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Supplements Improving Clinical and Managed Care Outcomes in Rheumatoid Arthritis: New Guidelines, Therapies, and

Managed Care Implications in Managing Rheumatoid Arthritis

Gary M. Owens, MD
Rheumatoid arthritis (RA) is a systemic inflammatory form of arthritis characterized by joint inflammation, pain, swelling, and stiffness. While contemporary treatment strategies based on early diagnosis, aggressive treatment, and regular monitoring have helped a significant number of patients achieve evidence-based treatment goals, RA still presents substantial management challenges to both clinicians and patients, and has the potential to lead to severe disability over time. In addition to its significant clinical consequences, RA has important economic implications. Both direct and indirect medical costs associated with RA are significant, including costs of medications, ambulatory and office-based care, and quality-of-life and productivity costs. In addition, a significant proportion of patients with prevalent RA have associated cardiovascular disease and other comorbidities, further compounding healthcare costs and complicating management of this disorder. Clinically favorable and cost-effective management must focus on prevention of disease progression and the improved patient health status and productivity than can result from optimal disease control. With the myriad of treatment options both available and emerging, managed care organizations are faced with difficult decisions surrounding the most clinically and cost-effective allocation of treatments designed to improve disease outcomes for patients with RA. It is vital that managed care clinicians and providers analyze both the overall burden and the specific costs of RA. This will allow a better understanding of how costs and issues relating to healthcare utilization affect the treatment of patients with RA and impact individualized therapy, care coordination, and outcomes.

(Am J Manag Care. 2014;20:S145-S152) Economic Impact of RA

While the clinical burden of rheumatoid arthritis (RA) is significant in and of itself, the patient and societal costs associated with this disorder are also substantial.1 Breaking down these outlays using cost-of-illness principles, a spectrum including direct, indirect, and intangible costs, can substantially impact management of RA. Direct costs associated with RA consist of the expenditures directly attributed to healthcare utilization. These expenditures include those for clinical consultation (primary and specialty care), biologic and imaging assessments, outpatient/office-based care, and inpatient care, which includes admissions for disease-related symptoms and/or surgery (such as joint replacement). Other direct costs include those incurred by emergency department visits, physical therapy, pharmaceutical treatments and related expenditures, and medical costs beyond the treatment of joint disease itself.1-3 The costs of such care may also include those related to nonmedical costs, such as out-of-pocket expenses incurred for caregivers or care that is not reimbursed on a regular basis.2 Indirect costs usually refer to loss of productivity, including paid productivity loss associated with employment, and loss of productivity outside the workplace, such as in the community or the home. These indirect costs may be classified in terms of productivity losses borne by the patient, the patient’s family, and the patient’s employer, as well societal costs (morbidity), and costs of lost productivity due to premature death caused by RA-related illness (mortality). Finally, intangible costs should also be considered, relating to the cost of patient suffering from pain or disability associated with RA along with diminished self-esteem and well-being. While such costs may be substantial in addition to the oftenmeasured direct and indirect costs, they are, unfortunately, rarely quantified, and lack the hard data needed for their actual burden to be assessed.2,4

An early major systematic review, published in 2000 and utilizing 4 computerized literature databases, was performed to assess costs associated with RA, as analyzed by 14 costof- illness studies.4 Costs were reported in 1996 dollars based upon the consumer price index for medical care. The actual costs calculated in the different studies included in the review varied across all cost categories. Overall, the analysis revealed that mean annual direct costs associated with RA averaged $5720 per patient per year. Mean costs for outpatient visits and inpatient hospital stays were $1855 and $4944, respectively. Indirect costs usually referred to the number of days absent from work annually, and these ranged from 2.7 to 30 days per year per employed patient. The mean annual indirect cost associated with RA was found to be $5822. The authors noted that by calculating mean cost as the main statistic published to date at that time, it was likely that the study overestimated the annual per-person costs of RA owing to a positively skewed distribution attributed to cost data. It is important to note that, for this analysis, inpatient costs were found to be the largest total annual medical costs associated with RA at that time, accounting for between 17% and 88% of total medical costs. Medication constituted between 8% and 24% of total costs, and physician visits accounted for 8% to 21% of total costs. It must be noted that this study was performed in 2000 and provides a historical perspective of the breakdown of costs associated with RA at that time, which may be compared with more current assessments.

Additional analyses of RA-associated costs have produced very wide ranges of cost estimations. A study published in 2004 estimated that direct medical costs ranged from $2298 to $13,549 per patient.5,6 More recent data have resulted in estimates of annual per patient direct medical costs of RA ranging from $2000 to $10,000, with estimates for indirect costs ranging from $1500 to $22,000.1,7,8 A large number of cost-of-illness studies have been performed in recent decades, and significant variability among these studies has been found. The main sources of discrepancies between the studies include sample characteristics (study size, RA characteristics such as severity and duration), the healthcare organization involved, and the methodology used to perform the cost calculations. While cost estimations have varied, it is well understood that the economic burden of RA has evolved significantly over the past decade, driven primarily by the launch of biologic therapies for treatment of the disorder and costs associated with the use of these medications rather than the higher inpatient costs identified as the primary cost driver in RA at the beginning of the century.2,4

Specialty Medication Costs

The US Food and Drug Administration does not designate individual medications or classes of drugs as specialty related; instead, this designation is frequently defined internally by a health plan or pharmacy benefit management service. These designations can vary substantially among different health plans and organizations, but are usually associated with a cost cutoff.9 Specialty drugs are often designated as such by the condition they are designed to treat, and these agents have provided new therapeutic options for many chronic conditions.

Such pharmaceuticals have demonstrated great efficacy and promise; however, this effectiveness does not come without cost. Historically, these medications were developed to treat only rare conditions that affected a limited number of patients, and were considered a good value despite their expense because they made treatment possible for patients with difficult-to-treat disorders who otherwise had limited therapeutic options.10 In recent years specialty drugs have become the designated standard of care for many common chronic diseases, including RA.9,10 The use of these agents has increased more rapidly than the use of traditional therapies and, because of this, payers are more carefully scrutinizing their associated costs and evidence for their actual value in patient management.9

In 2011 it was estimated that spending on specialty drugs accounted for approximately 25% of the total prescription drug spending processed via the medical and pharmacy benefit.9 These specialty agents are expected to account for 50% of the total spending for prescription drugs by 2018.9,11 As this type of spending continues to grow at a rate faster than that associated with more traditional treatments, payers and policy makers must better comprehend the costs of these drugs along with their clinical benefits so they are better able to implement appropriate therapy decision making for patients with the chronic disorders these agents are designed to treat.9 The treatment landscape is complicated by the fact that comparatively little is known about the actual utilization of specialty drugs and related spending in diseases such as RA, for which use of such agents is frequent, especially when assessed in relation to an individual patient’s total healthcare costs. It is challenging to accurately assess the use of specialty drugs and member spending across pharmacy and medical benefit databases due to limited access to these data and differences in how specialty drugs are captured in medical and pharmacy benefits claims.9 One study that attempted to address the issue of health plan utilization and cost of specialty drugs utilized medical and pharmacy administrative claims data from a Midwest healthcare plan to assess prevalence and trends for selected chronic conditions and their associated specialty drug use.9 RA was one of the 4 separate study cohorts (along with multiple sclerosis, psoriasis, and inflammatory bowel disease), with data on 4398 individuals identified within the RA cohort. The actual prevalence of RA was the highest among the 4 conditions studied, calculated to be 4489 per million members. Integration of medical and pharmacy benefits claims data was used to obtain a comprehensive understanding of the costs associated with RA and its associated specialty drug costs.9

The general results of the study demonstrated that, in 2010, among persons treated with a specialty drug, the annual specialty drug costs were more than 50% of the overall direct total cost of care. In patients with RA, the annual specialty drugs costs ($18,098) constituted 53% of the total per person per year (PPPY) total direct costs ($34,163). Across the entire population enrolled in that year (N = 979,735), the per member per year cost was highest for RA ($103.82) compared with the other conditions studied. The annual growth in PPPY cost of care from 2008 to 2010 for patients with RA was 8%, with an increase in specialty drug cost PPPY calculated to be 5.6% during the same time period (Figure). A 9.7% increase in RA prevalence was found over the 3 years studied, although the actual use of specialty drugs to treat RA remained fairly stable during this period. Increased use of specialty drugs may not necessarily be associated with a change in disease prevalence, and specialty drug use tends to be condition-specific; however, it must be noted that new specialty drugs continue to emerge and may be expected to have high associated cost. Payers would expect that newer high-cost specialty agents would potentially prevent disability, leading to improved quality of life (QOL) and productivity in patients with chronic diseases. While evidence supporting such an assertion is lacking in some conditions (such as multiple sclerosis), specialty drugs used to treat RA have clinical trial data suggesting significantly delayed disease progression to disability and evidence for disease remission, although their incremental disease-modifying benefit over traditional therapies has not been fully elucidated.9,12 As specialty drugs are a major factor in the rise in total cost of care of chronic conditions, including RA, both payers and providers must continue to diligently determine the comparative effectiveness of new and emerging agents versus existing therapies, and their appropriate place in the therapy armamentarium. Payers and providers must carefully analyze medical and pharmacy benefit drug cost trends and focus management activities on specialty agents in both benefit categories. Such management activities may include coordinated medical and pharmacy benefit formularies, specialty benefit designs, and specialty drug management programs, along with coordinating care management through the medical and pharmacy benefits to maximize the value and benefits that specialty drugs for RA may provide for patients affected by this disorder.9

Clinical and Economic Impact of RA-Associated Comorbidities

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