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Optimizing Clinical and Cost Outcomes for Managing Rheumatoid Arthritis
San Diego—Spending on specialty drugs is growing rapidly in the United States, with an increasing amount of spend shifting to the pharmacy benefit. Ranked first in per-member per-year costs are drugs for inflammatory diseases, such as rheumatoid arthritis (RA), plaque psoriasis, ulcerative colitis, and Crohn’s disease.
Given the high costs of RA, as well as its high prevalence, new strategies are needed to identify treatments for RA that offer optimal specialty manage- ment for high quality, cost-effective outcomes. To develop these strategies, use of comparative effectiveness research (CER) is an important tool to help, for example, tailor treatment for individual patients and optimize treatments based on outcomes data.
Managed care is in a unique position to use CER data to help develop strategies for effective RA management, and is 1 stakeholder among many (patients, physicians, industry, and payers) that need to work together to achieve optimal patient outcomes while managing costs.
These issues were discussed by experts during a satellite symposium at AMCP on current treatment issues in RA and using CER to improve RA patient outcomes. The event was sponsored by an educational grant from Bristol-Myers Squibb.
Treatment of Rheumatoid Arthritis
Yusuf Yazici, MD, assistant professor of medicine, NYU School of Medicine, director of the Seligman Center for Advanced Therapeutics & Behcet’s Syndrome Center, NYU Hospital for Joint Diseases, New York, NY, opened the session talking about critical issues physicians need to understand to pro- vide optimal care to patients with RA. Along with knowing how and why to evaluate RA remission and knowing the appropriate measurement and reporting of imaging and safety data, he talked about the need to understand issues related to the new updated 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA. Noting that the new ACR/EULAR criteria is intended to catch RA in patients as early as possible, Dr. Yazici highlighted that although the sensitivity of the 2010 criteria is higher than the 1987 criteria, its specificity is quite lower (55%). As such, he pointed out that use of the new criteria may result in potentially labeling patients with RA who do not have the disease. He also said that application of the new criteria was worse than the old criteria in determining a diagnosis of RA in 4 of 5 studies.
Dr. Yazici also touched on data from studies to help understand the different treatment strategies for optimal disease management. The key to treating RA optimally is to implement early, aggressive treatment that is tailored to meet the therapeutic goals of each patient, he said.
Citing new ACR guidelines for RA in progress for publication in 2015, he highlighted the strong recommendation for disease-modifying antirheumatic drug (DMARD) monotherapy to treat early disease in patients. For patients who need further treatment (ie, fail monotherapy, established RA), the guidelines strongly recommend the use of combination therapies with traditional DMARDs or tumor necrosis factor (TNF)-alpha inhibitors with or without methotrexate (MTX) or a non-TNF biologic with or without MTX or tofacitinib with MTX.
According to Dr. Yazici, the treatment approach used is more important than the actual DMARDs used and he stressed that as long as patients are being aggressively treated, all treatments work.
Applying CER to Optimizing Clinical and Cost Outcomes
Jeffrey D. Dunn, PharmD, senior vice president, VRx Pharmacy, Salt Lake City, UT, spoke on applying CER to improving and optimizing clinical and cost outcomes for patients with RA. He emphasized how challenging it is for providers, payers, and patients to identify the most effective allocation of drugs for the best management of RA. “Not every biologic DMARD works for every RA patient,” he said, “but little data exists to guide individualization of therapy.”
Dr. Dunn highlighted that when evidence from head-to-head trials comparing drugs is lacking, CER can provide the evidence needed to compare the effectiveness and safety of different RA treatments. This evidence can then be used to support clinical decision-making that reflects the real-world settings that are typical of day-to-day management of RA patients.
Evidence from CER comes from multiple sources, such as prospective observational studies, peer-reviewed and published retrospective analyses of healthcare data (ie, medical or pharmacy claims, electronic health records, regis- tries), systematic reviews/meta-analyses, Cochrane reviews, in-house data analy- sis, and tailored reviews (technology assessments) using published data.
The evidence compared in CER analyses include competing treatment alternatives (eg, novel vs standard care treatments), health or economic outcomes resulting from an intervention (eg, survival, cost-effectiveness), harms resulting from an intervention (eg, adverse events among competing interventions), and patient preferences for competing interventions.
Dr. Dunn used the example of biosimilars to talk about specialty pharmacy and the impact on CER. Reviewing the goals of a specialty pharmacy manage- ment program, he highlighted that 1 goal is to craft the contract to account for changes in the industry including generic biologics.
The issues with biosimilars, he said, are similar to the controversies generated over generic drugs over the past years and include issues in rating/interchangeability, data extrapolation/indication, safety, manufacturing, and cost.
Considerations for specialty/biosimilar management strategies include use of incentive programs for members and physicians (eg, differential reimbursement, pay-for-performance), specialty pharmacy integration, coordination/ collaboration (eg, data management and widespread use of information technol- ogy), patient support programs, and, importantly, shared risk.
Dr. Dunn emphasized the use of incentives in benefit design/formulary management of biosimilars, as well as the use of closed formularies based on CER. Overall, he said biosimilars provide a potentially positive incentive for managed care, insurers, and consumers to minimize out-of-pocket costs.
The key to applying CER to RA management, he said, is collaboration among all the primary stakeholders including patients, physicians, managed care organizations, industry, and payers.—Mary Beth Nierengarten
