Utilizing CER to Manage Rheumatoid Arthritis

San Diego—For managed care professionals, rheumatoid arthritis (RA) is among the most expensive and difficult diseases to manage. The FDA has approved several drugs to treat the disease, but it is sometimes hard to determine the option that would work best for patients.

At the AMCP meeting, speakers said that relying on comparative effectiveness research could help alleviate the problem. They spoke during a Satellite Symposium titled A Comparative Effectiveness Research Roadmap for Managed Care and the Treatment of Rheumatoid Arthritis. The symposium was supported by an educational grant from Bristol-Myers Squibb and Genentech, Inc., and an educational donation from Amgen Inc.

Neal Birnbaum, MD, director of the division of rheumatology at California Pacific Medical Center in San Francisco, said that when providers first diagnose patients with RA, they often begin treatment with low doses of drugs and then monitor the disease progression. However, studies have shown delaying treatment or prolonged under-treatment can lead to uncontrolled inflammation and irreversible tissue damage. He added that patients do not receive regular follow-up appointments and have minimal therapeutic adjustment, which can exacerbate the condition and increase costs.

In 2010, a group of leading rheumatologists made recommendations about treating the disease, which affects approximately 0.6% of the United States population. They mentioned the primary goal should be clinical remission, defined as the absence of signs and symptoms of significant inflammatory disease activity. They also said drug therapy should be adjusted every 3 months and providers should measure disease activity on a regular basis.

Dr. Birnbaum noted that studies have found patients with RA can have functional decline, bone erosion, and joint destruction within months of disease onset. Within 10 years of disease onset, 35% of people with RA are unable to work.

The FDA has approved several RA drugs, including Xeljanz^® (tofacitinib citrate), which was approved in November 2012 as the first oral nonbiologic drug to treat the disease in more than a decade. Dr. Birnbaum said adding an antitumor necrosis factor (TNF) agent or biologic therapy to methotrexate improves outcomes, but if patients do not have an adequate response to an anti-TNF agent, it is unclear what drug they should take instead.

Diana Brixner, PhD, RPh, professor and chair at the University of Utah College of Pharmacy, said utilizing comparative effectiveness research could help aid in making treatment decisions because RA is expensive to treat and there is no clear clinical superiority among the biologic drugs. She said patient-centered outcomes research could be particularly beneficial because it incorporates data from practice settings and patient populations and focuses on survival, function, symptoms, and health-related quality of life. If utilized appropriately, the research can help encourage proper utilization, guide reimbursement, and support evidence-based clinical decision-making, according to Dr. Brixner.

Jeffrey Dunn, PharmD, MBA, formulary and contract manager at SelectHealth in Utah, said managed care professionals face challenges in managing the disease. RA drug costs have increased, partially due to specialty medications. Dr. Dunn cited a CVS Caremark report from 2011 that found RA was the top category as measured by specialty costs. In addition, a lack of transparency regarding medical/pharmacy benefit designs makes it difficult to determine the total costs associated with treating the disease.

Dr. Dunn said another challenge is that as the number of biologic agents increases, there are no standard outcome measures and no guidelines on how to optimize treatment outcomes. In the coming years, providers will be compensated based on the quality of care and outcomes and be rewarded for proactively managing patients’ health.