacy expenditures were described separately, and were inflation adjusted to 2010 costs. Medical service utilization and pharmacy components included the all-cause annual number of office-based visits, outpatient visits, hospitalizations, average length of stay for hospitalizations, as well as the annual number of prescribed medications.

Each person in the MEPS database has a record of his/her total annual wages. The MEPS medical conditions file in the MEPS database contains 3-digit International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes based on medical and pharmacy utilization and self-reporting. The authors identified patients with RA by the presence of the ICD-9 diagnosis code 714, and stratified them into 1 of 2 major groups: TNF-alpha blocker users and TNF-alpha blocker nonusers. Users of TNF-alpha blockers were identified on the basis of pharmacy utilization and/or relevant intravenous therapy at office-based or outpatient visits with the ICD-9-CM diagnosis code 714.

TNF-alpha blocker nonusers were classified into 1 of 3 groups according to RA severity ranking (mild, moderate, or severe). Users of TNF-alpha blockers were not included in the severity-ranking analysis, because of the assumption that patients with the most severe form of RA were taking these medications, which is typically normative practice for this patient population.

Results

A total of 1152 patients were included in the study. Approxi­mately 5.6% of the patients (N = 65) were using TNF-alpha blockers. Of the patients with RA who were not using these drugs, 720 patients (62.50%) had mild RA, 159 (13.81%) had moderate RA, and 208 (18.05%) had severe RA.

Approximately 70% to 75% of the patients in all groups were female. The mean age ranged from 55 years to 60 years across the various study cohorts. Between 80% and 90% of all patients were white, and one third of all members resided in the Midwest or in the South.

Healthcare Expenditures

The incremental impact on annual medical expenditures, prescribed medication expenditures, and total healthcare expenditures is shown in Table 1. All 3 categories of expenditures were higher for TNF-alpha blocker users compared with non­users with mild RA. For example, on average, TNF-alpha blocker users spent $2096 more in annual medical expenditures compared with TNF-alpha blocker nonusers with mild RA (the reference group).

Similarly, on average, TNF-alpha blocker users spent $2454 more in annual prescribed expenditures and $4880 more in total healthcare expenditures compared with TNF-alpha blocker nonusers with mild RA.

Total healthcare expenditures, on average, were $1864 higher for TNF-alpha blocker nonusers with moderate RA and $2484 higher for TNF-alpha blocker nonusers with severe RA compared with TNF-alpha blocker nonusers with mild RA. Annual prescription expenditures were $611 higher for TNF-alpha blocker nonusers with moderate RA and $698 higher for TNF-alpha blocker nonusers with severe RA compared with patients with mild RA, and annual medical expenditures were $1088 higher for TNF-alpha blocker nonusers with moderate RA and $1640 higher for TNF-alpha blocker nonusers with severe RA compared with TNF-alpha blocker nonusers with mild RA.

Healthcare Resource Utilization

The notable differences in medical service utilization between the various study groups were with regard to all-cause emergency de­partment visits, the number of hospitalizations, the average length of stay for a hospitalization, and the number of prescribed medications (Table 2).

Significant differences with regard to emergency department visits and hospitalizations were observed between TNF-alpha blocker non­users with severe RA and TNF-alpha blocker nonusers with mild RA. The differences in the number of prescribed medications were significant between TNF-alpha blocker users and nonusers with mild RA, as well as between TNF-alpha blocker users with severe RA and nonusers with mild RA. With regard to emergency department visits and hospitalizations, TNF-alpha blocker nonusers with severe RA were almost twice as likely to incur an emergency department visit and a hospitalization compared with nonusers with mild RA. This group was almost 1.5 times more likely to have a greater length of stay compared with nonusers with mild RA as well.

TNF-alpha blocker users had a greater likelihood of having more prescription medications as were nonusers with severe RA and nonusers with moderate RA compared with nonusers of TNF-alpha blockers with mild RA.

Discussion

This study is unique in comparing how TNF-alpha blocker treatment affects patient-reported outcomes versus TNF-alpha blocker nonuse among patients with varying degrees of RA severity. The outcomes examined in this study are more detailed than those observed from claims data alone and emphasize the importance of patient-reported measures in examining how drug treatment can influence key outcomes in the management of RA. To our knowledge, this is the first study to link patterns of TNF-alpha blocker treatment to patient-reported outcomes. Our results reveal that TNF-alpha blocker treatment is associated with lower rates of hospitalizations and emergency department visits compared with other RA medications and compared with nonuse of TNF-alpha blockers in patients with moderate or severe RA.

As anticipated, one of the key findings was that patients with RA who were using TNF-alpha blockers incurred the highest total healthcare, medical, and prescription expenditures compared with the other RA groups. However, despite these increased costs, the authors found that patients with severe RA who were not using TNF-alpha blockers had more emergency department visits and hospitalizations and longer hospital stays compared with the other groups. Another key finding was that TNF-alpha blocker users had a greater likelihood of being employed compared with TNF-alpha blocker nonusers with moderate or severe RA.

Unadjusted means also show that TNF-alpha blocker users were less likely to have missed workdays compared with the other RA groups (ie, users and nonusers), although these differences were not significant. The demonstrated positive impact of TNF-alpha blocker use on employment status may be of importance to employers and to payers alike.

References
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