Biotechnology Healthcare - July/August 2008 - (Page 38)

DMARDs; corticosteroids; and biologic immunosuppressive drugs. At present, six biologics — three tumor necrosis factor-alpha (TNF-α) inhibitors, an interleukin 1 receptor antagonist, a T-lymphocyte activation inhibitor, and a CD20-directed cytolytic antibody that depletes B cells — have received a U.S. Food and Drug Administration indication for the treatment of RA. American College of Rheumatology (ACR) guidelines recommend that DMARDs, such as methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide, be used as first-line therapy before initiating treatment with one of the biologic agents as an add-on or as monotherapy (ACR 2002). Because of the high cost of biologics to treat RA, there has been some controversy regarding when during the course of treatment they should be initiated. Two large-scale trials, ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) (St. Clair 2004) and the PREMIER study (Breedveld 2006), found that adding a TNF-α blocker to methotrexate significantly improved the signs and symptoms of disease activity, and arrested or even reduced joint erosion in patients with early RA compared with those patients who were treated with methotrexate alone. proach has increased the utilization of high-cost biologic medications, resulting in an overall increase in the direct costs of RA treatment. Compared with the U.S. population not afflicted with RA (adjusted for age and gender), RA patients have 3 times the direct healthcare costs, twice the hospitalization rates, and 10 times the work disability rates (ACR 2002). One study found that average total direct costs for a patient treated with a biologic was $19,016 per year compared with $6,164 per year for a patient treated without a biologic (Michaud 2003). Annual medication costs can reach $15,000 to $20,000 per patient treated with a biologic agent (CVS Caremark 2007). Approximately 66 percent of direct costs ($6,324) were attributed to prescription drugs for all RA patients, 25 percent of whom received biologics (Michaud 2003). A review of 15 studies found that, on average, direct medical costs were $5,720 and indirect costs ranged from $1,080 to $37,501 per year (1996 dollars) for RA patients (Cooper 2000). work disability, the relative lack of research aimed at early treatment to avoid RA-related work loss should not reflect the greater importance of preventing disability (de Croon 2004). Numerous studies have examined factors that may predict work-related disability in RA patients, but there is an inconsistency in the association of disability with disease duration, impaired body function/structure, financial situation, and gender (de Croon 2004). Some evidence does suggest, however, a relationship between the following factors and the predictability of work disability in RA patients: age, disease activity, disease duration, emotional function, self-reported physical job demands, working hours, education, race, and health assessment questionnaire scores (Holte 2001, Allaire 1996, de Roos 1999, Chorus 2001). DIRECT COSTS Until recently, relatively low-cost medications have been used to treat RA. Since the advent of biologics, the management of RA has shifted dramatically — from the use of older pharmacologic agents mainly to control symptoms to the more intensive use of biologic treatments earlier in the course of the disease, with the goal of halting disease progression and achieving remission. This ap- DISABILITY IN RA PATIENTS Although direct medical costs for RA result from the utilization of healthcare resources — including medications — indirect costs are attributed, in part, to a reduced ability to perform daily activities both at home and at work due to the crippling effects of the disease. Indirect costs may include lost employee wages, along with low productivity and output levels. Within 2 to 3 years from the onset of RA, approximately 20 to 30 percent of RA patients with a paid job end up work-disabled; work disability has been reported to range from 13 percent at 6 months to 67 percent at 15 years from the onset of RA (Verstappen 2004). Despite its tremendous effect on PRODUCTIVITY LOSSES Understanding that RA-related disability can reduce work productivity is fundamental, especially given that most RA patients are between the ages of 35 and 50 (Burton 2006). But our ability to quantify the associated reduction in monetary terms is rudimentary, and calculating indirect costs is a major challenge. Although absenteeism, disability leave, and workers’ compensation have been the focus of many studies (Lee 1994, Clarke 1997, Fautrel 2002), new research suggests that presenteeism — a decrease in on-the-job performance usually resulting from illness — is the major factor in work productivity losses (Loftland 2004). Costs associated with reduced work productivity, essentially a function of an individual’s wages or compensation, can be quantified by measuring absenteeism and presenteeism using two common approaches — the human capital approach (HCA) and the friction cost approach (FCA). 38 BIOTECHNOLOGY HEALTHCARE · JULY/AUGUST 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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